DJHP - Biotechnology and Public Health

Delaware Journal of

Volume 9 | Issue 4

November 2023

Public Health A publication of the Delaware Academy of Medicine / Delaware Public Health Association

Biotechnology and Public Health

www.delamed.org | www.delawarepha.org

Delaware Academy of Medicine OFFICERS Lynn Jones, L.F.A.C.H.E. President Stephen C. Eppes, M.D. President Elect Ann Painter, M.S.N., R.N. Secretary

Delaware Journal of

November 2023

Public Health Volume 9 | Issue 4

A publication of the Delaware Academy of Medicine / Delaware Public Health Association

Jeffrey M. Cole, D.D.S., M.B.A. Treasurer S. John Swanson, M.D. Immediate Past President Timothy E. Gibbs, M.P.H. Executive Director, ex officio

DIRECTORS David M. Bercaw, M.D. Saundra DeLauder, Ph.D. Eric T. Johnson, M.D. Erin M. Kavanaugh, M.D. Joseph Kelly, D.D.S. Omar A. Khan, M.D., M.H.S. Brian W. Little, M.D., Ph.D. Daniel J. Meara, M.D., D.M.D. John P. Piper, D.O. Megan L. Werner, M.D., M.P.H. Charmaine Wright, M.D., M.S.H.P.

EMERITUS Barry S. Kayne, D.D.S. Joseph F. Kestner, Jr., M.D.

Delaware Public Health Association ADVISORY COUNCIL Omar Khan, M.D., M.H.S. Chair Timothy E. Gibbs, M.P.H. Executive Director

COUNCIL MEMBERS Alfred Bacon, III, M.D. Louis E. Bartoshesky, M.D., M.P.H. Gerard Gallucci, M.D., M.S.H. Allison Karpyn, Ph.D. Erin K. Knight, Ph.D., M.P.H. Laura Lessard, Ph.D., M.P.H. Melissa K. Melby, Ph.D. Mia A. Papas, Ph.D. Karyl T. Rattay, M.D., M.S. William Swiatek, MA, A.I.C.P.

Delaware Journal of Public Health Timothy E. Gibbs, M.P.H. Publisher Omar Khan, M.D., M.H.S. Editor-in-Chief Michael Fleming Guest Editor Kate Smith, M.D., M.P.H. Copy Editor Suzanne Fields Image Director

ISSN 2639-6378

3 | In This Issue Omar A. Khan, M.D., M.H.S. Timothy E. Gibbs, M.P.H.

4|G uest Editor Michael Fleming

6 | Harmonizing Progress: Bridging BioPharma, Technology, Academia, and Healthcare for Advanced Drug Manufacturing Patrick Callahan, J.D.

12 | CAR T Cells for Treating Severe Atopic Allergic Diseases Ronald P. Dudek, B.S., M.B.A. Zhengyu Ma, M.S., M.B.B.S., Ph.D.

20 | Bridging the Talent Gap: Connecting Talent to Bioscience Careers Katherine Lakofsky, Ed.D.

22 | Learning Lab: A Hands-On Way for Future Scientists to Engage with CRISPR Amanda Hewes, M.S. Sarah LaTorre Mak Sisson, M.A. Deirdre Hake, M.B.A.

24 | Nitro Biosciences: Enhancing immune response via an expanded genetic code Neil Butler, Ph.D. Aditya Kunjapur, Ph.D.

28 | Global Health Matters Newsletter September-October-2023

40 | Machine Learning Methods for Systematic Reviews: A Rapid Scoping Review Stephanie Roth,M.L.I.S., Medical Librarian Alex Wermer-Colan, Ph.D.

52 | AI Models and Drug Discovery Within Pharmaceutical Drug Market Bridget Klaus

54 | Economic Impact of Cancer Diagnosis on Employment, Wages and Intent to Return to Work Iftekhar Khan, M.D. Rishi Sawhney, M.D. Stephanie McClellan, D.N.P., M.B.A., M.S.N., R.N., C.M.S.R.N., N.E.-B.C. Kathrina Chua, M.D. Abeer Alfaraj, M.D. John Shevock, F.A.C.H.E., F.A.C.M.P.E. Dain Chun, M.S.

58 | S pecial Edition: October is Health Literacy Month!

Health Literacy Council of Delaware Chair

68 | Was the 2020 Presidential Election Nerve-Wracking?

Changes in Mental Health Among College Dreamers Sharron Xuanren Wang, Ph.D. Jarid Goodman, Ph.D. J-P Laurenceau, Ph.D.

78-80 | Lexicon & Resources 81 | Index of Advertisers

Fogarty International Center

The Delaware Journal of Public Health (DJPH), first published in 2015, is the official journal of the Delaware Academy of Medicine / Delaware Public Health Association (Academy/DPHA).

Submissions: Contributions of original unpublished research, social science analysis, scholarly essays, critical commentaries, departments, and letters to the editor are welcome.

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Copyright © 2023 by the Delaware Academy of Medicine / Delaware Public Health Association. Opinions expressed by authors of articles summarized, quoted, or published in full in this journal represent only the opinions of the authors and do not necessarily reflect the official policy of the Delaware Public Health Association or the institution with which the author(s) is (are) affiliated, unless so specified.

Any report, article, or paper prepared by employees of the U.S. government as part of their official duties is, under Copyright Act, a “work of United States Government” for which copyright protection under Title 17 of the U.S. Code is not available. However, the journal format is copyrighted and pages June not be photocopied, except in limited quantities, or posted online, without permission of the Academy/DPHA.Copying done for other than personal or internal reference use-such as copying for general distribution, for advertising or promotional purposes, for creating new collective works, or for resale- without the expressed permission of the Academy/DPHA is prohibited. Requests for special permission should be sent to managingeditor@djph.org.

IN T H IS ISSU E This issue of the DJPH focuses on Biotechnology, which plays a multifaceted role in public health improvement, ranging from early detection and prevention to the development of advanced treatments and interventions. The ongoing advancements in biotechnology continue to shape and enhance our ability to address public health challenges. Here are some examples of its impact:

Vaccines

Biotechnology is instrumental in the development and production of vaccines. Recombinant DNA technology is often employed to create safer and more effective vaccines. Modern vaccine development, including mRNA vaccines like those for COVID-19, showcases the power of biotechnology in creating rapid and targeted responses to emerging public health threats.

Drug Development

Biotechnology contributes to the discovery and development of new drugs. Through genetic engineering and bioprocessing, researchers can produce therapeutic proteins, monoclonal antibodies, and other advanced pharmaceuticals. Targeted therapies, personalized medicine, and more effective treatments for various diseases are outcomes of biotechnological advancements.

Gene Therapy

Biotechnology allows for the development of gene therapies, offering potential cures for genetic disorders by replacing or repairing faulty genes. In the future, gene editing technologies like CRISPR may provide precise and targeted interventions for genetic diseases.

Surveillance and Monitoring

Biotechnology facilitates the monitoring of public health trends by providing tools for the surveillance of infectious diseases and other health-related parameters. Tracking and analyzing genetic information of pathogens help in understanding their evolution, transmission patterns, and potential outbreaks.

Environmental Health

Biotechnology contributes to environmental health by providing tools for monitoring and cleaning up pollutants. Bioremediation, for example, uses living organisms to remove or neutralize environmental contaminants. Genetically engineered organisms can be designed to break down pollutants, contributing to the improvement of environmental and public health.

Nutrition and Food Safety

Biotechnology is utilized in developing genetically modified crops with improved nutritional profiles, which can address malnutrition and related health issues. Biotechnological methods are also employed in ensuring food safety, such as the rapid detection of contaminants in the food supply chain.

Data Analysis and Bioinformatics

The field of bioinformatics, which combines biology and information technology, is crucial for analyzing large-scale biological data. This aids in understanding disease patterns, identifying risk factors, and developing targeted interventions.

In addition, in Delaware, the biotechnology industry is a growing component of the State’s economy, employing thousands at all levels.

These advances in basic science can be seen as deeply impactful at the level of patient care and population health, especially as we increase our use of robotics, AI, and other key tech advancements to allow us to take better care of those we serve.

We hope you will enjoy and learn from this issue of the Journal, and as always, we look forward to your input and insights!

Omar A. Khan, M.D., M.H.S. Editor-in-Chief, Delaware Journal of Public Health

Doi: 10.32481/djph.2023.11.001

Timothy E. Gibbs, M.P.H Publisher, Delaware Journal of Public Health

3

Michael Fleming President, Delaware BioScience Association

Earlier this month, two area researchers were awarded the Nobel Prize for their pioneering discoveries in mRNA. The “groundbreaking findings” of these University of Pennsylvania scientists, Katalin Karikó and Drew Weissman, were instrumental in the development of mRNA vaccines against COVID-19.1 It is remarkable to consider such world-altering efforts took place in our backyard – and perhaps even more striking that it took a Nobel Prize for most people to learn of it. Serious researchers are typically not inclined to toot their own horn and even if they are, their institutions are often challenged to effectively communicate the importance and relevance of their work.

Yet stories such as Professor Karikó’s and Professor Weissman’s are all around us, certainly in abundance across our region and state.

I know this as the leader of the organization charged with growing and promoting the innovation and impact of Delaware’s life science sector, including both academic and private sector research and product and technology development. And I can also confidently say as a board member of the national group representing state bioscience associations that most of my peers from across the country are doing everything they can to replicate what we have.

We are incredibly fortunate to sit in an epicenter of the life sciences at a time when advances are accelerating through the application of new technologies like machine learning and AI, transforming human health and our economy in the process.

This special edition of the Delaware Journal of Public Health offers a perfect testimonial to support that proposition.

Here you will read of one new company’s exciting efforts to develop a vaccine platform to prevent infections caused by anti-microbial resistance; another firm is advancing a novel approach to treating severe atopic allergic diseases that are increasingly prevalent; and an industry leader writes of a strategy to advance biopharmaceutical manufacturing by fostering collaboration among biopharma, lab informatics, healthcare systems, and academia.

Beyond this cutting edge research, we learn in this edition about strategic investments and programs to grow our STEM talent workforce in Delaware, including a targeted effort to engage underrepresented populations in the immense career opportunities in life science manufacturing and design and programmatic rollout of the creative CRISPR in a Box education kit that teaches high school students how to perform a gene transformation with CRISPR in a short three-hour experiment.

Each day, thousands of Delaware BioScience community members head to work inspired by a passion for science and a commitment to help people live happier, healthier and more productive lives. There is no industry that simultaneously does more to impact public health and our economic fortunes and possibilities. We are grateful to the Delaware Academy of Medicine and the Delaware Public Health Association for this opportunity to share a small example of the extraordinary work of our dedicated companies, researchers and partners that demonstrates the promise and critical value the life sciences bring to our state and indeed, world.

Mr. Fleming may be contacted at Michael.fleming@delawarebio.org

REFERENCES 1. Nobel Assembly at Karolinska Institutet. (2023, Oct 2). Press release. Retrieved from: https://www.nobelprize.org/prizes/medicine/2023/press-release/

4 Delaware Journal of Public Health - November 2023

Doi: 10.32481/djph.2023.11.002

HIGHLIGHTS FROM

The

NATION’S HEALTH A P U B L I C AT I O N O F T H E A M E R I C A N P U B L I C H E A LT H A S S O C I AT I O N

November 2023 The Nation’s Health headlines Online-only news from The Nation’s Health newspaper Stories of note include: More communities shifting mental health crisis response away from police Kim Krisberg CDC study: Respectful care can support healthy pregnancies Minoli Ediriweera Nation in Brief Mark Barna As pandemic ebbs, community health worker funding drying up Mark Barna More Americans are familiar with the work of their local health department Michele Late Health Communications Working Group celebrates 25 years with Annual Meeting events Teddi Nicolaus APHA Affiliates take on climate change at state, community level Teddi Nicolaus Practicing kindness is good for your health Teddi Nicolaus

https://www.thenationshealth.org/ 5

Harmonizing Progress: Bridging BioPharma, Technology, Academia, and Healthcare for Advanced Drug Manufacturing Patrick Callahan, J.D. Director, LabWare; Advisory Board Member, BioCurrie and Acellus Health. Head, Science and Technology Committee, Prosperity Initiative, State of Delaware

ABSTRACT This paper proposes a quadrilateral approach to advance biopharmaceutical manufacturing by fostering collaboration among biopharma, lab informatics, healthcare systems, and academia. Through a retrospection based on Gary Pisano’s analysis and real-world examples like insitro and Spark Therapeutics, we highlight the imperative of continuous process innovation and regulatory collaboration. We emphasize leveraging technological advancements, particularly in machine learning and artificial intelligence (AI), to catalyze a paradigm shift in drug manufacturing and delivery. The discussion extends to fostering academic and business partnerships, akin to Silicon Valley’s ecosystem, and engaging healthcare systems in a more integrated role, exemplified by the advent of point-of-care manufacturing. The paper underscores the unique potential of the State of Delaware to propel forward the biopharma manufacturing space, advocating for a coordinated effort to translate scientific advancements into real healthcare benefits.

INTRODUCTION The landscape of biopharmaceutical manufacturing and delivery is at a pivotal juncture, poised for transformative advancements. At the heart of this transformation lies a collaborative synergy among biopharma, lab informatics, healthcare systems, and academia. Each sector brings to the table a wealth of knowledge, innovative solutions, and unique capabilities, the harmonization of which could usher in a new era of drug manufacturing and delivery, marked by efficiency, precision, and patient-centricity.

A retrospective glance into the business dynamics of the biopharma sector, as analyzed by Gary Pisano in his books “The Science-Based Enterprise”1 and “The Development Factor,”2 sheds light on both the challenges and the opportunities. Pisano’s scrutiny over a span of three decades revealed that despite a cascade of scientific discoveries, the expected profitability remained elusive for the biopharma industry. He underscored the imperative of continuous process innovation as a linchpin for competitive advantage, nudging firms towards an integrated strategy encompassing both product and process innovation.

Fast-forward to the present, the narrative is evolving. A remarkable wave of scientific advancements in biopharma, coupled with leaps in technology and artificial intelligence (AI), has been breaking ground. These advancements herald not only new cures for intractable diseases but also underscore the potential for a paradigm shift in manufacturing and delivery of these new discoveries. The new capabilities in machine learning, for instance, are now unlocking new horizons in drug discovery, as seen by pioneers like Daphne Koller, CEO and founder of insitro,3 a machine learning6 Delaware Journal of Public Health - November 2023

driven drug discovery company or the protein folding capabilities of Google DeepMind’s AlphaFold project.

However, the potential of these advancements can only be fully harnessed if paralleled by transformative strides in the biopharma manufacturing domain.

This paper delves into the nexus of collaborative engagement among biopharma, lab informatics, healthcare systems, and academia, outlining a quadrilateral approach towards pioneering transformations in biopharma manufacturing. Through a multi-faceted lens, we advocate how leveraging technology, enhancing regulatory collaboration, fostering academic and business synergy, and harmonizing healthcare systems can be instrumental in bridging the gap between groundbreaking discoveries and their seamless delivery to patients. Through this discussion, we aim to chart a way forward, envisioning a cohesive ecosystem that is primed to advance the biopharma manufacturing space right in our backyard.

PIONEERING TRANSFORMATIONS IN BIOPHARMACEUTICAL MANUFACTURING: A QUADRILATERAL APPROACH In the biopharmaceutical sector, innovation is key.

Manufacturing is a crucial step in this process. Although there has been rapid progress in research and development, the success of these innovations largely depends on effective manufacturing and delivery systems. The interaction between technology, regulatory cooperation, academic efforts, and healthcare provider involvement creates a necessary framework to advance the sector and increase its effectiveness and impact.4 Doi: 10.32481/djph.2023.11.003

LEVERAGING TECHNOLOGY, MANAGING DATA, AND INTEGRATING AI IN BIOPHARMACEUTICAL MANUFACTURING “Biopharmaceuticals could become the core of the pharmaceutical industry, but achieving this status requires significant transformations in laboratories, strategies, technology, and operations.”5 In biopharma, the production of large molecule medications through sophisticated biological processes and technologies necessitates a deep reliance on intricate data sets and a profound understanding of disease mechanisms and patient-specific profiles due to the nuanced nature of biological products. These ideas are particularly selfevident in products like autologous cell therapies, where the medicine is manufactured using the patient’s own cells.

Advancements in bio-manufacturing entail a slew of alterations across the process spectrum: moving from batch sampling to real-time sampling6; handling a diverse range of raw materials—unlike pharma which often deals with fewer than ten ingredients, biopharmaceuticals interact with over a hundred, including complex items like DNA, cell lines, and single-use components; improving environmental monitoring, by transitioning from facility monitoring in pharma to batchspecific monitoring in biopharma; and adapting to the distinct methods of drug creation, with pharma utilizing chemical processes, while biopharmaceuticals use living cells to produce drug substances.

In this context, reimagining data science, technology, and lab information management systems is crucial for crafting personalized treatments,7 deciphering complex biological pathways, and adhering to regulatory standards. The continuous collection and thorough analysis of diverse data sets are key, as they help unravel complex biological interactions and improve manufacturing processes, underscoring the vital role of sophisticated data management systems in biopharmaceutical development.8 The introduction of fully autonomous labs, real-time mechanistic models, and enhanced connectivity between labs has the potential to greatly improve biopharmaceutical manufacturing capabilities. Real-time mechanistic models are crucial as they help predict how environmental variables affect cell creation, a core aspect of biopharmaceutical products. Furthermore, the seamless integration of labs and AI, channeling into unified manufacturing execution systems, have become necessary to the success of manufacturing.

Daphne Koller, through her company insitro, is heavily involved in leveraging machine learning (ML) and AI to enhance understanding of complex biological pathways and tailor treatments. The primary objective is to “de-convolute” the biology of human diseases, which is often misunderstood or oversimplified due to traditional coarse-grained symptomatic classifications. The company focuses on collecting high-content data, including imaging data like MRI and histopathology, and molecular measurements from patients to understand the underlying biological processes corresponding to diseases.

Machine learning is utilized to identify subtle patterns that help distinguish distinct patient subsets, providing a clearer picture of disease biology.9

ENHANCING FDA COLLABORATION TO EXPEDITE BIOPHARMACEUTICAL MANUFACTURING THROUGH AI AND DATA SCIENCE The regulatory landscape in biopharmaceutical is intricate and dynamic, with agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) laying down rigorous guidelines and requirements. The complexity arises from the diverse nature of biopharmaceutical products, each necessitating specialized evaluation frameworks. Compliance with these regulations is non-negotiable and necessitates extensive documentation, validation, and quality assurance processes throughout the product lifecycle. The continual evolution of regulatory norms mandates that biopharmaceutical entities remain abreast of the latest updates and modifications, ensuring that their practices align with the prevailing standards and are poised to adapt to forthcoming changes.

Tighter collaboration between regulatory bodies such as the FDA and innovators in the biopharmaceutical sector is essential for leveraging advancements in technology, AI, and biopharmaceutical and can be substantiated by recent initiatives and discussions facilitated by the FDA. This is already underway with several initiatives including the “Scientific Public Private Partnerships and Consortia”;10 the FDA’s investment in Advanced Manufacturing, and the FDA’s interest in better AI and ML collaborations.11 However, this requires an even greater involvement by thinking of whole new paradigms in industry regulation. One positive aspect derived from the COVID-19 pandemic, despite its devastating effects, is the collaborative approach exhibited by the federal regulatory and global governing bodies during the development of COVID-19 vaccines. Many publications have discussed this collaborative endeavor, but the question remains on whether the practices forged during this time have been assimilated for future development efforts.12 Considering the swift and substantial advancements in technology, artificial intelligence, and biopharma, it’s not surprising that global regulatory bodies might struggle to keep up. However, just as the industry has utilized these advancements for progress, regulatory agencies could also leverage these technological strides, along with the recent experiences from the past pandemic. This situation underscores the need for increased collaboration between government entities and innovators. While maintaining oversight is crucial to avoid risking lives, halting progress for the same reason is not a feasible alternative. Given the complexity of biopharma manufacturing (as described earlier), it stands to benefit significantly from AI and data science practices. These advantages are crucial for biopharma facilities to attain operational success comparable to traditional pharma. Achieving this delicate balance requires a collaborative approach to cultivate a favorable environment for the rapid manufacturing and delivery of new biopharmaceutical drugs, ensuring both safety and innovation are upheld.

7

FOSTERING ACADEMIC AND BUSINESS PARTNERSHIPS IN MANUFACTURING AND DELIVERY

HEALTHCARE AND BIOPHARMA MANUFACTURING: A NECESSARY PARTNERSHIP FOR A PROMISING FUTURE.

In the State of Delaware, we are privileged to have a federal delegation and community leaders who ardently advocate for innovation in biopharmaceutical manufacturing.

Their efforts culminated in the establishment of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) in 2017, under the auspices of the National Institute for Standards and Technology.13 Since its inception, substantial investments have been funneled at various levels to propel NIIMBL into a premier institution. Located within the STAR campus of the University of Delaware, the facility benefits from shared resources with faculty and researchers as well as leaders in the chemical industry.14 Its strategic location has the potential to serve as a magnet for major biopharmaceutical enterprises to our region, fostering a collaborative setting for sharing advancements and promoting development.

The biopharmaceutical field often faces increased complexities, especially during the final stage of its lifecycle: delivering the product to the patient. With a shift towards personalized medicine, a manufacturing model is needed where living organisms, often using the patient’s own cells, are cultured either externally or within the patient. Biopharmaceuticals have a short shelf life, requiring careful monitoring during drug administration. This highlights the crucial role of hospitals and healthcare providers in both the manufacturing and delivery aspects of biopharmaceuticals.

Adjacent to Delaware, the Philadelphia region houses an array of distinguished organizations and research institutions. These entities have spearheaded significant advancements in cell and gene therapy discovery, earning the region the moniker “Cellicon Valley” as a testament to the burgeoning industry.15 A potent catalyst for enriching this ecosystem could be the influx of additional biopharmaceutical science businesses. By melding research and a fervor for education and innovation with the entrepreneurial spirit of both established companies and startups, a collaborative effect is on the cusp of being achieved. This blend of academic and business realms not only holds the promise of advancing biopharmaceutical manufacturing but also incubates a thriving nexus of commerce, education, and innovation.

The alliance between academia and business in driving advancements in biopharmaceutical manufacturing echoes the transformation witnessed in Silicon Valley.

The iconic region demonstrates how the unintentional interactions between academic institutions like Stanford University and numerous tech enterprises transcends mere technological advancements. Silicon Valley’s enduring leadership in business model innovation delivers deep and transformational insights, which have been pivotal to its success.16 Similarly, the biopharma sector could harness business model innovation, spurred by academic research and industry collaboration, to foster an environment conducive for groundbreaking advancements and economic growth. Just as Stanford’s academic research and technological innovations provided a fertile ground for entrepreneurial endeavors and established firms, the biopharma sector can leverage a symbiotic relationship between academia and business to fuel not only technological progress but also business model innovations that could significantly propel the sector forward. This illustrates a pathway for biopharma to achieve a blend of technological and business model innovation, mirroring the transformative ecosystem of Silicon Valley.

8 Delaware Journal of Public Health - November 2023

Point of care manufacturing in biopharma is a decentralized approach where certain advanced therapy medicinal products (ATMPs) are produced near or at the care location instead of in a centralized manufacturing facility. This approach aims to uphold strict product quality standards, improve patient access to vital treatments, and reduce therapy costs.17 The advent of pointof-care manufacturing is a step towards a more decentralized, patient-centered healthcare approach, aiming to reduce logistical issues and improve therapeutic outcomes by maintaining the quality of cellular products.18 However, there are operational, scalability, and regulatory challenges that need to be addressed to fully realize its potential, requiring continuous improvements in manufacturing processes. Alongside, advanced lab management solutions are emerging as important components, aiding better organization, efficiency, and compliance in biopharmaceutical research by providing improved data management, analytics, and collaboration solutions.19 Transitioning to a more integrated role in the biopharmaceutical lifecycle requires changes in how hospitals and healthcare providers operate and perceive their roles. First, adopting a lab-centric approach could change the traditional operational structure, allowing these entities to see themselves as active labs involved throughout the process, not just as endpoints.

This view supports a smoother operational flow in line with the evolving nature of biopharmaceuticals. Second, promoting innovation is essential. Current strict frameworks in many healthcare IT departments can discourage startups. A more open and collaborative approach could energize the innovation scene, bringing in new and effective solutions to improve manufacturing and delivery processes. Lastly, engagement should extend beyond just discovery. By taking on a more active leadership role in the manufacturing sector, hospitals and healthcare providers can diversify their contributions and enhance the entire biopharmaceutical process, working more comprehensively towards delivering personalized medicine.

The active participation of hospital systems in the biopharmaceutical manufacturing and delivery realm is a key step towards unlocking the promise of personalized medicine and raising the quality of patient care. The emerging sector of cell- and gene-based therapy manufacturing in North Carolina, boosted by a vibrant life science ecosystem driving innovative therapies from idea to market, serves as an example of such a collaborative ecosystem. It highlights the benefits brought by strong research frameworks, biopharma manufacturing expertise, ample resources, top-tier talent, and a supportive

business environment. By intertwining their operations with the biopharmaceutical sector, hospitals can notably reduce drug development timelines, ensuring a quick transition from lab discoveries to patient delivery. Moreover, the involvement of healthcare facilities provides a richer data pool, essential for refining drug formulations and delivery methods. This combined effort not only aligns with the goals of personalized medicine but also lays the groundwork for a more nimble, efficient, and patientcentered biopharmaceutical ecosystem.20 The journey of Spark Therapeutics encapsulates another example of the transformative power of collaboration between academia, hospital systems, and the biopharmaceutical sector. Originating from the Children’s Hospital of Philadelphia (CHOP), which had a longstanding commitment to gene therapy research, Spark Therapeutics was nurtured and propelled into a pioneering entity that led to the development and commercialization of LUXTURNA, the first FDA-approved gene therapy for a genetic disease.21 This narrative accentuates the crucial role that hospital systems play within the broader biopharmaceutical realm. By cultivating a fertile environment for research and innovation, and by forging synergistic alliances with emerging biopharmaceutical entities, hospital systems like CHOP not only facilitate the inception of groundbreaking companies like Spark Therapeutics but also expedite the trajectory of innovative therapies from research labs to patient bedside. The Spark Therapeutics case exemplifies how these collaborative frameworks can significantly compress drug development timelines, ensuring that novel therapies swiftly reach the patients in need. Furthermore, it underscores the substantial contributions hospital systems can make to (and benefit from) the evolving field of personalized medicine and biopharmaceutical manufacturing and delivery, delineating a roadmap towards a more agile, efficient, and patientfocused healthcare ecosystem.

CHARTING THE WAY FORWARD: FOSTERING GROWTH AND INNOVATION IN BIOPHARMACEUTICAL MANUFACTURING IN A REGION PRIMED FOR ADVANCES. In the State of Delaware, a confluence of advantageous circumstances, ranging from significant advancements in technology and AI to a strong foundational legacy in science, notably marked by the evolution of DuPont, uniquely positions us to propel forward the biopharmaceutical manufacturing space. At LabWare, we find ourselves as a strong contributor to not only the local community, but amidst the vibrant ecosystem engaging with biopharmaceutical entities globally in the realm of lab informatics in the biopharma space. Our burgeoning global partnerships with our clients have been and continue to nurture the evolution of our next-generation software, ingrained with AI and process automation, tailored to cater to the unfolding demands of future biopharmaceutical iterations.

The local presence of visionary institutes like NIIMBL coupled with the global connections to other international organizations such as NIBRT (National Institute for Bioprocessing Research and Training) amplify the potential for a harmonized endeavor with the FDA and international regulatory bodies. These institutions as well and their potential collaborative framework aims at upholding the paramountcy of quality and safety standards whilst fostering the advancement of science.

Further enriching our regional ecosystem are our advanced educational institutions that harbor a cadre of distinguished researchers and academics. Their expertise, in a myriad of pertinent fields, magnetizes innovative minds, thus serving as the bedrock of progressive innovation. A testament to the potential encapsulated in community healthcare’s interface with biopharmaceutical manufacturing is the recent spin out of Christiana Care’s startup in the gene editing space, CorriXR Therapeutics.22 This transition, albeit pioneering, underscores the necessity of a more accelerated pace in similar transitions, bolstered by a conducive community engagement and an aligned mindset. The industry requires a surge of such transitions, aiming for a hundred of these advancements annually.

CONCLUSION Planning a way forward involves forming a dedicated group to facilitate ongoing communication and feedback among all relevant stakeholders. Such a group, possibly overseen by Delaware Bio, would help keep responses aligned with the changing needs and challenges. Looking into global collaborations and adopting international best practices in biopharmaceutical manufacturing can offer a more comprehensive and globally coordinated framework for innovation. A clearly defined roadmap, listing short-term and long-term goals along with measurable metrics, will help in assessing the progress and impact of the initiatives planned in your quadrilateral approach.

Additionally, creating a state chair position for science and technology could play a crucial role, liaising with our governor and legislature and advocating for our state’s interests both internally and externally.

The core opportunity is recognizing that the biopharmaceutical manufacturing industry is at a crucial point, ready for necessary growth. This growth is key to delivering new, personalized therapies, translating many scientific advancements into real healthcare benefits. Additionally, creating an environment that encourages random discoveries and a culture of innovation like Silicon Valley’s is important. Such an environment could lead to unexpected breakthroughs, advancing the industry further and emphasizing the significant impact of biopharmaceutical manufacturing on global healthcare. We have all the necessary elements and pieces in place - what’s needed now is a belief in our systems and the right mindset from the leaders of each sector to believe in the vision, participate, and execute in a coordinated manner.

Mr. Callahan may be contacted at Patrick.callahan@labware.com

REFERENCES 1. Pisano, G. P. (2006). Science Business. Boston: Harvard Business Review Press.

2. Pisano, G. P. (1997). The Development Factory. Boston: Harvard Business School Press.

3. Insitro. (n.d.). About. Retrieved from: insitro.com: https://insitro.com/about 4. Castro, B. (2019, Dec). The next wave in biopharma manufacturing. Retrieved from: https://ispe.org/pharmaceutical-engineering/november-december-2019/ next-wave-biopharma-manufacturing 9

5. Otto, R., Santagostino, A., & Schrader, U. (2014, Dec 1).

Rapid growth in biopharma: Challenges and opportunities.

Retrieved from: https://www.mckinsey.com/industries/life-sciences/ our-insights/rapid-growth-in-biopharma

18. Nayak, S., Blumenfeld, N. R., Laksanasopin, T., & Sia, S. K. (2017, January 3). Point-of-care diagnostics: Recent developments in a connected age. Analytical Chemistry, 89(1), 102–123. https://doi.org/10.1021/acs.analchem.6b04630

6. Clint Pepper, P. (2019, Jun 5). Making real-time process analytical technology in biomanufacturing a reality. Retrieved from: https://www.pharmasalmanac.com/articles/making-real-time-processanalytical-technology-in-biomanufacturing-a-reality

19. GEN: Genetic Engineering & Biotechnology News. (2022, Mar 1). Point-of-care drug production would aid patients and industry. Retrieved from: https://www.genengnews.com/insights/point-of-care-drug-productionwould-aid-patients-and-industry/

7. Johnson, K. B., Wei, W.-Q., Weeraratne, D., Frisse, M. E., Misulis, K., Rhee, K., . . . Snowdon, J. L. (2021, January).

Precision medicine, AI, and the future of personalized health care. Clinical and Translational Science, 14(1), 86–93. https://doi.org/10.1111/cts.12884 8. Panahiazar, M., Taslimitehrani, V., Jadhav, A., & Pathak, J. (2014, Oct). Empowering personalized medicine with big data and semantic web technology: promises, challenges, and use cases. Proc IEEE Int Conf Big Data, 790-795.

Doi: https://doi.org/10.1109/BigData.2014.7004307 9. The, L. (2022, Nov 16). ‘It will be a paradigm shift’: Daphne Koller on machine learning in drug discovery. Retrieved from: https://www.mckinsey.com/industries/life-sciences/our-insights/it-will-bea-paradigm-shift-daphne-koller-on-machine-learning-in-drug-discovery#/ 10. FDA. (2023, Sep 8). Scientific public private partnerships and consortia. Retrieved from: https://www.fda.gov/drugs/science-and-research-drugs/scientificpublic-private-partnerships-and-consortia 11. Patrizia Cavazzoni, M. (2023, May 10). FDA releases two discussion papers to spur conversation about artificial intelligence and machine learning in drug development and manufacturing. Retrieved from: https://www.fda.gov/news-events/fda-voices/fda-releases-two-discussionpapers-spur-conversation-about-artificial-intelligence-and-machine 12. Druedahl, L. C., Minssen, T., & Price, W. N. (2021, October 8). Collaboration in times of crisis: A study on COVID-19 vaccine R&D partnerships. Vaccine, 39(42), 6291–6295. https://doi.org/10.1016/j.vaccine.2021.08.101 13. NC State University. (n.d.). national institute for innovation in manufacturing biopharmaceuticals (NIIMBL). Retrieved from: https://kenan.ncsu.edu/initiative/national-institute-for-innovation-inmanufacturing-biopharmaceuticals-niimbl/ 14. Chemours. (n.d.). New innovation center through strategic partnership with the University of Delaware. Retrieved from: https://www.chemours.com/en/chemistry-in-action/future-chemistry/ university-of-delaware-partnership 15. Penn Medicine / CHOP. (2023, Jun 21). Cellicon valley ‘23: The Future of cell and gene therapies. Retrieved from UPenn: https://www.med.upenn.edu/cellicon23/ 16. Martins, H., Dias, Y. B., & Khanna, S. (2016, Apr 26). What makes some silicon valley companies so successful. Harvard Business Review. Retrieved from: https://hbr.org/2016/04/whatmakes-some-silicon-valley-companies-so-successful 17. Delgado, J., Roddie, C., & Schmitt, M. (2022). Point-of-care production of CAR-T cells. In N. Kröger, J. Gribben, C. Chabannon, I. Yakoub-Agha, & H. Einsele, eds., The EBMT/ EHA CAR-T Cell Handbook. Springer, Cham.

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20. Bayer, S., Sandy, S., Schrader, U., & Spiegl, M. (2021, May 27).

Leveraging digital and analytics in biopharma operations: Six principles. Retrieved from: https://www.mckinsey.com/capabilities/operations/our-insights/ leveraging-digital-and-analytics-in-biopharma-operations-six-principles 21. Children’s Hospital of Philadelphia. (2017, Dec 19). Children’s Hospital of Philadelphia celebrates FDA approval of gene therapy for inherited blindness. Retrieved from: https://www.chop.edu/news/childrens-hospital-philadelphia-celebratesfda-approval-gene-therapy-inherited-blindness 22. Christiana Care. (2022, Oct 11). ChristianaCare spins out CorriXR therapeutics, new gene editing start-up. Retrieved from: https://news.christianacare.org/2022/10/christianacare-spins-out-firstcommercial-gene-editing-biotechnology-start-up-company-corrixrtherapeutics/

The Delaware Health Force program, with the support of Tech Impact’s Data lnnovation Lab, is a proud winner of a 2023 Drexel LeBow Analytics 50 Award.

Doing more TOGETHER, for Delaware.

11

CAR T Cells for Treating Severe Atopic Allergic Diseases Ronald P. Dudek, B.S., M.B.A. Cellergy Pharma, Inc. Zhengyu Ma, M.S., M.B.B.S., Ph.D. Cellergy Pharma, Inc., and Nemours Children’s Health – Delaware

ABSTRACT The prevalence of allergic diseases is rising rapdly in the US and the world. While antibody drugs and corticosteroids can provide symptom relief, they cannot cure allergic diseases. Described herein is a novel approach to treating severe atopic allergic diseases - chimeric antigen receptor-engineered T cells - that target and eliminate the cells that produce the causative agent of all atopic allergic diseases, immunoglubulin E (IgE).

“Essentially it boils down to two questions: Can we identify a population of cells that are bad? And can we target them specifically? Whether that’s asthma or chronic diseases or lupus, if you can find a bad population of cells and get rid of them, then CAR T cells could be therapeutic in that context.” – Dr. Carl June, renowned University of Pennsylvania CAR T cell pioneer.1

CHIMERIC ANTIGEN RECEPTORENGINEERED T CELLS Chimeric antigen receptor-engineered T cells (CAR T cells) are a relatively new class of biologic product originally developed to treat hematologic malignancies. Four products have been approved for treating B-cell leukemia and lymphoma, and two for treating multiple myeloma.2 Growth in the field is explosive and many more products are in development for treating blood and solid organ cancers.

A chimeric antigen receptor (CAR) is a synthetic receptor that is engineered into immune effector cells, typically T cells. A CAR is composed of several domains including a targeting domain, a transmembrane domain, an activation domain derived from the T cell receptor, and a co-stimulatory domain. While CAR T cells are the most common type of product, CAR NK cell, and CAR macrophage products are also being developed. All marketed products to date are composed of autologous CAR T cells, where the patient provides the cells for CAR engineering. The patient’s white blood cells are collected by an apheresis instrument (leukapheresis), and shipped to a central manufacturing center, where the T cells are selected, activated, expanded and engineered with the CAR. The product is shipped to the cancer center where it is infused into the patient.3 Four CAR T cell products have received FDA approval for treating B-cell lymphoma and B-cell leukemia – Kymriah® (Tisagenlecleucel), Yescarta® (Axicabtagene ciloleucel), Tectarus® (Brexucabtagene autoleucel) and Breyanzi® (Lisacabtagene maraleucel). All target CD19, a pan B cell marker present on both healthy and cancerous B cells. Two CAR T cell products have been approved for treating multiple myeloma, a plasma cell cancer – Abecma® (Idecabtagene vicleucel) and Carvykti® (Ciltacabtagene autoleucel). Both target B Cell Maturation Antigen (BCMA), present on both healthy and cancerous plasma cells.

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Expression of a CAR T cell target should ideally be restricted to tumor cells, or, if not, off-tumor, on-target toxicity should be manageable. In the case of the CD19 and BCMA-targeted CAR T cells, healthy B cells and plasma cells are eliminated, resulting in hypogammaglobulinemia, necessitating the periodic infusion of donor-derived intravenous immunoglobulins (IVIG).

MOVING CAR T CELLS BEYOND THE TREATMENT OF CANCER TO THE TREATMENT OF IMMUNE-MEDIATED DISEASES CAR T cells targeting CD19 and BCMA are now being applied to the treatment of autoimmune diseases. By targeting and eliminating all B cells and plasma cells, the cells that produce autoantibodies are also eliminated.4 Autoimmune disease indications that are being investigated for treatment by CD19targeted CAR T cells include systemic lupus erythematosus, lupus nephritis, and systemic sclerosis.

We have been developing CAR T cell therapies to target another class of immune-mediated diseases, atopic allergic diseases. Here, instead of targeting and eliminating all B cells and plasma cells, we target and eliminate only the B cells and plasma cells that produce immunoglobulin E (IgE), the cause of all atopic allergic diseases.5 As a living drug, CAR T cells have been shown to persist for more than a decade in humans.6 Our approach therefore holds the promise of achieving long-term symptom relief, or even a cure, of allergic diseases, with a single treatment. Since IgE constitutes very small fraction (~0.1%) of total immunoglobulin compared with IgG, elimination of IgE should not significantly impact overall humoral immune response and does not require IVIG infusions.

The molecular marker targeted by our CAR T cells is the transmembrane form of IgE (mIgE), the B-cell antigen receptor exclusively present on all IgE-producing B cell types.7 We have developed two unique CAR designs for targeting membrane IgE– the EMPD CAR and the ACED CAR (Figure 1). The EMPD CAR recognizes the extracellular membrane-proximal domain (EMPD), a 52-aa region present only on mIgE, not on secreted IgE. The EMPD CAR empolys a traditional deisng, using a single chain variable fragment (scFv) derived from an EMPDDoi: 10.32481/djph.2023.11.004

Figure 1. The EMPD and ACE CARs that recognize mIgE

specific monoclonal antibdy for target binding. The ACED CAR, in contrast, uses the alpha chain extracellular domain of the high affinity IgE receptor FcεRI.8 The affinity of the targeting domain has been optimized to prevent binding to serum IgE. In preclinical in vitro and in vivo studies, both EMPD CAR T cells and ACED CAR T cells specifically target cells expressing membrane IgE, and not cells that have passively bound secreted IgE to their Fc receptors.

CLINICAL APPLICATIONS OF MIGE-TARGETED CAR T CELLS A CAR T cell product that can eliminate serum IgE can be efficacious in the treatment of all atopic allergic diseases including allergic asthma, food allergy, atopic dermatitis, chronic rhinitis, and chronic urticaria. The potential long-term efficacy of the CAR T cell approach is particularly attractive for treating severe allergic asthma and food allergy, two diseases that remain difficult to manage despite of the development of targeted approaches such as monoclonal antibody drugs.

UNCONTROLLABLE SEVERE ALLERIC ASTHMA Asthma is a heterogeneous inflammatory disease of the airways characterized by a clinical history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation. Approximately 25 million Americans have asthma.9 From 2008 to 2013, asthma accounted for $81.9 billion each year in total economic cost in the USA: $50.3 billion per year in health care costs, $29.0 billion per year in mortality costs, and $3.0 billion per year in costs due to missed school days and workdays.10 Allergic asthma is the leading type of childhood asthma. About 6.5% of children aged <18 years in the US have asthma, while about 8% of adults in the US have asthma.

Between 5-10% of asthma patients have severe asthma. About 20% of those with severe asthma are uncontrolled despite adherence to therapy and proper use of inhalers. Individuals with uncontrolled severe asthma cannot achieve symptom control despite maximal therapy with inhaled corticosteroids (ICS). Quite often, maintenance oral corticosteroids (OCS) are necessary to avoid life-threatening exacerbations. Uncontrolled asthma is associated with significant health and economic costs because of frequent and intense episodes of symptoms that may increase risk of emergency department visits, hospitalizations, and work and school absenteeism. Uncontrolled asthma will cost the US economy an estimated $300 billion (in 2018 dollar values) in the next 20 years in direct medical costs alone.11,12 Racial disparities exist in the prevalence and mortality of asthma.13 Non-Hispanic African Americans were 40 percent more likely to have asthma than non-Hispanic Whites. Non-Hispanic Blacks are almost three times more likely to die from asthma related causes than the non-Hispanic White population and non-Hispanic Black children have a death rate eight times that of non-Hispanic White children.

Three FDA approved antibody products are used to treat uncontrollable severe atopic allergic asthma: Xolair® (omalizumab), Dupixent® (dupilumab), and Tezspire® (tezepelumab).14 The half-life of these whole molecule antibodies is approximately three weeks, and so they must be administered once of twice monthly, perhaps for the lifetime of the patient.

Cessation of therapy frequently results in relapse. Neither Xolair, Dupixent nor Tezspire can cure uncontrollable severe atopic allergic asthma. They can reduce but not eliminate severe disease exacerbations. Two, Xolair and Dupixent, can reduce, but not eliminate, the use of corticosteroid drugs.

Compared to these products, mIgE-targeted CAR T cells can offer substantial improvements in patient care. CAR T cells are living organisms that persist in patients, perhaps for ten years or longer. Administered as a single product infusion, CAR T 13

cells have been shown to result in long-term efficacy in the treatment of hematological malignancies.15 By eliminating the production of IgE, it is expected that mIgE-targeted CAR T cells can eliminate atopic allergic asthma disease exacerbations, can eliminate the use of corticosteroids, and can possibly even cure the disease.

Compared to Palforzia, mIgE-targeted CAR T cells are administered one-time only, and can completely eliminate disease exacerbations, The CAR T cells are a universal food allergy treatment solution and no do not require continual food avoidance. Long-term efficacy, perhaps even a cure of severe food allergies, may be possible.

FOOD ALLERGY

CONCLUSIONS

Food allergy is an IgE-mediated immune system reaction that occurs soon after eating a certain food. Even a tiny amount of the allergy-causing food can trigger signs and symptoms. The symptoms of an allergic reaction to food can range from mild (itchy mouth, a few hives) to severe (throat tightening, difficulty breathing). Anaphylaxis is a serious allergic reaction to food allergens that is sudden in onset and can cause death.

Chimeric antigen receptor engineered T cells are now moving beyond the treatment of cancer to the treatment of immunemediated diseases including autoimmune diseases and severe allergic diseases. The pan B cell target, CD19, and the plasma cell target, BCMA, have been convenient CAR T cell targets for eliminating all immunoglobulin-producing cells, and within this population, the B cells and plasma cells that produce autoimmune antibodies. Targeting membrane IgE enables a more specific CAR T cell approach, eliminating only IgE-producing cells without significant side effects. mIgE-targeted CAR T cells are disease-modifying, and not merely symptom-reducing, unlike all marketed products for treating severe allergic diseases. The approach holds the promise of achieving long-term symptom relief, perhaps even a cure, from a single product administration.

Approximately 32 million people in the United States have food allergies. Ten percent of adults in the US suffer from food allergies; as do 7.7% of children.16 Eight major food allergens – milk, egg, peanut, tree nuts, wheat, soy, fish and crustacean shellfish – are responsible for most of the serious food allergy reactions in the United States. Between 1997 and 2008, the prevalence of peanut or tree nut allergy appears to have more than tripled in American children. African American children are at higher risk of developing food allergies than non-Hispanic White children, as are children from urban centers, and children from households earning less that $50,000 per year.

The quality of life of children with food allergy is very low. They have a higher likelihood of being bullied. Normal behaviors like dining out at restaurants, play dates at friends’ houses, or camp sleepovers, are curtailed. Physical development can be compromised by the avoidance of milk and eggs. Parents of children with food allergies have greater psychological stress and exhibit higher blood pressure than parents of children without food allergies.17 Childhood food allergy results in significant direct medical costs for the US health care system and even larger costs for families with a food-allergic child. According to a 2013 study by the Northwestern Feinberg School of Medicine, the overall economic cost of food allergy was estimated at $24.8 billion annually ($4184 per year per child). Costs borne by the family totaled $20.5 billion annually, including lost labor productivity, out-of-pocket, and opportunity costs.18 There are no approved drugs to treat food allergy. Once a serious allergic reaction (anaphylaxis) starts, epinephrine is the only effective treatment. Epinephrine should be injected within minutes of the onset of symptoms. More than one dose may be needed. Not treating anaphylaxis promptly with epinephrine increases the risk of a fatal reaction.

Palforzia®, an oral immunotherapy for the mitigation of allergic reactions to peanuts, has recently been approved for use in the USA. The product is a powder composed of defatted peanut flour, and is administered orally in a 6-10 month series of dose escalations in the physician’s office.19 The product is not a cure, and at best, lessens the frequency and severity of allergic reactions to peanuts. Adverse events related to therapy are not uncommon, and 20% of patients cannot complete therapy. Food avoidance must continue. The product must not be administered to patients with uncontrolled asthma.

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Mr. Dudek may be contacted at rdudek@cellergypharma.com

REFERENCES 1. Raeke, M. (2023, Aug 22). The boundless potential of CAR T cell therapy, from cancer to chronic and common diseases: A Q&A with Carl June. Penn Medicine News Retrieved from: https://www.pennmedicine.org/news/news-blog/2023/august/carl-juneon-the-boundless-potential-of-car-t-cell-therapy 2. Feins, S., Kong, W., Williams, E. F., Milone, M. C., & Fraietta, J. A. (2019, May). An introduction to chimeric antigen receptor (CAR) T-cell immunotherapy for human cancer. American Journal of Hematology, 94(S1), S3–S9. https://doi.org/10.1002/ajh.25418 3. Blache, U., Popp, G., Dünkel, A., Koehl, U., & Fricke, S. (2022, September 5). Potential solutions for manufacture of CAR T cells in cancer immunotherapy. Nature Communications, 13(1), 5225. https://doi.org/10.1038/s41467-022-32866-0 4. Schett, G., Mackensen, A., Mougiakakos, D. (2023). CAR T-cell therapy in autoimmune diseases. Lancet. S0140-6736(23). https://doi.org/10.1016/S0140-6736(23)01126-1 5. Gould, H. J., & Sutton, B. J. (2008, March). IgE in allergy and asthma today. Nature Reviews. Immunology, 8(3), 205–217. https://doi.org/10.1038/nri2273 6. Scholler, J., Brady, T. L., Binder-Scholl, G., Hwang, W. T., Plesa, G., Hege, K. M., . . . June, C. H. (2012, May 2). Decadelong safety and function of retroviral-modified chimeric antigen receptor T cells. Science Translational Medicine, 4(132), 132ra53. https://doi.org/10.1126/scitranslmed.3003761 7. Talay, O., Yan, D., Brightbill, H. D., Straney, E. E., Zhou, M., Ladi, E., . . . Wu, L. C. (2012, February 26). IgE+ memory B cells and plasma cells generated through a germinal-center pathway. Nature Immunology, 13(4), 396–404. Epub20120301. https://doi.org/10.1038/ni.2256

8. Ward, D. E., Fay, B. L., Adejuwon, A., Han, H., & Ma, Z. (2018, October 10). chimeric antigen receptors based on low affinity mutants of FcepsilonRI re-direct T cell specificity to cells expressing membrane IgE. Frontiers in Immunology, 9, 2231. https://doi.org/10.3389/fimmu.2018.02231

14. Kardas, G., Panek, M., Kuna, P., Damiański, P., & Kupczyk, M. (2022, December 6). Monoclonal antibodies in the management of asthma: Dead ends, current status and future perspectives. Frontiers in Immunology, 13, 983852. https://doi.org/10.3389/fimmu.2022.983852

9. Chung, K. F., Wenzel, S. E., Brozek, J. L., Bush, A., Castro, M., Sterk, P. J., . . . Teague, W. G. (2014, February). International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. The European Respiratory Journal, 43(2), 343–373. Epub20131218. https://doi.org/10.1183/09031936.00202013

15. Melenhorst, J. J., Chen, G. M., Wang, M., Porter, D. L., Chen, C., Collins, M. A., . . . June, C. H. (2022, February). Decadelong leukaemia remissions with persistence of CD4+ CAR T cells. Nature, 602(7897), 503–509. https://doi.org/10.1038/s41586-021-04390-6

10. Nurmagambetov, T., Kuwahara, R., & Garbe, P. (2018, March). The economic burden of asthma in the United States, 2008-2013. Annals of the American Thoracic Society, 15(3), 348–356. https://doi.org/10.1513/AnnalsATS.201703-259OC 11. Peters, S. P., Ferguson, G., Deniz, Y., & Reisner, C. (2006, July).

Uncontrolled asthma: A review of the prevalence, disease burden and options for treatment. Respiratory Medicine, 100(7), 1139–1151. https://doi.org/10.1016/j.rmed.2006.03.031 12. Yaghoubi, M., Adibi, A., Safari, A., FitzGerald, J. M., & Sadatsafavi, M. (2019, November 1). The projected economic and health burden of uncontrolled asthma in the United States. American Journal of Respiratory and Critical Care Medicine, 200(9), 1102–1112. https://doi.org/10.1164/rccm.201901-0016OC

16. Neugut, A. I., Ghatak, A. T., & Miller, R. L. (2001, January 8). Anaphylaxis in the United States: An investigation into its epidemiology. Archives of Internal Medicine, 161(1), 15–21. https://doi.org/10.1001/archinte.161.1.15 17. Khamsi, R. (2020, December). Food allergies: The psychological toll. Nature, 588(7836), S4–S6. https://doi.org/10.1038/d41586-020-02778-4 18. Gupta, R., Holdford, D., Bilaver, L., Dyer, A., Holl, J. L., & Meltzer, D. (2013, November). The economic impact of childhood food allergy in the United States. JAMA Pediatrics, 167(11), 1026–1031. https://doi.org/10.1001/jamapediatrics.2013.2376 19. Perkin, M. R. (2022, June). Palforzia for peanut allergy: Panacea or predicament. Clin Exp Allergy, 52(6), 729–731. https://doi.org/10.1111/cea.14145

13. Perez, M. F., & Coutinho, M. T. (2021, September 30). An overview of health disparities in asthma. The Yale Journal of Biology and Medicine, 94(3), 497–507.

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The DPH Bulletin

From the Delaware Division of Public Health

November 2023

DPH encourages flu vaccination in the face of a potentially active flu season As temperatures drop and leaves fall, the Division of Public Health (DPH) reminds Delawareans that this is also flu season.

DPH hosts 2023 Immunization Summit on December 7 in Dover The 2023 Immunization Summit will be held on December 7, 2023 from 1:00 p.m. to 6:00 p.m. at Bally's, located at 1131 N. Dupont Highway in Dover, Delaware.

Sponsored by the Division of Public Health (DPH) and the Delaware Academy of Medicine, the event will update doctors and nurses on the immunization status of Delawareans, current vaccine coverage rates, and new and future vaccines. Organizers expect up to 150 providers to attend.

Confirmed guest speakers are Stephen Eppes, MD, who will address Respiratory Syncytial Virus; and Captain Sarah Schillie, MD of the Centers for Disease Control and Prevention who will address Hepatitis A and B. Jennifer Vodzak, MD of Nemours Children’s Health will present “Emerging Vaccine Pipeline.”

Heather Simpson and Lydia Greene from Back to the Vax will speak on vaccine hesitancy. A panel will discuss vaccination rates and requirements, DPH initiatives for flu, HPV, COVID-19, Vaccines for Children, and the Bridge Program.

“Attending this summit will keep you informed about current vaccines and what is to come,” said James Talbott, manager of DPH’s Immunization Program.

Registration is $40.00 for Continuing Medical Education (CME) credits and $20 without CME. Public Health and Medical Residents attend for free.

Registrations are being taken until December 6. To register and for an agenda, visit the Immunization Coalition of Delaware at https://immunizedelaware.org/upcomingevents/2023-immunization-summit/.

16 Delaware Journal of Public Health - November 2023

Infection with flu can cause mild to severe illness, and sometimes even death. Getting an annual vaccine reduces the chance of becoming ill, missing work and fun family events, and developing complications that could lead to hospitalization.

For the 2023-2024 flu season, everyone who is 6 months of age or older should receive a flu vaccination. Children under the age of five, older adults, pregnant women, and individuals with chronic underlying medical conditions should get a flu vaccination as soon as possible. DPH emphasizes vaccination for those who live or work with infants under six months of age, as well as for those who live or work in congregant settings such as long-term care and correctional facilities.

Within the past few months, Australia and New Zealand had a particularly active flu season. In addition, Respiratory Syncytial Virus (RSV) and COVID-19 variants continue to circulate.

Pharmacies, participating medical provider offices, Federally Qualified Health Centers (for their patients), and DPH clinics offer flu vaccines. DPH provides flu vaccines at locations where DPH mobile units also provide health care.

DPH recommends preventing getting vaccinated for the flu, COVID-19, and RSV if eligible. Stay home if sick, seek treatment if you test positive for any of the illnesses, and wear a mask if you or someone close to you is at higher risk of illness.

For more information about the flu and vaccination sites, visit flu.delaware.gov or call 1-800-282-8672.

2023-2024 COVID-19 vaccine urged for age 6 months and older The Food and Drug Administration (FDA) authorized and approved the updated 2023-2024 COVID-19 vaccines from Pfizer BioNTech, Moderna, and Novavax. The updated vaccines are better designed to protect against the currently circulating COVID-19 variants to prevent severe illness.

The Centers for Disease Control and Prevention (CDC) recommends that everyone 6 months and older get the updated vaccine. Anyone whose last dose of a COVID-19 vaccine was at least two months ago, including those who have never been vaccinated, are eligible. Those younger than 5 years may require more than one dose of the vaccine depending on their previous vaccinations, but those 5 years and older will only need one dose regardless of previous status.

Everyone can obtain the vaccine free of charge in one of three ways: 1. Many commercial insurance plans available through the government or a private employer are required to provide the vaccine at no cost.

2. For those without health insurance or their insurance does not provide the vaccine at no cost, vaccines are available free of charge at Federally Qualified Health Centers (FQHCs), public health clinics, local pharmacies, and certain providers through the State of Delaware’s Immunization Program and at Walgreens, CVS, and other ETrueNorth network pharmacies through the federal government’s Bridge Access Program.

3. Children from low-income families who receive their vaccines from the CDC’s Vaccines for Children program can get their updated COVID19 vaccine where they traditionally receive all their vaccines.

To locate vaccine sites participating in the Bridge Access Program, visit vaccines.gov or call 1-800-232-0233. To learn more about the updated 2023-2024 COVID-19 vaccines and find locations where administered, visit de.gov/covidvaccine. Visit the Division of Public Health at de.gov/coronavirus for all COVID-19 information.

The federal government is offering free COVID-19 test kits for home delivery. Visit covidtests.gov to request your shipment.

The DPH Bulletin – November 2023

DPH releases annual cancer data reports

The Delaware Department of Health and Social Services, Division of Public Health (DPH) presented its data report, Cancer Incidence and Mortality in Delaware, 2016-2020, to the Delaware Cancer Consortium (DCC) in October.

A compendium report, Census Tract-Level Cancer Incidence in Delaware, 2016-2020, presents incidence rates by census tract for all cancer sites combined (all-site cancer), as well as the 23 top sitespecific cancer types for incidence and mortality.

Between 2006 and 2020, mortality rates for all-site cancer decreased an average of 1.8% per year in Delaware and decreased an average of 1.7% per year in the U.S. Delaware’s current ranking of 15th among the states for highest all-site cancer mortality is the same ranking as in the 2022 report.

In this report, cancer incidence rates are compared for the period 2006 to 2019 because the COVID-19 pandemic resulted in delays and reductions in cancer screening and diagnosis, leading to a decline in 2020 incidence counts and rates that was considered an anomaly.

Between 2006 and 2019, all-site cancer incidence rates decreased an average of 1.1% per year in Delaware and an average of 0.6% per year in the U.S. While progress continues to be made, Delaware’s 2016-2020 all-site cancer incidence rate (457.6 per 100,000 population) is higher than the U.S. rate (442.2 per 100,000 population).

The Screening for Life (SFL) program provides payment for cancer screening tests to qualified Delaware adults. Eligible individuals can receive mammograms, Pap and HPV tests, and screening tests for prostate, colorectal, and lung cancer when recommended by a doctor. Contact SFL at https://www.dhss.delaware.gov/dph/dpc/sfl.html or call 302-744-1040 to speak with a case manager or enrollment specialist.

To learn how to prevent, detect, and treat chronic diseases and obtain assistance with a cancer screening, visit the Healthy Delaware website at HealthyDelaware.org or call the Delaware Comprehensive Cancer Control Program at 302744-1040. For more information about the DCC, visit https://www.healthydelaware.org/Consortium.

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Preparedness tools help Delawareans with Access and Functional Needs

Caregivers, relatives, and advocates of Delawareans who have access and functional needs should help them plan for natural disasters and other emergencies such as hazardous materials accidents, disease outbreaks, and power outages.

Persons with Access and Functional Needs (AFN) are defined as persons with a variety of visual, hearing, mobility, cognitive, emotional, and mental limitations. AFN also includes older people, children, those with limited or no English language proficiency, persons from diverse cultures, individuals who use life-support systems, people who use service animals, and people who are medically or chemically dependent. Delawareans with access and functional needs may require additional support in one or more of the following functional areas: maintaining independence, communication, transportation, self-supervision, and medical care before, during, and after an incident.

Published in 2023

The Division of Public Health, Family Health Systems Section published three data briefs in 2023 that are posted to the Delaware Healthy Mother and Infant Consortium’s website: 1. Birth Defects, Delaware Profile 20102019 2. Reproductive Health, Delaware Profile, 2012-2021 3. Sudden Death in the Young, 2017-2021.

Delawareans who live alone or have access and functional needs should ask someone dependable to serve as their preparedness buddy, and another to be an alternate buddy. The preparedness buddy should regularly check in on their designated buddy to ensure they have enough medication, oxygen, medical supplies, food, and water.

Family Health also published two doula reports that are posted to the Delaware Thrives website under the Doula Ad Hoc Committee's landing page:

There is also a Preparedness Buddy brochure to use for creating a personal emergency plan for all persons, including those with access and functional needs. The Preparedness Buddy brochure gives a step-by-step template to complete an emergency plan using a personal support network or buddy system. Find this document at https://dhss.delaware.gov/dhss/dph/php/preparedne ssbuddy.html.

2. Doula Stakeholder Engagement: Report on Interviews with Licensed Providers of Maternal Health, July 2023.

1. Doula Stakeholder Engagement: Focus Group Study Report, July 2023

This year, DPH also published two oral and dental health documents: 1. Read about the Bureau of Oral Health and Dental Services’ data brief, The Oral Health of Delaware’s Kindergarten and Third Grade Children, 2022 in the April 2023 issue of the Delaware Journal of Public Health.

2. The Bureau of Health Planning and Resources Management published the Delaware Dentists Survey, 2022.

Use another tool, the Travel Buddy brochure, to design a personal travel plan for all persons, including those with access and functional needs.

Travel Buddy provides a step-by-step template to complete a travel safety plan using a personal support network. Access this travel brochure at https://dhss.delaware.gov/dhss/dph/php/files/Travel_ Buddy.pdf.

The DPH Bulletin – November 2023 18 Delaware Journal of Public Health - November 2023

Page 3 of 3

STUDENT FINANCIAL AID AVAILABLE Healthcare Workforce Initiative

Funded by the Delaware American Rescue Plan Act (ARPA) for shortages in the healthcare field due to the COVID-19 pandemic.

Loan amount averages between $2,500 to $15,000 annually. Don’t let money be a barrier to a rewarding career in healthcare!

TO APPLY, VISIT: https://delamed.org/student-financial-aid/

CONTACT: Giselle Bermudez, MS, Student Financial Aid Coordinator gbermudez@delamed.org (302) 733-1122 Se Habla Español!

INTEREST FREE LOANS For Delaware Residents, at-tending Delaware Institutions of higher learning, who are willing to commit to working in Delaware after graduation for a set period of time.

This program is supported by State and Local Fiscal Recovery Funds thru the Department of Treasury and State of Delaware [SLFRP0139] As a recipient of Federal financial assistance, the Delaware Academy of Medicine / Delaware Public Health Association does not exclude, deny benefits to, or otherwise discriminate against any person on the basis of race, color, national origin, disability, sex, or age in admission to, participation in, or receipt of the services and benefits under any of its programs and activities, whether carried out by Delaware Academy of Medicine / Delaware Public Health Association directly or through a contractor or any other entity with which Delaware Academy of Medicine / Delaware Public Health Association arranges to carry out its programs and activities.

Loans available for nursing, physician assistant, behavioral health, dental and medical tech, and many more.

Full Details at website.

Since 1930 - making a difference in Delaware

19

Bridging the Talent Gap: Connecting Talent to Bioscience Careers Katherine Lakofsky, Ed.D. Associate Director, Bioscience Workforce, Delaware Biotechnology Institute, University of Delaware/ Delaware Bioscience Association

ABSTRACT There is an urgent need to engage, educate, and train a skilled workforce for Delaware’s growing life science sector. A sizeable number of these jobs can be obtained with a high school diploma or GED, coupled with an industry informed short-term training program. Unfortunately, this is not widely known, and many disadvantaged populations do not have access to the necessary training. Through a partnership between the Delaware Bioscience Association and the Delaware Biotechnology Institute at the University of Delaware, efforts are currently underway to develop a pilot training program, specifically focusing on the skills needed for biomanufacturing and basic laboratory operations. Additionally, the program will devote significant resources to the identification and recruitment of participants with an emphasis on engaging historically underrepresented populations, as well as removing barriers to accessing the training. The goal is to connect talent to available careers in the industry, providing participants with increased economic mobility and financial stability.

The key to a thriving economy is a thriving workforce. There also remains a persistent gap in health outcomes between poor and rich populations and this gap can be mainly contributed to social determinants of health.1 One way to address this challenge is to increase access to opportunities that provide the skills needed to be successful in the modern workplace. As such, workforce development programs have been a key area of focus for improving economic mobility and decreasing economic inequality. Here in Delaware, there is a significant opportunity to further develop the bioscience economic development engine by improving the connection between talent and careers.

A recent report from the Delaware Prosperity Partnership (DPP) and the Delaware BioScience Association (Delaware Bio) shows that bioscience is a leading economic driver in Delaware.2 The report stated that Delaware’s location in the heart of the midAtlantic region gives it distinct business advantages, in addition to low property taxes and overall favorable tax policies. Delaware’s bioscience community has seen significant growth in recent years, employing approximately 11,000 individuals and directly generating $2 billion in GDP. Additionally, the number of new biotechnology R&D companies has seen a 65% increase over the last ten years and Delaware now ranks 7th nationally for life science funding per capita.

Recent developments underscore the significant momentum and opportunity for Delaware in the bioscience sector. These include the announcement of a several hundred-milliondollar-investment in a new pharmaceutical development and manufacturing facility in Middletown, Delaware,3 hundreds of millions of dollars in investment planned for a new science and innovation park at the former DuPont Chestnut Run site,4 a new life science facility planned at the Delaware Technology Park in Newark,5 and a $10 million program supporting the expansion of lab space.6 Through information collected from companies, market data and media reports, it can be fairly estimated that over the next three years Delaware life science companies will need to fill many hundreds of these jobs.7 In order to ensure the continued growth and success of these companies in Delaware, a robust talent pipeline is needed.

20 Delaware Journal of Public Health - November 2023

In 2022, Delaware Bio and the Delaware Biotechnology Institute at the University of Delaware launched a new partnership to develop a comprehensive strategy for life science workforce development in Delaware. The first step was to engage in extensive discussions with employers, training and educational institutions, state and federal government stakeholders and organizations implementing innovative best practices in other states and regions. This work revealed the urgent need – and significant opportunity – for Delaware to pilot new approaches to recruiting and training a life science talent pipeline, with a particular focus on engaging and mobilizing underrepresented populations. Specifically, there is a growing opportunity for life science careers in biomanufacturing and laboratory roles that do not require a 4-year college degree. These positions offer full benefits and the potential for long-term advancement and rich career development. This trend is also seen on a national level with biopharmaceutical and biomanufacturing sectors experiencing strong sustained growth over the past five years; this growth is expected to continue over the next five years.8 As a result, we are currently developing a pilot training program that incorporates innovative strategies and partnerships to provide a skilled workforce that can fuel future growth in the important areas of biomanufacturing and laboratory operations, with a target launch date in early 2024. The specific goals of the project are to 1) connect individuals from underserved communities through partnerships with community organizations to training that provides the necessary skills for biomanufacturing and laboratory roles, 2) provide participants with the appropriate tools and supports for career development and success and 3) strengthen partnerships with industry to build a talent pipeline and expand recruitment funnels.

The current growth in the life science industry is being challenged by shrinking talent pools nationwide, and an overall lack of awareness of the diverse types of careers available in the industry. This creates a need for new types of outreach and awareness initiatives. To help achieve this, our pilot program Doi: 10.32481/djph.2023.11.005

will partner with nonprofit community organizations with deep community knowledge and experience providing educational and career services. Specifically, we will collaborate with community partners serving the urban population within the city of Wilmington to build effective relationships and build trust within the community, in an effort to build awareness and encourage residents to enter the life science workforce. These organizations have existing relationships within the community that can be leveraged to create meaningful engagement with traditionally underserved populations. Additionally, these partnerships will inform and activate essential wrap-around, supportive services to help ensure student retention and ultimate professional success.

The program will be open to any individual with a high school diploma or GED credential. Recruitment will target underemployed or unemployed individuals, with an emphasis on engaging historically underrepresented populations. Classes will be offered at no cost, and students will be provided with a stipend to remove or reduce challenges and barriers, such as lagging technology, lack of transportation, access to childcare, and to help offset lost income. To reduce potential geographic barriers limiting access to training, we are considering multiple training locations and formats. Sites will be prioritized based on proximity or public transit access to target communities; mobile training systems that provide hands-on industry relevant skills will also be explored.

Dr. Lakofsky may be contacted at klakofsk@udel.edu

REFERENCES 1. Healthy People 2030. (n.d.). Social determinants of health. https://health.gov/healthypeople/objectives-and-data/socialdeterminants-health 2. Delaware Bioscience Association, & Delaware Prosperity Partnership. (2021). Life sciences in Delaware: momentum and opportunity. https://www.delawarebio.org/page/Life-SciencesDelaware-Momentum-Opportunity 3. Pharmaceutical Technology. (2022, Aug 25). WuXi STA’s pharmaceutical manufacturing campus, Delaware, USA. https://www.pharmaceutical-technology.com/projects/wuxi-stamanufacturing-campus-delaware/ 4. Gonzalez, G. (2022, Aug 4). Chestnut Run innovation and science park. Delaware Business Times. https://delawarebusinesstimes.com/supplements/innovation/chestnutrun-innovation-science-park/ 5. Bothum, P. (2023, Jun 14). Life science synergy: new facility at the Delaware Technology Park has major potential for UD. UDaily. https://www.udel.edu/udaily/2023/june/science-research-technology/ 6. Owens, J. (2022, May 3). State increases lab space grant support. Delaware Business Times. https://delawarebusinesstimes.com/news/lab-space-grant-support/ 7. Owens, J. (2023, Mar 8). Already a major pharma producer, Delaware preps for big influx. Delaware Business Times. https://delawarebusinesstimes.com/news/pharma-manufacturing/ 8. Coalition of State Bioscience Institutes, & TEConomy Partners LLC. (2023). 2023 Life Sciences Workforce Trends Reports. https://www.csbioinstitutes.org/_files/ugd/ dd6885_61b783096bb64884916c682034d8345c.pdf

21

Learning Lab: A Hands-On Way for Future Scientists to Engage with CRISPR Amanda Hewes, M.S.; Sarah LaTorre; Mak Sisson, M.A.; Deirdre Hake, M.B.A. Gene Editing Institute, ChristianaCare

ABSTRACT The Learning Lab serves as a resource for students to come into a laboratory space and work with genomic scientists on cutting-edge CRISPR research. This opportunity was created to reach students with fewer resources in their classroom. We hope to expand this program further in the coming years throughout all of Delaware to further our mission of inclusion and equity in education.

Committing to equity in workforce development is a lofty promise for most companies. A hiring manager can make changes in their screening process, an initiative can sponsor vocational programs in schools, and a lab team can even donate their time and resources to a college for a career preparation event.

But do these solutions provide lasting impact? In biotech and biopharma companies, there’s still an extreme deficit of diversity. African Americans represent only 6% of the workforce, people of color make up 24% of executive teams, and women are still subject to a glass ceiling from entry-level to the C-suite of biotechnology companies headquartered across the U.S., only making up 31% of executive teams and 23% of CEOs.1 While 56% of workers say focusing on diversity, equity and inclusion is good for their company, companies still struggle to find the best way to build a strong workforce with new perspectives and diverse talent.2 At the Gene Editing Institute, we believe that the key to a new generation of talented scientists with diverse perspectives is demystifying gene editing and providing students with guidance and tools to shape their own pathway through STEM. That was part of the reason behind our creation of the CRISPR in a BoxTM education kit, a kit designed to teach high school and college students how to perform a gene transformation with CRISPR in a short three-hour experiment. This kit could be brought into a classroom and integrated into a gene editing curriculum, allowing students to see a blue-to-white color change on a bacterial plate due to a simple cut and edit in a synthetic gene within a plasmid. The hope was that this reaction would give students a clear-cut example of a changed genome and drive their curiosity forward. If a color-change reaction was possible right in front of their eyes, what else could CRISPR do? How could it benefit the worlds of healthcare, agriculture, and environmental science? What would they be able to do with these tools in their hands?

After CRISPR in a Box™ was launched and made widely available through our partnership with Carolina Biological, we began to see positive results. Teachers who brought the kit into the classroom started providing feedback about some of the hurdles they were facing. We had designed this kit within our fully stocked laboratory, where CRISPR, centrifuges, 22 Delaware Journal of Public Health - November 2023

pipettes, and bench space were all readily available. A high school laboratory, even a great one, may not have the necessary equipment to run something like this. In some cases, through our initial work bringing this to schools, we had to bring our own lab equipment out to high schools to ensure the experiment would work. This was no fault of the teachers, but it made us acutely aware that any teachers who had purchased our kit and had run into the same problems wouldn’t be getting the most out of the experiment.

We also looked back at our mission statement: ‘ChristianaCare’s Gene Editing Institute seeks to empower, inspire, and engage the next generation of scientists committed to advancing gene editing technology.’ If we weren’t including new perspectives in our lab because of missing materials or lack of space for this experiment, we weren’t fulfilling our mission. Nothing discouraged us more than a student who sought to perform an experiment but didn’t feel as if their class had the capability to do so for reasons outside of their control.

So, we thought: why not bring students to our own lab space?

Why not create a field trip experience where students could learn what we do where we do it?

There were certainly advantages to doing this. Students on fields trips sharpen their skills of perception by utilizing multiple senses: sight, hearing, and touch.3 They develop a positive attitude for learning, motivating them to develop connections between the theoretical concepts in the classroom and what they’ve experienced.4 A field trip with a single focus impacts students’ cognitive skills, knowledge, interests, and future career.5 With all of that in mind, we began the process of creating a field trip experience for students. We found space within the building that houses our lab that could be renovated for our purposes, and soon lab benches, extension cords, and vinyl decals were being placed in a classroom right in front of the doors to our lab entrance.

We began reaching out to teachers who had joined us previously for different workshops where CRISPR in a Box™ was taught. We worked with their schedules to bring their students into our lab space (which we dubbed our Doi: 10.32481/djph.2023.11.006

Learning Lab) for an in-depth look at CRISPR’s ability to edit a genome, along with the opportunity to tour our lab and meet our scientists. We chose two schools to do a small pilot study in spring 2023: St. George’s Technical High School and Delcastle Technical High School. Each had a vocational program that specialized in biotechnology, giving us an ideal class to perform the experiment and test the program model.

We anticipated that we’d teach those two pilot sessions, gather some student data about their experience, and launch the program more fully in the fall of 2023.

Then, more schools became aware of our program. Suddenly, we were filling seven learning labs. Then, four more, then three more, for a total of 14 Learning Labs. We saw our number of students increase from 30 to over 150 in the first three months of the program’s pilot, with four different schools taking an interest over the school year and an additional two in the summer. We were astounded as requests for Learning Labs continued from long-time supporters and teachers entirely new to our program.

With the aid of pre- and post-lab surveys, we gained insight into how the pilot program resonated with students.

• 50% of students reported feeling more confident in a lab setting.

• 60% of students increased their confidence in micro pipetting and basic lab skills.

• 68% of students maintained or increased their interest in STEM subjects.

• 71% of students maintained or increased their interest in pursuing careers in STEM. • 2 out of 3 students gained a more positive attitude toward how CRISPR and how gene editing could be used to help advance healthcare.

And who knows? Maybe as soon as 2028, the Gene Editing Institute will hire a Learning Lab alumnus, fulfilling our mission statement to fill our lab with determined, talented scientists with an interest in CRISPR supported by our own scientists.

Amanda Hewes can be contacted at: Amanda.m.hewes@christianacare.org

REFERENCES 1. Agarwal, J., Elliott, C., Kennedy, J. T., Brady, T., Cheatham, C., Banks, B., . . . Meek, C. (2022). (rep.). Measuring diversity in the biotech industry (3rd ed.). BIO. Retrieved from: https://www.bio.org/sites/default/files/2022-06/261734_BIO_22_DEI_ Report_P4.pdf 2. Minkin, R. (2023). Diversity, equity and inclusion in the workplace. Washington, DC: Pew Research Center. Retrieved September 28, 2023, from: https://www.pewresearch.org/social-trends/2023/05/17/diversityequity-and-inclusion-in-the-workplace/ 3. Nabors, M. L., Edwards, L. C., & Murray, R. K. (2009). Making the case for field trips: What research tells us and what site coordinators have to say. Education, 129(4), 661–667.

4. Falk, J. H., Martin, W. W., & Balling, J. D. (1978). The novel field trip phenomenon: Adjustment to novel settings interferes with task learning. Journal of Research in Science Teaching, 15(2), 127–134. https://doi.org/10.1002/tea.3660150207 5. Hutson, T., Cooper, S., & Talbert, T. (2011). Describing connections between science content and future careers: Implementing Texas curriculum for rural at-risk high school students using purposefully-designed field trips.

Rural Educator, 31, 37–47.

Teachers, likewise, were incredibly receptive to our programming and the opportunities it presented for their students.

“The best part was getting to hear from a group of accomplished women who found so many different paths to this place in their careers,” said Dave Eroh, Brandywine High School teacher and supporter of the program. “I think they saw themselves in all of them.”

Given the positive feedback we have received thus far in our student and teacher survey data and interest in repeated Learning Labs from previous attendees, we plan to expand this program across the state in the upcoming years. We currently have ambitious goals to engage 25 schools by the end of spring 2024, expanding the program to students in Kent and Sussex Counties, and engaging 1,000 students in Gene Editing 360™ programming by the end of the year.

We are committed to bringing CRISPR in a Box™ to as many young people as possible. We are also open and eager to engage with other youth-serving organizations who want to bring a novel gene editing experience to their constituents.

Our partnerships continue to grow our program further and support the next generation of scientists entering the world of biotechnology, and we hope to continue to grow and expand through the state of Delaware.

23

Nitro Biosciences: Enhancing immune response via an expanded genetic code Neil Butler, Ph.D. and Aditya Kunjapur, Ph.D. Co-founders, Nitro Biosciences; University of Delaware, Department of Chemical and Biomolecular Engineering

ABSTRACT Novel modalities of vaccine will be required to address the current and future public health concerns we face.

Many infectious diseases lack clinically approved vaccines causing immense burden to the health care system both domestically and abroad. More concerningly, the prevalence of antimicrobial resistance (AMR) is anticipated to rise over the coming decades and limit our tools to treat these infections. There is thus an urgent need to develop vaccinations to overcome these rising gaps in treatment and prevent infections moving forward. At Nitro Biosciences, we are developing a platform to create next-generation vaccines for diseases currently lacking clinically approved products. By harnessing an expanded genetic code, we can precisely modify antigens to enhance their immunogenicity, enabling a broadening of the scope of antigens to target in vaccine development and enhancing the potential to create efficacious vaccines where other efforts have failed.

THE GROWING PUBLIC HEALTH NEED FOR NEXT GENERATION VACCINES Microbial infections acutely impact those across the globe with underdeveloped or compromised immune systems, particularly children and the elderly. Despite this known risk to public health, many bacterial pathogens such as E. coli, Shigella, and C. difficile lack clinically approved vaccines. Most concerningly, common methods of treatment for microbial infections are becoming less potent. In 2019, antimicrobial resistance was directly attributed to over one million annual deaths and over 250,000 deaths of children under 5.1 Here in the United States, more than 2.8 million infections of antibiotic resistant bacteria occur annually with 48,000 associated deaths.2 Urgent innovations are needed, as this burden is only expected to continue to grow over the next few decades and is predicted to result in 10 million annual deaths by 2050.3 Given the current rate of antibiotic discovery, we will need to improve measures to prevent infection, namely vaccines, to limit future burden.

NITRO BIOSCIENCES: NEXT-GENERATION VACCINES ENABLED VIA NITRATION Recruitment of the immune system to target disease-associated antigens has been a powerful tool to both prevent and cure disease. However, for several diseases, the natural immune response toward the most conserved antigens is quite weak. For several bacterial species, many of the antigens prevalent across serotypes of the disease have evolved to evade immune detection and are weakly immunogenic. If these antigens were delivered in the manner of a traditional vaccine, the response can be poor to nonexistent, leading to a lack of protection or therapeutic efficacy.

Through our platform at Nitro Biosciences, we aim to amplify immune recognition toward these weakly immunogenic targets.

Through a process known as genetic code expansion, we can selectively introduce an immunogenic (nitrated) residue 24 Delaware Journal of Public Health - November 2023

within the sequence of protein antigens. The introduction of this nitrated residue within antigens can stimulate a stronger immune response.4–9 Immunization with nitrated versions of antigens which normally are either weakly immunogenic or well tolerated modifies presentation to the immune system.

The nitrated antigen contains epitopes absent from the weak wild-type antigen, which then triggers a strong CD4+ helper T cell based immune response. This stimulates the production of antibodies including cross-reactive antibodies which bind to unmodified variants of the antigen. While immunization with unmodified antigens in previously reported cases resulted in little to no immune response, immunization with nitrated variants was capable of breaking tolerance in previous tested studies.

Building upon this technology, we are developing improved methods for nitrated antigen delivery. By rewiring bacterial metabolism, we have created a bacterial strain that can autonomously produce nitrated forms of any user-defined recombinant antigen.10 Our goal is to use these live attenuated bacteria as nitrated antigen producers and delivery vehicles to transport antigens directly to regions of infection or disease.

Through this strategy, we intend to overcome two major limitations of current vaccination strategies – the lack of localized immune response and the inability to target crossserotype or more generalized antigens.

Previous recent attempts to create vaccines for microbial infections using traditional means have had limited success, despite often robust markets. Notably, in the case of C. difficile, several attempts at traditional protein toxoid vaccination failed due to lack of efficacy, despite significant investment and a sizable predicted market (estimated $1B market11 and 500K annual patient size12). Investment in next-generation vaccine modalities to solve challenges in preventative medicine for infectious disease will be required to address broader public health concerns.

Doi: 10.32481/djph.2023.11.007

The team developing this next generation vaccine modality is composed of founders Dr. Aditya Kunjapur, Assistant Professor of Chemical and Biomolecular Engineering at the University of Delaware, and Dr. Neil Butler. Together, we developed the foundational technology core at the University of Delaware, leading to the incorporation of Nitro Biosciences to translate the potential of this technology as a tool for future vaccines. Since incorporating, the team has raised over $200,000 in non-dilutive funds. These include mechanisms in Delaware, such as the UD Blue Hen Proof of Concept program and Delaware Biotechnology Institute Entrepreneurial Proof of Concept program, as well as nationally through the NSF I-Corps program and the 2021 Langer Prize in Innovation and Entrepreneurial Excellence from the American Institute of Chemical Engineers (awarded to Dr. Kunjapur).

Without novel methods for prevention or treatment of infection, the predicted burden from antimicrobial resistance (10 million annual deaths by 2050) may come to fruition. Through our nextgeneration vaccine platform, we aim to reduce this risk and create vaccines to prevent infections across disease states.

Dr. Butler may be contacted at ndb@udel.edu

REFERENCES 1. Murray, C. J. L., Ikuta, K. S., Sharara, F., Swetschinski, L., Aguilar, G. R., Gray, A., . . . Naghavi, M., & the Antimicrobial Resistance Collaborators. (2022, February 12). Global burden of bacterial antimicrobial resistance in 2019: A systematic analysis. Lancet, 399(10325), 629–655. https://doi.org/10.1016/S0140-6736(21)02724-0

7. Tian, H., He, Y., Song, X., Jiang, L., Luo, J., Xu, Y., . . . Yao, W. (2018, August 28). Nitrated T helper cell epitopes enhance the immunogenicity of HER2 vaccine and induce anti-tumor immunity. Cancer Letters, 430, 79–87. https://doi.org/10.1016/j.canlet.2018.05.021 8. Tian, H., Kang, Y., Song, X., Xu, Y., Chen, H., Gong, X., ...

Yao, W. (2020, April 28). PDL1-targeted vaccine exhibits potent antitumor activity by simultaneously blocking PD1/ PDL1 pathway and activating PDL1-specific immune responses. Cancer Letters, 476, 170–182. https://doi.org/10.1016/j.canlet.2020.02.024 9. Li, F., Li, H., Zhai, Q., Li, F., Wu, T., Sha, X., . . . Tao, H. (2018, May 15). A new vaccine targeting RANKL, prepared by incorporation of an unnatural Amino acid into RANKL, prevents OVX-induced bone loss in mice. Biochemical and Biophysical Research Communications, 499(3), 648–654. https://doi.org/10.1016/j.bbrc.2018.03.205 10. Butler, N. D., Sen, S., Brown, L. B., Lin, M., & Kunjapur, A. M. (2023, July). A platform for distributed production of synthetic nitrated proteins in live bacteria. Nature Chemical Biology, 19(7), 911–920. https://doi.org/10.1038/s41589-023-01338-x 11. Coherent Market Insights. (2022). Clostridium vaccine market analysis. Retrieved from: https://www.coherentmarketinsights.com/market-insight/clostridiumvaccine-market-2359 12. Centers for Disease Control and Prevention. (2022). What is C-diff? Retrieved from: https://www.cdc.gov/cdiff/what-is.html

2. Centers for Disease Control and Prevention. (2019). Antibiotic resistance threats in the United States. Retrieved from: https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threatsreport-508.pdf 3. Coque, T. M., Graham, D. W., Pruden, A., So, A. D., Topp, E., Grooters, S. V., . . . Salazar, M. (2023). Bracing for superbugs: Strengthening environmental action in the One Health response to antimicrobial resistance. United Nations Environment Programme. https://www.unep.org/resources/superbugs/environmental-action 4. Grünewald, J., Tsao, M.-L., Perera, R., Dong, L., Niessen, F., Wen, B. G., . . . Schultz, P. G. (2008, August 12).

Immunochemical termination of self-tolerance. Proceedings of the National Academy of Sciences of the United States of America, 105(32), 11276–11280. https://doi.org/10.1073/pnas.0804157105 5. Grünewald, J., Hunt, G. S., Dong, L., Niessen, F., Wen, B. G., Tsao, M.-L., . . . Smider, V. V. (2009, March 17). Mechanistic studies of the immunochemical termination of self-tolerance with unnatural amino acids. Proceedings of the National Academy of Sciences of the United States of America, 106(11), 4337–4342. https://doi.org/10.1073/pnas.0900507106 6. Gauba, V., Grünewald, J., Gorney, V., Deaton, L. M., Kang, M., Bursulaya, B., . . . Ramirez-Montagut, T. (2011, August 2). Loss of CD4 T-cell-dependent tolerance to proteins with modified amino acids. Proceedings of the National Academy of Sciences of the United States of America, 108(31), 12821–12826. https://doi.org/10.1073/pnas.1110042108 25

Immunization in the First State

New & Emerging Vaccines

Delaware Updates

Vaccine Hesitancy

Thursday, December 7, 2023 1:00 - 6:00 pm Bally's Dover Casino Resort 11 1

CME

p

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Medical Society of Delaware and the Delaware Academy of Medicine/Delaware Public Health Association. The Medical Society of Delaware is accredited by the ACCME to provide continuing medical education for physicians.

The Medical Society of Delaware designates this live activity for a maximum of 5.25 AMA PRA Category 1 Credit™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Sponsors

https://immunizedelaware.org/upcoming-events/2023-immunization-summit/ 26 Delaware Journal of Public Health - November 2023

The DPH Bulletin – Special flu edition From the Delaware Division of Public Health 2023-24 flu vaccine is now available The Division of Public Health (DPH) recommends that Delawareans 6 months of age and older get the 2023-24 flu vaccine, ideally by the end of October.

Getting the annual flu vaccine protects you and those at risk of flu complications from getting sick.

Vaccination can prevent hospitalization and death.

Preliminary estimates show that last season, people who were vaccinated against flu were about 40% to 70% less likely to be hospitalized due to flu illness or related complications. Hospital beds can be for those needing them most.

Flu viruses are constantly changing. The composition of U.S. flu vaccines is reviewed annually by the U.S. Food and Drug Administration’s Vaccines and Related Biological Protects Advisory Committee. Vaccine composition is updated as needed to best match the flu viruses that research indicates will be most common. U.S. flu vaccines will contain an updated influenza A strain for the 2023-24 influenza season, which begins October 2.

Those at higher risk of becoming ill from the flu should closely manage their health. Individuals at higher risk are children younger than 5 years old (especially children younger than 2 years), adults 65 years and older, pregnant people, and those with chronic underlying medical conditions. Chronic conditions include asthma, Chronic Obstructive Pulmonary Disease and other lung diseases, heart disease, diabetes, neurologic conditions, blood disorders, obesity, and weakened immune systems.

Those with a known severe allergic reaction to eggs should consult with a health care provider prior to receiving the influenza vaccine to determine the appropriate influenza vaccine for them.

DPH strongly urges flu vaccinations for those who live or work with infants under 6 months of age and those who live or work in settings with many people, such as multi-family households, apartments, schools, offices, and correctional facilities.

Vaccination is important for health care workers, especially those who work in long-term care facilities or who live with or care for people at highest risk.

For more information about flu, visit flu.delaware.gov and cdc.gov/flu, or call 1-800-282-8672. Click here for the difference between cold and flu.

September 2023

Tips to prevent flu • Get your flu vaccine every year.

• Avoid close contact with sick people.

• Cover coughs and sneezes with a tissue, or cough or sneeze into your inner elbow.

• Wash hands often with soap and water for 20 seconds or use hand sanitizer.

• Do not touch your eyes, nose, and mouth.

• Practice good health habits: o Clean and disinfect frequently touched surfaces. o Get plenty of sleep! o Exercise. o Manage stress. o Drink plenty of fluids. o Eat nutritious food.

• If sick with flu-like illness, stay home for at least 24 hours after the fever is gone without using fever-reducing medicine. A fever is a measured temperature of 100.4 degrees Fahrenheit or greater. If symptoms worsen, call your doctor.

Seniors 65+ need higher-dose flu vaccine For adults 65 years and older, the Centers for Disease Control and Prevention preferentially recommends one of three higher dose or adjuvanted flu vaccines: Fluzone HighDose Quadrivalent, Flublok Quadrivalent, and Fluad Quadrivalent vaccines. If these are not available, people age 65 and older should get a standard-dose unadjuvanted inactivated flu vaccine instead. Visit https://www.cdc.gov/flu/highrisk/65over.htm.

Many locations have flu vaccine

The flu vaccine is free to most Delawareans, including those without insurance. Individuals without insurance may receive vaccines for flu at Public Health clinics and community vaccination events. Visit flu.delaware.gov or call 1-800-2828672 for more information and vaccine locations.

27

www.fic.nih.gov www.fic.nih.gov www.fic.nih.gov www.fic.nih.gov

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medicine and communityAt the intersection of medicine and communityAt the intersection of based health… p. 5 SEPT/OCT 2023 medicine and communitybased health… p. 5 SEPT/OCT 2023 medicine and communitybasedOF health… p. 5 SEPT/OCT FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF 2023 HEALTH • DEPARTMENT HEALTH AND HUMAN SERVICES basedOF health… p. 32 5 SEPT/OCT FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF 2023 HEALTH • DEPARTMENT HEALTH AND HUMAN SERVICES

Fogarty Fogarty bolsters bolsters research research equity equity with with supplemental supplemental awards awards Fogarty Fogarty bolsters bolsters research research equity equity with with supplemental supplemental awards awards FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF HEALTH • DEPARTMENT OF HEALTH AND HUMAN SERVICES FOGARTY INTERNATIONAL CENTER • NATIONAL INSTITUTES OF HEALTH • DEPARTMENT OF HEALTH AND HUMAN SERVICES

for Advanced Injury Research Training" won a supplemental for Advanced Injury Training" a supplemental grant earmarked for Research women working as won junior faculty in grant earmarked for women working as junior faculty in Altrauma and injury research.

In the same region, Dr. Wael for Advanced Injury Research Training" won a supplemental for Advanced Injury Research Training" won a supplemental trauma and injury“GeoHealth research. InHub the for same region, Dr. Wael AlDelaimy's project, Change grant earmarked for women working asClimate junior faculty inand grant earmarked for women working asClimate junior faculty inand Delaimy's project, “GeoHealth Hub forAfrica," Change Health in the Middle East and North will support trauma and injury research. In the same region, Dr. Wael Altraumain and research.

InNorth the same region, Wael AlHealth theinjury Middle East and Africa," will Dr. support trainees rural“GeoHealth and Syrian refugee communities in and Delaimy'sfrom project, Hub for Climate Change Delaimy'sfrom project, for Climate Change trainees rural“GeoHealth and SyrianHub refugee communities in and Jordan.

Health in the Middle East and North Africa," will support Health in the Middle East and North Africa," will support Jordan. trainees from rural and Syrian refugee communities in trainees ruralDr. andGabriel SyrianDe refugee communities in In Southfrom America, Erausquin’s project, Jordan.

Jordan.

In South America, Dr. Gabriel De Erausquin’s project, “Multidisciplinary Training Program in Neuropsychiatry,” “Multidisciplinary Training Program in Neuropsychiatry,” earned a America, Fogarty supplement Quechua-speaking In South Dr. Gabriel to Desupport Erausquin’s project, In South America, Dr. Gabriel De Erausquin’s project, earned a FogartyDr. supplement to support Quechua-speaking neuroscientists.

Brisa Sanchez’s Guatemala project, “Multidisciplinary Training Program in Neuropsychiatry,” “Multidisciplinary Training Program in Neuropsychiatry,” neuroscientists.

Dr. Brisa Sanchez’s Guatemala project, “Social determinants of cardiovascular disease risk over earned a Fogarty supplement to support Quechua-speaking earned a Fogartyand supplement toSteenland's support Quechua-speaking “Social determinants of cardiovascular disease risk over the life course,” Dr. Nelson “Regional neuroscientists. Dr. Brisa Sanchez’s Guatemala project, neuroscientists.

Dr. Brisa Sanchez’s project, the life course,” and Dr. Nelson Steenland's “Regional GEOHealth Hub," inGuatemala Peru also received “Social determinants of cardiovascular disease risk over “Social determinants of cardiovascular disease risk over GEOHealth Hub," in Peru also received awards to educate researchers from the life course,” and Dr. Nelson Steenland's “Regional the life course,” and Dr. Nelson Steenland's “Regional awards to educate researchers from indigenous populations.

GEOHealth Hub," in Peru also received GEOHealth populations.

Hub," in Peru also received indigenous awards to educate researchers from awards to educate researchers In Asia, Dr. populations.

Albert Ko’s project, from “Research indigenous indigenous populations.

In Asia, Dr.and Albert Ko’s project, “Research Mentoring Building Capacity of Mentoring and Building Capacity of underrepresented Minority Research In Asia, Dr. Albert Ko’s project, “Research In Asia, Dr.inAlbert Ko’s project, “Research underrepresented Minority Research Scientists India,” received a supplement Mentoring and Building Capacity of Mentoring and Building Capacity of Scientists in India,” received a supplement to assist junior andMinority mid-career scientists underrepresented Research underrepresented Minority Research to assist junior and mid-career scientists from underrepresented Indian minorities Scientists in India,” received a supplement Scientists in scientists India,” received a supplement from underrepresented Indian minorities who mentor from similar to assist junior and mid-career scientists to assist junior and mid-career scientists who mentor scientists from similar backgrounds. Thefrom finalunderrepresented DEI awardee is Dr. Virasakdi Indian minorities from underrepresented Indian minorities backgrounds.

The final DEI awardee is Dr. Virasakdi Chongsuvivatwong's and whoproject, mentor“Research scientists training from similar whoproject, mentor scientists from similar Chongsuvivatwong's “Research training and Capacity Strengthening for LMICs in Southeast Asia,” backgrounds. The final DEI awardee is Dr. Virasakdi which backgrounds.

The finalfrom DEI awardee Dr. Virasakdi Capacity Strengthening for LMICs in is Southeast Asia,” which trains Muslim women Indonesian ethnic minority Chongsuvivatwong's project, “Research training and Chongsuvivatwong's “Research ethnic training and trains Muslim womenproject, from Indonesian minority groups.

Capacity Strengthening for LMICs in Southeast Asia,” which Capacity Strengthening for LMICs in Southeast Asia,” which groups. trains Muslim women from Indonesian ethnic minority trains women from minority of “TheseMuslim 14 supplements mayIndonesian potentially ethnic reach hundreds groups. groups.

“These 14 supplements may potentially reach hundreds new underrepresented trainees that would not otherwiseof be new underrepresented traineessaid thatDr. would not otherwise be exposed tosupplements research training,” Flora director “These 14 may potentially reachKatz, hundreds of “These 14 supplements may potentially reach hundreds of exposed to research training,” said Dr. Flora Katz, director of Fogarty’s Division of trainees International Training Research. new underrepresented that would notand otherwise be new underrepresented that would not otherwise be of Fogarty’s Division of trainees International Training and Research.

“An expected, additional benefit is that these training exposed to research training,” said Dr. Flora Katz, director exposed towill research said Dr. Flora director “An expected, additional benefit is that theseKatz, training programs engagetraining,” institutions—those in the of Fogarty’s Division ofnew International Training located and Research. of Fogarty’s Division ofnew International Training and Research. programs will engage institutions—those located in the areas where these underrepresented trainees live.”

“An expected, additional benefit is that these training “An expected, additional benefit is that these training areas where these underrepresented trainees live.” programs will engage new institutions—those located in the programs will engage new institutions—those located in the areas where these underrepresented trainees live.” areas where these underrepresented trainees live.”

Researchers persevere in Ukraine Researchers persevere in Ukraine

FOCUS FOCUS FOCUS FOCUS 28 Delaware Journal of Public Health - November 2023

• Bringing evidence-based care to PTSD sufferers • to PTSD sufferers Researchers persevere incare • Bringing Finding aevidence-based ‘win’ while war isUkraine waged Researchers persevere inisUkraine • Finding a ‘win’ while war waged Normalizing mental health care • Bringing evidence-based care to PTSD sufferers Bringing evidence-based care to PTSD sufferers • mental health Probing athe biology pain during • Normalizing Finding ‘win’ whileof war iscare wagedthe Ukrainian crisis • Finding a ‘win’ while war is waged the biology paincare during Read theRead Ukrainian crisis More on on pages 33–36 more pages 6–9 • Probing Normalizing mental of health • Normalizing mental health care Read more on pages 6–9 • Probing the biology of pain during the Ukrainian crisis • Probing the biology of pain during the Ukrainian crisis Read more on pages 6 – 9 Read more on pages 6 – 9

Fogarty Fogarty International Fogarty International Fogarty International Center International Center Center Center

Fogarty is providing more than $1.7 million in additional Fogarty than $1.7tomillion in additional funding is to providing currently more funded grants promote diversity, funding to currently funded grants to promote diversity, equity, and inclusion (DEI) in its research training programs.

Fogarty is providing more than $1.7 million in additional Fogarty is providing more than $1.7 million in additional equity, and inclusion (DEI) in its research training programs. funding to currently funded grants to promote diversity, funding to currently grants to promote diversity, Grants that received funded additional include the “Women equity, and inclusion (DEI) in itsfunds research training programs. equity, and inclusion (DEI) in itsfunds research training programs.

Grants that received additional the “Women and HIV: Translation of Research into include Practice: Promoting and in HIV: Translation of Research into Practice: Promoting DEI the Kenya Medical Research Institute/University Grants that received additional funds include the “Women Grants thatKenya received additional funds include thewhich “Women DEI in the Research Institute/University of Washington HIVMedical Research Training is and HIV: Translation of Research into Program,” Practice: Promoting and HIV: Translation of Research into Practice: Promoting of Washington HIV Research Training Program,” which helmed

by Kenya Dr. Carey Farquhar and aims to support firstis DEI in the Medical Research Institute/University DEI in the Medical Research Institute/University helmed

by Kenya Dr. Carey Farquhar and aims to supportfrom first generation Kenyan college graduates students of Washington HIV Research Trainingand Program,” which is of Washington HIV Research Training Program,” which is generation Kenyan college graduates and students from extreme poverty or rural backgrounds.

A to second Kenyan helmed by Dr. Carey Farquhar and aims support first helmed by Dr. Carey Farquhar and aims to support first extreme poverty ruralKinuthia’s backgrounds.

A second Kenyan award goes to Dr.orJohn project, “Promoting generation Kenyan college graduates and students from generation Kenyan college graduates and students fromto award goes to Dr. and John Kinuthia’s project, “Promoting Diversity, Equity, Inclusivity in Research Training extreme poverty or rural backgrounds. A second Kenyan extreme poverty orand rural backgrounds.

A second Kenyan Diversity, Equity, Inclusivity in Research Training Optimize HIV and Treatment.” will betoused award goes to Prevention Dr. John Kinuthia’s project,Funds “Promoting award goes to Prevention Dr. John Kinuthia’s project,Funds “Promoting Optimize HIV and Treatment.” will be used to train health providers from the Diversity, Equity, and Inclusivity in Research Training to Diversity, Equity, and Inclusivity in Research Training to to train health providers from the semi-nomadic Turkana tribe the Optimize HIV Prevention and in Treatment.”

Funds will be used Optimize HIV Prevention and Treatment.”

Funds will be used semi-nomadic Turkana tribe in the country’s northwest region.

A third to train health providers from the to train health providers from the country’s northwest region.

A third grant in the East Africantribe nation is semi-nomadic Turkana in the semi-nomadic Turkana tribe in the grant in thefor East African nation is earmarked Dr. Craig Cohen’s country’s northwest region. A third country’s northwest region.

A third earmarked forDevelopment Dr. Craig Cohen’s “Sustainable for HIV grant in the East African nation is grant in training the East African nation is “Sustainable Development for HIV Health” program. earmarked for Dr. Craig Cohen’s earmarked for Dr. Craig Cohen’s Health” training program.

“Sustainable Development for HIV “Sustainable Development for HIV Also on the continent, trainees in Health” training program.

Health” training program.

Also on the continent, trainees in Dr. Scott Heysell’s project, “DevelDr. Scott Heysell’s project, “Developingon research leaderstrainees at the interAlso the continent, in Also on the continent, in oping research leaderstrainees at the intersection of malnutrition and tuberculosis in Tanzania,” will Dr. Scott Heysell’s project, “DevelDr. Scott Heysell’s project, “Develsection of malnutrition and tuberculosis in Tanzania,” will gain hands-on experience in and an understanding of global oping research leaders at the interoping research leaders at the intergain hands-on experience in andMedina-Marino’s an understanding of global health Dr. and Andrew “Khulani sectionengagement. of malnutrition tuberculosis in Tanzania,” will sectionengagement. of malnutrition tuberculosis in Tanzania,” will health Dr. and Andrew Medina-Marino’s “Khulani Siphile Siphuhle Training Program in South Africa" received gain hands-on experience in and an understanding of global gain hands-on experience in and aninunderstanding of global Siphile Siphuhle Training Program South Africa" received support to train LGBTQI+ individuals from Historically health engagement. Dr. Andrew Medina-Marino’s “Khulani health engagement.

Dr. Andrew Medina-Marino’s “Khulani support to trainInstitutions LGBTQI+ individuals from Historically Disadvantaged (HDIs) in Siphile Siphuhle Training Program inSouth SouthAfrica.

Africa"Two received Siphile Siphuhle Training Program in South Africa" received Disadvantaged Institutions (HDIs) in South Africa.

Two other South African projects won DEI from supplements to support to train LGBTQI+ individuals Historically support to train LGBTQI+ individuals from Historically other South African projects won DEI supplements to enhance resources for HDIs.(HDIs) Theseininclude GailTwo Wyatt’s Disadvantaged Institutions South Dr. Africa.

Disadvantaged Institutions (HDIs) South Africa. enhance resources for HDIs. Theseininclude GailTwo Wyatt’s “Sustainable Academic Capacity ofDr. Excellence other South African projects wonBuilding DEI supplements to other South African projects won DEI supplements to “Sustainable Academic Capacity Building of Excellence through Training Program Learning enhance Research resourcesand for HDIs. These include Dr. Gail Wyatt’s enhance resources for Edward HDIs. These include Dr. Gail Wyatt’s through Research and Training Program Learning Collaborative" and Dr. Murphy’s “Blood Research “Sustainable Academic Capacity Building of Excellence “Sustainable Academic Capacity Building of Excellence Collaborative" and Dr. Edward “Blood Research and EnhAnced Training againstMurphy’s HIV in South Africa.” through Research and Training Program Learning through Research and Training Program Learning and EnhAnced Training against HIVNorth in South Africa.”

Dr. Hani Mowafi’s “Middle East and Africa Program Collaborative" and Dr. Edward Murphy’s “Blood Research Collaborative" and “Middle Dr. Edward Dr. Hani Mowafi’s EastMurphy’s and North“Blood AfricaResearch Program and EnhAnced Training against HIV in South Africa.” and EnhAnced Training against HIV in South Africa.”

Dr. Hani Mowafi’s “Middle East and North Africa Program Dr. Hani Mowafi’s “Middle East and North Africa Program

SEPTEMBER/OCTOBER 2023

From capacity building to capacity transfer in Uganda

Dr. Jerold Ellner's decades-long career as an immunologist and HIV researcher taught him this valuable lesson. Today he shares this advice with the young global health and infectious disease researchers he trains as part of the Fogarty-funded Training of Ugandans in Basic and Translational Research on TB and Emerging Infectious Diseases program.

“ If everything were done in-country, then U.S. involvement could be refocused on transferring the capacity for cutting edge research to Ugandans.

”

Ellner’s own career began in 1972 with a fellowship from the National Institute of Allergy and Infectious Diseases (NIAID). A few years later, he took a faculty position at Case Western Reserve University.

He crossed paths there with Dr. Frederick Robbins, working then as a university professor. In the early days of the HIV epidemic, Robbins—who’d won the 1954 Nobel prize (with Drs. John Enders and Thomas Weller) for isolating and cultivating polio viruses in tissue cultures—believed a similar approach might be useful to study HIV in Africa. Robbins needed help to create a new program in Uganda and tapped Ellner as co-principal investigator on a grant from NIAID’s program, International Collaboration for AIDS Research (ICAR).

2

Building infrastructure Ellner, an MD who studied immunology, got help from Dr. Brooks Jackson setting up a quality control clinical laboratory in Uganda in the late 1980s. "We had funding from the World AIDS Foundation and USAID to buy equipment. We established a first-rate laboratory, probably the best in sub-Saharan Africa at the time.” Over the years, both the lab and the research program evolved, offering unique opportunities to countless Ugandan scientists along the way. “At least a hundred individuals from Uganda have trained at Case Western and have since become leaders,” said Ellner. That list includes Dr. Harriet Mayanja-Kizza, former dean of medicine, and Dr. Moses Joloba, dean of biomedical science at Makerere University.

The partnership recently celebrated its 35th year. Case Western Reserve University remains involved as does Rutgers-New Jersey Medical School, where Ellner is currently a professor, and Johns Hopkins, where Jackson was Chair of the Department of Pathology before becoming Dean of the University of Minnesota School of Medicine.

Scientific contributions, past & future Ellner contributed to the first AIDS vaccine trial in sub-Saharan Africa. “Pasteur Merieux provided the vaccine; NIH provided the funding,” he said. The experimental vaccine developed by the French pharmaceutical company didn’t produce an ideal level of immune response, so Pasteur Merieux abandoned the project. But, Ellner noted, the team did complete a proofof-concept vaccine trial for HIV in Africa, a remarkable achievement.

Photo courtesy of Jerrold Ellner

“If you wait for everything to be in place before you start your research, you’ll run out of time. Sometimes you just have to say, ‘let’s go with what we have.’”

Jerrold Ellner, MD, has worked in Uganda doing research on infectious diseases including HIV and TB since the late 1980s.

And the trial led to the development of a cytotoxic T -lymphocyte lab at the Joint Clinical Research Centre in Kampala.

“Our current Fogarty training grant brings Ugandans to the U.S. for intensive instruction and coursework in basic and translational technology.

Then they return to Uganda and usually get a PhD from Makerere University.” The goal is to develop a cadre of scientists doing bench-based research. He recently introduced data science into this program.

Though many aspects of research are now done on-site, the final data is commonly analyzed in the U.S. “The country would benefit from building capacity to analyze its own clinical data, particularly since a lot of this research impacts public policy.” If everything were done in-country, then U.S. involvement could be refocused on capacity building and transferring the capacity for cutting edge research to Ugandans, Ellner added.

“Working in Uganda, I vacillated between thinking everything is possible and nothing is possible.

That vacillation is a sign of enormous growth—if everything is easy, someone else can do it.”

29

SEPTEMBER/OCTOBER 2023

Catching up with the first cohort of APTI fellows

By Mariah Felipe

Now back in Nigeria for the last year of his APTI fellowship, Oyebola established the Centre for Genomic Research in Biomedicine at Mountain Dr. Kolapo Oyebola worked in the sickle cell branch at NLHBI as Top University, Nigeria. This part of his APTI fellowship. center focuses on investigating sickle cell disease and other noncommunicable diseases (NCDs) in populations of African descent.

their goals for the future.

Photo courtesy of Thomas Hormenu

Dr. Thomas Hormenu

Through this training he was also able to develop a research protocol to screen for risk factors associated with undiagnosed diabetes and hypertension and to assess the effect of lifestyle interventions on diabetes remission.

Following his APTI training, Hormenu plans to continue researching the prevalence of and risk factors associated with diabetes and hypertension in Ghana and other sub-Saharan African countries. He aims to contribute to the development of culturally sensitive and appropriate interventions for diabetes prevention and remission, ultimately improving the quality of life in these regions.

Dr. Kolapo Oyebola A senior researcher at the University of Lagos, Dr. Kolapo Oyebola, had the opportunity to work in the National Heart, Lung, and Blood Institute (NHLBI) sickle cell branch. There he studied a condition called clonal hematopoiesis and how it can impact transplantation

30 Delaware Journal of Public Health - November 2023

Following his APTI training, Oyebola will continue his research in genomics and bioinformatics, particularly focusing on understanding the genetic factors underlying NCDs in African populations.

Dr. Idowu Aimola

CHIA-CHI/Charlie Chang

A senior lecturer from the University of Cape Coast, Ghana, Dr. Thomas Hormenu received cardiometabolic epidemiology training at the National Institutes of Diabetes and Digestive and Kidney Disease (NIDDK) as an APTI fellow. There he investigated behavioral and psychosocial Dr. Thomas Hormenu studied factors that influence the prevacardiometabolic epidemiology lence of undiagnosed diabetes in at NIDDK as part of his APTI fellowship.

Africans living in the U.S. and explored social determinants of cardiometabolic health in African immigrants.

in sickle cell disease (SCD) patients. Clonal hematopoiesis is an age-related condition marked by the accumulation of genetically abnormal blood cells.

Photo courtesy of NHLBI

The African Postdoctoral Training Initiative (APTI), established in 2019, prepares future generations of African researchers with four-year fellowships, which include two years spent in an NIH lab and an additional two years at home institutions in Africa. A partnership between the African Academy of Sciences, NIH, and the Bill and Melinda Gates Foundation, the program supports 10 fellows each year. Past and current fellows have come from 14 countries and have been hosted by nine NIH Institutes and Centers. The first cohort is now in their final APTI year. Fogarty caught up with three fellows from that inaugural group to learn more about how the program has impacted their careers and research, and

Dr. Idowu Aimola of Nigeria (seated) spent the first two years of his APTI fellowship in the lab of Dr. Francis Collins (standing) at NHGRI.

As an APTI fellow, Dr. Idowu Aimola, a professor in the Department of Biochemistry at Ahmadu Bello University in Zaria, Nigeria, received training in single-cell genomics techniques and computational approaches while working in the lab of former NIH director, Dr. Francis Collins, at the Center for Precision Health Research at the National Human Genome Research Institute (NHGRI).

Aimola has successfully established at his university a laboratory equipped for single-cell genomics research.

His lab hosts multiple doctoral and master’s students and maintains strong collaborations with Collins’ laboratory while actively seeking to establish new regional and international partnerships to advance single-cell genomics research in Africa.

3

PP RR OO FF II LL EE Measuring Measuring the the prevalence prevalence of of mental mental disorders disorders in in western western Kenya Kenya

4 4

Edith Kamaru Kwobah, MD, PhD Edith Kamaru Kwobah, MD, PhD Fogarty Fellow: 2015-2016 Fogarty Fellow: U.S. institution: U.S. institution: Foreign institution: Foreign institution: Research topic: Research topic: Current affiliation: Current affiliation:

2015-2016 Vanderbilt University Vanderbilt University Moi Teaching Hospital, Kenya Moi Teaching Hospital, Kenya Mental health delivery in LMICs Mental health delivery in LMICs Head of the department of mental health Head the department at MoiofTeaching Hospitalof mental health at Moi Teaching Hospital Photo courtesy of AMPATH Photo courtesy of AMPATH

There is no such thing as a typical work week for Dr. There is no such thing as a typical work week forofDr. Edith Kamaru Kwobah, a psychiatrist and head Edith Kamaru Kwobah, a psychiatrist and head of mental health at Moi Teaching and Referral Hospital mental health at Moi Teaching and Referral Hospital in Eldoret, Kenya. Her every day looks different; she in Kenya.

Her and every day looks different; she is aEldoret, clinician, teacher, administrator, heads seven is a clinician, teacher, and administrator, heads seven different departments, and in her “free time,” she works different departments, and in time,” she works on her research and checks inher on “free the small groups she on her research and checks in on the small groups she helps manage. helps manage.

“It is not an eight-to-five job with a clear structure,” said “It is not an eight-to-five job different with a clear structure,” said Kwobah.

“Working on many things at the same Kwobah.

“Working on many different things at the same time requires strict time management skills.” Skills that time requires strict time management skills.” that her Fogarty fellowship helped her develop, sheSkills added. her Fogarty fellowship helped her develop, she added.

Kwobah connected with Fogarty through Duke University Kwobah connected with Fogarty through Duke and the AMPATH consortium, which stands for University Academic and the AMPATH consortium, which stands for Academic Model Providing Access to Healthcare. The partnership Model Providing Access to Healthcare. includes Moi University, Moi Teaching The and partnership Referral includes Moi University, Moi Teaching Referral Hospital, the Kenyan government, and and the AMPATH Hospital, the Kenyan government, and the AMPATH consortium of North American universities led by Indiana consortium of North the American universities Indiana University. Initially, consortium focusedled itsby research University.

Initially, the consortium focused its research and training on HIV and other chronic diseases, such and trainingand on HIV and other while chronic diseases, scant such as diabetes hypertension, conducting as diabetes and hypertension, while conducting scant research on mental health. research on mental health.

“When I joined the hospital in 2013, I realized that we “When joined thebaseline hospitaldata in 2013, I realized that we did not Ieven have on how common mental did not even have baseline data on how common mental health problems are in our region. My goal was to find health problems are region.

My goal was to find that baseline data soin weour could develop interventions that baseline data so we could develop interventions for patients,” said Kwobah. With this in mind, for for said Kwobah.

With thiswas in mind, her patients,” Fogarty research project, which part offor her her Fogarty research project, which was of her fellowship training, she decided to study part the prevalence fellowship she decided to study the prevalence of commontraining, mental disorders across a sample population of common mental disorders across a sample population in western Kenya. in western Kenya.

For her study, she and her team interviewed 420 adults For study,Kenya. she and her team interviewed fromher western Researchers found that,420 justadults like from western Kenya.

Researchers found that, just health like in the rest of the world, the most common mental in the rest of the world, the most common mental health disorders in the region were depression, anxiety, and disorders thedisorder. region were depression, anxiety, and substancein use Their most interesting and substance use disorder.

Their most interesting and concerning finding was that at least 45% of their study concerning was that of ataleast 45%health of their study participantsfinding had symptoms mental disorder participants had symptoms of a mental health disorder at some point in their lifetime. This number is high, at some point in their lifetime.

ThisOrganization number is high, considering that the World Health reports considering that the World Health Organization reports

the worldwide average as roughly 25%. Another the worldwide average as roughly Another important finding: at least 16% of 25%. the people they important finding: at least 16% of the people interacted with had attempted suicide at leastthey once in interacted withAgain, had attempted suicide athigher least once their lifetime. this is significantly thanin their lifetime.

Again, this is significantly higher than the WHO average. Lastly, they found a significant the WHO average.

Lastly, they found a significant treatment gap—more than 75% of participants had treatment gap—more 75% of participants had never sought care for than mental illness. never sought care for mental illness.

Her Fogarty project provided a baseline for a new Her Fogarty project providedprogram a baseline for aUniversity new mental health care delivery at Moi mental health care delivery program at Moi University that integrates therapy into a system initially created that integrates therapy into a system initially created to manage chronic diseases like HIV, hypertension, to manage chronic diseases like HIV, hypertension, and diabetes. As a part of this program, Kwobah and diabetes.

As a part of this program, her team train primary care workersKwobah at the and her team train primary care atfor themental hospital and community workersworkers to screen hospital and community workers to screen for mental disorders and link community members to care.

They disorders and link community members to care.

They also provide community education for village elders, also provide community education for village elders, chiefs, teachers, religious leaders, and police officers chiefs, teachers, religious leaders, and police officers to increase mental health awareness and reduce the to increase mental health awareness and reduce stigma around seeking treatment. Going forward,the stigma seeking treatment.

Going using forward, Kwobaharound hopes to continue this research the Kwobah hopes to continue this research using data from her Fogarty year to evaluate how theythe can data frommental her Fogarty to evaluate howinthey can increase healthyear interventions used Kenyan increase mental health interventions used in Kenyan health care settings. health care settings.

Kwobah knew early on that serving those with mental Kwobah knewbe early that serving those with mental illness would her on calling.

“Of all the rotations after illness would be her calling.

“Of all the rotations after medical school, psychiatry was my favorite.” Because medical school, psychiatry was my favorite.”

Because of her passion for this field, she continues her work of herafter passion for thisthe field, she continues her work even she leaves hospital. even after she leaves the hospital.

Her advice to those pursuing the Fogarty program is to Her advice those pursuing Fogarty program is to “identify antoarea that you are the truly interested in and “identify an area that you are truly interested in and would like to be associated with 20 years from now.” would like to be associated with 20 years from now.”

31

Q&A

RAJ PANJABI, MD, MPH

Dr. Raj Panjabi served as special assistant to President Biden and senior director for Global Health Security and Biodefense at the White House National Security Council from 2022 to 2023. He also led the U.S. President’s Malaria Initiative and advised the WHO’s Independent Panel for Pandemic Preparedness and Response. He was an assistant professor at Harvard Medical School, an associate physician at Brigham and Women’s Hospital, and a faculty member of Harvard Kennedy School of Government. In 2007, he co-founded Last Mile Health. Born in Liberia, Panjabi fled with his family from civil war when he was 9.

What are your takeaways from the U.S. President’s Malaria Initiative?

When President Biden appointed me to lead the U.S. President’s Malaria Initiative in February 2021, it didn’t surprise me to see so many countries using a communitybased approach to work towards reducing mortality and morbidity of malaria, and, in some cases, eliminating it. So, one of the first things I tried to do with the teams at USAID and CDC, which together implement the U.S. President’s Malaria Initiative, was to reverse a 15-year-old policy that said U.S. government funds could not be used to pay community health workers. It’s crucial to combine medicine with community-based efforts to distribute the fruits of modern science equitably.

Where did we succeed and where did we fall short in the global COVID-19 response?

The U.S.’s biggest successes are around demonstrating global leadership and mobilizing financing for the global response. Some $34.5 billion is estimated to have been spent on the COVID response by the U.S. and other countries. The U.S. contributed almost $20 billion of that, if you count $16 billion through multilateral organizations and funds used to deliver vaccines to countries (plus testing, treatment, oxygen, and other items). Some 70% of the global adult population has been vaccinated with the primary vaccine series, including 80% of the over–60 age group and 82% of health care workers. And as the variants evolved—from the very first strain to omicron and its subvariants—our ability to keep focus on genomic sequencing has been vital. This is progress.

But more must be done. The gap has been in terms of speed and equity. Africa still lags behind other regions— less than 30%, on average, are fully vaccinated in subSaharan Africa—and, generally, low-income countries around the globe are behind in vaccination, testing and treatment. To date, over 687 million vaccines have been delivered to over 116 countries, but we've got to do more 32 Delaware Journal of Public Health - November 2023

to decentralize manufacturing so that countries and regions can make vaccines and medicines locally.

How do we keep preparedness alive barring a global crisis?

Muscles get stronger by using them, so we can build our preparedness muscles by using our existing response muscles that we use to tackle HIV/AIDS, malaria, tuberculosis, and other infectious diseases globally. Take the countries in Southeast Asia that receive research dollars for malaria and HIV. Vietnam did well early in the COVID-19 pandemic, partly because they'd been building their health systems to combat epidemics.

We’ve also got to do better at telling the story of how we are stopping infectious disease outbreaks faster. Uganda stopped its 2022 Ebola outbreak in less than 100 days, which was faster than had been done in the past. This kind of progress is important and helps people understand the value of advance planning and prevention.

How do we get out ahead of misinformation and disinformation?

There’s no silver bullet. Investing in communities is an antidote to the plague of mistrust we face in public health.

Whether it’s a community health worker in Liberia or a church leader in the U.S., local actors have lived experience and expertise that we in government or the policy community often lack. They may not have medical or public health degrees, but they work in the marginalized communities that are at highest risk of suffering from misinformation and disinformation, so they are the ones who best understand how to convey health and science information.

Finally, we’ve got to put our words where the problem is and then put our money there, too. We need to say that pandemic policy is not just about investing in products, we need to invest in people—in a stronger public health workforce.

5

FOCUS FOCUS

Bringing evidence-based PTSD care to Ukraine Bringing evidence-based PTSD care to Ukraine

By Susan Scutti

UU

By Susan p to Scutti a third of Ukrainians, both civilian and military,

suffered from post-traumatic stress disorder (PTSD) p to a third of Ukrainians, both civilian andRussia, military, during the country’s 2014-21 conflict with suffered from post-traumatic stress disorder (PTSD) as estimated by the UN. Since the Russian invasion in during the country’s 2014-21 conflict with Russia, February 2022, millions more have been exposed to combat as by the UN. Since invasion in andestimated war-related traumas.

Yet, the veryRussian few of the nation’s February 2022, millions more have been exposed to combat mental health care professionals have trained in evidenceand war-related traumas.

Yet, very few of the nation’s based treatment for these conditions. A Fogarty-funded mental healthtocare professionals have trained in evidenceproject aims change that. based treatment for these conditions. A Fogarty-funded project aims that.

“PTSD is oneto of change the most common mental health disorders,” says Dr. Israel Liberzon, Texas A&M University (TAMU).

“PTSD is one ofofthe most common mental health disorders,” About 60-70% PTSD patients benefit from treatment, yet says Dr. Israel Liberzon, Texas A&M University (TAMU). the reason why a patient benefits from one treatment and About 60-70% of PTSD patients benefit from treatment,we yet not another remains unclear.

“We have psychotherapy, the reason why a patient benefits from one treatment and have pharmacotherapy, all of them effective, but not 100%. not another remains “We have psychotherapy, What we don’t have isunclear. an ecological understanding (onewe that have pharmacotherapy, all of them effective, but not 100%. accounts for the interactions between an individual and his What don’t have is ecological understanding (one that or herwe environment) of an PTSD,” says Liberzon. accounts for the interactions between an individual and his or her environment) of PTSD,” says Liberzon.

“Wanting to understand the mechanism of disease—whether it is genetic, biological, or psychological—and to identify the “Wanting to understand the mechanism of disease—whether components that contribute to the disorder’s development it is genetic, biological, or psychological—and to identify the and symptoms is why I run a lab,” says Liberzon.

His team components that contribute to the disorder’s development scans patients’ brains to examine changes within their and symptoms why I run a lab,” says mechanisms.

Liberzon. His team neural circuitryisand underlying disease “If we scans patients’ brains to examine changes within understand the mechanisms, we can develop new their treatment neural circuitry and underlying disease mechanisms. we strategies.

We can treat and prevent deterioration.

We “If can understand the mechanisms, we can develop new treatment match the individual to the treatment.” strategies. We can treat and prevent deterioration. We can match the individual to the treatment.”

Developing capacity

Photo courtesy Photo courtesy of Tetiana of Nickelsen Tetiana Nickelsen

Liberzon’s five-year Fogarty project builds research capacity Developing capacity to implement trauma care after mass violence and involves Liberzon’s five-year buildsU.S. research capacity collaboration amongFogarty faculty project from several universities to implement trauma care after mass violence and involves and the National University of “Kyiv-Mohyla Academy” collaboration among offer faculty from several U.S. universities in Ukraine. Courses instruction in evidence-based and the National University of “Kyiv-Mohyla Academy” methods including pharmacotherapy, prolonged exposure in Ukraine. Courses offer instruction in evidence-based methods including pharmacotherapy, prolonged exposure Dr. Tetiana Nickelsen teaches a class in a bunker in Lviv, Ukraine.

Dr. Tetiana Nickelsen teaches a class in a bunker in Lviv, Ukraine.

therapy, and behavioral activation—a type of therapy for treating depression and other psychological comorbidities. therapy, and behavioral activation—a type of therapy for treating depression other psychological Once a year, a teamand of U.S. professionals willcomorbidities. visit Ukraine and conduct in-person instruction for the trainees (who Once a year, a team U.S. professionals will visit Ukraine are psychiatrists andofpsychologists), explains Dr. Tetiana and conduct in-person instruction for the trainees (who Nickelsen, research scientist at TAMU and an investigator are psychiatrists and psychologists), explains Dr. Tetiana on the project. Five trainees will be invited to participate in a Nickelsen, research scientist at U.S. TAMU and an investigator summer school program in the on the project. Five trainees will be invited to participate in a summer program in the and U.S.only moved to the U.S. Nickelsenschool was born in Ukraine to join Liberzon’s lab six years ago. She started her career in Nickelsen borntrainee in Ukraine and selected only moved to the U.S.in 2004 as a was Fogarty who was to participate to join Liberzon’s lab six years ago.

She started her career in summer school at the University of Alabama, Birmingham.

2004 as a Fogarty trainee who was selected to participate “That experience changed my life dramatically,” she says. in summer school home, at the she University of Alabama, Birmingham.

After returning dedicated her career to improving “That experience changed my life dramatically,” she says. health care delivery and access in Ukraine, through both After returning home, she dedicated her career to research and advocacy. She created her own NGOimproving and health deliveryinvestigator and access on in Ukraine, both served care as principal multiple through grants from research and advocacy.

She created her own NGO and various foundations. served as principal investigator on multiple grants from various foundations.

“When Russia invaded Ukraine, I reached out to Dr. Liberzon, who was also born in Ukraine, and we decided we “When Russiasays invaded Ukraine, I reached out to Dr. had to help,” Nickelsen.

Liberzon, who was also born in Ukraine, and we decided we had to help,” Nickelsen.

Working insays Ukraine “We want to find people with the right motivation— Working Ukraine people who in want to teach and spread their knowledge “We want to find people with the right motivation— and help Ukrainians build a better health care system,” people who want to teach and spread their knowledge says Nickelsen. Following the 2014 revolution, Ukraine’s and help Ukrainians build a better health care psychiatric care system began to change for thesystem,” better, with says Nickelsen.

Following 2014 Ukraine’s reforms continuing to thisthe day.

Stillrevolution, Nickelsen knows that psychiatric care system began to change for the better, with Ukrainian psychologists and psychiatrists are inadequately reforms continuing to this day.

Still Nickelsen knows trained and use historically relied-upon methods (as that Ukrainian psychologists and psychiatrists are inadequately opposed to evidence-based methods to treat patients) and trained and those use historically relied-upon methods (as “sometimes methods harm people.” opposed to evidence-based methods to treat patients) and “sometimes those methods people.”a cadre of well“Another goal of the project harm is to develop trained Ukrainian mental health providers and researchers, “Another goal of the project is toplus develop a cadre of wellwho will examine interventions the implementation, trained Ukrainian mental health providers and adoption and dissemination of interventions, to researchers, see which who will examine interventions plus the implementation, ones are efficient and effective in their regions,” says adoption dissemination interventions, which Liberzon. and Long-term, he and of Nickelsen expecttoa see professional ones are efficient and effective in their regions,” says society of Ukrainian mental health researchers will be Liberzon.

Long-term, Nickelsen expectwithin a professional established, one that he willand foster collaboration the society of Ukrainian mental health researchers country and with scientists around the globe. will be established, one that will foster collaboration within the country and with scientists around the globe.

33

FOCUS ON RESEARCH IN UKRAINE FOCUS ON COVID AWARDS

Finding a ‘win’ while war is waged in Ukraine

Despite difficulties, the Ukrainian health care system has shown resilience and is relatively high functioning since the invasion began, says Dumchev. Some facilities directly affected by military action no longer operate, but some partially destroyed clinics have begun renovations.

“There’s a deficit in the health care workforce, especially in the most affected regions.”

The Soviet era as historical context Some Ukrainian health care system problems can be traced to its roots; it was created during the period Ukraine existed as a republic within the Soviet Union (1922–1991). “The Soviet health care system was very specialized and siloed with limited connections between different services,” says Dumchev. For example, HIV care within Ukraine has operated separately, disconnected from primary care or even other infectious diseases.

Following the 2014 revolution, real change began, says Dumchev. “The role of the primary care doctor has grown, becoming the gateway for all other services, while all the clinics try to provide additional services relevant to their main offering—so HIV centers might treat TB, hepatitis or mental health."

Before the start of the Russian invasion, only 60% of the estimated 210,000 PLWH were receiving antiretroviral therapy (ART). Among HIV-positive people who inject drugs (PWID), ART rates were even lower. “All former Soviet countries and many Eastern European countries have their HIV epidemics driven by injected drug use,” notes Dumchev.

DeHovitz explains that the collapse of the Soviet Union

Unexploded ordnance in farmland in Yahidne, Ukraine.

meant economic changes and political dislocation occurring alongside a dramatic increase in opiate trafficking, particularly from Afghanistan. “It was a perfect storm: at the same time that political and economic disruption occurred (with people losing their jobs and having no money), there was also increased availability of cheap drugs. Substance use really took off.” Ukraine also did not deploy some of the interventions that can reduce substance use, he adds, noting that substitution therapy—in the form of methadone and buprenorphine— goes against cultural norms embedded in post-Soviet society.

Owczarzak says that stigma has also contributed to high rates of HIV in Ukraine. Her research examining the lives of women living with HIV shows that many patients fear their health care providers will shame them for using drugs.

Using data to make a difference To optimize HIV care, Dumchev's project with Owczarzak focuses on unused information. Owczarzak explains: “We ask providers to collect a lot of information from their clients, but usually it’s just used for reports or it's like, ‘Okay, you met your metrics; we’ll give you funding again.’” Ukraine’s nationwide medical information system is a rich source of unused data and the project seeks “to empower providers and case managers to use that information for improving the health outcomes of their clients,” says Owczarzak.

Dumchev says, “The goal is to enhance the instruments for data exchange between clinical personnel and case managers to improve HIV treatment outcomes. We also intend to help patients get case management services to prevent them from dropping out of care—or if they’ve dropped out, to quickly get back in.”

Training methodologies Dumchev believes training researchers in the U.S. is a “crucial” aspect of his project with DeHovitz. He, himself, entered a Fogarty program after finishing his medical . . . continued on p. 8 . . . continued on next page

34 Delaware Journal of Public Health - November 2023

7 7

Photo courtesy of U.S. Department of State/Chuck Kennedy

The initial shock of a Russian invasion in February 2022 spurred Dr. Kostyantyn Dumchev, scientific director at the Ukrainian Institute of Public Health Policy, to leave Kyiv for his hometown in southwestern Ukraine. “In the first weeks, we were trying to help the country, doing all we could to mobilize aid,” he says. Returning to the capital city within months, he and his colleagues promptly resumed their research. Dumchev is a primary investigator on two separate projects: one a training program with Dr. Jack DeHovitz, distinguished service professor, SUNY Downstate Medical Center; another a research study with Dr. Jill Owczarzak, associate professor, Johns Hopkins University

FOCUS ON RESEARCH IN UKRAINE FOCUS ON RESEARCH IN UKRAINE

Finding a ‘win’ while war is waged in Ukraine Finding a ‘win’ while war is waged in Ukraine . . . continued from p.7 with HIV Research Training Programs with HIV Research Training Programs in Georgia and Kazakhstan.

“Ultimately in Georgia and Kazakhstan.

“Ultimately it might enhance collaborations among it might enhance collaborations among the various countries.” the various countries.”

degree at Vinnitsya National Medical Univerdegree at Vinnitsya Medical of University to earn an MPHNational from University Alabama sity to earn an MPH from University of Alabama at Birmingham. “All the people who’ve trained at Birmingham.

“All the people who’ve trained in the U.S. in sim2ilar programs have become in the U.S. in the sim2ilar programs have become assets within Ukrainian health care system.” assets within the Ukrainian health care system.”

Asked if he can meet his goals in the context of Asked if he cansays, meet“I’m his assuming goals in the of war, DeHovitz thecontext war will war, DeHovitz says, “I’m assuming the war will be over at some point during the five-year be overofatthis some point Iduring the five-year period grant… have to assume that. I period of this grant…

I have to assume believe, once that happens, there will bethat. in- I believe, once that happens, there will be creased resources for health care and theincreased for health and And the evolutionresources of the public healthcare system. evolution of the public health system.

And we’ll be well-positioned to help.” He’s also been we’ll be well-positioned to research help.” He’s also been cultivating cross-national and training cultivating cross-national research and training

Photo Photo courtesy courtesy of Kostyantyn of Kostyantyn Dumchev Dumchev

. continued from p.7 page ... .. continued from previous

Dr. Kostyantyn Dumchev is a principal Dr. Kostyantyn Dumchev is a principal investigator in the Fogarty-funded Ukraine investigator the Fogarty-funded HIV ResearchinTraining Program. Ukraine HIV Research Training Program.

Owczarzak says it still humbles and Owczarzak says it still and impresses her that her humbles Ukrainian impresses her that her Ukrainian colleagues continue to work, conduct colleagues continue tocommitted work, conduct research, and remain to research, and remain committed to providing care. “We don't know when providing care.

“We don't know when this conflict is going to end—we don't this is going going to to end—but end—we don't knowconflict how it's if we know how it's going to end—but if we can provide another tool to improve can provide another tool to improve HIV care engagement metrics, then HIV care engagement metrics, then that’s a win.” that’s a win.”

Normalizing Normalizing mental mental health health care care in in Ukraine Ukraine others when you’re worried that they’re struggling.” others when you’re worried that they’re struggling.”

Under the Soviet regime, psychiatric services were often Under the Soviet regime, psychiatric services were used to punish politically inconvenient citizens andoften used to punish politically inconvenient citizens and “It oppress targets of the regime, comments Mazhanaia. oppress targets of the regime, comments Mazhanaia.

“It was a very punitive system so obviously people did not was a very punitive system so obviously people did not have a habit of going to mental health service providers have habit of going to mental health service providersuse whenathey needed help.”

Other barriers to widespread when they needed help.”

Other barriers to widespread of such services included difficult-to-access siloed careuse of such services difficult-to-access siloed care delivery systems included and a lack of evidence-based training delivery systems for andthe a lack of evidence-based training providers themselves. Following for the providers themselves.

Following independence, this began to change independence, this began to change and, after the 2014 revolution, efforts and, after the 2014 revolution, efforts intensified, says Mazhanaia. intensified, says Mazhanaia.

Photo Photo courtesy courtesy of U.S. of U.S. Department Department of State/Chuck of State/Chuck Kennedy Kennedy

A third of all Ukrainians have at least one lifetime A third of all have at least oneestimate. lifetime Many experience of Ukrainians mental disorder, scientists experience of mental disorder, scientists estimate. believe the Russian 2022 invasion has exacerbatedMany mental believe the Russian 2022PTSD, invasion has exacerbated mental health issues, including depression, and anxiety, health issues, including PTSD, depression, and anxiety, yet the Ukrainian health care system is stretched beyond yet the Ukrainian care systemsenior is stretched beyond capacity, says Dr. health Alona Mazhanaia, lecturer at capacity, says Dr. Alona Mazhanaia, senior lecturer at National University of “Kyiv-Mohyla Academy” (NaUKMA) National University of “Kyiv-Mohyla Academy” (NaUKMA) and principal investigator on a Fogarty project that seeks and principal investigator on a Fogarty seeks to understand delivery of mental healthproject care inthat Ukraine. to understand delivery of mental health care in Ukraine.

“Building the mental health care “Building the health care system has tomental move forward now. system has to move forward People already need services,now. and we People need services, and time we cannot already wait until some unknown cannot wait until some unknown time when everything is less tumultuous.” when everything is less tumultuous.”

The process of conceptualizing how The process of care conceptualizing how mental health might be delivered Local and international organizations mental health care might be delivered Local and international organizations included formulating a new national have mobilized within Ukraine, included a happening new national have mobilized within Ukraine, strategy, formulating “but that was at the providing mental health services and strategy, “but that was happening at the providing mental health services and usual slow speed of policy and regulatory coordinating resources, she says. usual slow speed of policy and regulatory coordinating resources, she says. framework development.” When her “There’s also large-scale training framework development.”

WhenMazhanaia her “There’s also large-scale Fogarty project began in 2021, of primary care providerstraining to deliver Fogarty project began in 2021, Mazhanaia of primary care providers to deliver The Yahidne School in Yahidne, Ukraine, where hoped to gather information that might mental health services using mhGAP The School in Yahidne, Ukraine, moreYahidne than 360 people were forced to livewhere for hoped to gather information that health might mental services using by mhGAP contribute to “closing the mental to their health patients.”

Developed WHO, more than 360 people were forced to live for nearly a month in February and March 2022, is contribute to “closing the mental health to their patients.”

Developed by WHO, treatment gap in Ukraine.” the Mental Health Gap Action Program nearly a month in February and March 2022, is now being turned into a museum. treatment gap in Ukraine.” the Mental Health interventions Gap Action Program now being turned into a museum. (mhGAP) includes (mhGAP) includes interventions All that changed in February 2022. “With full-scale invafor prevention and management of priority conditions: All that changed in February 2022. full-scale for prevention and management of priority conditions: sion, this tremendous shock hit our“With society, so it allinvabecame depression, schizophrenia and other psychotic disorders, sion, this tremendous shock hit our society, all became depression, schizophrenia and other psychotic disorders, very urgent,” she says. She revised her studyso toitunderstand suicide, epilepsy, dementia, substance use disorders, and very urgent,” she says. She revised her providers study to understand suicide, epilepsy, in dementia, the landscape of mental health service in Ukraine, mental disorders children.substance use disorders, and the landscape of mental health service providers in Ukraine, mental disorders in children. including their knowledge, attitudes, practices, and capacity including their knowledge, attitudes, practices, and for scaling-up mental health treatment approaches. capacity "To “One other effort is what is called ‘psychoeducation’— for scaling-up treatment approaches.

“One other effort is care whatofisyour called ‘psychoeducation’— continue on is mental a form health of resistance.

Resilience is not "To somenormalizing taking mental health. continue a form of resistance.

Resilience is not somenormalizing of it. your mental health. thing thaton is is inherited—it is something that is earned by Normalizing taking talkingcare about Normalizing the concept thing that inherited—it something that must is earned by Normalizing talking about it. Normalizing the concept carrying onisduring a time is when you simply endure.” of mental health service providers.

Normalizing asking carrying on during a time when you simply must endure.” of mental health service providers. Normalizing asking

8 8

35

FOCUS ON RESEARCH IN UKRAINE FOCUS ON RESEARCH IN UKRAINE

Probing Probing the the biology biology of of pain pain during during the the Ukrainian Ukrainian crisis crisis About two decades ago, scientists shifted their focus About two decades ago, scientists shifted their focus from pain as a symptom of underlying illness to chronic from pain as a symptom of underlying illness to chronic pain as a disease in itself. This led to exploring new pain as a disease in itself. This led to exploring new therapeutic approaches. Unfortunately, today’s pain therapeutic approaches. Unfortunately, today’s pain medications are neither precise nor side effect-free. “We medications are neither precise nor side effect-free. “We need to better understand pain mechanisms—the biology need to better understand pain mechanisms—the biology of pain—to come up with better drugs,” says Dr. Yuriy of pain—to come up with better drugs,” says Dr. Yuriy Usachev, a professor of neuroscience and pharmacology Usachev, a professor of neuroscience and pharmacology at University of Iowa who runs a collaborative project at University of Iowa who runs a collaborative project between the university and Ukrainian partners studying between the university and Ukrainian partners studying the role of the body’s complement system in chronic pain. the role of the body’s complement system in chronic pain.

His five-year project, funded by the National Institute of His five-year project, funded by the National Institute of Neurological Disorders and Stroke (NINDS) with support Neurological Disorders and Stroke (NINDS) with support from Fogarty, began in June 2019. from Fogarty, began in June 2019.

His team aims to identify new drug targets by defining His team aims to identify new drug targets by defining the role played by the complement system in the biology the role played by the complement system in the biology of chronic pain. The complement system, the immune of chronic pain. The complement system, the immune system’s frontline of defense, cleans up damaged cells, system’s frontline of defense, cleans up damaged cells, helps the body heal after an infection or injury, and helps the body heal after an infection or injury, and assists in destroying microscopic infectious organisms. assists in destroying microscopic infectious organisms.

The system’s name indicates its “complementary” nature The system’s name indicates its “complementary” nature in enhancing the work of infection-fighting cells. in enhancing the work of infection-fighting cells.

A A perilous perilous period period

million million Ukrainians.

Ukrainians. II can can only only imagine imagine this this [Russian [Russian invasion] invasion] resulted resulted in in more more people people harmed—so harmed—so chronic chronic pain pain will will be be aa critical critical and and major major public public health health issue. issue.

Research Research findings findings

””

It’s well known that the immune system is a contributor It’s well known that the immune system is a contributor to inflammatory and neuropathic pain, which can to inflammatory and neuropathic pain, which can be caused by various diseases or injuries. Growing be caused by various diseases or injuries. Growing evidence now indicates the complement system is evidence now indicates the complement system is “almost inevitably involved in most pain conditions,” “almost inevitably involved in most pain conditions,” says Usachev. Using mouse models, Usachev’s team says Usachev. Using mouse models, Usachev’s team has verified that the complement system is a critical has verified that the complement system is a critical modulator and regulator of neuropathic pain. They also modulator and regulator of neuropathic pain. They also discovered that the site of action for the complement discovered that the site of action for the complement system in neuropathic pain is the spinal cord. “The system in neuropathic pain is the spinal cord. “The therapeutic implication is that any new drug will need therapeutic implication is that any new drug will need to have good blood brain barrier permeability,” says to have good blood brain barrier permeability,” says Usachev. “Another important finding is that, among Usachev. “Another important finding is that, among the multiple cell types in the spinal cord, microglia is the multiple cell types in the spinal cord, microglia is the key one.” The project has also shown neurons to be the key one.” The project has also shown neurons to be involved, most likely indirectly. Going forward, Usachev’s involved, most likely indirectly. Going forward, Usachev’s team will focus on understanding how connectivity from team will focus on understanding how connectivity from complement system to microglia to neurons works. complement system to microglia to neurons works.

36 Delaware Journal of Public Health - November 2023

A timeline of Usachev’s project tells a tale of the worst A timeline of Usachev’s project tells a tale of the worst possible circumstances to conduct research in Ukraine. possible circumstances to conduct research in Ukraine.

On March 11, 2020, WHO declared COVID-19 a pandemic On March 11, 2020, WHO declared COVID-19 a pandemic (that did not officially end until May 5, 2023). In February (that did not officially end until May 5, 2023). In February 2022, Russia invaded Ukraine and continues its offensive 2022, Russia invaded Ukraine and continues its offensive to this day. to this day.

Usachev believes studying chronic pain in Ukraine is Usachev believes studying chronic pain in Ukraine is crucial. Persistent pain affects 100 million Americans and crucial. Persistent pain affects 100 million Americans and 15 million Ukrainians. “I can only imagine this [Russian 15 million Ukrainians. “I can only imagine this [Russian invasion] resulted in more people harmed—so chronic invasion] resulted in more people harmed—so chronic pain will be a critical and major public health issue,” he pain will be a critical and major public health issue,” he says. says.

There’s a very strong interrelationship between postThere’s a very strong interrelationship between posttraumatic stress disorder (PTSD) and pain, notes Usachev. traumatic stress disorder (PTSD) and pain, notes Usachev.

“Pain contributes to PTSD, but PTSD is also a risk factor “Pain contributes to PTSD, but PTSD is also a risk factor for developing chronic pain.” He adds that one aspect for developing chronic pain.” He adds that one aspect of pain “that is not emphasized enough is that it’s not of pain “that is not emphasized enough is that it’s not only physiological, but also psychological.” Emotions can only physiological, but also psychological.” Emotions can significantly amplify pain and convert it from transient to significantly amplify pain and convert it from transient to chronic, he says. chronic, he says.

While the primary motivation for the project is to improve While the primary motivation for the project is to improve pain management and overall health of Ukrainians, pain management and overall health of Ukrainians, contributing to the global body of knowledge about pain contributing to the global body of knowledge about pain will be another key outcome. will be another key outcome.

9 9

Photo Photo courtesy courtesy U.S. U.S. Army Army National National Guard/Amy Guard/Amy Carle Carle

Persistent pain pain affects affects 100 100 million million Americans Americans and and 15 15 ““ Persistent

Ukrainian soldiers provide medical response in a simulated casualty situation Ukrainian soldiers provide medical response in a simulated casualty situation in 2018. in 2018.

DIRECTOR’S COLUMN

By Dr. Peter Kilmarx, Acting Director, Fogarty International Center

The collateral benefits of PEPFAR The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has been an essential part of the global response to HIV/AIDS. Its numerous collateral benefits include building capacity to address other health threats.

I was the country director for the U.S. Centers for Disease Control and Prevention (CDC) in Botswana when President George W. Bush announced the PEPFAR program two decades ago. At that time, the prevalence of HIV-1 infection in pregnant women was 37%. Botswanan President Festus Mogae rightly stated that the country faced extinction.

With support from PEPFAR and other funders, Botswana was able to rapidly ramp up HIV screening, antiretroviral treatment, and viral load testing. I attended patients in the public HIV clinic in Gaborone every Thursday morning and witnessed first-hand the “Lazurus effect” of people who’d been gravely ill with advanced HIV infection; once started on treatment, they’d gain back lost weight, get up from their sick beds, and return to their usual activities.

PEPFAR funding in Zimbabwe were present in Sierra Leone or its neighboring countries, which greatly hampered the Ebola response. Had PEPFAR programs been present in West Africa, many of the more than 11,000 deaths from Ebola could have been averted.

A third example of an added benefit of PEPFAR has been the implementation of medical and health professional education programs in Africa funded by PEPFAR and implemented by Fogarty. Beginning in 2010, PEPFAR supported the Medical Education Partnership Initiative (MEPI), followed by the Health-Professional Education Partnership Initiative (HEPI) and the African Forum for Research and Education in Health (AFREhealth). The NIH Common Fund and other NIH Institutes and Offices provided additional funding for related research training and capacity building programs.

The primary goal of all these programs was to strengthen the education of health professionals in Africa to address the severe health workforce shortages on the continent, increasing the number of graduates, the quality of their education, and their retention, especially in underserved areas. Interventions included raising the number of medical school enrollees, revising curricula, recruiting new faculty, enhancing faculty development, expanding the use of clinical skills in laboratories and community and rural training sites, strengthening computer and telecommunications capacity, and increasing e-learning.

Photo courtesy of Peter Kilmarx

Meanwhile, PEPFAR also supported the development of a robust national HIV surveillance system in Botswana with routine genomic sequencing of HIV-1 isolates from around the country. When the COVID-19 pandemic reached Botswana, Dr. Sikhulile Moyo, a Fogarty trainee and grantee, leveraged that capacity for genomic surveillance As the world’s largest program of SARS-CoV-2 thereby becoming the focused on a single disease—HIV/ first to sequence, identify, and alert AIDS—PEPFAR has transformed the the world about the emergence of the public health landscape in countries omicron variant in November 2021. where it’s been implemented. Rates This was just one of many examples Dr. Peter Kilmarx (right) meets President Festus Mogae (left) at the 10th Anniversary of CDC of new HIV infection and deaths from worldwide of PEPFAR-supported Botswana (BOTUSA) in 2005.

HIV/AIDS have declined significantly. public health capabilities being Beyond this, there have been substantial collateral brought to bear in response to COVID-19. benefits in preparedness and response to other infectious disease threats, the capacity of public health programs I experienced another example of the broader public generally, and a transformation in health education and health benefits of PEPFAR in 2014 when I was the CDC research capabilities in academic institutions. We at country director implementing PEPFAR programs in Fogarty have been proud to partner with PEPFAR in these Zimbabwe. In September, I was deployed to lead the CDC efforts.

Ebola response in Sierra Leone, which, like neighboring countries Liberia and Guinea, had much lower HIV prevaNote: The current PEPFAR authorization ended on lence and did not have PEPFAR programs. None of the September 30, 2023 critical public health systems we’d established with

10

37

PEOPLE PEOPLE PEOPLE

Global Global Global HEALTH HEALTH HEALTHBriefs Briefs Briefs

Fogarty scientist receives Fulbright fellowship Fogarty scientist scientistreceives receives Fulbright Fulbright fellowship Dr.Fogarty Joshua Rosenthal, senior scientist at fellowship Fogarty, received a

NIH launches HIV vaccine trial NIH NIH launches HIV HIV vaccine vaccine trial has A trial oflaunches a preventive HIV vaccinetrial candidate

ASTMH names new CEO ASTMH ASTMH names new newCEO CEO Jamie Baynames Nishi, executive director of the Global Health Tech-

USAID spotlights health systems USAID USAID spotlights spotlights health health systems systems strengthening strengthening strengthening USAID has published several briefs that describe

Dr. Dr. Joshua Joshua Rosenthal, Rosenthal, senior senior scientist scientist at at Fogarty, Fogarty, received received a a Fulbright-Kalam Climate Fellowship from the United States-India Fulbright-Kalam Fulbright-Kalam Climate Climate Fellowship Fellowship from from the the United United States-India States-India Educational Foundation. Rosenthal will collaborate with the Educational Foundation.

Foundation.

Rosenthal Rosenthal will collaborate collaborate with the the SriEducational Ramachandra Institute of Higherwill Education andwith Research Sri Sri Ramachandra Ramachandra Institute Institute of of Higher Higher Education Education and and Research Research (SRIHER) to create a new master's in public health (MPH) (SRIHER) (SRIHER) tofocused to create create aon new a new master's master's in in public public health health (MPH) (MPH) curriculum climate change and health. curriculum curriculum focused focused onon climate climate change change and and health. health.

Jamie Jamie Bay Bay Nishi, Nishi, executive executive director director of the the Global Global Health Health Technologies Coalition (GHTC), has beenof selected as the new TechCEO of nologies nologies Coalition Coalition (GHTC), (GHTC), has has been been selected selected asHygiene as the the new new CEO CEO of of the American Society of Tropical Medicine and (ASTMH). the the American American Society Society of of Tropical Tropical Medicine and and Hygiene Hygiene (ASTMH).

(ASTMH).

She succeeds current CEO KarenMedicine A. Goraleski, who is stepping She She succeeds succeeds current CEO CEO Karen Karen A.A. Goraleski, Goraleski, who is is stepping stepping down after 13 current years.

Executive Director of GHTCwho since 2017, down down after after 1313 years. years.

Executive Executive Director Director of of GHTC GHTC since since 2017, 2017, Nishi was previously managing director at Devex.

Nishi Nishi was was previously previously managing managing director director at at Devex.

Devex.

Former grantee receives groundbreaking USAID grant Former Former grantee grantee receives receives groundbreaking groundbreaking USAID USAID grant The South African Medical Research Council (SAMRC), ledgrant by its

The The South South African African Medical Medical Research Research Council Council (SAMRC), (SAMRC), led byby itsits president and former Fogarty grantee, Dr. Glenda Gray,led secured president president and and former former Fogarty Fogarty grantee, grantee, Dr. Dr. Glenda Glenda Gray, Gray, secured secured a $45 million USAID grant for HIV vaccine research in Africa. The a $45 a $45 million million USAID USAID grant grant for for HIV HIV vaccine vaccine research research in in Africa.

Africa.

The The grant backs the BRILLIANT Consortium, consisting of eight African grant grant backs backs the the BRILLIANT BRILLIANT Consortium, Consortium, consisting consisting of of eight eight African African nations to advance the field toward a safe and globally effective HIV nations nations to to advance advance the the field field toward toward a safe a safe and and globally globally effective effective HIV HIV vaccine. vaccine. vaccine.

Happi elected to National Academy of Medicine Happi Happielected elected totoNational National Academy Academy ofofMedicine Medicine Fogarty grantee, Dr. Christian Happi of Redeemer’s University

Fogarty Fogarty grantee, Dr.Dr. Christian Christian Happi Happi of of Redeemer’s Redeemer’s University and the grantee, African Center of Excellence for Genomics ofUniversity Infectious and and the the African African Center Center of of Excellence Excellence for for Genomics Genomics of of Infectious Infectious Diseases (ACEGID), was elected to the U.S. National Academy of Diseases Diseases (ACEGID), (ACEGID), was was elected elected to to the the U.S. U.S. National National Academy Academy of of Medicine for his impact on infectious disease research in Africa.

Medicine Medicine for for his his impact impact on on infectious infectious disease disease research research in in Africa.

Africa.

His achievements include sequencing the first full SARS-Cov-2 His His achievements achievements include include sequencing sequencing the first first full full SARS-Cov-2 SARS-Cov-2 genome in Africa, which guided publicthe health interventions. genome genome in in Africa, Africa, which which guided guided public public health health interventions. interventions.

Coley recognized for work in biodiversity Coley Coley recognized recognized forforwork work inbiodiversity biodiversityof Science The Panamanian Association for in the Advancement

The The Panamanian Panamanian Association Association forfor the the Advancement Advancement of of Science Science (APANAC) recognized Dr. Phyllis “Lissy” Coley for her work studying (APANAC) (APANAC) recognized recognized Dr. Dr. Phyllis Phyllis “Lissy” “Lissy” Coley Coley for for her her work work studying studying biodiversity in the country and training local institutions and biodiversity biodiversity in in the the country country and and training training local local institutions institutions and and scientists in the study and use of the nation’s natural resources. scientists scientists in in the the study study and and use use of of the the nation’s nation’s natural natural resources. resources.

Coley established the Fogarty-supported International Cooperative Coley Coley established established the the Fogarty-supported Fogarty-supported International International Cooperative Cooperative Biodiversity Groups (ICBG) program in Panama.

Biodiversity Biodiversity Groups Groups (ICBG) (ICBG) program program in in Panama.

Panama.

38 Delaware Journal of Public Health - November 2023

Abegun trial A trial ofenrollment aofpreventive a preventive HIVHIV vaccine vaccine candidate hasThe has in the U.S. and candidate South Africa. begun begun enrollment enrollment in the in the U.S. U.S. and and South South Africa.

Africa.

The Phase 1 trial will evaluate a novel vaccine known The Phase 1 trial 1 trial willwill evaluate evaluate novel a novel vaccine vaccine known known forPhase its safety and ability to ainduce an HIV-specific for for its its safety safety and and ability ability to induce to induce an an HIV-specific HIV-specific immune response in people. The National Institute immune immune response response in people. in people.

TheThe National National Institute of Allergy and Infectious Diseases (NIAID) isInstitute of Allergy of Allergy and and Infectious Infectious Diseases Diseases (NIAID) (NIAID) is is contributing funding for this study. contributing contributing funding funding forfor thisthis study. study.

USAID USAID has has published published several several briefs briefs thatthat describe describe health systems strengthening approaches that have health health systems systems strengthening strengthening approaches approaches thatthat have have been successfully applied in USAID-supported been been successfully successfully applied applied in USAID-supported inofUSAID-supported settings.

Briefs cover a variety topics— from settings. settings.

Briefs Briefs cover cover a variety a variety topics— of topics— from from financial services for health to of incorporating digital financial financial services services for health health incorporating to incorporating digital technologies intofor social andtobehavior changedigital technologies technologies intointo social social andand behavior behavior change change programming—and include case studies. programming—and programming—and include include case case studies. studies.

WHO publishes TB control handbook WHO publishes publishes TBTB control control handbook handbook TheWHO handbook provides practical advice on

The The handbook provides provides practical advice advice on on how tohandbook implement WHOpractical recommendations how how to implement to implement WHO WHO recommendations recommendations on tuberculosis (TB) infection prevention and on on tuberculosis tuberculosis (TB) (TB) infection infection prevention andand control within the clinical andprevention programmatic control control within within the the clinical clinical and and programmatic programmatic management of TB, using a public health management management offirst TB, using using public a public health healthof approach.

It isof theTB, in aamodular series approach. approach.

It is It the is the first first in a in modular a modular series of of practical guides meant to aid in variousseries aspects practical practical guides guides meant meant to aid to aid in various in various aspects of the programmatic management of TB. aspects of the of the programmatic programmatic management management of TB. of TB.

Global Fund to offer reduced HIV Global Global Fund Fund to to offer offer reduced reduced HIV HIV treatment treatment treatment The Global Fund to Fight AIDS, Tuberculosis

The Global Global Fund Fund to Fight to Fight AIDS, AIDS, Tuberculosis Tuberculosis andThe Malaria (the Global Fund), together with and and Malaria Malaria (the (the Global Global Fund), Fund), together together with with its partners and generic pharmaceutical its its partners partners and and generic generic pharmaceutical pharmaceutical manufacturers, plan to offer tenofovir disoproxil manufacturers, manufacturers, plan plan toand offer to offer tenofovir tenofovir disoproxil disoproxil fumarate, lamivudine dolutegravir (TLD), fumarate, fumarate, lamivudine lamivudine and and dolutegravir dolutegravir (TLD), a first-line HIV treatment, for under US$45(TLD), per aperson, first-line a first-line HIV treatment, treatment, for under under US$45 US$45 perper perHIV year.

This will for allow governments person, person, per per year. year.

This This will will allow allow governments governments in resource-limited settings to expand access to in resource-limited in resource-limited settings to expand to expand access access to to critical HIV services.settings critical critical HIVHIV services. services.

WHO releases hypertension impact report WHO WHO releases releases hypertension hypertension impact impact report report The first-ever report from WHO provides

The The first-ever first-ever report report from from WHO WHO provides provides statistics on the global burden of hypertension statistics statistics on on thethe global global burden of for hypertension of hypertension and recommendations andburden tools nations andenhance and recommendations recommendations and and tools tools forfor nations nations to hypertension prevention, control, to enhance tosurveillance. enhance hypertension hypertension prevention, prevention, control, control, and The report also includes andand surveillance. surveillance.

TheThe report report alsoalso includes includes “hypertension profiles” for each member state “hypertension “hypertension profiles” profiles” for each each member member state state outlining current burdenforand control measures for outlining outlining current current burden burden andand control control measures measures forfor this disease. thisthis disease. disease.

11 1111

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Global Health Matters September/October 2023 Volume 22, No. 5 ISSN: 1938-5935 Fogarty International Center National Institutes of Health Department of Health and Human Services Communications director: Andrey Kuzmichev Andrey.Kuzmichev@nih.gov

Writer/editor: Mariah Felipe Mariah.Felipe@nih.gov Writer/editor: Susan Scutti Susan.Scutti@nih.gov Digital analyst: Merrijoy Vicente Merrijoy.Vicente@nih.gov Designer: Carla Conway In rare cases when a correction is needed after an issue’s printed version has been finalized, the change will be made and explained in the online version of the article.

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NIH recently revised its Foreign Subaward Agreement Policy; changes go into effect January 2, 2024.

Changes to the NIH Foreign Subaward Agreement Policy go into effect in January 2024.

The most notable revision to the policy requires that “subaward agreements must stipulate that foreign subrecipients will provide access to copies of all lab notebooks, all data, and all documentation that supports the research outcomes as described in the progress report, to the primary recipient with a frequency of no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission.”

It is also important to note that by “access to,” it is understood that such access may be entirely electronic.

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Managing editor: Judy Coan-Stevens Judith.Coan-Stevens@nih.gov

NIH updates policy on foreign subawards

These changes aim to ensure that NIH-funded projects maintain the highest standards of research integrity while fostering international scientific cooperation.

By enhancing transparency, accountability, and security in foreign collaborations, NIH hopes to foster continued global scientific cooperation while protecting American innovation and research excellence.

For more information on these policy changes and their implications for your research, please visit the NIH subaward webpage on grants.nih.gov.

39

Machine Learning Methods for Systematic Reviews: A Rapid Scoping Review Stephanie Roth, M.L.I.S., Medical Librarian Librarian, Lewis B. Flinn Medical Library, ChristianaCare Alex Wermer-Colan, Ph.D. Academic Director, Loretta C. Duckworth Scholars Studio, Temple University Libraries

ABSTRACT Objective. At the forefront of machine learning research since its inception has been natural language processing, also known as text mining, referring to a wide range of statistical processes for analyzing textual data and retrieving information. In medical fields, text mining has made valuable contributions in unexpected ways, not least by synthesizing data from disparate biomedical studies. This rapid scoping review examines how machine learning methods for text mining can be implemented at the intersection of these disparate fields to improve the workflow and process of conducting systematic reviews in medical research and related academic disciplines. Methods.

The primary research question that this investigation asked, “what impact does the use of machine learning have on the methods used by systematic review teams to carry out the systematic review process, such as the precision of search strategies, unbiased article selection or data abstraction and/or analysis for systematic reviews and other comprehensive review types of similar methodology?” A literature search was conducted by a medical librarian utilizing multiple databases, a grey literature search and handsearching of the literature. The search was completed on December 4, 2020. Handsearching was done on an ongoing basis with an end date of April 14, 2023. Results. The search yielded 23,190 studies after duplicates were removed. As a result, 117 studies (1.70%) met eligibility criteria for inclusion in this rapid scoping review. Conclusions. There are several techniques and/or types of machine learning methods in development or that have already been fully developed to assist with the systematic review stages. Combined with human intelligence, these machine learning methods and tools provide promise for making the systematic review process more efficient, saving valuable time for systematic review authors, and increasing the speed in which evidence can be created and placed in the hands of decision makers and the public.

METHODS Machine learning refers to a wide range of computational methods involving the optimization of statistical and analytical processes towards enhanced pattern recognition and classification of common features across diverse datasets. At the forefront of machine learning has been experimentation and research involving data mining, especially text mining. Machine learning methods have shown promising applications in the field of information retrieval for identifying keywords, topics, and stylistic patterns across a body of texts.

In the last decade, sophisticated methods of machine learning have become increasingly possible at scale thanks to innovations in graphical processing units and related computing hardware.

The significance of these methodological evolutions for the field of information science and several other fields remains under-examined today. While systematic reviews are a growing practice in library and information science, evidence on the usefulness of machine learning methods for the improvement of automated searches and filtration of resources and other review methods is lagging recent advancements in the field.

Furthermore, assessment of tools and their applications in realworld scenarios remains minimal, with library practitioners needing more guidance on what resources can enable more efficient searching and reviews.

40 Delaware Journal of Public Health - November 2023

This rapid scoping review, then, seeks to address a potential blind spot in the current review literature for the wide variety of machine learning approaches and methods that have been applied to the systematic review process. To this end, this paper sets out to examine the impact of machine learning and related language processing algorithms, with a focus on what impact these techniques can have on improving the efficiency of human workflows.

Completing a systematic review is no small endeavor, typically taking months of planning and over a year to complete. This was felt firsthand by the review team in undertaking this rapid scoping review. While the timeframe does not appear to be rapid, it was necessary for the review to become rapid to avoid spanning several more years due to the broad nature of the research question.

To this end, this review investigates the effectiveness and impact of machine learning for each main stage of the systematic review process. The intended audience is librarians/information professionals who often are the ones guiding researchers through these stages; and to those who develop or are interested in developing future tools/ software for systematic reviews.

This rapid scoping review is categorized by the general stages of the systematic review: Doi: 10.32481/djph.2023.11.008

PROTOCOL/PLANNING STAGE This stage involves investigating the feasibility of the review, gathering a team, and formulating/preregistering a protocol outlining the detailed methods the review will follow, including the predetermined inclusion/exclusion criteria for study selection. Working with a librarian is important at the onset of the review and during the protocol development stage.

Search Stage This stage of the review involves working with a co-authored librarian or information specialist who will create, test, and provide the team with a comprehensive search strategy and translate this search strategy across several databases and grey literature sources. Additional methods may be employed such as citation chaining. Review team members with the most subject matter expertise will hand search the literature.

SCREENING STAGE Title/Abstract Screening This stage of the review involves screening the title/abstracts found in the search results for relevancy. This process is conducted by two independent and blinded reviewers. Studies are filtered by Yes/No, no reasons are recorded for exclusion.

Full Text Screening This stage of the review involves screening only the full texts of the included studies (Yes responses) from the title/abstract phase. Full texts of these studies are gathered, read, and checked against the predefined inclusion/exclusion criteria.

This process is also conducted by two independent and blinded reviewers. Studies are filtered by Yes/No, reasons for exclusion are provided at this phase.

DATA EXTRACTION STAGE This stage of the review involves extracting the data from the included studies from the results of the full text review stage, characteristics of studies are recorded and other important data that will inform the review and statistical analysis if a meta-analysis is required.

Appraisal/Synthesis and Analysis Stage Critical Appraisal This stage of the review involves analyzing the included studies for risk of bias and/or assessing the quality of the study designs and methods.

Synthesis/Writing This stage of the review involves synthesizing the evidence from the included studies. Conclusions are drawn from the evidence and gaps are explored for further research. The written portion of the review can be completed without including a meta-analysis or other statistical analysis.

Meta-analysis/Analysis This stage of the review is only for those that require a metaanalysis or statistical analysis. Not every review requires one. It is recommended to work with a biostatistician at the onset of the review to determine if one is necessary.

Since a rapid scoping review, PRISMA-ScR was utilized for the reporting of this review. A protocol was registered in the Open Science Framework as a preregistration: https://osf.io/j8ydg/

SELECTION CRITERIA The following criteria had to be met for a study to meet inclusion criteria for this rapid scoping review: research methods studies, a focus on machine learning, text analysis and/or automation, a focus on all or one or more stage(s) of the systematic review process, and the use of a machine learning application to assist with any or all stages of the review process. This review takes into consideration the overall landscape of machine learning and text analysis in systematic reviews, especially in terms of emerging trends and methods, while also being attentive to the barriers to facilitation and widespread adoption when user-friendly tools are not readily available.

Systematic reviews including all evidence syntheses were excluded since this review focuses on papers about the methods used in systematic reviews. Studies about updating a systematic review were excluded since this review to examines machine learning in the context of doing a new systematic review.

Editorials, book chapters and similar works were also excluded.

SEARCH METHODS To identify studies to include or consider for this rapid scoping review a medical librarian (SR), developed detailed search strategies for each database. The search was developed for PubMed (NLM) and was translated to Embase (Elsevier), Scopus (Elsevier), LISTA (EbscoHost) and the Social Science Premium Collection (ProQuest).

An attempt to locate grey literature was carried out using a Google search and scanning the SuRe Info web resource (https://sites.google.com/york.ac.uk/sureinfo/home).

A handsearch was conducted by scanning reference lists and the following journals or conference proceedings of BMC Systematic Reviews, Journal of Clinical Epidemiology, International Conference on Evaluation and Assessment in Software Engineering, Journal of Biomedical Informatics, JAMIA, AMIA, Research Synthesis Methods, BMC Bioinformatics, Expert Systems with Applications, ESMAR Conf and MLA vConference.

The search includes a date restriction of 2003 to present. The date restriction is justified due to the slow growth of machine learning overall and the use of machine learning in systematic reviews is a present-day advancement. Although this is not an exact cut-off date, the authors did not see a reason to search further back in the literature, as there were no potential harms or risks to persons due to the nature of this rapid scoping reviews focus on research methods.

The full systematic review search was completed on December 4, 2020, and formal handsearching was done on an ongoing basis with an end date of April 14, 2023.

While this review began before PRISMA-S for searching was published, the search methods are reported with the exclusion of a formal peer review of the search strategies.

Details of the search are provided in the Supplementary Materials and are available in the Temple University institutional repository, TUScholarShare.

41

Original Search Results by Database: • PubMed (NLM) (10,695 Results) • Embase (Elsevier) (981 Results) • Scopus (Elsevier) (5,831 Results) • LISTA (EbscoHost) (2,921 Results) • Social Science Premium Collection (ProQuest) (2,589 Results) The search resulted in 23,190 studies (including 147 from grey literature sources and 38 from hand searching). The 4,440 duplicate studies were found and omitted using Endnote X.7 for the deduplication of records and 18,750 references were eligible to screen.

STUDY SELECTION Titles and abstracts were screened independently and blinded by two reviewers (SR, AWC) to identify studies that potentially met inclusion criteria. Endnote X.7 was used to manage references and remove duplicates before importing into Abstrackr to ensure blinded screening among reviewers. Abstrackr was selected as a screening tool because it uses machine learning to rank studies by relevance. The two blinded reviewers only screened the first 6,995 titles and abstracts. This threshold was decided upon since there were no longer relevant articles. Any disagreements between reviewers of those that were screened, were resolved by a third reviewer (JP) who served as a tiebreaker.

The full text of 283 potentially eligible studies were then

reviewed for eligibility by two independent reviewers (SR, AWC). There were no disagreements identified between reviewers. DeepL was used to translate one non-English language study. It was determined that 166 studies were excluded for the following reasons: wrong study type, wrong outcome, duplicate study, and the lack of availability of a full text. It was determined that 117 studies (1.70%) met eligibility criteria and were included in the final analysis. Details of the study selection process are detailed in the PRISMA Flow Diagram (Figure 1).

DATA EXTRACTION Data was extracted from each of the included studies using a custom data extraction form. Two review authors extracted data using Excel spreadsheets, there were no discrepancies between reviewers. Characteristics of included studies are available in the online supplementary materials

RESULTS This rapid scoping review categorizes the results based on the stage of the systematic review and in order of the review process. A category was also created for multiple review stages; this category includes papers that included multiple tools/software and/or methods for more than one stage of the review or a single tool/software and/ or method that could be used for multiple stages of the review process. Results by review stage:

Figure 1: PRISMA Flow Diagram PRISMA 2020 flow diagram for new systematic reviews which included searches of databases, registers and other sources

Screening

Identification

Identification of studies via databases and registers

Records identified from*: Databases (n = ) Registers (n = )

Records removed before screening: Duplicate records removed (n = ) Records marked as ineligible by automation tools (n = ) Records removed for other reasons (n = )

Records screened (n = )

Records excluded** (n = )

Reports sought for retrieval (n = )

Reports not retrieved (n = )

Included

Reports assessed for eligibility (n = )

Reports excluded: Reason 1 (n = ) Reason 2 (n = ) Reason 3 (n = ) etc.

Identification of studies via other methods

Records identified from: Websites (n = ) Organisations (n = ) Citation searching (n = ) etc.

Reports sought for retrieval (n = )

Reports assessed for eligibility (n = )

Reports not retrieved (n = )

Reports excluded: Reason 1 (n = ) Reason 2 (n = ) Reason 3 (n = ) etc.

Studies included in review (n = ) Reports of included studies (n = )

*Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers). **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools.

From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71. For more information, visit: http://www.prisma-statement.org/

42 Delaware Journal of Public Health - November 2023

Protocol/Planning Stage No studies were identified for this stage of the review.

Search Stage Utilization of machine learning tools for systematic review searching can have its own set of time savings advantages when employed correctly with the involvement of a librarian or information expert. Several studies evaluated new or existing machine learning tools to support the search stage of the systematic review (studies cited in the online supplementary materials). These tools include RCT tagger, Litsearchr, WordNet, Robot Search, Zettair, SLR.qub tool (Systematic Literature Review – query builder), TerMine, Leximancer and Paperfetcher. A tool included in this category is the automated deduplication tool, Deduklick.

Several studies addressed user-friendliness, an important aspect for adoption of machine learning for systematic reviews. While Grames reported on the user-friendliness of the R package, Litsearchr, another caveat to implementation identified was the need for basic experience in using the R coding language. One barrier to the adoption of machine learning in systematic reviews is not having basic knowledge of how-to code. Most researchers conducting systematic reviews will not have this specialized skill set. While not expected, having a basic to advanced understanding in how to code can offer several benefits. One benefit of utilizing code is that there is no cost, as once free systematic review tools move to become proprietary (e.g., Covidence). The availability and cost of tools included in this rapid scoping review are reported in the online supplementary materials.

Screening Stage Screening titles/abstracts is one of the most laborious and timeconsuming stages of the systematic review process and it is here when systematic review teams are truly tested to see if they have both the capacity and the time to complete a full systematic review. By design, machine learning is a suitable method for ameliorating this problem. While there is plenty of literature in this area, many are computer science-based studies describing complex algorithms or methods that will likely not result in the development of a public-facing tool in the short term. Hamel et al., provides some guidance and a set of recommendations for implementing machine learning in the title/abstract screening stage of the systematic review.1 Less than 20 studies in this category referenced an existing tool available for public use. Several examples of publicly available tools include: DistillerSR,2 Rayyan, Colandr, Abstrackr, EPPIReviewer, ASReview, RobotAnalyst, SWIFT Review, MetaMap, RapidMiner, and SyRF. In some cases, a tool in development was mentioned that either could not be found or no longer exists and/ or never made it to production for public use such as StArt,3,4 Revis5 and TWISTER.6 It is not certain if they were later merged with another tool, if they are still in the development stage, or if they never were intended for public use.

A main barrier to adoption of machine learning in systematic reviews is user-friendliness. Only 11 studies7–17 addressed userfriendliness when evaluating their tool or process.

A few projects in existence to assist with the screening stage of the review are not yet suitable for the public or for those without advanced coding skills.18–20

The use of machine learning has shown to reduce the time and human effort devoted to the screening stage of a systematic review;7, 21–40 however, the availability of their data was absent, making it hard to replicate. Extensive research is being done in this area, but data and/or computer scientists need to work together and across disciplines to learn from prior work. Data transparency allows others to build upon their work. However, there seems to be more proprietary tools in this category, making it difficult.

Data Extraction Machine learning can have time saving advantages for the data extraction stage of the systematic review that involves manually reading and extracting relevant texts from the included and chart the data. Duc An Bui, et al41 utilized a PDF text classification tool to see how it helped with the data extraction stage of the systematic review, focusing on PDFBox (https:/PDF box/pdfbox. apache.org/) in combination with an annotation tool called GATE. Two studies42,43 referenced the tool, EXACT (https://bio-nlp.org/ EXACT/), a tool designed to assist in the data extraction of clinical trials from a trials registry, clinicaltrials.gov. Both studies report that the data extracted was accurate and had a significant reduction on workload.

Torres & Cruzes introduced a tool called, Textum which used machine learning to assist researchers in analyzing specific parts of a paper. It estimated to have an overall 80% reduction in the time spent analyzing the texts of a traditional review.44 However, today, this tool could not be located online, and it is not clear if it ever existed for public use. Other studies noted machine learning methods might help with the data extraction stage of the systematic review, but they have not yet resulted in a tool for the public.45,46 However, only one has shared data from their study, which is a barrier to further developing machine learning for this stage of the review.45 One limitation to adoption of these tools is that only one study in this category mentioned being user-friendly. The AFLEX-tag tool was reported to have a usercentered design.47 Unfortunately, this tool does not seem to be publicly available.

Appraisal/Synthesis and Analysis Stage The appraisal, synthesis, and analysis stages of the systematic review are areas where machine learning can aid, but likely not be a replacement for, human input. Several tools in this category were based on coding algorithms,48 with the exception of RobotReviewer (https://www.robotreviewer.net/) , a tool publicly available that could assist with reducing the time spent on the risk of bias assessment stage, but not serve as a complete replacement for manual risk of bias assessment.48–50 A couple of R packages were also designed to help with the final analysis stage of the systematic review, such as Robumeta51 and PublicationBias52 which can assist with the sensitivity analysis for publication bias in systematic reviews.

Lingo3G is a machine learning tool that could support scoping reviews utilizing clustering to generate themes and/or a set of codes across several studies more rapidly than manual methods for synthesizing and coding the literature.53 Marshall et al.

(2015)48 described a novel method for using support vector machines (SVM) to help automate the risk of bias assessment of clinical trials in systematic reviews. The author’s goal was to pair it with another tool in the pipeline to semi-automate the screening of abstracts.

43

Millard et al. reported a tool that was found to reduce the amount of time required by human reviewers for the risk of bias assessment.54 On average it was found that more than 33% of research articles could be labeled with higher certainty than that of a human reviewer. While the use of machine learning to assist with the risk of bias assessment was like the method introduced

by Marshall et al.,48,49 one difference according to Millard et al.54 is that their team tested its method using full text articles rather than only titles and abstracts.

Multiple Review Stages In a case study by Clark et al., multiple tools were used to complete a full small-scale systematic review in just two weeks (2weekSR) for multiple stages of the review.55 One of the tools they used for the 2weekSR, was the RobotReviewer (https://www.robotreviewer.net/), a semi-automation tool that uses machine learning to help with the risk of bias assessment of randomized controlled trials. A suite of automation tools used for the completion of a 2weekSR included the Systematic Review Accelerator,55,56 which is designed to speed up each stage of the systematic review process. Recently the 2weekSR was tested on large scale systematic reviews,57 completed within a few weeks. While review team members for the 2weekSR had protected research time to work on these projects, the findings are still demonstrative of the time reduction benefit of using machine learning.

Similarly, Haddaway et al. evaluates the use of partial automation using computational methods to assist in the facilitation of conducting a mapping review,58 since mapping reviews (and similarly scoping reviews) often assess a greater volume of literature than a traditional systematic review, partial automation can offer several workload advantages for the review team for various stages of the review. Lagopoulos & Tsoumakas, explored similar advantages with the hybrid machine learning tool, Elastic (https://www.elastic.co/what-is/elasticsearch-machine-learning). Elastic had assisted with the preparation, retrieval, and appraisal stages of the systematic review. Utilizing this technology was called a technology assisted review (TAR). This hybrid approach is one that doesn’t involve creating a Boolean query by information experts. It relies instead upon initial machine learning retrieval methods, inter-review ranking and intra-review ranking.

When Altena, A. J. et al.59 examined multiple machine learning tools for multiple systematic review stages, one noteworthy tool that stood out was Swift-Review (https://www.sciome.com/swiftreview/). Swift-Review uses statistical text mining and machine learning methods to help with search refinement to mine for relevant terms and with literature prioritization to help rank order documents for manual screening. Interestingly, Altena reports a low uptake in utilizing tools like Swift-Review in systematic reviews despite the advantages they may provide. Barriers to adoptability were usability, licensing, the steep learning curve, lack of support, mismatch to the workflow and the lack of time needed to assess or evaluate a new tool.

It is important for researchers to evaluate how much time should be devoted to assessing, evaluating, and implementing new tools.

Further complicating this effort is the fact that free tools often are not sustainable with little support for users, especially when they are created by an individual or as a side hobby. This can often make the effort for review teams to implement machine learning 44 Delaware Journal of Public Health - November 2023

tools more time intensive which is a barrier to the time reduction they normally offer. Out of the studies in this category, only two studies by Fabbri et al.3,4 address the user-friendliness of the machine learning tool for systematic reviews, StArt (http://lapes.dc.ufscar.br/tools/start_tool). It would be helpful if future studies adopt this approach.

Miranda et al., explores the development of a new tool with screenshots of how it is applied to assist with several stages of the systematic review (i.e., the search, article selection, and data extraction). However, this tool doesn’t appear to be available to the general public.60

DISCUSSION This rapid scoping review examines the use of machine learning and related language processing algorithms and its impact on improving the efficiency of human workflows that researchers have been developing to reduce the amount of time necessary to complete each stage of the systematic review when compared to manual methods. Completing a systematic review that is done adequately is a time-consuming task and takes a minimum of a year or more depending on several factors.

A few limitations of this review include not exploring machine learning research outside of systematic reviews, which may have led to omitting papers still potentially relevant to the systematic review process. While not a formal exclusion of the paper, the search did not explore all computer science and computational method sources, databases and/or journals.

This rapid scoping review provides important insights into the state of machine learning developments to reduce the time and human labor spent on conducting a new systematic review from start to finish. Included in this review were the barriers to adoption of machine learning for researchers and the lack or reproducibility of machine learning data for those developing new software or tools.

CONCLUSION Testing and providing more robust insights into the implementation of these machine learning methods and/or tools, such as demonstrating and rating the user-friendliness for the general user, are especially important, but are not widely demonstrated in the current literature. The results of this review may help computer scientists and/or programmers to eliminate research waste by identifying what methods or tools are already being developed across several disciplines. Perhaps new collaborations will result in building new tools that can universally address the current inefficiencies of conducting a manual systematic review. Librarians and information specialists will be able to find new ways to partner with researchers to supplement laborious tasks with machine learning.

While machine learning can assist with the systematic review process at various stages, it is still an emerging field for wide-scale application and must rely upon human input to be successfully implemented. Those who are developing tools or machine learning algorithms should work to make sure their research is clear and transparent to allow others to build upon their work.

Future machine learning tools will need to be built with the end-user in mind for ease of use and widespread adoption. The barriers to adoption of machine learning should be considered and addressed during development.

Based on the current research, the use of machine learning to make the systematic review process more efficient remains favorable. Nevertheless, the researcher will need to be able to evaluate this new technology and select those that are best suited for their systematic review team’s needs. Combined with human intelligence, machine learning looks promising for making the systematic review process more efficient, saving time for the review team, and increasing the speed in which evidence is created. However, more experimental research studies with reproducible and open datasets are needed in the future to prove its effectiveness.

While this is an evolving area, currently machine learning is not a replacement for human effort. Those with the most systematic review methodological expertise, librarians, information specialists, statisticians, are all still essential in the overall design and implementation of the systematic review. Machine learning has the potential now to accelerate the rate of review completion for researchers and/or librarians and other information experts who invest time in learning and adopting these new tools.

ACKNOWLEDGEMENTS Many thanks to Ania Korsunska for her assistance in screening titles/abstracts and to Jenny Pierce, MS for her assistance in serving as a tiebreaker.

DATA AVAILABILITY STATEMENT Search strategies and the deduplicated citations are deposited in TUScholarShare available at: https://scholarshare.temple.edu/handle/20.500.12613/4637 Appendices and supplementary materials such as the data extraction template, search strategies, and characteristics of included studies can be found at: https://osf.io/x84t5/ Ms. Roth may be contacted at stephanie.roth@christianacare.org

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The DPH Bulletin

From the Delaware Division of Public Health

September 2023

Homeowners with drinking water problems eligible for treatment

Delaware homeowners with private wells whose drinking water tests high for Total coliforms, E. coli, fluoride, nitrate, nitrite, and sodium can apply to receive a free water treatment system through the Division of Public Health (DPH). Funded through the State of Delaware's Fiscal Year 2023 capital budget (Bond Bill), this program will operate on a first-come, first-served basis until its $200,000 budget expires or additional funds are secured.

Know your Evacuation Zone The Delaware Emergency Management Agency (DEMA) wants everyone to know their Evacuation Zone. State officials will be using Evacuation Zones A, B, C, or D when issuing evacuation warnings or mandatory evacuation orders.

The zones encompass low-lying areas susceptible to flooding and storm surge and are in the hurricane evacuation plan that DEMA updated with the U.S. Army Corps of Engineers, the Federal Emergency Management Agency, and planners in all counties.

Evacuating by zone reduces unnecessary travel and roadway congestion, allowing faster and safer movement for those at risk.

Use the Know Your Zone locator on the PrepareDE.org website to identify your Evacuation Zone. Write it down and keep it in on the refrigerator or with the household and vehicle emergency kits.

Become familiar with your zone before a disaster, as it features evacuation routes for your area.

When an alert is issued for an Evacuation Zone, the Delaware Emergency Notification System (DENS) will send an emergency alert to individuals who have signed up to receive them. DENS alerts will come by text, call, email, or social media, depending on the preferences selected. Local television and radio stations will also announce when evacuation warnings or orders are issued.

If your address is not within an Evacuation Zone, stay informed about emerging dangers in your area.

Eligible individuals must provide proof of enrollment in State or Federal assistance programs such as SNAP, WIC, Supplemental Security Income, LIHEAP, or Temporary Assistance for Needy Families. Applicants must also provide water quality test results from the Delaware Public Health Laboratory. Successful applicants can receive a treatment system, installation, and the first year of maintenance. Homeowners and tenants with landlord approval/sign-off can apply.

Starting Sept. 1, 2023, all Delawareans can receive free bacterial and chemical water test kits for their primary residence. Previously, they cost $4 per kit.

Drinking water test kits can be picked up at the Delaware Public Health Laboratory, located at 30 Sunnyside Road, Smyrna, DE; and at the following three DPH Environmental Health Field Services offices: • 258 Chapman Road, Newark, DE 19702 • Thomas Collins Building, Suite 5, Dover, DE 19901 • Thurman Adams State Service Center, Suite 1700, 544 S. Bedford St, Georgetown, DE 19947.

DPH reminds residents that water quality standards for private wells are not regulated by the federal or state government; they are the responsibility of the homeowner. Click here for contaminants covered by the Safe Drinking Water Act and their health impacts.

For more information about the new program, email DHSS_DPH_PrivateWell@delaware.gov or call 302-744-4546 Option 9.

48 Delaware Journal of Public Health - November 2023

Figure 1. Rate of people who filled high-dose opioid prescriptions (>= 90 MMEs) per 1,000 people, Delaware, 2012-2021

Source: Delaware Department of Health and Social Services, Division of Public Health, My Healthy Community, August 2023.

Note: There was an 83% change between 2012 and 2021.

Prescription drug dispensing data updated on My Healthy Community The My Healthy Community (MHC) Dashboard includes a color-coded matrix of communities that may be at higher risk of Opioid Use Disorder (OUD).

The matrix and other recent updates present prescription drug dispensing trends in Delaware.

The Division of Public Health (DPH) and the Delaware Division of Professional Regulation Office of Controlled Substances made Prescription Monitoring Program (PMP) data publicly available.

The agencies updated the Mental Health and Substance Use Disorder section’s PMP tab with funding from the Centers for Disease Control and Prevention’s Overdose Data to Action grant. The grant also funds the Delaware PMP. Indicators of a high need for treatment are the rate of prescriptions for high dose (greater than or equal to 90 Morphine Milligram Equivalents (MMEs) (Figure 1) and extended-release opioids. These indicators are shown by count and rate of prescriptions and include data on the number of people filling those prescriptions. Trend data for filled prescriptions indicate a steady decline in dispensed opioids and an increase in OUD treatment medications.

DPH continues to educate physicians and pharmacists on best practices for pain management.

This includes offering one-on-one education and continuing education opportunities and working with Delaware providers to create educational materials for providers and patients. DPH compiled an inventory of Delaware-specific, evidence-based pain management resources for prescribers and dispensers at Prescription Medications | Help is Here Delaware. For more information on acute pain management and alternatives to opioids for pain, read the CDC Clinical Practice Guideline for Prescribing Opioids for Pain published in 2022.

The DPH Bulletin – September 2023

Delaware State University offers Trauma Healing workshops and certificate program Delaware State University (DSU) provides healing workshops on Trauma 101 and other topics at the request of organizations, according to Kim Graham, MA, LMSW, Director, DSU Trauma Academy.

DSU also offers a six-course, 18-credit certificate program, “Healing Trauma from an African Centered Healing Approach.” Its goal is to give students who study mental health intervention, as well as mental health practitioners and other professionals, the opportunity to explore healing from an AfricanCentered paradigm. The alternative healing paradigm is designed to build resilience in children, adults, and communities exposed to trauma and toxic stress.

For more information on the certificate program, visit DSU’s Trauma Academy at https://wchbs.desu.edu/research/traumaacademy.

Suspected drug overdose data now available on My Healthy Community The Division of Public Health (DPH) added suspected drug overdose data to the My Healthy Community (MHC) data dashboard. It can be viewed on the Drug Overdose Deaths tab within MHC’s Mental Health and Substance Use Disorder section.

The Centers for Disease Control and Disease Prevention Overdose Data to Action grant funded the addition, which was completed in collaboration with the Delaware Division of Forensic Science.

Suspected drug overdose death counts are an early signal of changing trends in Delaware’s opioid overdose epidemic. Suspected drug overdose deaths based on forensic investigator scene impressions are reported to DPH within a week of occurrence and are considered preliminary until further tests are conducted.

For free 24/7 counseling, coaching, and support, as well as links to mental health, addiction, and crisis services call the Delaware Hope Line at 1-833-9-HOPEDE.

Page 2 of 3 49

September is Ovarian Cancer Awareness Month

Ovarian cancer starts in the ovaries, the walnut-sized organs located on both sides of the uterus.

Often there are no symptoms until it spreads.

Ovarian cancer symptoms are vaginal bleeding, pain or pressure in the pelvic area, bloating, abdominal or back pain, feeling full quickly, needing to urinate more often or urgently, and/or constipation. Talk to your doctor if you have unexplained signs or symptoms of ovarian cancer.

According to the Centers for Disease Control and Prevention (CDC), in Delaware for the period 20162020, among females of all races and ethnicities, the age-adjusted incidence rate of ovarian cancer was 9.8 per 100,000 women (95% Confidence interval: 8.7-11) and 332 cases were reported.

The CDC notes that while any woman can get ovarian cancer, risk factors are: • being middle-aged or older • having close family members (such as a mother, sister, aunt, or grandmother) who had ovarian cancer • having a genetic mutation such as the BRCA1 or BRCA2 gene mutations or one associated with Lynch syndrome • had breast, uterine, or colorectal cancer • are of Eastern European or Ashkenazi Jewish background • having endometriosis • never gave birth or had trouble getting pregnant • took estrogen by itself (without progesterone) for 10 or more years.

Providers might consider genetic counseling and genetic testing for females who have a first degree relative with the disease, whose family members have more than one type of cancer, or if multiple generations of close family have any cancer. Those with a genetic predisposition of ovarian cancer can be prescribed more frequent ovarian cancer screenings (such as ultrasound and blood tests), as well as surgery and medications to reduce risk. No ovarian screening test is currently reliable for the general population.

The Delaware Cancer Treatment Program covers ovarian cancer treatment for women enrolled in the program.

The DPH Bulletin – September 2023 50 Delaware Journal of Public Health - November 2023

Prevent injury and disability from falls Governor John Carney and Lieutenant Governor Bethany Hall-Long proclaimed September 18-22, 2023, as Falls Prevention Awareness Week. ‘

Broken bones, head injuries, and temporary or permanent disabilities can result from falls. In the U.S., falls are the leading cause of trauma-related hospitalizations among U.S. adults aged 65 and older, according to the Centers for Disease Control and Prevention. Falls are the most common cause of traumatic brain injuries for older adults and young children and cause over 95% of hip fractures. In Delaware in 2022, 2,954 falls occurred to adults aged 65 and older, and 568 of them resulted in a head injury, according to the Division of Public Health’s Office of Emergency Medical Services.

The Delaware Coalition for Injury Prevention's Falls Prevention Team encourages adults of all ages to prevent falls by visiting their health care provider annually to review medications and physical activity levels, and to get a falls risk assessment. Adults, especially seniors and those using wheelchairs and walkers, should have annual vision and hearing exams to reduce their risk of falling.

Delawareans can improve coordination, balance, strength, and flexibility by taking a balance class. A Matter of Balance© classes are held in communities throughout the state. Call Volunteer Delaware 50+ at 302-515-3020 or Bayhealth at 302-7447135 for a schedule.

ChristianaCare offers BingoCize, an evidence-based fall prevention program integrating Bingo and exercise, and the ThinkFirst to Prevent Falls© program, which addresses medications, balance, healthy eating, and home modifications. These classes are available in person and virtually at no cost. To schedule these programs or for more information, contact injuryprevention@christianacare.org.

For more information, visit https://www.ncoa.org/, https://www.cdc.gov/steadi/index.html, and https://dhss.delaware.gov/dph/ems/trauma.html.

Page 3 of 3

IS YOUR TEEN TEXTING ABOUT VAPING?

SCAN THE QR CODE TO USE THE

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Teens use emojis to cover their tracks when they text about vaping. They talk about buying vapes, sharing them, trying different flavors, and more.

Use the decoder to find out if they might be vaping.

VapeFreeDE.com

51

AI Models and Drug Discovery Within Pharmaceutical Drug Market Bridget Klaus Intern, Delaware Academy of Medicine/Delaware Public Health Association

ABSTRACT This literature review aims to highlight new drug discovery specifically in the United States, and introduce how artificial intelligence can be used to help reduce development time and costs.

INTRODUCTION In the evolving landscape of healthcare, the pharmaceutical drug market plays a pivotal role in providing essential medications to individuals worldwide. This literature review aims to highlight new drug discovery specifically in the United States, and introduce how artificial intelligence can be used to help reduce development time and costs.

DRUG DISCOVERY The drug discovery and development process is a lengthy, complex, and costly process. It is entrenched with a high degree of uncertainty that a drug will actually succeed. Developing a new drug from the original idea to the launch of a finished product is a complex process that can take 12–15 years and cost in excess of $1 billion.1 The idea for a target can come from a variety of sources including academic and clinical research and from the commercial sector. A target can be a protein, DNA, or RNA that causes or contributes to a disease. Its validation consists of demonstrating that modulating the target has a therapeutic effect.2 It may take many years to build up a body of supporting evidence before selecting a target for a costly drug discovery program. Once a target has been chosen, the pharmaceutical industry—and, more recently, some academic centers—have streamlined a number of early processes to identify molecules which possess suitable characteristics to make acceptable drugs.

After the identification of a lead molecule that might produce the best-desired effects, lead optimization is done to consider it the preclinical candidate. Extensive amounts of testing must take place including in vitro, in vivo, preclinical, and clinical testing. It takes many years before testing begins on humans and even more to begin clinical trials. Arguably, the time and cost to develop a candidate drug are two of the largest challenges hindering companies from entering this process. By reducing the amount of time and overall cost of the R&D process, it could incentivize the creation of many new drugs and ultimately allow drug companies to reduce prices because of the decreased cost.

ARTIFICIAL INTELLIGENCE A potential innovation that can impact the drug market is artificial intelligence (AI), which is a field of study that combines computer science and large datasets in order to solve unique problems. Implementation of AI into the drug research and development process can reduce the cost, time, and amount of studies needed to get a drug created. Although this is a new application to this field, AI has already shown positive results in 52 Delaware Journal of Public Health - November 2023

research, speeding up trials, and reducing the cost and risk related to preclinical and clinical trials.3 Applying AI to the market can help provide a more efficient and targeted approach to drug discovery, thereby also increasing the likelihood of successful drug approvals.4 The development of machine learning theory and the accumulation of pharmacological data has allowed AI to impact various parts of the development process. Some of these areas include peptide synthesis, structure-based virtual screening, ligand-based virtual screening, toxicity prediction, drug monitoring and release, pharmacophore modeling, quantitative structure-activity relationship, drug repositioning, polypharmacology, and physiochemical activity.5 One of the main applications of AI in drug design is the ability to assess specific molecular characteristics for fast in silico screening and identification of potential drugs with desired properties.6 With these capabilities, AI has also been able to assist in the identification of lead molecules.3 There are numerous different algorithms that can be applied to large data sets to allow AI to interpret and display new insights into the data. Common machine learning algorithms include logistic regression (LR), naive Bayesian classification (NBC), k nearest neighbor (KNN), multiple linear regression (MLR), support vector machine (SVM), probabilistic neural network (PNN), binary kernel discrimination (BKD), linear discriminant analysis (LDA), random forest (RF), artificial neural network (ANN), partial least- squares (PLS), principal component analysis (PCA) and more.3 These algorithms can be applied in a multitude of ways to provide researchers with various insight into their drug data. This can cause difficulty (especially for a non-specialist) to assess the usefulness and limitations of a particular method for the problem at hand.6 Research is being done on how effective AI is in the prediction of absorption, distribution, metabolism, excretion, and toxicology (ADMET) properties of lead drugs. The goal of evaluating ADMET properties is to accurately predict a candidate drug. AI can be beneficial in the deselection of compounds that have less favorable predicted ADMET properties and compounds to which various factions within the sponsor organization may feel strong attachment or decisional bias. AI has been found to improve the quality of hit and lead series and the probability of success of candidate compounds compared to what humans alone can do.7 Humans still drive a majority of the research and development process though, as AI is not able to account for certain unamendable values such as enthalpy-entropy compensation, the chemistry of vicinal waters in receptors, multisite and multi-pose Doi: 10.32481/djph.2023.11.009

docking, and the picosecond timescale fluctuations of a receptor pocket.7 While there are many uncertainties in AI modeling, AI should be used as a supplement to human expertise rather than substituting it. Confidence in AI decision quality should be made after careful evaluation of the methods, limitations of the algorithms being used, and the complexity of the model, and many other various factors.

It is also necessary to address that, within the drug design process, the number of parameters that may have influence on biological activity is typically high and relations may be strongly non-linear. With limited amounts of experimental data, the predictive ability of statistical learning systems may suffer from the “curse of dimensionality.”6 This could limit the application of AI to solely determine lead drug compounds. As of 2023 there have been no instances where AI or machine learning (ML) have solely determined a lead to candidate drug or later-stage development decisions.7 Utilization of AI enables the prioritization and optimization of lead compounds, reducing the need for extensive and costly animal testing. Personalized medicine approaches can be facilitated through AI algorithms that analyze real-world patient data, leading to more effective treatment outcomes and improved patient adherence.4 Although to date the application of AI has been used as a supplement along with human oversight, the future holds promise for the improvement of AI models for use in an integrated manner within the drug development industry.

CONCLUSION Applying AI to the research and development of pharmaceutical drugs accelerates the drug discovery process and reduces development costs. This reduction in time and cost will not only help incentivize companies to develop new innovations, but also allow them to reduce the cost of prescription drugs and obtain more profit. Implementation of advanced AI models can help reduce the current financial burden prescription drug costs place on consumers within the US and other countries.

REFERENCES 1. Hughes, J. P., Rees, S., Kalindjian, S. B., & Philpott, K. L. (2011, March). Principles of early drug discovery. British Journal of Pharmacology, 162(6), 1239–1249. https://doi.org/10.1111/j.1476-5381.2010.01127.x 2. Pankevich, D. E. (2014). Drug development challenges. In B. M. Altevogt (Ed.), Improving and accelerating therapeutic development for nervous system disorders: workshop summary (pp. 9-24). National Academies Press. https://www.ncbi.nlm.nih.gov/books/NBK195047/ 3. Zhong, F., Xing, J., Li, X., Liu, X., Fu, Z., Xiong, Z., . . . Jiang, H. (2018, October). Artificial intelligence in drug design.

Science China. Life Sciences, 61(10), 1191–1204. https://doi.org/10.1007/s11427-018-9342-2 4. Vora, L. K., Gholap, A. D., Jetha, K., Thakur, R. R. S., Solanki, H. K., & Chavda, V. P. (2023, July 10). Artificial intelligence in pharmaceutical technology and drug delivery design.

Pharmaceutics, 15(7), 1916. https://doi.org/10.3390/pharmaceutics15071916 5. Gupta, R., Srivastava, D., Sahu, M., Tiwari, S., Ambasta, R. K., & Kumar, P. (2021, August). Artificial intelligence to deep learning: Machine intelligence approach for drug discovery.

Molecular Diversity, 25(3), 1315–1360. https://doi.org/10.1007/s11030-021-10217-3 6. Duch, W., Swaminathan, K., & Meller, J. (2007). Artificial intelligence approaches for rational drug design and discovery.

Current Pharmaceutical Design, 13(14), 1497–1508. https://doi.org/10.2174/138161207780765954 7. McNair, D. (2023, January 20). Artificial intelligence and machine learning for lead-to-candidate decision-making and beyond. Annual Review of Pharmacology and Toxicology, 63, 77–97. https://doi.org/10.1146/annurev-pharmtox-051921-023255

Ms. Klaus may be contacted at bridgetklaus07@gmail.com

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Economic Impact of Cancer Diagnosis on Employment, Wages and Intent to Return to Work Iftekhar Khan, M.D.; Rishi Sawhney, M.D.; Stephanie McClellan, D.N.P., M.B.A., M.S.N., R.N., C.M.S.R.N., N.E.-B.C.; Kathrina Chua, M.D.; Abeer Alfaraj, MD; John Shevock, F.A.C.H.E., F.A.C.M.P.E. Bayhealth Cancer Center Dain Chun, M.S. Ph.D. Student, Center for Pharmacometrics and Systems Pharmacology, University of Florida

ABSTRACT Objective: To assess the work hours and income of patients who have been diagnosed with cancer, treatable with curative intent. The study evaluated the impact of lost wages on patients and their families in the population that is served by Bayhealth Medical Center. Methods: This study was conducted between 2016 and 2020. The curative cancer focus included breast, lung, prostate, colorectal, testicular, uterine, cervical, bladder, esophageal, head and neck, and stomach. Patients were identified on their survivorship visit with Medical Oncology or Radiation Oncology. Two surveys were used to collect information specific to employment status, leave of absence/change in hours, and monthly income. Results: Survey one had 142 participants. Survey two had 134 participants. In survey one, 99.3% of participants reported being employed at least half time at the time of diagnosis. On the Survivorship visit, 95% reported being currently employed at least half time. Only 87% were employed in the same job and title.

When reporting income, 64% of participants had the same income, and 25.4% reported a reduction in income since being diagnosed and completing cancer treatment. In survey two, completed one-year post-survivorship visit, 83.6% of participants reported being employed at least half time. Of those, 76.9% were working for the same employer as they were at time of diagnosis. To that end, 26.1% of participants reported their income as lower than it was at time of diagnosis. Conclusion: A cancer diagnosis with treatment can and does have an impact on a person’s ability to remain employed at least half time and sustain the same level of income.

INTRODUCTION With the development of new treatments and earlier diagnoses, the number of Americans living with cancer is growing. A 2014 report issued by the American Cancer Society estimated the number of individuals in the United States living with cancer to be 14.5 million. This growth was projected to be 19 million by 2024. In 2022, the National Cancer Institute estimated there will be over 22.5 million survivors by 2032.1 With continued advancements in early detection and screening, the number of people living with cancer comes with economic and employment concerns.

The National Cancer Institute reported in 2019 the economic burden of cancer cost nationally to be over $21 billion.2 The annual report went on to estimate the out of pocket expense for patients and families to exceed $16 billion with more than $4 billion in time cost.2 Considering the amount of time traveling to and from appointments, waiting for care to be delivered, and receiving care, this number may be drastically under estimated. The American Cancer Society confirmed a higher level of attention needs to be paid to patients’ medical financial hardship and financial distress due to the cost of treatment and the implications it has on patient’s ability to live and function in a pre-diagnosis state.3

BACKGROUND Research around employment, cancer diagnosis cost, and survivorship has been conducted in specific populations and in geographical areas. In 2001, Fesko conducted exploratory 54 Delaware Journal of Public Health - November 2023

research with the use of patient interviews to compare workplace challenges faced by HIV positive patients and those with cancer.4 Another study specifically addressed breast cancer survivors and a look at how employment status impacted quality of life.5 Telephone interviews have been conducted to assess the long term effects of cancer survivorship on employment for workers aged 55 and older.6 In 2013 a study of over 2,000 cancer survivors was conducted to evaluate the impact of living in a rural versus urban area and how it influenced employment.7 Majority of cancer patients self-report they are working at the time of diagnosis. The question remains, is there a pattern or trends pointing out those patients who cannot or will not return to work due to the new challenges of living with a cancer diagnosis? In all the studies listed, a diagnosis of cancer is found to have a direct correlation to reduced work hours and reduced income.

METHODS Participants and Survey

This study was conducted between 2016 and 2020. The focus was on specific curative cancers and stages including breast (Stage I, Stage II, Stage III); lung (Stage I, Stage II, Stage III); prostate (Stage I, Stage II Stage III); colorectal (Stage I, Stage II, Stage III), testicular (Stage I, Stage II, Stage III, Stage IV), uterine (Stage I, Stage II, Stage III), cervical (Stage I, Stage II, Stage III), bladder (Stage I, Stage II, Stage III), esophageal (Stage I, Stage II, Stage III), head and neck (Stage I, Stage II, Stage III, Stage IVa), and stomach (Stage I, Stage II, Stage III).

Doi:

One to three months after the completion of treatment participants were asked to complete a survey (Period 1), assessing the following: employment status, income changes, hours worked, and return to work status after cancer treatment has been completed. The questions were aimed to explore how specific cancer diagnoses and treatments may affect patients’ likelihood of returning to work. The survey questions captured the following: 1) patients’ employment status prior to cancer diagnosis, 2) leave of absence, 3) current employment status at time completing the survey, 4) employment job type, 5) level of income, 6) hours worked prior to and after being diagnosed with cancer, and 7) intent to return to work.

At one year from the initial survey, participants completed a second survey (Period 2).

Furthermore, we employed a marginal modeling approach utilizing Generalized Estimating Equations (GEE) to account for employment status and work hours, while incorporating three distinct time points: the time of cancer diagnosis, the time of the initial survey, and the time of the second survey.

Marginal adjacent categories were offered using logit model for ordinal responses using uniform correlation structure.8,9 logit(P logit( P( Y it ≤ j| j| Xi)) ))=ß =ß0j+ß1xi(timei=1) I ( A) +ß2 xi (timei=2) I ( A) Where i=130, t =1,2,3, j= 1,2 and I(A) is the indicator function for the event A. Here X i denotes the covariate matrix for subject i that includes the response variable of the time.

Outcome Variable Measures

This survey captured the following: 1) patients’ employment status prior to cancer diagnoses, 2) leave of absence, 3) current employment status at time completing the survey, 4) employment job type, 5) level of income, 6) hours worked after being iagnosed with cancer, and 7) intent to return to work.

The electronic medical record was used to collect cancer type and staging.

Statistical Analysis

Chi-squared tests were employed for comparative analysis of changes in job title, employer, and income between periods 1 and period 2.

The employment status variable consists of an ordinal response category, encompassing three levels: “not employed,” “part-time” (defined as fewer than 20 hours), and “full-time.”

Also, work hours are represented as an ordinal response variable categorized into three groups: less than 30 hours, over 30 hours but less than 40 hours, and 40 hours or more per week. In the covariate analysis, demographic factors such as gender, race, education, and marital status were accounted for.

The Wald test was employed to compare the goodness-of-fit between two nested GEE models. P-values of 0.05 or less were considered statistically significant.

Table 1. A Comparative Analysis in Change of Job Title, Employer, and Income Between Periods 1 and 2 Outcome

Categories

Period 1, n=142 (%)

Period 2, n=134 (%)

P-value

Job title

Yes, the same job and title Yes, same job with title with reduced responsibilities No Non-response

124 (87.3) 8 (5.6) 10 (7.0) 0 (0.0)

96 (71.6) 6 (4.5) 30 (22.4) 2 (1.5)

0.001a

Same Employer

Yes No Non-response

133 (93.7) 8 (5.6) 1 (0.7)

103 (76.9) 25 (18.7) 6 (4.5)

<0.001b

Income

Substantially higher Somewhat higher Approximately the same Somewhat lower Substantially lower Non-response

1 (0.7) 14 (9.9) 91 (64.1) 17 (12.0) 19 (13.4) 0 (0.0)

3 (2.2) 26 (19.4) 70 (52.2) 8 (6.0) 26 (19.4) 1 (0.7)

0.02c

a-Pearson’s chi-squared test, b-McNemar’s chi-squared test, c-Fisher exact test

Table 2. Summary Table of Employment Status and Work Hour of Previous Diagnosis, Period 1, and Period 2 Outcome

Categories

Time diagnosed with cancer, n=142 (%)

Period 1, n=142 (%)

Period 2, n=134 (%)

Employment status

full-time part-time No Non-response

111 (78.2) 30 (21.1) 1 (0.7) 0 (0.0)

102 (71.8) 33 (23.2) 7 (4.9) 0 (0.0)

89 (66.4) 23 (17.2) 18 (13.4) 4 (3.0)

Work hours

Less than 30 hours 30-40 hours Greater than 40 hours Non-response

23 (16.20) 41 (28.87) 77 (54.22)ww 1 (0.70)

42 (29.6) 43 (30.3) 56 (39.4) 1 (0.7)

38 (28.4) 31 (23.1) 63 (47.0) 2 (1.5) 55

Table 3. Parameter Estimates for the Marginal Proportional Odds in Response of Employment Status and Work Hours Outcome

Employment status

Work hours

Parameter

Estimate

SE

95% Confidence Interval

p-value

ß01 ß02

-3.066

0.174

(-3.408, -2.724)

<0.001

-1.393

0.222

(-1.828, -0.959)

<0.001

Time 1

0.385

0.152

(0.087,0.684)

0.011

Time 2

0.811

0.218

(0.383,1.238)

<0.001

ß01 ß02

-1.552

0.191

(-1.926, -1.178)

<0.001

-0.288

0.174

(-0.629, 0.053)

0.097

Time 1

0.616

0.131

(0.359, 0.873)

<0.001

Time 2

0.473

0.160

(0.159, 0.787)

0.003

*Estimated standard errors based on the sandwich covariance matrix; SE: Standard error

RESULTS Group 1 consisted of one hundred forty-two (142) participants.

Group 2 consisted of one hundred thirty-four (134) participants.

Breast cancer was the largest group size with 74 participants or 52.1%. The second largest group size was prostate cancer with 20 participants or 14.1%. The third largest group size was head and neck cancer with 17 participants or 12%. Regarding the alteration of job titles, there was a shift in job titles across two distinct periods (P-value=0.001). In period 1, 10 patients (7%) had a different job title, while in period 2, this number increased to 30 patients (22.4%). Furthermore, there was a change in employer over time (P-value<0.001). 8 patients (5.6%) answered that they had a change in employer in period 1, and 25 patients (18.6%) in period 2. Additionally, a discernible decrease in income levels was observed between the two periods (P-value=0.02). In period 1, 19 patients (13.4%) reported having substantially lower income compared to when they were diagnosed with cancer, while in period 2, this number increased to 26 patients (19.4%) (Table 1).

Based on the marginal proportional odds model results, the odds of being employed were 1.470 times greater at the time when diagnosed with cancer ( e0.385=1.470, 95% CI of [1.09, 1.98]) than period 1. Moreover, it was observed that the odds of being employed were substantially greater at the time of cancer diagnosis (e0.811 =2.250, 95% CI of [1.47, 3.45]) than in period 2 (Table 2). In relation to work hours, when diagnosed with cancer, patients had 1.852 times greater odds (e0.616=1.852, 95% CI of [1.43, 2.39]) of engaging in longer work hours compared to period 1. Furthermore, when diagnosed with cancer, patients had 1.604 times higher odds (e0.473=1.604, 95% CI of [1.17, 2.20]) of engaging in longer work hours compared to period 2 (Table 3). No demographic covariates were found to be statistically significant; therefore, they were not included in the model.

CONCLUSION Over the last decade, the cost of cancer care has continued to rise. With multiple factors attributed to this increase, the result for patients equates to financial toxicity. In addition to financial toxicity, patients suffer from side effects extending beyond diagnosis and treatment. These side effects for many are life altering and impair one’s ability to continue or maintain employment similar to before diagnosis. As evidenced through this study, a cancer diagnosis and treatment have a direct impact on the ability to maintain employment and sustain income levels.

The reduction of income coupled with rising cost of cancer care 56 Delaware Journal of Public Health - November 2023

leads to growing disparities in how patients can be treated over time. The implementation of financial navigation programs in addition to ongoing supportive care and survivorship are essential to cancer patients continued success and access to high quality healthcare.

Dr. Khan may be contacted at Iftekhar_khan@bayhealth.org.

REFERENCES 1. National Cancer Institute. (2022). Office of cancer survivorship; statistics and graphs. Retrieved from: https://cancercontrol.cancer.gov/ocs/statistics 2. National Cancer Institute. (2021). Annual report to the nation part 2: Patient economic burden of cancer care more than $21 billion in the Unites States in 2019. NCI Press Release.

Retrieved from: https://www.cancer.gov/news-events/press-releases/2021/annual-reportnation-part-2-economic-burden 3. O’Rourke, K. (2022, March 15). Cancer care causes financial hardship for patients: A new annual report examines the outof-pocket cancer care costs for patients by age group and cancer type: A new annual report examines the out-of-pocket cancer care costs for patients by age group and cancer type. Cancer, 128(6), 1154–1155. https://doi.org/10.1002/cncr.34137 4. Fesko, S. L. (2001). Workplace experiences of individuals who are HIV+ and individuals with cancer. Rehabilitation Counseling Bulletin, 45, 2–11. https://doi.org/10.1177/003435520104500101 5. Timperi, A. W., Ergas, I. J., Rehkopf, D. H., Roh, J. M., Kwan, M. L., & Kushi, L. H. (2013, June). Employment status and quality of life in recently diagnosed breast cancer survivors. PsychoOncology, 22(6), 1411–1420. https://doi.org/10.1002/pon.3157 6. Farley Short, P., Vasey, J. J., & Moran, J. R. (2008, February).

Long-term effects of cancer survivorship on the employment of older workers. Health Serv Res, 43(1 Pt 1), 193–210. https://doi.org/10.1111/j.1475-6773.2007.00752.x 7. Sowden, M., Vacek, P., & Geller, B. M. (2014, June). The impact of cancer diagnosis on employment: Is there a difference between rural and urban populations? J Cancer Surviv, 8(2), 213–217. https://doi.org/10.1007/s11764-013-0317-3

AYUDA ECONÓMICA DISPONIBLE Iniciativa de Trabajo de Salud

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Este programa esta financiado por los fondos de recuperación fiscal estatales y locales a través de el Departamento de Tesorería y el estado de Delaware [SLFRP0139].

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Desde 1930 - marcando la diferencia en Delaware

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SPECIAL EDITION

OCTOBER IS HEALTH LITERACY MONTH!

Message from the Health Literacy Council of Delaware Chair

Health Literacy as a Pathway to Wellbeing A Celebration of Health Literacy Month Greg O’Neill, Patient & Family Health Education Director, Christiana Care

In an age where health information is abundant, and misinformation is equally (if not more) prevalent, the importance of health literacy cannot be overstated. October is recognized as Health Literacy month, and the Health Literacy Council of Delaware is using the month to bring awareness to this vital concept statewide.

“Health Literacy is the ability to obtain, understand, and apply health information to make informed decisions about one’s health and well-being.”

It serves as the foundation upon which individuals can build a healthier and more fulfilling life. It is multi-faceted, encompassing skills such as reading, listening, analytical thinking, and decision-making (see the article from Michael Villaire).

Far too often, medical terminology and healthcare materials are difficult to understand, especially for those with limited education and/ or unfamiliar with the English language. Patients and their loved ones are frequently inundated with information from medical professionals or from their own research, resulting in overload,

confusion, and frustration. The National Assessment of Adult Literacy—a large, nationally representative sample of health literacy in the United States—suggests that

36%

of U.S. adults have substantial limitations in their ability to understand and use health information necessary to prevent and manage disease and chronic conditions and effectively seek and obtain healthcare.1 Contrary to popular belief, health literacy is not exclusively the responsibility of the individual receiving healthcare (see the article from Wilma Alvarado-Little). Medical providers, policymakers, and educators each play crucial roles in ensuring that health information is accessible and comprehensible to all communities. By ensuring all participants in a loved one’s healthcare have a solid foundation of health literacy, we as a state stand to gain: 1. Improved Health Outcomes: Individuals with higher health literacy are more likely to engage in preventive behaviors, manage chronic conditions effectively, and adhere to treatment plans. This leads to better health outcomes and reduced healthcare costs.

Kutner, M., Greenberg, E., Jin, Y., and Paulsen, C. (2006). The Health Literacy of America’s Adults: Results From the 2003 National Assessment of Adult Literacy (NCES 2006–483). U.S. Department of Education. Washington, DC: National Center for Education Statistics.

1

58 Delaware Journal of Public Health - November 2023

2. Enhanced Patient-Provider Communication: Effective communication between healthcare providers and patients is vital for accurate diagnosis and treatment. Health-literate patients can ask questions, understand instructions, and actively participate in their care.

also helped launch standard development for the statewide Community Health Worker Apprenticeship program (see the article from Tim Gibbs), which has successfully graduated 27 newly certified Community Health Workers, with a fourth cohort well underway.

3. Increased Health Equity: Research shows that a person’s level of health literacy is closely linked to socioeconomic status and education level. Improving health literacy can help reduce health disparities by giving everyone, regardless of their background, the tools to take control of their health.

Additionally, we are in the early stages of integrating health literacy into high school and post-secondary curricula, as well as building a dedicated workforce pipeline from our state colleges into in-demand healthcare careers in Delaware (see the article from Peg Enslen). These and many other endeavors culminate into one dedicated vision-achieving more equity through health literacy.

4. Increased Autonomy: A health-literate individual not only possesses the knowledge needed to make informed decisions about their health, but they are confident in their choices, promoting a sense of autonomy and self-efficacy.

The Health Literacy Council of Delaware was founded to initiate these gains for the First State.

Under the auspices of the Delaware Literacy Alliance, the Council brings together, key leaders and stakeholders from anchor healthcare, education, and state institutions to chart a path forward for health literacy integration across the age and culture spectrum. The Council already has made significant strides. We have received a generous grant from Highmark Delaware (see the article from Denee Crumrine). We have

Health literacy is an essential skill that inspires individuals to take control of their health. It is a key fixture in achieving positive health outcomes, reduced healthcare costs, and increased health equity. This October, join the Health Literacy Council of Delaware as we highlight this imperative aspect of healthcare. Ultimately, health literacy is not just a concept; it is a path to empowerment, better health, and a brighter future for all.

To learn more about the Delaware Health Literacy Council, or to join, please contact Greg O’Neill at GONeill@Christianacare.org, Co-Chair Megan McNamara Williams at megan@deha.org, or Adara Scholl at ascholl@pmgconsulting.net.

Our very own Greg O’Neill speaks with Helen Osborne, the highly acclaimed author and founder of Health Literacy Month, on a systems perspective of health literacy.

Listen to the podcast here! >

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On October 23, Governor John Carney will formally announce October as Health Literacy Month at the Carvel building in Wilmington. By signing an official proclamation, the Governor declares the state’s acknowledgment of this vital initiative. We are deeply grateful for this act, and we look forward to continued efforts to enhance health literacy in the First State.

click O C TToOlearn B Emore R Iand S register H E Afor L events, TH L I Tthe E links R Aprovided C Y Mbelow!

ONT H !

To learn more and register for events, click the links provided below!

MONDAY

TUESDAY

3

2 U.S. Health Literacy Policy & Press Event, 11a-1230p Virtual Event

WEDNESDAY

THURSDAY

FRIDAY

4

5

6

11

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Health Literacy in Action Conference Virtual Event

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17 Health Literacy through the 18

Health Equity Network Session: Hader Warraich, MD, 4p-5p For event link, please email: goneill@christianacare.org

Throughout the month, use our promos, and share Health Literacy Month within and across your networks!

Lens of Trauma-Informed Healing, 10a-1p Virtual Event

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30 Health Literacy Research Conference – Health Literacy Lessons for the Age of AI Virtual Event

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Delaware Annual Healthcare Forum, 8a-430p Bally's Dover Casino Resort, Rollins Center, Dover, Delaware

31 Health Literacy Research Conference – Health Literacy Lessons for the Age of AI Virtual Event

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of an Educational Health 19 Effects Promotion Program on Mental Health Literacy and Maternal Wellbeing, 8a-10a, Virtual Event

Accelerating Clinical and Translational Research Webinar, 12-1p Virtual Event

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27Get Tips from an NPD! 11a-1p In-Person Event, Union Hospital

Why not start celebrating early? In September 27-29, join the Health Care Education Association (HCEA) Virtual Conference: Patient Education Improves Quality and Outcomes Participate in the Network of the National Library of Medicine's (NNLM) #citeNLM Wikipedia Edit-a-thon, facilitated by the University of Pennsylvania. Click here to learn more.

Join the 2023 Bayhealth Nursing Research Conference in November!

To learn more, visit: Bayhealth.org/research-conference

Brought to you by in Partnership with the Health Literacy Council of Delaware.

rought to you by

in Partnership with the Health Literacy Council of Delaware.

60 Delaware Journal of Public Health - November 2023

2023 UNITED STATES HEALTH LITERACY POLICY & PRESS EVENT: TAKING ACTION FOR A HEALTHIER NATION

The National Council to Improve Patient Safety Through Health Literacy, the Memory Keepers Discovery Team at the University of Minnesota School of Medicine, and other partnering health literacy experts across the nation hosted the 2023 United States Health Literacy Policy & Press Event, on October 2, 2023.

This crucial gathering brought together policymakers, press/media, health professionals, researchers, educators, healthcare leadership, and advocates to address the pressing issue of health literacy and advocate for systems-level policy change to improve clear health communication across the nation.

It has been over 10 years since the National Action Plan to Improve Health Literacy, yet no major system’s approach to addressing health literacy has been enacted.

In order to meet the Healthy People 2030 objectives, reduce healthcare expenditures, and increase patient safety, education, satisfaction, and health promotion, we need policymaker and education and healthcare leadership support.

This event served as an excellent opportunity to engage with expert speakers, access the latest resources, and interview key thought leaders in the field of health literacy. To access the recording of this virtual event, see here.

61

ON THE NATIONAL FRONT LET’S REMOVE THE BARRIERS AND BE BETTER Michael Villaire, Chief Operating Officer, Institute for Healthcare Advancement

Welcome to October, also known as Health Literacy Month.

Created in 1999 by Helen Osborne, Health Literacy Month is an opportunity for those of us in the field to reach out and spread the word about what health literacy is, why it’s important, and what we can all do to help improve health literacy in our own space.

Every year, the list of activities taking place during October in pursuit of this objective continues to grow. If you’re interested in joining in, visit healthliteracymonth.org for ideas, tools, and plenty of information about health literacy, brought to you by the Institute for Healthcare Advancement (IHA). IHA is a 501(c)(3) non-profit public benefit corporation, whose mission is to advance health literacy toward health equity. Our job is to provide you with the tools you need to be the best health literacy advocate you can be.

WRITTEN MESSAGES • • • • •

Unable to read—text grade reading level beyond the reader’s ability.

Looks too hard to read—no headings, limited white space, dense text with no graphics.

Jargon—using words such as hypertension rather than high blood pressure, for example.

Language—not written in reader’s preferred/ native language.

Too much information—writer did a brain dump of everything they know on the subject, rather than focusing on what the reader needs to know.

There are lots of ways to think about health literacy. I do a fair number of lectures on health literacy, often in the form of a Health Literacy 101 lecture. These talks are mainly designed for those who have never heard of health literacy (or only heard about it in passing) and want to know more. One of the tenets of health literacy is brevity; short, easy-to-understand messages tend to be understood and used better than longwinded messages with too much information.

SPOKEN MESSAGES • Not taking into account the listener’s situation—if you’ve just told someone they have cancer, they’re likely not going to be listening too closely to the next thing you say.

• Not establishing trust—if you are rushing, not listening, or if the patient has had a previous bad encounter with the healthcare system.

• Not testing if your message has been understood—using a tool such as teach-back • Not taking conversational turns—Say something, listen to what the other person has to say, and build upon that.

• Not using qualified interpreters—for those who need language access services.

So, one way I talk about health literacy is that it’s a way to remove barriers. Think about all the ways your message can be misunderstood/not understood/ ignored completely by the recipient.

And these examples don’t even scratch the surface.

There are plenty of ways you can learn to use health literacy practices to become a health literacy advocate. Visit us at healthliteracysolutions.org.

62 Delaware Journal of Public Health - November 2023

ON THE REGIONAL FRONT HEALTH LITERACY INITIATIVES AND LESSONS LEARNED WITHIN PUBLIC HEALTH AGENCIES Wilma Alvarado-Little, MA MSW, Associate Commissioner New York State Department of Health & Director, Office of Minority Health and Health Disparities Prevention

Located in the northeastern part of the United States, New York State is extremely diverse - from the perspectives of culture, history, language, geography, economy, to name a few.

Spreading across approximately 55,000 miles and taking into consideration the diversity of health needs across the state, the New York State Department of Health (NYS DOH) is dedicated to improving the health of all New Yorkers. This is evident in a Prevention Agenda which is New York State’s health improvement plan, the blueprint for state and local actions to improve the health and well-being of all New Yorkers, and to promote health equity in all populations who experience disparities1.

In addition, strategies for successful partnerships include long standing relationships with local health departments, community health centers, hospital systems, community-based organizations, individuals, and groups who rely on the State Department of Health for quality services to achieve health equity and eliminate health disparities. This report provides an overview of previous, current, and forthcoming health literacy activities spearheaded by the New York State Department of Health Office of Minority Health and Health Disparities Prevention (OMH HDP) that support the importance of effective communication and health literacy across the Department.

The current initiatives reflect a multilevel approach to improve effective communication and health literacy across the Department’s internal and external partners. The NY health 2

literacy initiatives developed within the past two years strengthen the case to address health equity, support innovative programs and policies as well as posit research efforts for future DOH and statewide initiatives. In addition, the health literacy initiatives promote collaborative efforts across organizations and communities and identify successful strategies to identify disparities among New York’s racial and ethnic minority populations. As previously mentioned, the New York State Department of Health is the first health department at the state level in the United States to execute an organization-wide health literacy survey.

Qualitative insights from the survey will address the following areas: adding to the current knowledge base for the full spectrum of health literacy issues which involve the definition of health literacy, mandated or optional training, and current DOH efforts.

The NYS DOH Health Literacy efforts are recognized as an important aspect of the provision of healthcare services. Health information should be presented in a manner that is relevant, understandable, and resonates with the diverse communities throughout New York State. OMH HDP staff address health literacy in the many aspects of programs and initiatives. It applies to data, the public, and work environments. It is also infused in areas of language access and cultural and linguistic competency.

DOH is seen to be the front runner in providing information about health and healthcare and can achieve health equity when information is understood, explained in a manner that resonates with the individual, and provides this in an environment of trust and collaboration.

[1] health.ny.gov/prevention/prevention_agenda/2019-2024/. Retrieved April 4, 2019.

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One October 5, Christiana Care hosted the Health Equity Network Sessions conversation with Dr. Haider Warraich, who recently joined the FDA and is focused on chronic disease.

Dr. Warraich is the Director of the Heart Failure Program at the VA Boston Healthcare System and Assistant Professor of Medicine at the Harvard Medical School. He also serves as an Associate Physician at Brigham and Women’s Hospital. He has published more than 150 papers, including in the New England Journal of Medicine and the Journal of the American Medical Association. His research focuses on heart disease, end of life care, and disparities in the health system.

He frequently writes for the New York Times and Washington Post, and he is the author of the books Modern Death, State of the Heart, and The Song of Our Scars.

During his presentation, Dr. Warraich spoke to the paradigm shift that has occurred concerning life expectancy, which has remarkably doubled within just 150 years. However, despite the increase of the quantity of life, the quality of life has drastically decreased, in large part due to chronic diseases such as heart disease, diabetes, and chronic lung disease.

“It is evident that the years that we live free of disability have actually decreased over time.”

Eight of the 10 most common causes of death in the United States are now all chronic conditions starting with heart disease, which remains our #1 cause of death.

64 Delaware Journal of Public Health - November 2023

Dr. Warraich shared some interesting facts throughout his presentation: •

The healthcare system pays the most for drugs that treat common conditions like atrial fibrillation, which is an abnormal heart rhythm or heart failure, or high cholesterol, and other chronic conditions, particularly diabetes.

•

58% of Americans live with more than one

•

20% of Americans ages 20 to 29 have more

•

•

•

chronic condition.

than one chronic condition.

Around the world, the four most common causes of death are all chronic diseases: cardiovascular disease, cancer, lung disease, and diabetes.

30% of Caucasian deaths and 60% of

African American deaths from heart disease are preventable.

Minority communities, as well as rural communities, face significant barriers to quality healthcare and health information. Dr. Warraich shared, “We don’t have physicians practicing where they’re actually needed, which is in fact a very concerning thing.”

The solution to changing chronic condition outcomes lies in the collaboration of interventions, including public health messaging, policy, and technical innovation. Dr Warraich stated, “I think we must focus in on the fact that health literacy, patient engagement, and patient centered care are really going to be at the heart of anything that we do.”

This was a powerful presentation, and we look forward to Dr. Warraich’s continued efforts to resolve the health challenges in front of us.

LOCAL HAPPENINGS HEALTH LITERACY COUNCIL OF DELAWARE RECEIVES BLUEPRINTS FOR THE COMMUNITY GRANT Denee Crumrine, Corporate Communications Manager, Highmark Blue Cross Blue Shield Delaware

Highmark Blue Cross Blue Shield Delaware is proud to support the Health Literacy Council of Delaware through the BluePrints for the Community Grant Program.

BluePrints for the Community, housed by the Delaware Community Foundation, was established to increase access to care and reduce health care disparities in Delaware. The program has contributed over $35 million to the community since its inception in 2007. This year, the program awarded the Health Literacy Council of Delaware $200,000 for its health information communication efforts.

“Highmark Blue Cross Blue Shield Delaware and Highmark Health Options are actively engaged with statewide literacy improvement efforts and are pleased to support the Health Literacy Council of Delaware,” stated Nick Moriello, president of Highmark Blue Cross Blue Shield Delaware.

“By ensuring Delawareans have the tools and resources they need to understand their health information, while simultaneously making inclusive accommodations as healthcare organizations, we can promote better health decisions and ultimately improve health outcomes.”

53% of American adults find it difficult to understand health information

36% are unable to use basic health information to make decisions about their health (Kutner et al., 2006)

Furthermore, roughly 35% of Delawareans, aged 16 to 74, are not proficient readers, and at least 20% read below a sixth-grade level, (PMG, 2023).

Improving health literacy can help reduce health disparities and healthcare costs by giving everyone in the First State, regardless of their background, the tools to take control of their wellbeing.

The Health Literacy Council of Delaware plans to use the grant to develop an official state Health Literacy awareness campaign and a dedicated state website. Both initiatives aim to increase access to quality informational materials and care, and simultaneously reduce health disparities in all communities, particularly Delaware’s uninsured and underserved populations. These dedicated efforts will provide access to reliable training materials, best practices, and resources to support clear communication across health institutions and organizations. Content will be regularly updated and informed by leading organizations, including the Centers for Disease Control and Prevention, Agency for Healthcare Research and Quality, Institute for Healthcare Advancement, and the National Academy of Science, Engineering and Medicine.

The Health Literacy Council of Delaware was founded to elevate Health Literacy as a priority for the First State. Under the auspices of the Delaware Literacy Alliance, the Council brings together, key leaders and stakeholders from anchor healthcare, education, and state institutions to chart a path forward for health literacy integration across the age and culture spectrum.

“This grant will help us achieve impactful changes for the vulnerable populations of the state,” said Greg O’Neill, Patient & Family Health Education Director at ChristianaCare and Chair of the Health Literacy Council of Delaware. “We are extremely excited and grateful for this opportunity.”

Highmark Blue Cross Blue Shield Delaware serves approximately 500,000 members through the company’s health care benefits business. It is an independent licensee of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield companies.

For more information, visit highmarkbcbsde.com.

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HEALTH LITERACY IN THE FIRST STATE THE IMPORTANCE OF TEACHING HEALTH LITERACY SKILLS Peg Enslen, Health Sciences Education Associate, Delaware Department of Education

Our education system has a huge responsibility to teach literacy to the students we serve. Literacy is not just the responsibility of the ELA teacher but a commitment of all teachers to have all students reading and writing in their discipline. The Career & Technical Education (CTE) Health Science and Health Education educators have an even greater responsibility to teach health literacy to their students.

Teaching students how to obtain, process, and understand health information and services is needed to make the right health decisions.

“By intentionally focusing on our young people and teaching health literacy, we can significantly influence the health of the next generation.”

Good health is complicated because of all the available information. Not all information is accurate, and some may even be dangerous.

Healthcare is continuously improving, technology is becoming more sophisticated, and healthcare providers are learning more about the field of medicine every day. Certain medical and behavioral conditions are on the rise, and there is an enhanced sense of urgency to support our communities through crises such as the COVID pandemic and long-term medical and behavioral conditions that have resulted.

Teaching students about health and healthcare systems, how to schedule appointments, access and read pamphlets and other forms of media, and how to make informed choices has never been more important. Health literacy can place students on a trajectory of healthy living for their entire lives. Educators need to be very intentional about teaching students how to navigate healthcare 66 Delaware Journal of Public Health - November 2023

systems. Whether it be medical or behavioral health, there is a plethora of variables such as acute and chronic, conditions that may require long-term maintenance that each person needs to learn how to effectively navigate.

As we consider teaching students about health and supporting students in developing health literacy skills, we are influencing the students’ knowledge of health, healthcare, and how to live healthy lifestyles. Moreover, consider the groups of people such as family members and other consumers of healthcare that students encounter through their role within their communities or as healthcare professionals themselves. Parents, siblings, grandparents, aunts, uncles, and many others can be supported and influenced by the knowledge of health and development of health literacy skills for which students develop. Consider the young person who becomes a healthcare professional and the influence they will have on other consumers of healthcare. That influence will have a significant impact on the health of future generations.

Educators in conjunction with health professionals, public, and community health workers need to devote time and be intentional in teaching health literacy to ensure our youth have knowledge about health and how to live healthy lifestyles. The knowledge gained will benefit many others in our local communities and beyond.

COMMUNITY HEALTH WORKERS AND HEALTH LITERACY IN DELAWARE IS GOOD FOR EVERYONE Tim Gibbs, Executive Director, Delaware Academy of Medicine and Delaware Public Health Association

As many readers of this newsletter are aware, Community Health Workers (CHWs) are on the rise nationally and locally, and they are a priority of the Academy/DPHA. CHWs have been called by numerous names over the years (health ambassadors, promotores de salud/ promatora, health navigators, outreach works, peer educators, and more), and they fill an essential role in the public health and clinical team: •

Outreach and Education,

•

Coaching and Social Support,

•

Care Coordination, and

•

Advocacy (https://chwadelaware.org/about-us/ what-are-chws/).

“In Delaware, we are fortunate to be a part of a groundswell of effort to elevate CHWs with a common educational curriculum.”

Ultimately, we are working as part of a larger team of stakeholders toward State codification of the CHW profession, including CHW certification and new ways in which to fund their work, moving them from grant funded positions to reimbursed positions in a variety of key and strategic settings.

The groundswell effort has many moving parts, including the newly formed Community Health Workers Association of Delaware (https:// chwadelaware.org/), spearheaded by Delaware Division of Public Health. Funding from Health Resources and Services Administration (HRSA) is also supporting Statewide educational programs and stipends for attendees of those programs.

New Castle County programming has been funded via the Public Health Management Corporation,

and Kent and Sussex programs have been funded through the Sussex County Health Coalition (SCHC).

Of the core competencies of CHWs, health literacy (and a CHW’s ability to impart health literacy to the general public) is a key teachable attribute around which there is a lot of action and energy. Health literacy has been a byline of this organization for years, stemming from our previous work as the State of Delaware’s medical library system, and continuing today through our programs like Delaware Mini Medical School.

To be more engaged on the health literacy forefront in Delaware, and to connect with our partners at the newly emerging Health Literacy Council of Delaware, led by Greg O’Neil, Co-Chair Megan McNamara Williams at megan@deha.org, or Adara Scholl at ascholl@pmgconsulting.net.

As the basic training programs for CHWs have been created and rolled out by PHMC and the SCHC, we have been heartened to witness their emphasis on health literacy as a core competency. If you are interested in becoming a CHW, links to those HRSA funded training programs and application for stipends are here: •

https://chwcore.org (PHMC Program for New Castle County)

•

https://www.delawarechw.com/ (SCHC Program for Kent and Sussex Counties)

Higher level CHW training also entails additional health literacy education as a requirement of the State of Delaware’s Department of Labor’s CHW apprenticeship program and Division of Public Health. As the State’s affiliate to the American Public Health Association, we are 100% behind this push.

67

Was the 2020 Presidential Election Nerve-Wracking?

Changes in Mental Health Among College Dreamers Sharron Xuanren Wang, Ph.D. Department of Sociology and Criminal Justice, Delaware State University Jarid Goodman, Ph.D. Department of Psychology, Delaware State University J-P Laurenceau, Ph.D. Department of Brain Sciences, University of Delaware

ABSTRACT U.S. presidential elections can be stressful for many Americans; however, there is little research as to how elections might influence mental health of undocumented immigrants specifically. The 2020 U.S. Presidential Election had the potential to dramatically influence immigration policies with the Democratic candidate promising a pathway toward citizenship for undocumented immigrants who arrived in the U.S. as minors (i.e., dreamers), and the incumbent Republican candidate threatening to terminate the DACA program. Using an online survey method, this exploratory longitudinal study examined whether dreamers’ mental health changed following the U.S. presidential election, while also examining risk factors associated with their mental health. We employed GAD-7 and PHQ-9 questionnaires as preclinical screens for anxiety and depression. We found that the mean anxiety and depression scores decreased significantly following the election, i.e., when the democratic candidate was declared the winner.

Risk factors for mental health problems also differed before and after the election. Risk factors for depression before the election included being female, Hispanic white, having a low self-reported status on the subjective social ladder, and having high perceived discrimination; risk factors for depression after the election included coming to the U.S. at an older age and high perceived discrimination. Risk factors for anxiety before the election included being female, having more siblings, both parents working, and high perceived discrimination. Risk factors for anxiety after the election included low self-reported status on the subjective social ladder, being a freshman, and high perceived discrimination. Preliminary results suggest that mental health of dreamers improved after the election. In addition, while risk factors differed before and after the election, perceived everyday discrimination remained a consistent risk factor for mental health issues.

ACKNOWLEDGMENTS The authors acknowledge the assistance of Kevin Noriega in serving as the liaison between the researchers and the population of dreamers at the University.

FUNDING This project was financially supported by a grant from the Delaware-CTR (grant number: U54-GM104941).

INTRODUCTION The year 2020 has introduced a variety of challenges to mental health. In the United States, the first case of coronavirus disease 2019 (COVID-19) infection was reported in January 2020, and widespread infection was documented by March, signaling the start of the COVID-19 pandemic on U.S. soil. In addition to the pandemic, the year 2020 was also a particularly contentious election year for the U.S., with the outcome of the presidential election having a potentially dramatic 68 Delaware Journal of Public Health - November 2023

impact on American politics, including policies governing undocumented immigrants. This past election season has affected many people in the U.S. emotionally, particularly racial minorities and immigrants. The present study employed a longitudinal survey method to examine the mental health of a subset of undocumented immigrants (i.e., dreamers) currently enrolled at a public university before and after the 2020 U.S. presidential election.

It has been estimated that about 11 million people living in the U.S. are undocumented1 with one third having entered the U.S. as minors.2 In 2012, President Obama established Deferred Action for Childhood Arrivals (DACA), a 2-year program allowing some qualified undocumented immigrants who arrived in the U.S. as minors (colloquially known “dreamers”) to be exempted from deportation and obtain work permits. About 830,000 people have been accepted into the DACA program until President Donald Trump put a temporary end to the program in 2019. It was estimated in 2017 that about 241,000 DACA recipients were enrolled in U.S. colleges.3 Overall, it has been Doi: 10.32481/djph.2023.11.011

estimated in 2020 that 450,000 undocumented students were enrolled in U.S. colleges and universities.4 While there is extensive evidence that dreamers and their families experience a myriad of social, economic, and public health disadvantages, emerging evidence has indicated that the COVID-19 pandemic has made matters worse, especially in terms of mental health.5–8 Notably, undocumented families were largely barred from government economic relief, such as stimulus checks provided through the CARES Act and unemployment benefits. In addition, many undocumented immigrants may be less likely to seek healthcare assistance for COVID, due to lack of health insurance and also fears of detainment or deportation. Thus, the health crisis and economic fallout from the COVID-19 pandemic provided new challenges with the potential to further harm mental health of undocumented immigrants.

The 2020 U.S. presidential election likely provided another source of mental health distress for undocumented immigrants, considering predictions that the outcome of the presidential election would dramatically influence immigration policies, including the fate of the DACA program.9 Specifically, incumbent presidential candidate Donald Trump had promised to end the DACA program, while the democratic candidate Joseph Biden had announced his plans to provide dreamers a pathway toward citizenship. Therefore, it had been reasonably assumed that the election outcome would have a dramatic impact on the future and wellbeing of undocumented immigrants living in the U.S., and as a result, their mental health.10 There is extensive evidence that sudden current events including natural disasters, epidemics or pandemics, can impact health outcomes.11 Some research has also examined how a political event such as the U.S. presidential election might similarly influence mental health, especially among racial minorities.12,13 For example, mental health outcomes among Black Americans improved after the 2008 presidential election.12 To our knowledge, the effect of the 2020 presidential election on mental health has not been adequately investigated in dreamers.

Dreamers are an important and growing immigrant population in the U.S., however, quantitative studies on this group are lacking due to data constraints preventing researchers from distinguishing legal status. The little research that has been conducted on this population has indicated trends for disadvantages in mental health, compared to non-Hispanic and Hispanic white U.S. citizens.5,14,15 The present study employs an advantageous group of undocumented college students currently enrolled at a public university in Delaware. We used a survey method approach to examine changes in mental health symptoms before and after the 2020 U.S. presidential election, and also to potentially identify risk factors associated with mental health symptoms in this population. This study hopes to gather important data on undocumented immigrants’ mental health that should facilitate the development of public policies that help this under-served population.

DATA AND METHODS Participants were recruited from a population of approximately 150 undocumented undergraduate college students currently enrolled at a public university in Delaware. These students are DACA recipients who have been awarded a scholarship from TheDream.US foundation. This scholarship provides out-of-state tuition and other related expenses allowing dreamers from “locked-out states” (i.e., states with policies that restrict their access to college) to attend one of four partner colleges to obtain a four-year degree.

The presidential election took place on November 3rd 2020. The pre-election survey was conducted on October 6th 2020 and the post-election survey was conducted on December 1st 2020. Eighty-three students were recruited for the pre-election survey and 79 students remained for the post-election survey, with a retention rate of 95%.

The pre-election survey contained questions pertaining to their demographic information (age, gender, race, ethnicity, country of origin, age of migration), education, employment background, and measures to evaluate their mental health. The post-election survey only included measures for mental health. The two surveys were linked through students’ identification numbers and email addresses. An arbitrary and anonymous ID number was attached to each respondent, and the original identifiers were removed from all digital copies of the surveys. The cases with missing values on the mental health outcomes were dropped using listwise deletion. All procedures were approved by the University’s Institutional Review Board.

Outcome Measures

The outcome of interest was mental health status, measured using two widely validated questionnaires for anxiety and depression, i.e., the Generalized Anxiety Disorder scale – 7 item (GAD-7) and the Patient Health Questionnaire – 9 item (PHQ-9), respectively. We also included the fear of COVID-19 scale (FCV-19S) as one of the outcome variables.

For each assessment, the respondent read a list of symptoms and rated how often they experienced each symptom over the past two weeks (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). The GAD-7 and PHQ-9 have been employed for predicting the presence of anxiety and depressive disorders. In the clinical setting, a score of 10 or greater on the GAD-7 or PHQ-9 serves as a cutoff point, suggesting the patient should be further evaluated for anxiety or depression disorders, respectively. This is based on research indicating a PHQ-9 score ≥ 10 has a sensitivity of 88% and a specificity of 88% for major depression (Kroenke, Spitzer, & Williams, 2001).

Likewise, a GAD-7 score ≥ 10 has a sensitivity of 89% and a specificity of 82% for generalized anxiety disorder.16 Notably, the GAD-7 questionnaire has good internal reliability with a Cronbach’s alpha of 0.91 when used in the general population17 and a Cronbach’s alpha of 0.85 when employed in college students.18 The GAD-7 has also been used to measure mental health in undocumented college students.19 69

Covariates

In addition to the PHQ-9 and GAD-7, the present study also utilized the FCV-19S as one of the outcome variables. This is a 7-item scale with robust psychometric properties.20 The FCV-19S has been shown to a reliable measure of COVID-19 fears among males and females, as well as individuals of all ages. Higher overall scores on the FCV-19S indicate more severe fear of COVID-19.

Potential risk factors for mental health issues included demographic and socioeconomic characteristics as well as perceived discrimination measured using the perceived discrimination scale. Demographic variables include continuous variables, such as age and the square of age. In addition, we have included a binary variable for biological sex (female = 1, male = 0), a binary variable for race (white = 1, non-white = 0), a continuous variable for age of migration, a categorical variable for year in college, and a binary variable for place of birth (Mexico = 1, others = 0). Socioeconomic variables include number of siblings as a continuous variable, mother and father’s unemployment status as binary variables, subjective social ladder as a continuous variable, and student working at least parttime or full-time as a binary variable (yes = 1, no = 0).

We also included DACA status as a binary variable (yes = 1, no = 0), everyday discrimination scale as a continuous variable, and whether the person was paying attention to election-related news as a binary variable (yes = 1, no= 0).

A self-report of subjective social status was also measured using the MacArthur Scale of Subjective Social Status.21 We first calculated the mean scores for the mental health outcomes on the PHQ-9 and GAD-7, and the number of respondents meeting the cutoff on each questionnaire.

We then performed a t-test and z-test to determine whether there were significant differences in the mean pre- and post-election scores and differences in the number of respondents meeting the cutoffs before and after the election. We also performed logistic regressions to identify risk factors associated with their mental health scores and meeting the mental health cutoffs.

RESULTS Table 1 displays descriptive statistics for the mental health risk factors. All variables are derived from the pre-election survey. The mean age for our sample (n=79) is 21 (SD: 2.23). More than half of the respondents in are sample were females (67%). Regarding ethnicity, 97% of the respondents identified as Hispanic. In terms of race, 47% identified as white, 49% identified as other, and the rest as black or Asian. Eighty-five percent of the participants were DACA recipients at the time of the survey. It should be noted that younger dreamers may be less likely to have DACA status, due to the Trump Administration’s refusal to accept new DACA applications. The average age of migration for our sample was 4 years old (SD: 2.19). The majority of respondents (71%) reported Mexico as their country of birth. The average number of siblings was 2.6 (SD: 1.44). The average number reported on the subjective social ladder scale was 4.14 (SD: 1.12).

70 Delaware Journal of Public Health - November 2023

Table 2 presents the descriptive statistics for the mental health outcome variables before and after the election.

The mean FCV-19S score was 18.7 before the election and 20.52 after the election, an increase of 1.82 points. A t-test indicated that the increase was significant, suggesting that fear of covid-19 was higher after the election, compared to before the election (t test = 2.91; p level=0.0047). The average GAD score decreased from 8.67 (SD=6.13) before the election to 6.84 (SD=5.49) after the election. The t-test indicated that this decrease was significant (t test = -3.18; p level = 0.0021). The average PHQ score decreased from 10.09 (SD=6.62) before the election to 7.61 (SD=6.18) after the election, and the difference was significant according to a t-test test (t test=-4.58, p level < 0.001).

Table 1. Descriptive Statistics Variables Age (mean)

21

SD: 2.23

Sex (%) Male

32.91

Female

67.09

Total

(100)

Ethnicity (%) Hispanic

97%

Race (%) White

47.47

Black

1.32

Asian

2.63

Others

48.69

Total

(100)

DACA recipient (%)

84.81

Age of migration (mean)

3.68

SD: 2.19

Origin of Birth (%) Mexico

70.89

Other

29.11

Total

(100)

Number of siblings

2.56

SD: 1.44

Subjective social ladder

4.14

SD: 1.12

Both parents employed (%)

54.43

Respondent currently working (%)

50.63

College year (%) Freshmen

10.13

Sophomore

26.58

Junior

27.8

Senior and above

35.45%

Total

(100.00)

Paid attention to the election (%)

84.81

Perceived discrimination scale

8.00

N

79

SD: 5.35

Table 2 also displays the percentage of respondents meeting the mental health cutoffs before and after the election, as well as the z tests to test whether differences in the proportion of respondents meeting the cutoff changed significantly. The suggested cutoff score for FCV-19S is 16.5. It has been demonstrated previously that a score of 16.5 or higher significantly predicts anxiety, health anxiety, and posttraumatic stress symptoms.22 The percentage of respondents in our study who met the FCV-19S cutoff remained the same before and after the election. In contrast, the proportion of respondents meeting the cutoffs on the GAD-7 and PHQ-9 differed before and after the election.

Specifically, before the election, 40% of the sample met the cutoff for depression, and 53% met the cutoff for anxiety. These numbers went down to 28% and 30%, respectively, after the election. The z test indicated that the decrease in the percentages of respondents meeting

the cutoffs was significant for the PHQ-9 (z test = -2.90, p =0.00), but not for the GAD-7 (z test =-1.35, p =0.18).

In summary, the results on mental health analyses indicate a significant increase in fear of COVID-19 (measured using the FCV-19S), but a significant decrease in anxiety and depression scores (measured using GAD-7 and PHQ-9, respectively) before and after the election.

In contrast, while the proportion of those meeting the clinical cutoffs for anxiety and depression also decreased following the election, the decrease was only statistically significant for depression.

Table 3 lists additional details about how the percentages of respondents meeting the GAD-7 and PHQ-9 cutoffs changed pre- and post-election. Notably, about half of the respondents who met the PHQ-9 and GAD-7 cutoffs before the election continued to meet the clinical cutoffs after the election.

Table 2. Mental Health Variables Mental Health Variables

Pre-Election

Post-Election

Difference

T test

p level

Mean FCV-19S

18.7

20.52

1.82

2.91

0.0047

(SD)

(5.49)

(7.64)

Mean GAD

8.67

6.84

-1.84

-3.18

0.0021

(SD)

(6.13)

(5.49)

Mean PHQ

10.09

7.61

-2.48

-4.58

0

(SD)

(6.62)

(6.18) Z test

p

% meet FCV-19S cutoff

60.76

60.76

0

0

1

% meet PHQ cutoff

53.16

30.38

-22.78

-2.9036

0.00

% meet GAD cutoff

37.97

27.97

-10.00

-1.35

0.18

Note: The cutoff score we used for FCV-19S is 16.5, for GAD-10 is 10, and for PHQ-9 is 10.

Table 3. Percentages Meeting PHQ, GAD, and FCV-19S Cutoff Pre- and Post-Election PHQ Pre-election

Post-election Do not meet the cutoff

Meet the cutoff

N

Do not meet the cutoff

33 (41.8)

4 (5.00)

37 (46.84)

Meet the cutoff

22 (27.85)

20 (25.32)

42 (53.16)

N

55 (68.62)

24 (30.38)

79 (100)

GAD Pre-election

Post-election Do not meet the cutoff

Meet the cutoff

N

Do not meet the cutoff

41 (51.90)

8 (10.13)

49 (62.03)

Meet the cutoff

16 (20.25)

14 (17.72)

30 (37.97)

N

57 (72.15)

22 (27.85)

79 (100)

Do not meet the cutoff

Meet the cutoff

N

Do not meet the cutoff

18 (22.78)

13 (16.46)

31(39.24)

Meet the cutoff

13 (16.46)

35 (44.30)

48 (60.76)

N

31 (39.24)

48 (60.76)

79 (100)

FCV_19S Pre-election

Post-election

Note: values expressed as N (% of total) 71

Table 4 displays results from the logistic regression models to estimate risk factors for meeting the PHQ-9 and GAD-7 cutoffs before the election. The logistic models estimating meeting the PHQ-9 and GAD-7 cutoffs are analyzed separately. The coefficients and the odds ratios are reported in the table. Note that the coefficients are the log of odds ratios. In other words, the odds ratios are calculated from exponentiating coefficients. Therefore, the coefficients and the odds ratios indicate the same results.

In the PHQ-9 model, the coefficients and odds ratios for female, white, subjective social ladder, and perceived discrimination scale were significant at the p < 0.05 level.

Specifically, the odds ratio for the variable female is 8.41 (p=0.024), indicating that holding all other independent variables constant, female college dreamers were 8.4 times more likely than their male counterparts to meet the PHQ-9 cutoff before the election. The odds ratio for the variable Hispanic white is 6.90 (p = 0.021), suggesting that Hispanic white college dreamers were about seven times more likely than other college dreamers to meet the PHQ-9 cutoff score before the election, holding other covariates constant. The odds ratio for the variable subjective social ladder was 0.39 (p=0.013), indicating that the odds of meeting the PHQ-9 cutoff before the election was predicted to decrease by 61% for each additional scale increase in the subjective social ladder, holding other covariates constant. Lastly, in this model, the odds ratio for the everyday discrimination scale was 1.37 (p=0.000). This result suggests that the odds of meeting the PHQ-9 cutoff before the election was predicted to increase by 37% for each additional scale increase on the perceived everyday discrimination scale, holding other covariates constant.

In the GAD-7 model, the coefficients and odds ratios were statistically significant for the following variables: female, number of siblings, both parents working, and perceived everyday discrimination scale. The odds ratio for female was 11.14 (p=0.041), suggesting that holding all other covariates constant, female college dreamers were 11 times more likely than their male counterparts to meet the GAD-7 cutoff before the election. The odds ratio for the number of siblings was 1.95 (p=0.044), indicating that holding all covariates constant, the odds of meeting the GAD-7 cutoff before the election was predicted to increase by 95% for each additional sibling the college dreamer had. Lastly, the odds ratio for the everyday discrimination scale was 1.37 (p=0.000). This result suggests that the odds of meeting the GAD-7 cutoff before the election was predicted to increase by 37% for each additional scale increase on the perceived everyday discrimination scale, holding other covariates constant.

In summary, before the election, the risk factors for college dreamers meeting the depression cutoff included being female, being Hispanic white, low in the subjective social ladder, and high in perceived discrimination. In addition, the risk factors for college dreamers meeting the anxiety cutoff included being female, having more siblings, both parents working, and having high perceived discrimination. The Hosmer-Lemeshow tests for the goodness-of-fit of both the PHQ-9 and GAD-7 models indicate that the present models are appropriate.

72 Delaware Journal of Public Health - November 2023

Tables 4 and 5 present results from the logistic regression models to estimate risk factors for meeting the PHQ-9 and GAD-7 cutoffs after the election. The logistic models estimating whether respondents met the PHQ-9 and GAD-7 cutoffs were analyzed separately. In the PHQ-9 model, the coefficients and odds ratios for the following variables were significant at the p<0.05 level: meeting the PHQ-9 cutoff before the election, age of migration, and score on the perceived discrimination scale. The odds ratio for meeting the PHQ-9 cutoff before election was 8.28 (p=0.018), suggesting that college dreamers who met the PHQ-9 cutoff before the election were 8 times more likely to meet the PHQ-9 cutoff after the election compared to other dreamers, holding all independent variables constant. In addition, the odds ratio for age of migration was 0.58 (p=0.041), indicating the odds of meeting the PHQ-9 cutoff after the election was predicted to decrease by 42% for each additional year added to age of migration. Lastly, the odds ratio for the perceived everyday discrimination scale is 1.23 (p=0.011), suggesting that the odds of meeting the PHQ-9 cutoff after the election was predicted to increase by 23% for each additional scale increase in perceived everyday discrimination, holding other covariates constant.

Regarding the likelihood of meeting the GAD-7 cutoff, the odds ratios for the following variables were statistically significant at the p < 0.05 level: meeting the GAD-7 cutoff before the election, subjective status on the social ladder, being a freshman, and perceived everyday discrimination.

Results indicated that college dreamers who met the GAD7 cutoff before the election were 11 times more likely to meet the GAD cutoff after election compared to other college dreamers, holding other covariates constant (OR = 11.09, p=0.029). In addition, the odds of meeting the GAD cutoff after the election was predicted to decrease by 67% for each additional scale increase in the subjective social ladder, holding other covariates constant (OR=0.33, p=0.035). Results also revealed that relative to sophomores, freshmen are about 178 times more likely to meet the GAD cutoff after the election while holding all the independent variables constant (OR=178.56, p=0.018). Lastly, the odds of meeting the GAD cutoff after the election was predicted to increase by 19% for each additional scale increase on the perceived everyday discrimination scale, holding other covariates constant (OR=1.19, p=0.039).

In summary, after the election, the risk factors for college dreamers meeting the depression cutoff included having met the PHQ-9 cutoff before the election, age of migration, and high perceived discrimination. In addition, the risk factors for college dreamers meeting the anxiety cutoff after the election included having met the GAD-7 cutoff before the election, reporting low status on the subjective social ladder, being a freshman, and having high perceived discrimination. The Hosmer-Lemeshow tests for the goodness-of-fit of both the PHQ-9 and GAD-7 models indicate that the present models are appropriate.

Table 4. Logistic Regression: Predicting of Meeting the PHQ and GAD Cutoff Before Election

PHQ Variable

GAD

Coefficient

SE

Odds Ratio (95% CI)

Significance

Coefficient

SE

Odds Ratio (95% CI)

Significance

Age

3.91

3.93

50.13 (0.02, 110063.9)

0.319

0.81

4.39

2.26 (0.00, 12192.97)

0.853

Square of age

-0.08

0.09

0.92 (0.78, 1.09)

0.346

-0.02

0.08

0.98 (0.81, 1.18)

0.815

Male

REF

REF

REF

REF

REF

REF

REF

REF

Female

2.13*

0.94

8.41 (1.32, 53.49)*

0.024

2.41*

1.18

11.14 (1.11, 112.05)*

0.041

Hispanic White

1.93*

0.84

6.90 (1.33, 35.66)*

0.021

0.41

0.96

1.51 (0.23, 9.85)

0.669

Other race

REF

REF

REF

REF

REF

REF

REF

REF

DACA recipient

0.05

1.19

1.05 (0.10, 10.82)

0.966

-0.04

1.21

0.96 (0.09, 10.29)

0.974

Age of migration

0.42

0.25

1.52 (0.94, 2.46)

0.088

0.22

0.23

1.24 (0.79, 1.95)

0.35

Born in Mexico

1.37

0.88

3.93 (0.70, 22.03)

0.12

-0.27

0.90

0.77 (0.13, 4.47)

0.767

Born in other countries

REF

REF

REF

REF

REF

REF

REF

REF

Number of siblings

0.41

0.29

1.50 (0.86, 2.63)

0.153

0.67*

0.33

1.95 (1.02, 3.74)*

0.044

Subjective social ladder

-0.95*

0.38

0.39 (0.18, 0.82)*

0.013

0.37

0.36

0.69 (0.34, 1.40)

0.304

Both parents working

1.49+

0.83

4.45 (0.87, 22.69)+

0.073

2.11*

0.92

8.27 (1.36, 50.17)*

0.022

Not working

REF

REF

REF

REF

REF

REF

REF

REF

Currently working

-0.55

0.77

0.58 (0.13, 2.62)

0.475

0.51

0.9

1.66 (0.28, 9.68)

0.574

Freshmen

-1.51

1.57

0.22 (0.01, 4.78)

0.336

-1.65

1.69

1.19 (0.01, 5.21)

0.327

Sophomore

REF

REF

REF

REF

REF

REF

REF

REF

Junior

-0.33

1.05

0.72 (0.09, 5.66)

0.756

1.79

1.22

5.98 (0.55, 65.37)

0.142

Senior and above

-1.39

1.16

2.45 (0.03, 2.43)

0.232

-0.31

1.34

0.74 (0.05, 10.15)

0.819

Current GPA

-1.05

0.96

0.35 (0.05, 2.30)

0.275

-0.96

1.12

0.38 (0.04, 3.45)

0.393

Discrimination scale

0.32***

0.09

1.37 (1.15, 1.64)***

0

0.32***

0.09

1.37 (1.15, 1.64)***

0

Paid attention to election

-0.41

1.06

0.67 (0.08, 5.36)

0.705

-1.48

1.14

0.23 (0.02, 2.11)

0.192

FCV-19S

0.1

0.07

1.11 (0.97, 1.28)

0.144

0.13

0.08

1.13 (0.96, 2.11)

0.134

Constant

-47.88

44.04

0.00 (0.00,0.00)

0.277

-12.52

48.91

0.00 (0.00, 0,00)

0.798

N =79

N =79

Prob > chi2 = 0.0003

Prob > chi2 = 0.0002

Pseudo R2 = 0.4195

Pseudo R2 = 0.4559

Hosmer-Lemeshow chi2(8) = 4.35

Hosmer-Lemeshow chi2(8) = 4.21

prob>chi2 =0.8240

prob>chi2 =0.8373

Note: + indicates p <=0.1; * indicates p<=0.05; ** indicates p<=0.01; *** indicates p<=0.001 73

Table 5. Logistic Regression: predicting of meeting the PHQ and GAD cutoff after the election

PHQ Variable

GAD

Coefficient

SE

Odds Ratio (95% CI)

Significance

Coefficient

SE

Odds Ratio (95% CI)

Significance

Met cutoff before election

2.11*

0.89

8.28 (1.44, 47.73)*

0.018

2.41*

1.10

11.09 (1.28, 96.01)*

0.029

Age

3.57

3.15

35.78 (0.07, 17318.07)

0.257

4.22

3.16

67.78 (1.24, 33353.87)

0.182

Square of age

-0.08

0.07

0.93 (0.81, 1.06)

0.262

-0.09

0.07

0.92 (0.81, 1.05)

0.205

Male

REF

REF

REF

REF

REF

REF

REF

REF

Female

-0.89

0.92

0.41 (0.07, 2.51)

0.337

-1.63

1.01

0.20 (0.03, 1.43)

0.108

White

-1.45

1.05

0.24 (0.03, 1.86)

0.167

0.41

1.02

0.66 (0.09, 4.94)

0.688

Other race

REF

REF

REF

REF

REF

REF

REF

REF

DACA recipient

0.32

1.33

1.38 (0.10, 18.71)

0.807

0.56

1.47

1.74 (0.10, 31.37)

0.706

Age of migration

-0.54*

0.26

0.58 (0.35, 0.98)*

0.041

-0.55+

0.29

0.58 (0.33, 1.01)+

0.054

Born in Mexico

-0.26

0.84

0.77 (0.15, 3.96)

0.753

0.28

0.91

1.33 (0.22, 7.96)

0.757

Born in other countries

REF

REF

REF

REF

REF

REF

REF

REF

Number of siblings

0.04

0.24

1.04 (0.66, 1.66)

0.858

0.24

0.28

0.79 (0.45, 1.36)

0.393

Subjective social ladder

-0.80+

0.47

0.45 (0.18, 1.13)+

0.089

-1.10*

0.52

0.33 (0.12, 0.92)*

0.035

Both parents working

0.42

0.8

1.52 (0.32, 7.32)

0.601

-1.31

0.85

0.33 (0.05, 1.44)

0.125

Not working

REF

REF

REF

REF

REF

REF

REF

REF

Currently working

-0.93

0.78

0.39 (0.09, 1.81)

0.232

-1.31

0.85

0.27 (0.05, 1.44)

0.125

Freshmen

1.53

1.75

4.62 (0.15, 141.45)

0.381

5.18*

2.2

178.56 (2.39, 13335.17)*

0.018

Sophomore

REF

REF

REF

REF

REF

REF

REF

REF

Junior

1.13

1.27

3.10 (0.26, 37376)

0.374

0.83

1.4

2.29 (0.15, 35.73)

0.555

Senior and above

0.47

1.16

1.59 (0.16, 15.42)

0.688

1.54

1.13

4.67 (0.51, 42.81)

0.173

Current GPA

1.04

1.21

2.82 (0.27, 29.92)

0.391

0.9

1.31

2.46 (0.19, 31.86)

0.492

Discrimination scale

0.20*

0.08

1.23 (1.05, 1.43)*

0.011

0.17*

0.08

1.19 (1.01, 1.41)*

0.039

Paid attention to election

1.47

1.2

4.35 (0.41, 46.01)

0.222

2.66+

1.46

14.34 (0.82, 250,04)+

0.068

FCV-19S

-0.03

0.05

0.97 (0.88, 1.07)

0.558

-0.06

0.06

0.95 (0.85, 1.06)

0.337

Constant

-44.05

35.23

0.00 (0.00, 0.00)

0.211

-51.4

35.23

0.00 (0.00, 0.00)

0.145

n=79

n=79

Prob > chi2 = 0.0201

Prob > chi2 = 0.0081

Pseudo R2 = 0.3471

Pseudo R2 = 0.3953

Hosmer-Lemeshow chi2(8) = 6.02

Hosmer-Lemeshow chi2(8) = 3.87

prob>chi2 =0.6446

prob>chi2 =0.8682

Note: + indicates p <=0.1; * indicates p<=0.05; ** indicates p<=0.01; *** indicates p<=0.001 74 Delaware Journal of Public Health - November 2023

DISCUSSION AND CONCLUSION The political discourse about dreamers is often centered on the benefits and drawbacks of different immigration policies, whereas the mental health of this population is rarely considered. The present study was designed to gain a preliminary understanding of how a major political event, i.e., the U.S. 2020 presidential election, might influence mental health among undocumented college students. While undocumented college students are commonly considered a hard-to-reach population, the present study recruited a readily available population of dreamers at a Delaware university and tracked their mental health before and after the election. We predicted that, if the incumbent Republican candidate (who opposed the DACA program) won the election, the dreamers in our sample would demonstrate worse mental health (i.e., increased measures of anxiety and depression). If, on the other hand, the Democratic candidate (who voiced support for the DACA program) won the election, this would have a positive impact on mental health of dreamers in our sample. Our findings indicated that, after the Democratic candidate was declared the winner, mental health improved in our sample.

There was a significant decrease in mean scores on the PHQ9 and GAD-7 questionnaires after the election vs. before the election (signifying a potential drop in depression and anxiety, respectively). In addition, the percentage of dreamers who met the cut off for depression on the PHQ-9 scale also dropped significantly after the election (the percentage of respondents meeting the cutoff for anxiety on the GAD-7 also decreased post-election, but not significantly). Importantly, previous research has shown that respondents with a higher score on the PHQ-9 or GAD-7 scale are more likely to be diagnosed with a depressive or anxiety disorder upon further evaluation.16 However, further research will be required to determine whether election results can actually affect whether dreamers meet the official criteria for diagnosis.

The present study also identified important risk factors for mental health problems in this population before and after the election. Pre-election risk factors for depression included being female, Hispanic white, having a low self-reported status on the subjective social ladder, and having high perceived discrimination. Post-election risk factors for depression included coming to the U.S. at an older age and high perceived discrimination. Pre-election risk factors for anxiety included being female, having more siblings, having two working parents, and high perceived discrimination. Post-election risk factors for anxiety included low self-reported social status on the subjective social ladder, being a freshman, and high perceived discrimination. The findings demonstrate how risk factors for a potential mental illness may depend on pre-election anxieties and post-election outcomes. Notably, however, perceived discrimination remained a prominent risk factor for depression and anxiety before and after the election, demonstrating the timelessness of this factor in negatively impacting mental health.

Our findings are consistent with previous research indicating high incidence of mental health issues among undocumented immigrants23 and how potential changes to immigration policy can impact mental health.10 Despite a need for mental health services, prior research suggests that undocumented immigrants may be less likely to seek mental health services due

to low access as well as financial and psychosocial barriers.24 Undocumented immigrants have lower access to health services in general, and fears of detainment and deportation may further dissuade this population from seeking medical attention.25,26 However, even when undocumented college students have access to on-campus mental health services, they might normalize mental health issues as being part of their tentative immigration status and may not seek mental health treatment due to its inability to fully resolve their immigration-related concerns.24 Going forward, community outreach will remain a critical component to any program that hopes to alleviate mental health issues among undocumented immigrants. Such programs will need to address financial as well as psychosocial barriers for obtaining mental health services. In addition, our present findings may be useful in identifying individuals at greater risk for anxiety and depression, and community members and policymakers may devote special attention to targeting these individuals in their outreach programs. In particular, the critical finding that elections may be nerve-wracking for undocumented immigrants suggests that heightened mental health outreach may be especially important during election season.

Dr. Wang may be contacted at xsgoodman@desu.edu

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19. Suárez-Orozco, C., Katsiaficas, D., Birchall, O., Alcantar, C. M., Hernandez, E., Garcia, Y., . . . Teranishi, R. T. (2015).

Undocumented undergraduates on college campuses: Understanding their challenges and assets and what it takes to make an undocufriendly campus. Harvard Educational Review, 85(3), 427–463. https://doi.org/10.17763/0017-8055.85.3.427 20. Ahorsu, D. K., Lin, C. Y., Imani, V., Saffari, M., Griffiths, M. D., & Pakpour, A. H. (2022). The fear of COVID-19 scale: Development and initial validation. International Journal of Mental Health and Addiction, 20(3), 1537–1545. https://doi.org/10.1007/s11469-020-00270-8 21. Adler, N. E., Epel, E. S., Castellazzo, G., & Ickovics, J. R. (2000, November). Relationship of subjective and objective social status with psychological and physiological functioning: Preliminary data in healthy white women. Health Psychol, 19(6), 586–592. https://doi.org/10.1037/0278-6133.19.6.586 22. Nikopoulou, V. A., Holeva, V., Parlapani, E., Karamouzi, P., Voitsidis, P., Porfyri, G. N., . . . Diakogiannis, I. (2022). Mental health screening for COVID-19: A proposed cutoff score for the Greek version of the Fear of COVID-19 Scale (FCV-19S).

International Journal of Mental Health and Addiction, 20(2), 907–920. https://doi.org/10.1007/s11469-020-00414-w 23. Sudhinaraset, M., Ling, I., Gao, L., Chavarin, J., & Gee, G. C. (2022, July). The association between Deferred Action for Childhood Arrivals, health access, and mental health: The role of discrimination, medical mistrust, and stigma. Ethnicity & Health, 27(5), 1075–1087. https://doi.org/10.1080/13557858.2020.1850647 24. Cha, B. S., Enriquez, L. E., & Ro, A. (2019, July). Beyond access: Psychosocial barriers to undocumented students’ use of mental health services. Soc Sci Med, 233, 193–200. https://doi.org/10.1016/j.socscimed.2019.06.003 25. Maldonado, C. Z., Rodriguez, R. M., Torres, J. R., Flores, Y. S., & Lovato, L. M. (2013, February). Fear of discovery among Latino immigrants presenting to the emergency department.

Acad Emerg Med, 20(2), 155–161. https://doi.org/10.1111/acem.12079 26. Hacker, K., Anies, M., Folb, B. L., & Zallman, L. (2015, October 30). Barriers to health care for undocumented immigrants: A literature review. Risk Management and Healthcare Policy, 8, 175–183. https://doi.org/10.2147/RMHP.S70173

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LEXICON Analogous Cell Therapies Medicine manufactured using patient’s own cells.

Anaphylaxis An acute allergic reaction to an antigen to which the body has become hypersensitive.

Antimicrobial Resistance (AMR) Occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines making infections harder to treat and increasing the risk of disease spread, severe illness and death.

Atopic Allergic Disease The genetic predisposition to develop an allergic reaction that produces an exaggerated immunoglobulin E (IgE) response when a person is exposed to otherwise harmless environmental substances.

Autoimmune Disease Happens when the body’s natural defense system can’t tell the difference between your own cells and foreign cells, causing the body to mistakenly attack normal cells.

Biopharmaceutical Complex medicines made from living cells or organisms, often produced using cutting-edge biotechnological methods.

Chimeric Antigen Receptor (CAR) A synthetic receptor that is engineered into immune effector cells, typically T cells.

Coronavirus Aid, Relief, and Economic Security Act (CARES) Authorized direct payments to individuals, generous monthly rebates to families with children, and extended unemployment benefits for laid-off workers.

Corticosteroids An anti-inflammatory medicine. They’re a synthetic version of hormones, normally produced by the adrenal glands.

Cronbach’s Alpha A way of assessing reliability by comparing the amount of shared variance, or covariance, among the items making up an instrument to the amount of overall variance.

Deferred Action for Childhood Arrivals (DACA) program Created to protect eligible young adults who were brought to the U.S. as children from deportation and to provide them with work authorization for temporary, renewable periods.

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LEXICON Generalized Anxiety Disorder scale-7 (GAD-7) A seven-item diagnostic tool validated in both the primary care setting and the general population. The GAD-2 is an ultra-quick version of the seven-item scale that incorporates the first two questions of the GAD-7, which are also critical components of any anxiety disorder.

Genetic Code Expansion (GCE) Artificially modified genetic code in which one or more specific codons have been re-allocated to encode an amino acid that is not among the 22 common naturally-encoded proteinogenic amino acids.

Hematologic Malignancies Cancers that begin in blood-forming tissue, such as the bone marrow, or in the cells of the immune system.

Immunogenicity The ability to induce a humoral and/or cell-mediated immune response.

Intractable diseases Disease that has resulted from an unidentifiable cause, does not have a clearly established treatment, and is associated with a considerably high risk of disability.

Myeloma A cancer of the plasma cells.

Physiochemical Activity Normal intracellular and extracellular physical and chemical processes that are crucial for maintenance of normal homeostasis of a cell.

Recombinant DNA, proteins, cells, or organisms that are created by combining genetic material from two different sources in order to alter their characterization.

Toxoid Vaccine The use of toxoids (as antigens) to induce an immune response in protecting against diseases caused by toxins secreted by specific bacteria.

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RESOURCES Cellergy Pharma

https://cellergypharma.com/ https://geneeditinginstitute.com/home

CRISPR In A Box™

https://www.rockland.com/globalassets/documents/protocols/CRISPR-in-a-Box-Ed-Kits-Protocol.pdf

Delaware Biotech, Pharmaceutical, and Life Sciences Companies https://biopharmguy.com/links/state-de-all-geo.php

DelawareBio – Advancing Bioscience Innovation https://www.delawarebio.org/

Delaware Biotechnology Institute https://www.dbi.udel.edu/

Delaware Prosperity Partnership (DPP) Advancement in Biomanufacturing https://www.choosedelaware.com/key-industries/delaware-biotech-science-technology/

National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) https://niimbl.my.site.com/s/about-niimbl

NitroBiosciences http://www.nitrobiosciences.com/ University of Delaware – Biopharmaceutical Innovation https://www.udel.edu/research-innovation/biopharmaceutical/

80 Delaware Journal of Public Health - November 2023

Index of Advertisers The Nation's Health. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 American Public Health Association Drexel LeBow Analytics 50 Awards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Drexel University The DPH Bulletin - November 2023. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Delaware Division of Public Health Healthcare Workforce Initiative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Delaware Health Force Immunization Summit 2023. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Immunization Coalition of Delaware The DPH Bulletin – Special Flu Edition - September 2023. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Delaware Division of Public Health The DPH Bulletin - September 2023 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Delaware Division of Public Health Healthcare Workforce Initiative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Delaware Health Force Submission Guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Delaware Journal of Public Health

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Delaware Journal of

Public Health

Submission Guidelines

updated August, 2023

About the Journal Established in 2015, The Delaware Journal of Public Health is a peer-reviewed electronic publication created by the Delaware Academy of Medicine/Delaware Public Health Association. The publication acts as a repository of news for the medical, dental, and public health communities, and is comprised of upcoming event announcements, past conference synopses, local resources, peer-reviewed content ranging from manuscripts and research papers to opinion editorials and personal interest pieces, relating to the public health sector. Each issue is largely devoted to an overarching theme or current issue in public health.

The content in the DJPH is informed by the interest of our readers and contributors. If you have an event coming up, would like to contribute an Op-Ed, would like to share a job posting, or have a topic in public health you would like to see covered in an upcoming issue, please let us know.

If you are interested in submitting an article to the Delaware Journal of Public Health, or have any additional inquiries regarding the publication, please contact the managing editor at managingeditor@djph.org, or the publisher at tgibbs@delamed.org.

Information for Authors Submission Requirements The DJPH accepts a wide variety of submission formats, including brief essays, opinion editorials pieces, research articles and findings, analytic essays, news pieces, historical pieces, images, advertisements pertaining to relevant, upcoming public health events, and presentation reviews.

Additional types of submission not previously mentioned may be eligible, please contact a staff member for more information.

The initial submission should be clean and complete, without edits or markups, and contain both the title and author(s) full name(s). Submissions should be 1.5 or double spaced with a font size of 12. Once completed, articles should be submitted via the submission page at https://djph.org/submissions/submit-an-article/ Graphics, images, info-graphics, tables, and charts are welcome and encouraged to be included in articles. Please ensure that all pieces 82 Delaware Journal of Public Health - November 2023

are in their final format, and all edits and track changes have been implemented prior to submission. To view additional information for online submission requirements, please refer to the DJPH website: https://djph.org/submissions/submit-an-article/ Trial registration information is required for all clinical trials and must be included in the final article and/or abstract.

Abstracts Authors must submit a structured or unstructured abstract along with their article.

Abstracts will have a maximum of 200 words, including headings. Structured abstracts should employ 4-5 headings, and may include Objectives, Methods, Results, and Conclusions.

A fifth heading, Policy Implications, may be used if relevant to the article. All abstracts should provide the date(s) and location(s) of the study if applicable, as well as any trial registration information.

Submission Length

Conflicts of Interest

While there is no prescribed word length, full articles will generally be in the 2,500-4,000word range, and editorials or brief reports will be in the 1,500-2,500-word range. If there are any questions regarding the length of a submission or APA guidelines, please contact a staff member.

Any conflicts of interest, including political, financial, personal, or academic conflicts, must be declared prior to the submission of the article, or in conjunction with a submission.

Conflicts of interest are any competing interests that may leave readers feeling misled or deceived, and/or alter their perception of subject matter. Declared conflicts of interest will be published alongside articles in the final publication.

Copyright The journal and its content is copyrighted by the Delaware Academy of Medicine / Delaware Public Health Association (Academy/DPHA).

The contents are licensed under Creative Commons License – CC BY-NC-ND (https://creativecommons.org/licenses/by-nc-nd/4.0/).

Images are NOT covered under the Creative Commons license and are the property of the original photographer or company who supplied the image.

Nondiscriminatory Language Use of nondiscriminatory language is required in all DJPH submissions. The DJPH reserves the right to reject any submission found to be using sexist, racist, or heterosexist language, as well as unethical or defamatory statements.

Opinions expressed by authors of articles summarized, quoted, or published in full within the DJPH represent only the opinions of those authors and do not necessarily reflect the official policy of the Academy/DPHA, the DJPH, or the institution with which the authors are affiliated.

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Delaware Academy of Medicine / DPHA

P.O. Box 89 Historic New Castle, DE 19720

www.delamed.org | www.djph.org Follow Us:

The Delaware Academy of Medicine is a private, nonprofit organization founded in 1930. Our mission is to enhance the well being of our community through medical education and the promotion ofpublic health. Our educational initiatives span the spectrum from consumer health education tocontinuing medical education conferences and symposia.

The Delaware Public Health Association was officially reborn at the 141 st Annual Meeting of the American Public Health Association (AHPA) held in Boston, MA in November, 2013. At this meeting, affiliation of the DPHA was transferred to the Delaware Academy of Medicine officially on November 5, 2013 by action of the APHA Governing Council. The Delaware Academy of Medicine, who’s mission statement is “to promote the well-being of our community through education and the promotion of public health,” is honored to take on this responsibility in the First State.

ISSN 2639-6378