FY 2021 Research Rainmaker Annual Report

SPRING 2022

RESEARCH RAINMAKER An annual publication of the Office of Research

Table of Contents From the Vice Chancellor..............................................................................2 1. Creating a Vision........................................................................................7 UTHSC Operational Strategic Plan for Research, 1st Edition........................7

2. Improving Infrastructure...........................................................................9 New Offices Created (OSP, ORD, OSW, ORMC)..........................................10 Existing Offices Overhauled (LACU, IACUC, IBC, RSA)............................12 Clinical Trial Offices (CRC, CTU)........................................................................14 Making the Best Use of Research Space (Allocation of Research Space Plan).................................................................................................................15 Institutional Research Cores.................................................................................16 3. Creating a more Interdisciplinary, Entrepreneurial Culture...............19 New Leadership.......................................................................................................20 New Award Programs (CORNETs, Innovation Lab)...................................21 New Lecture and Seminar Series (LEADS, VCR DLS).............................22 4. Developing Statewide Institutes and Networks..................................25 New Institutes (ISHPS, TennIRM, TN-CTSI)..................................................25 New Consortia (MRC SC-CHR, TN-PHC).......................................................28 Creation of Integrated Statewide Clinical Trial Networks (EDW, CTGB, CTN2).........................................................................................................................30 5. Reaping the Harvest.................................................................................35 6. Coming Attractions..................................................................................37 OSPR-2.........................................................................................................................37

From the Vice Chancellor It is my pleasure to provide you with the first Annual Report from the Office of Research.

In preparation for hiring a new Vice Chancellor for Research in 2015, UTHSC Chancellor Steve Schwab held a Town Hall where he described the person UTHSC hoped to recruit. He described the individual as a “research rainmaker.” This was the genesis of our journey and, therefore, the title of our annual report.

I arrived in late June 2015 with a charge to supply a vision, and an Operational Strategic Plan for Research (OSPR) to accomplish our institutional research goals. The UT Board of Trustees and UT President had provided the lofty goal of doubling research over a ten-year period. We defined that goal as doubling total annual grant and contract award dollars.

My purview for elevating UTHSC institutional research included all six colleges and four campuses. Therefore, the group of twenty-five leading research faculty who wrote the OSPR came from all colleges and campuses. The first OSPR was approved by Chancellor Schwab in August 2016, and covered the period FY17 through FY21. It defined six areas of research excellence, each with three focus areas, and nine cross-cutting platforms required to support research in all areas. The theme of the first OSPR was that success would be determined by our ability to form interdisciplinary and intra-professional teams of research faculty, breaking down barriers to institutional collaboration. We then had to build, sometimes from scratch, an infrastructure to support the success of the UTHSC research community.

I was charged with overseeing the implementation of the OSPR, which I did with the help of a VCR’s Research Cabinet composed thirty research leaders from all UTHSC campuses and colleges. The OSPR supplied the vision and five-year blue print, but its success was made possible by the UTHSC leadership, the chancellery and deans, the faculty and total research community acting in concert towards common goals.

You will read about the details of the accomplishments in this seminal annual report. The achievements include elevating total annual grants and contracts by more than 50% over the five-year period of FY17-FY21 reaching $126.6 million which is a record in UTHSC history. There are many factors that led to this success:

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Created the Collaborative Research Network (CORNET) awards to fund data collection for larger extramural grants while incentivizing interdisciplinary collaboration (program ROI: >$30M)

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Created statewide clinical trial entities and networks, resulting in a record number of clinical trials: Clinical Trials Network of Tennessee (CTN2), Tennessee Clinical and Translational Science Institute (TN-CTSI), Enterprise Data Warehouse (EDW), and Clinical Trials Governance Board (CTGB)

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Fostered large interdisciplinary grants by developing new institutes and consortia: the Memphis Consortium on Sickle Cell Disease and Classical Hematology Research (director: Dr. Ken Ataga); the Tennessee Population Health Consortium (director: Dr. Jim Bailey); the TN-CTSI (directors: Dr. Karen Johnson and Dr. Michelle Martin); the TN Institute of Regenerative Medicine (TennIRM) (director: Dr. Gábor Tigyi); and the Institute for the Study of Host Pathogen Systems (director: Colleen Jonsson). The VCR’s office led the recruitment of Dr. Ataga and Dr. Jonsson.

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Seeded and encouraged entrepreneurial and industryfriendly culture via internal and external collaboration and partnerships. Created new partnerships with Oak Ridge National Laboratory and St. Jude Children’s Research Hospital.

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Created a partnership with the UT Foundation to receive and direct individual and corporate donations to institutional research priorities.

The theme of the first OSPR was that success would be determined by our ability to form interdisciplinary and intra-professional teams of research faculty, breaking down barriers to institutional collaboration.

We transformed research infrastructure by creating new offices and overhauling existing ones. These efforts were led by our Senior Associate VCR, Dr. Steve Youngentob, and more recently Senior Associate VCR, Dr. Sam Dagogo-Jack, in the area of clinical trial administration.

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Unified the Office of Sponsored Programs and improved its processes, enabling UTHSC to handle and complete a record number of proposals in FY21

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Created new offices: Office of Research Development, Office of Research Communications and Marketing, and Office of Scientific Writing

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Established new streamlined electronic submission and review processes for institutional compliance committees (IRB, IBC, IACUC, RSC, and RCOI). Reorganized the

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Laboratory Animal Care Unit and the Office of Research Safety Affairs (leadership, staff, SOPs, policies and new campus training) •

Established structured oversight of institutional core facilities, optimized their operations, and introduced key improvements

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Established the Clinical Trial Unit and expanded the Clinical Research Center to assist UTHSC clinician scientists with the set up and conduct their clinical trials.

We are well on our way to doubling UTHSC research in 10 years. For this I want to thank our chancellor, Dr. Steve Schwab, who allowed us to be creative in exploring new approaches to expanding institutional research. As this annual report is being published, Steve is nearing his retirement and I cannot thank him enough for his leadership and friendship. For this reason, I want to dedicate this first Research Rainmaker Annual Report to Steve Schwab.

We have created the 2nd edition of the OSPR which covers FY22 to FY26. It includes the very successful Areas of Excellence from the 1st OSPR with new areas: Stem Cell Therapeutics and Regenerative Science; Woman’s Health; and Infectious Diseases (which had previously been a focus area under Respiratory Disorders). We also have a new chancellor, Dr. Peter Buckley, under whose leadership we will continue to expand our institutional research journey. We look forward to working with Peter.

I want to thank the leadership and staff of the Office of Research, whose dedication and perseverance has helped create an outstanding research environment at UTHSC.

Steven R. Goodman, PhD Vice Chancellor for Research The University of Tennessee Health Science Center

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CREATING A VISION

UTHSC Research has changed significantly over the last five years, undergoing a transformation that has resulted in record-breaking growth.

In celebration of our achievements, we offer here the successes of the strategic priorities and initiatives that have brought us to this historic point. This kicks off what will be an Office of Research Annual Report beginning in 2022.

Steven R. Goodman, PhD, was hired in 2015 as the Vice Chancellor for Research at UTHSC. He ushered in a new era of growth by championing the idea of thinking institutionally about research, and implementing a strategic plan based on the ideal of unifying individual interests around larger, common aims of the institution as a whole.

UTHSC OPERATIONAL STRATEGIC PLAN FOR RESEARCH, 1ST EDITION (FY17-21) The 2016 UTHSC Operational Strategic Plan for Research (OSPR-1) was written by research faculty leaders from all six UTHSC colleges and three campuses. It provided a shared vision and five-year blueprint for growing the UTHSC research enterprise. Stimulating collaborations that cross departments, colleges, and campuses was established as the primary way to achieve institutional aims. The plan focused on the importance of utilizing resources to stimulate interdisciplinary and interprofessional research while providing an infrastructure that is second to none.

The OSPR-1 authors selected six broad areas of existing strengths around which to build interdisciplinary and inter-professional research teams. These areas of excellence each contained three focus areas, and guided where investments and resources could be placed specifically to encourage development.

Creating such clusters of collaborative and vital research is embedded in every effort undertaken by the Office of Research to achieve its stated mission: “to cultivate and support scientific discovery, innovation, commercialization, and economic growth within the University of Tennessee Health Science Center and the state of Tennessee, with the dedication to improve the health of Tennesseans, the nation, and the global community.”

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IMPROVING INFRASTRUCTURE

A premier research institution demands not only highly qualified researchers and state-of-the art facilities, but an infrastructure designed to enhance faculty success and investigator productivity.

To ensure our researchers and the new collaborative environment would flourish, the Office of Research implemented many infrastructure improvements, creating new offices and restructuring and overhauling others.

The sweeping changes made over the past six years revitalized many individual offices, allowing them to deliver a new level of support to researchers. Many improved service metrics point to the success of these changes, from reduced turnaround time to increased accuracy.

A new level of quality has been reached through increased certifications and improved safety standings, allowing individual offices, groups, and committees to exceed target goals and achieve efficiency-related cost-savings. Perhaps just as prized by leadership is the culture shift these changes have brought. Management has noted improved morale, born of new confidence within their teams, and a new pride of service and reputation.

Each entity in the following pages continues to build upon the progress of the past few years, analyzing processes to find more ways to improve procedure efficiency while cutting expenses and increasing research support.

By investing in improved infrastructure, the Office of Research is better serving its researchers, improving its competitive ranking, and attracting new talent. The commitment to strengthening and deepening our support systems, whether those be fundamental business services, enhanced technology capabilities, or improved training, ultimately paves the way for continued accelerated growth of UTHSC’s research portfolio.

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NEW OFFICES CREATED OFFICE OF SPONSORED PROGRAMS (EST. 2017)

The unification of all pre- and post-award functions under the Office of Research was one of the strategic goals outlined in the OSPR-1.

This unification focused on right-sizing the UTHSC office, as well as developing collaborative sponsored programs offices on our Knoxville, Chattanooga, and Nashville campuses. This, along with other newly developed services, allows the UTHSC Office of Research to support all activities associated with an agreement, grant, or clinical trial life cycle.

Steve Youngentob, PhD

The Sr. Associate Vice Chancellor for Research, Dr. Steve Youngentob, led the unification process in 2017. Sponsored programs staff previously under the Office of Finance were transferred to a newly created Office of Sponsored Programs (previously Grants and Research Agreements). Additional researchspecific related activities (data use agreements, equipment release requests, and research agreements) moved to the new unified office.

Sarah White, EdM, was hired as Associate Vice Chancellor for Research to lead the new Office of Sponsored Programs. Additional contract and grant administrators were hired, and new procedures were developed to govern the functioning of the office.

The consolidation of services under one office seamlessly integrated the proposal submission process, contract negotiations, and acceptance of awards. This, in turn, created an economy of scale.

The growing portfolio of MTAs, CDAs, sub-awards, clinical trial agreements, and grant submissions was accommodated with the introduction of workflow management. These changes also improved UTHSC’s efficiency in conducting regulatory compliance and fulfilling sponsor financial reporting requirements.

The unified office has dramatically improved turn-around time and is performing equal to or better than available benchmarks.* Work volume metrics show the office has handled a record number of transactions in the past five years.

Sarah White, EdM

*Metrics may be found on the Office of Sponsored Programs webpage: uthsc.edu/research/sponsored-programs/dashboard-metrics/ 10

THE OFFICE OF RESEARCH DEVELOPMENT (EST. 2015) •

Provides targeted funding opportunities to faculty.

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Oversees intramural funding opportunities: bridge funding, new grant support, CORNET awards.

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Provides grant consulting services through Hanover, including proposal review, prospecting and workshops.

Lisa Youngentob Director

Jamie Whartenby Director

THE OFFICE OF SCIENTIFIC WRITING (EST. 2017) •

Serves UTHSC faculty, postdoctoral trainees, and students at our Memphis, Nashville, Chattanooga, and Knoxville campuses

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Provides scientific writing support for manuscripts for publication and grant proposals; copy editing; grant consulting in the preparation of a compelling application.

Kyle Johnson Moore, PhD Director

THE OFFICE OF RESEARCH MARKETING & COMMUNICATION (EST. 2016) •

Produces marketing collateral and documents for Office of Research umbrella units

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Writes all press release from the Office of Research

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Manages the UTHSC research website, Research Rainmaker blog, Office of Research social media, and messaging to the UTHSC research community

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Oversees the Research Hot Topics and other lecture series, and plays the lead role in VCR event planning.

Lee Ferguson Director 11

EXISTING OFFICES OVERHAULED Sr. Associate Vice Chancellor for Research, Dr. Steve Youngentob, spearheaded and oversaw the renewal and rebuilding of the following compliance offices.

LAB ANIMAL CARE UNIT (LACU) The 2016 staff and leadership reorganization of the LACU resulted in new ways of thinking, planning and operating. Key positions in operations management and facility oversight were created.

Standard operating procedures, guidance documents, and stricter training requirements were introduced, bringing a new level of quality to UTHSC’s animal care and a new level of satisfaction to its customers and users. The LACU now maintains 100% AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care) certification, thanks to the new requirement that all husbandry staff achieve the appropriate level of certification for their position.

David Hamilton, DVM, DACLAM Director

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) In 2016, the IACUC introduced critically needed policy-related and operational changes to ease investigator burden and enhance regulatory compliance. An extensive review of all existing policies covering animal research activities unveiled opportunities to streamline the submission and review process of animal use protocols and improve approval time. The requirement that all animal use protocols undergo full committee review was replaced with an option for designated member review. Mandatory pre-review (including veterinary and safety review) and a nonstop rolling review process slashed review time from three months to a median of 13 days. Committee members now review protocols as they arrive, ensuring the timely reviews investigators have come to expect. New guidelines and procedures clarified expectations for investigators and reviewers, bringing about a greatly enhanced functioning of the IACUC and its working relationship with animal researchers.

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Jeff Steketee, PhD Chair

INSTITUTIONAL BIOSAFETY COMMITTEE (IBC) In 2016, the IBC replaced its paper-based application system with an online platform that revolutionized the process of writing, submitting, and reviewing protocol applications. Constructed in-house, using logic that enables investigators to only “see” protocol sections needed for their proposed work, this tool eliminates confusion about the types of information required. New, standardized language for risk assessments and mitigation was written and embedded into the form, further reducing investigator burden. Protocol completion is now faster, easier, and much more accurate – which, in turn, has made the pre-review and full committee review much more efficient and effective.

Mark Miller, PhD Research Integrity Officer

RESEARCH SAFETY AFFAIRS (RSA) In 2017, the RSA office underwent a complete overhaul, with a reorganization of staff and leadership, and the establishment of new standard operating procedures, policies, and training practices. It introduced initiatives to achieve a major culture shift, moving away from policing researchers and towards providing customer service to achieve improvements. In its new spirit of collaboration, the RSA worked with committees to develop new campus safety procedures and now works jointly with them to investigate incidents and inspect LACU facilities. The cumulative result of these changes is a significant decrease in the number of safety findings in yearly lab inspections, often to zero. Turnaround on safety review of protocols also drastically improved: safety reviews of IACUC and IBC protocols are complete within 48 and 72 hours, respectively.

Other RSA initiatives rolled out over the past few years include fume hood evaluations: an additional 24 fume hoods were restored to service within the past year and airflow rates in all hoods were brought within the accepted safe-operating range, saving UTHSC an estimated $84,000 per year in energy costs. The RSA also now provides NSF-compliant biosafety cabinet certifications and maintenance at less than half the market rate charged by vendors.

Tim Barton Director

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CLINICAL RESEARCH OFFICES

CLINICAL RESEARCH CENTER Under the leadership of Dr. Sam Dagogo-Jack, the Clinical Research Center is a catalyst for major transformation of the research culture that stimulates clinical research among UTHSC partner institutions and organizations. It expands clinical research capacity and improves the quality and efficiency of support services.

The center provides integrated resources and services, designed to enhance interdisciplinary clinical and translational research. These include standardized operational procedures, educational requirements, and centralized scheduling research staff independent of clinic site location.

Sam Dagogo-Jack, MD, BM Director

Clinical research activities at UTHSC and partner institutions and organizations are significant and have increased in scope and number over the last decade. These research activities encompass a strong group of funded clinical investigators with extensive infrastructure support. Investigators from Methodist-LeBonheur Healthcare, St. Jude Children’s Research Hospital, the VA Medical Center, and Regional One Health utilize resources at UTHSC’s Clinical Research Center.

CLINICAL TRIALS UNIT Led by Dr. Csaba Kovesdy, the Clinical Trials Unit provides research support to UTHSC affiliated investigators to improve the quality, efficiency, and regulatory compliance for the conduct of clinical research. Its specialized staff provides various services and support various unique roles in the research setting, allowing providers to streamline research trials independent of their clinic staff. The Clinical Trials Unit has the ability to provide research support in outlying hospitals and physician offices.

Csaba Kovesdy, MD, FASN Medical Director 14

MAKING THE BEST USE OF RESEARCH SPACE ALLOCATION OF RESEARCH SPACE PLAN Improving infrastructure necessitated making the best use of all the resources available, including the valuable and limited resource that is research space. An early impetus for re-examining space use was the 2015 challenge of filling the brandnew Translational Science Research Building. No guidelines existed for allocating space according to current and future needs.

The Office of Research formed a committee with broad faculty representation to write a formal guide to the assignment and usage of space. The resulting document was the 2016 Allocation of Research Space Plan. The plan provides an open and transparent process that guides the assignment, solicitation, and usage of space based on clear metrics. Key features in determining the allocation of research space to a faculty member are a rolling three-year average of extramural

funding, the type and scope of their research, as well as the building where it is conducted. Faculty metrics, in turn, are collectively used to determine a space allocation metric for their respective college.

The plan reinforces the OSPR-1’s emphasis on collaboration, suggesting new and newly renovated space should be used to stimulate inter departmental and team research in areas of excellence. It includes annual review processes, and a triennial review, to assure the most efficient and effective alignment with the research mission while allowing for growth of successful programs.

As the amount, quality, and type of campus research space are continuously evolving, the allocation guidelines and formulas are reevaluated at three-year monitoring intervals.

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INSTITUTIONAL RESEARCH CORES In 2015, the Office of Research developed a centralized organization of UTHSC research cores. While different shared resources existed prior to this, some were used solely by individual colleges, and some were simply pieces of equipment in individual laboratories.

Developing a definition of what constituted an institutional core and providing centralized leadership of them allowed for structured oversight of these facilities and optimization of their operations.

UTHSC Institutional Cores are now defined as a shared resource funded by an institutional subsidy, whose users come from multiple colleges, departments, and campuses. Taking the aspirations and goals of the OSPR-1 as a guide, new cores were created, some existing cores were changed to collaborations between individual departments and the Office of Research, and new equipment was purchased for others.

Dr. Tiffany Seagroves is the Associate Vice Chancellor for Research - Research Cores. The cores are managed using three-year pro forma business plans to develop budgets and data-based metrics to measure success on a yearly basis. The cores charge internal service fees based upon market evaluation and set to the bottom-third to bottom-half of internal prices of our peers.

Tiffany Seagroves, PhD

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ADVANCED IMAGING CORE (AIC)

FLOW CYTOMETRY & CELL SORTING (FCCS)

LAB ANIMAL CARE UNIT (LACU)

MEDICINAL CHEMISTRY CORE

MOLECULAR BIOINFORMATICS (MBIO)

MOLECULAR RESOURCE CENTER (MRC)

REGIONAL BIOCONTAINMENT LAB (RBL)

RESEARCH HISTOLOGY CORE

PROTEOMICS & METABOLOMICS (PMC)

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CORE HIGHLIGHT: AIC The Advanced Imaging Core (AIC) is an exciting new addition to the UTHSC’s institutional cores. The AIC provides advanced microscopy imaging and data analysis services through its state-of-the-art equipment and expertise.

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Light-sheet fluorescence, wide-field fluorescence, and super-resolution fluorescence microscopy imaging equipment enables researchers to capture subcellular structures and identify protein localization patterns with high accuracy in both 2D and 3D.

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An LaVision Ultramicrscope II light-sheet fluorescent microscope (LSFM) is available in the LSFM Unit and a Zeiss Elyra 7 system is available in the super resolution microscopy (SRM) Unit.

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These cutting-edge technologies minimize sample photodamage during imaging. Live imaging on the Elyra 7 system allows users to track fast cellular processes, such as vesicle movement, and to observe various signaling events.

Structured illumination microscopy image of bovine pulmonary artery endothelial cells stained with MitoTracker Red, AF488-phalloidin, and DAPI. Photo courtesy of Dr. Rachel Helms.

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CREATING A MORE

INTERDISCIPLINARY, ENTREPRENEURIAL CULTURE

Dr. Monica Jablonski (center), 2017 Innovation Award winner with Chancellor Steve Schwab (left) and

Our faculty are a powerhouse of ideas who often produce discoveries suitable for intellectual property development. Faculty start-ups have developed new therapeutics and diagnostics to improve medical care, facilitated the retention of key faculty and personnel, and have brought new money and jobs to our state economy. The UT Research Foundation is the primary entity providing assistance and resources that help faculty, staff and students of the UT system move ideas to the marketplace.

The Office of Research has striven over the past five years to expand its strategic partnership with UTRF in order to achieve the double aim of encouraging a more entrepreneurial culture and creating new avenues for interdisciplinary activities. We made strategic hires, created new award programs and lecture series, and developed new initiatives designed to integrate the new boundary-crossing focus of UTHSC with existing UTRF efforts.

By combining forces with UTRF, the Office of Research further encourages cross-departmental, cross-college, and cross-campus collaborations. Developing such interprofessional, interdisciplinary teams has been key to expanding our research portfolio and funding.

An inherent consequence of these efforts has also been the evolution of industry partnerships locally, regionally, and statewide.

UTRF VP Richard Magid (right).

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NEW LEADERSHIP AVCR, INDUSTRY RELATIONS AND GLOBAL PARTNERSHIPS •

Developed CORNET collaborations with Southern Research, West China Medical University, and Harbin Medical University

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Helped establish clinical trials of Innolife, Ltd. through CTN2

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Led the establishment of a UTHSC drug discovery focus group, and helped launch the UTHSC-ORNL drug discovery and development collaboration

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Helped establish the UTHSC startup incubator program and the competitive Innovation Lab award to UTHSC faculty developing their spin-off companies

Gábor Tigyi, MD, PhD AVCR

AVCR, ENTREPRENEURSHIP •

Working with UTRF Vice President Richard Magid, PhD, developed training programs/seminars on intellectual property development, patent filing, and marketing of intellectual property, and the nuts-and-bolts of launching startup companies

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Helped create the new entrepreneurship-focused seminar series (LEADS)

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Works with faculty to attract grants that drive their entrepreneurial efforts forward

Steve Bares AVCR

AVCR, BUSINESS DEVELOPMENT

Phil Cestaro AVCR 20

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Helped write the business plan for the Clinical Trials Network of Tennessee (CTN2 - see page XX).

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Executive Director of CTN2, creating a centralized budgeting and contracting process, and provided business oversight for this 501c3 wholly owned subsidiary of UTRF

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Recruits external industry users for UTHSC’s institutional Research Cores

NEW AWARD PROGRAMS CORNET AWARDS The Collaborative Research Network (CORNET) awards have been exceptionally important to UTHSC’s development over the last six years. This award program is designed to break down barriers between UTHSC colleges, UT campuses, UTHSC and other universities (national and global), UTHSC and industry.

The CORNETs were conceived by VCR Steven Goodman to support new teams that cross a barrier, doing new research. This competitive intramural grant program gives researchers the initial funding they need to collect data for larger extramural grants while addressing the specific strategic goal of incentivizing collaboration. Since 2016, VCR Goodman has awarded 63 CORNETs worth a combined $2.26 million. Extramurally funded grants, totaling almost $30.4 million, have stemmed from CORNET work, a 13.45-fold return on investment.

Jianxiong Jiang, PhD, associate professor in Pharmaceutical Sciences and Neurobiology, and Wei Li, PhD, Distinguished Professor and director of the College of Pharmacy Drug Discovery Center, were recently awarded $1.15 million from the National Institute of Neurological Disorders and Stroke to develop a potential new drug target to treat epileptic seizures. The grant put the total external dollars generated from CORNET-funded work over the $30 million mark.

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TEAMS

Have received CORNET awards

$2.26

MILLION

Total CORNET funds awarded

$30.4

MILLION

In extramural awards resulting from CORNET work

13.45

FOLD ROI

INNOVATION LAB A partnership with the Memphis Bioworks Foundation, this award provided a dedicated lab in the Memphis Bioworks building. A 420 square-foot turnkey space was made available at no cost to researchers for up to 12 months, as they developed their intellectual property in anticipation of submitting an SBIR and/or STTR proposal. New companies using the Innovation Lab were required to submit at least one SBIR and/or STTR grant application during the year of occupancy.

Monica M. Jablonski, PhD, professor of Ophthalmology, was selected as the first user of the innovation lab space. Dr. Jablonski successfully developed a topical micro-emulsion-based formulation for delivery of hydrophilic drugs to the posterior pole of the eye. The micro-emulsion was created to combat the shortcomings traditionally linked to standard eye drops. Her spin-off company, OculoTherapy, LLC, is working toward commercializing this and other technologies.

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NEW LECTURE AND SEMINAR SERIES LEADS SEMINAR SERIES The LEADS (Launching Entrepreneurial Activities and Discovery in Science) seminar series was created to bring successful and engaging entrepreneurial scientists involved in biotech, life sciences, pharma and device sectors to UTHSC to relay their entrepreneurial stories to our faculty, staff, and students. Specifically, UTHSC LEADS focuses on speakers who have taken an idea from “bench-tobedside”, connecting research done in the laboratory to develop new ways to treat patients. They are a resource and inspiration to researchers interested in moving from an academic to an industry position.

VCR DISTINGUISHED LECTURE SERIES The VCR Distinguished Lecture Series was created to educate and help the research community stay abreast of the world’s most pressing research topics. The series brings nationally and internationally prominent speakers to present on topics of interest to a broad range of faculty crossing disciplines and departments.

Invited lecturers typically spend two to three days on UTHSC’s campus, delivering a scientific lecture, and meeting with UTHSC administration, faculty and staff to share ideas and foster collaborative efforts centered on research and entrepreneurial ventures.

Since 2016, the Office of Research has welcomed over twenty prominent investigators ranging in expertise from T0 to T4. One of the most successful examples of a VCR Distinguished Lecturer is Aaron Ciechanover, MD, DSc, Israeli biochemist and 2004 Nobel Prize winner in Chemistry.

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Dr. Richard A. Gibbs VCR Distinguished Lecturer

Dr. Aaron Ciechanover, 2004 Nobel Laureate VCR Distinguished Lecturer

Dr. Thom Chittenden VCR Innovator Lecturer

Dr. Amy L. Hester LEADS Lecturer

DEVELOPING STATEWIDE INSTITUT AND NETWORKS

Dr. Colleen Jonsson at the UTHSC RBL.

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The Office of Research has bolstered reserach across all trnaslational stages, from T0 to T4, through several approaches. The creation and development of new statewide institutes, consortia, and clinical trial networks have attracted significant new funding and leaders to UTHSC.

NEW INSTITUTES INSTITUTE FOR THE STUDY OF HOST PATHOGEN SYSTEMS (EST. 2017)

The Office of Research led the recruitment of Colleen Jonsson, PhD, a world-renown virologist, in 2017 to direct UTHSC’s Institute for the Study of Host Pathogen Systems (ISHPS) and the Regional Biocontainment Lab (RBL). She has synergized infectious disease research among an interdisciplinary group of faculty across the UTHSC enterprise. Shortly after she was hired, Dr. Jonsson secured a $23 million NIH U19 award to create and lead the Center of Excellence for Encephalitic Alphavirus Therapeutics (CEEAT) at UTHSC. Dr. Jonsson is an Endowed Van Vleet Chair of Excellence in Virology and has played a lead role in UTHSC’s response to the pandemic, converting the RBL to a COVID-19 research facility in early 2020. She has led teams sequencing the virus, working to determine possible antivirals or therapeutics to treat it, and developing COVID-19 diagnostic tools. At the same time, she has remained active in training and mentoring graduate students and younger faculty, who will be the next generation of virus researchers. Her efforts over the last three years have been instrumental in helping UTHSC reach new heights in national recognition and funding, earning her a UT President’s Award in 2021.

Dr. Jonsson’s Impact on COVID 19 pandemic •

Led collaboration with nearly 200 different academic and industry entities to test antivirals and disinfectants using in vitro and in vivo models.

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Published several papers dealing with subjects ranging from cytokines and the immune response from SARS CoV-2 infection to virtual and in vitro antiviral screening.

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Developed two small animal models, tests to measure neutralizing antibodies, and tests to sequence full length genomes.

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Screened nearly 100,000 molecules and has several hit to lead studies in progress

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Working with the City of Memphis and Shelby County to map the spread of variants.

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TENNESSEE INSTITUTE OF REGENERATIVE MEDICINE (EST. 2017)

The Tennessee Institute of Regenerative Medicine (TennIRM) was created to translate scientific discovery into organ repair and replacement therapies. Gábor Tigyi, MD, PhD, is the executive director.

Over four years, TennIRM has established a network of 70 leading researchers who perform basic, clinical, and translational research in the areas of stem cell biology, 3D bio-printing, and tissue engineering. The institute has brought together the expertise of UTHSC, the University of Memphis, and St. Jude Children’s Research Hospital. Most recently, it has welcomed members from the College of Veterinary Sciences and the Regenerative Medicine Laboratory at the University of Tennessee, Knoxville, and the Joint Institute of Biological Sciences at Oak Ridge National Laboratory.

The tremendous economic potential and entrepreneurial nature of regenerative medicine has helped TennIRM attract a strong group of industry advisers. Shannon Brown, senior vice president of FedEx, chairs the TennIRM Industry Advisory Committee; Ann Burgess, former vice president for Global Biologics with Wright Medical Group N.V., is co-chair.

Other committee members include Reid Dulberger, chief economic development officer, EDGE for Memphis and Shelby County; Dan Shimko, director and technical fellow, Spinal Biologics R&D, Medtronic; Dun Liu, Revotek USA; Phil Cestaro, executive director, Clinical Trials Network of Tennessee (CTN2); and Lilliam A. Baez, director, U.S. Commercial Service, U.S. Department of Commerce, and Robert Blaudow, Department Head, Natural Sciences at Southwest Tennessee Community College.

TennIRM has revealed the strength of regenerative medicine as a research category within the state’s academic community. In its four years of existence, TennIRM researchers have published over 400 journal articles, and have generated over $39 million in extramural award funding for their various research projects. The institute has also been instrumental in helping UTHSC gain the recognition of national and global organizations, such as the Regenerative Medicine Foundation. TennIRM’s existence led to Memphis being selected as the host city of the 8th annual International Experimental Biology and Medicine Conference on the subject of regenerative medicine.

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TennIRM RESEARCH Novel 3D Bio-fabrication Methodologies and Manufacturing for Enhanced Tissue Regeneration and Implantable Devices Aims: to integrate state-of-the-art metallic, polymeric, and hybrid additive manufacturing technologies with multi-disciplinary expertise contributing to novel 3D bio-fabrication methodologies for creating tissue generative platforms and devices.

3D Bio-printed Blood Vessels – Basic and Translational Approaches Aims: to develop animal models for improving the clinical application of 3D bio-printed blood vessels developed by Revotek. FDA approval is pending for the first human trial of stem cell derived bioprinted blood vessels in Memphis.

Engineering of Vascularized Bone/ Cartilage Graft Aims: to reestablish the functional integrity of joints affected by osteoarthritis (including the osteochondral interface) using adipose-derived stem cells from subcutaneous fat tissues.

Gene Editing of Hematopoietic and Cancer Stem-like Cells Aims: to develop improved, clinically applicable, gene editing technologies in preclinical models for targeted delivery of the gene editing molecular machinery and small molecules into different types of stem cells using unique nanotechnology platforms.

TENNESSEE CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE (EST. 2018)

UTHSC’s Center for Innovation in Health Equity Research: A Community Cancer Alliance for Transformational Change.

The Tennessee Clinical and Translational Science Institute (TN-CTSI) was established to stimulate the discovery and translation of biomedical research into clinical practice to improve state and worldwide population health through a diverse set of services and resources. By providing critical education and training, funding opportunities, resources and interdisciplinary expertise, the institute helps clinical and translational researchers advance their discoveries and develop novel therapies aimed at improving health care for all.

The TN-CTSI has a major focus on health disparities.

The TN-CTSI is led by Karen C. Johnson, MD, MPH, Endowed Professor of Women’s Health and chair of the UTHSC Department of Preventive Medicine, and Michelle Martin, PhD, professor in the Department of Preventive Medicine and director of

TN-CTSI is an integrated institute spanning the entire state to address the most pressing health needs in our area. It has participation from all six colleges and all campuses at UTHSC. The institute collaborates with other UT units, such as the UT Institute of Agriculture, especially the extension service, and the UT Advanced Computing Facility in Knoxville.

The TN-CTSI is In the process of applying for a Clinical and Translational Science Award (CTSA) from the National Center for Advancing Translational Sciences. The CTSA program supports a national network of medical research institutes, which collaborate to catalyze innovation in training, research tools, and best practices for individuals locally and regionally in clinical and translational science.

BERD Clinic One of the ways the TN-CTSI supports rigorous methodology and scientific reproducibility is through its Biostatistics, Epidemiology, and Research Design (BERD) Clinic.

This multidisciplinary team of experts provide consultations to help researchers understand the underlying statistical aspects of their research design so they can adequately plan projects (e.g., study design, analytic approaches, simple power analyses).

The BERD team also collaborates with investigators, pairing expertise with studyspecific needs and providing specialized advice in molecular bioinformatics, health services research and population health.

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NEW CONSORTIA MEMPHIS CONSORTIUM FOR SICKLE CELL AND CLASSICAL HEMATOLOGY RESEARCH (EST. 2017)

In 2017, Kenneth Ataga, MD, an internationally recognized expert clinician and researcher in sickle cell disease, was recruited to UTHSC

by Chancellor Steve Schwab, VCR Goodman, Dr. Mitchell Weiss, chair of Hematology at St. Jude Children’s Research Hospital, and several of Memphis hospital CEO’s. He was previously the director of the Sickle Cell Center at the University of North Carolina, Chapel Hill, and is one of the leading clinical trialists for sickle cell disease in the world. Dr. Ataga was brought to UTHSC as an endowed chair and inaugural director of the UTHSC Center for Sickle Cell Disease and the Memphis Consortium for Sickle Cell Disease and Classical Hematology Research, a UTHSC and affiliated hospitals (Methodist LeBonheur Healthcare and Regional One), St. Jude Children’s Research Hospital, University of Memphis collaborative efforts in sickle cell disease research from childhood to adulthood.

Ken Ataga, MD Director

The consortium is a representation from several participating institutions: UTHSC, UT-Methodist University Hospital, Regional One Health, and St. Jude Children’s Research Hospital. Its goals are to develop collaborative sickle cell research among these participating entities, and to create standardized evidenced-based clinical care across that will support clinical and translational research.

Leading this research consortium, Dr. Ataga has also unified the care of adult sickle cell patients in Memphis, and has brought UTHSC an enormous number of federal and industry grants. He has led or collaborated in studies of novel drug therapies in sickle cell disease.

Dr. Ataga’s most recent award was a $3.2 million grant in 2021 from the National Heart, Lung and Blood Institute for a project that enlists artificial intelligence in the fight against sickle cell disease. Santosh Saraf, MD, associate professor in the Department of Medicine at the University of Illinois at Chicago, is a co-PI on the grant.

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TENNESSEE POPULATION HEALTH CONSORTIUM (EST. 2021)

The Tennessee Population Health Consortium, launched in 2021, is a statewide initiative dedicated to transforming primary care practices in Tennessee. Jim Bailey, MD, Robert S. Pearce Endowed Chair in Internal Medicine, professor of Medicine and Preventive Medicine, is the consortium’s executive director.

The overarching goal of the consortium is to support primary care practices across Tennessee through workforce development, implementing telemedicine initiatives, and developing a fellowship program in health system improvement. The Office of Research ensured the start of this consortium with $1.2 million in donations from various sources that came through the UT Foundation.

Focusing on the root causes of obesity-associated chronic illness in Tennessee, the consortium has three main initiatives: the Tennessee Heart Health Network (launched in May with a $4.5 million grant from the Agency for Healthcare Research and Quality), the Diabetes Wellness and Prevention Coalition, and the Cancer Prevention and Control Jim Bailey, MD Program. The consortium is also building a statewide population health Executive Director data infrastructure, the Tennessee Population Health Data Network, to track health outcomes and improve heart health, diabetes, and cancer care across Tennessee.

The consortium is composed of interdisciplinary faculty, staff, and friends of UTHSC from its campuses in Memphis, Nashville, Chattanooga, and Knoxville, as well as the University of Tennessee. Key partners across the state include Ascension Saint Thomas, Ballad Health, Christ Community Health Services, Church Health, Erlanger Health System, East Tennessee State University, ETSU Health, Methodist LeBonheur Healthcare, Regional One Health, the University of Memphis, UT Medical Center, and West Tennessee Healthcare.

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CREATION OF INTEGRATED STATEWIDE CLINICAL TRIAL NETWORKS Starting in 2016, the Office of Research developed a coordinated set of innovations to increase clinical trial research.

ENTERPRISE DATA WAREHOUSE

Central to the development of UTHSC clinical trials is the development of the Enterprise Data Warehouse (EDW) by Robert Davis, MD, Director of the Center for Biomedical Informatics (CBMI) and Governor’s Chair. Dr. Davis developed the HIPAA-compliant, IRB-approved EDW with partner hospitals who sign a data use agreement with UTHSC. UTHSC has developed agreements with Methodist LeBonheur Healthcare (Memphis), UT Medical Center (Knoxville), and University Clinical Health (Memphis), St. Thomas (Nashville), and Erlanger Health System (Chattanooga).

The enormous amount of data being collected in electronic medical records creates additional clinical and research value when extracted, transformed, deidentified and loaded in research enterprise data warehouses that extend beyond a single facility’s walls.

When utilized at scale, this “big data” is currently transforming healthcare nationwide by, for example, enabling providers and researchers to user population data in identifying and preventing diseases, and developing treatments through the conduct of large-scale clinical trials with greater statistical power and precision.

The EDW is the centerpiece for the function of the TN-CTSI, the Clinical Trials Network of Tennessee (CTN2), and the Clinical Trials Governance Board (CTGB), and our vision for UTHSC clinical trials.

UTHSC EDW DATA FLOW

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CLINICAL TRIALS GOVERNANCE BOARD (EST. 2016) The UTHSC Clinical Trials Governance Board (CTGB) was created to centralize interactions between UTHSC clinical trials offices across the state of Tennessee. Built as a federated model, its goal is to support and grow clinical research by promoting access to resources and opportunities for investigators and faculty throughout the UTHSC system. It represents established clinical research offices on all campuses and aims to provide a fully integrated model of developing and sharing best practices for clinical research. CTGB coordinates with various clinical research offices to ensure adequate provision of services and resources to all affiliated investigators to improve quality, efficiency, and regulatory compliance of the conduct of clinical trials.

The CTGB is led by Giuseppe Pizzorno, PhD, PharmD, professor and associate dean of research at UTHSC’s Chattanooga campus, and is the first chief research officer for Erlanger Health System.

The broad representation and expertise of the CTGB members can be seen below:

Giuseppe Pizzorno, PhD Chair, CTGB

CLINICAL TRIALS GOVERNANCE BOARD MEMBERS Chair: Giuseppe Pizzorno, PhD, PharmD ADR, COM, Chattanooga Chief Research Officer, Erlanger Health System Co-Chair: Andy Griffith, MD, ADR Sr. ADR, COM Karen Johnson, MD, MPH Chair, Department of Preventive Medicine, COM Sam Dagogo-Jack, MD, BM, MSc, FRAP Sr. AVC for Research, Clinical Director, Clinical Research Center Csaba Kovesdy, MD, FASN Medical Director, Clinical Trials Unit Ken Ataga, MD Director, Sickle Cell Center John Jeffries, MD Director, Cardiovascular Institute Dennis Black, MD Scientific Director, Children’s Foundation Research Institute VP of Clinical Research, LeBonheur

Penny Asbell, MD, FACS, MBA, FARVO Chair, Department of Opthalmology, COM Franklin Garcia-Godoy, DDS, MS, PhD Medical Director, Dental Clinical Research Center Ansley Stanfill, PhD, RN ADR, College of Nursing Martin Croce, MD Sr. VP and Chief Medical Officer, Regional One Health Paul Hauptman, MD Dean, Graduate School of Medicine, Knoxville COM Geoffrey Smallwood, MD Clinical Trials Office, St. Thomas Research Institute Sue Theus, PhD Associate Chief of Staff/Research, VA Medical Center, Memphis Teresa Hartnett, EdD Associate Dean of Finance Administration, COM, ExOfficio Steven R. Goodman, PhD Vice Chancellor for Research 31

CLINICAL TRIALS NETWORK OF TENNESSEE (EST. 2017) CTN2 is a statewide clinical trial facilitator, bringing together hospitals, academic-grade research, and shared health data from across Tennessee to spearhead groundbreaking clinical research studies. CTN2 is the vision of VCR Steven Goodman, who serves as its president and CEO. CTN2 is a site management organization, created to enable UTHSC clinical faculty researchers to design, solicit, and conduct robust statewide clinical trials at multiple partner hospitals and practice plans throughout the state of Tennessee.

Actively supported by leadership and principal investigators in all UTHSC colleges, CTN2 is a 501(c) (3) subsidiary of the UT Research Foundation (UTRF), governed by a board representing participating institutions (including hospital systems and large practice plans). Phil Cestaro, hired in 2017 as Associate Vice Chancellor for Research and Business Development, is the Executive Director.

The innovative network is a unique asset to Tennessee residents. As it has grown it has been a boon to both public health and health care access.

With its current fourteen partner hospitals and practice plans across the entire state, citizens in

every region of Tennessee now have the opportunity to participate in CTN2 studies and reap the benefits of clinical research. Historically, Tennesseans have been underrepresented in largescale studies leading to drug approval. CTN2 also affords state residents potential access to effective medications prior to wide approval.

Finally, CTN2 has proved an ingenious solution to the challenge UTHSC faced in capturing certain elusive research expenditures. As UTHSC does not own the hospitals in which its faculty practice, and where industry sponsored trials led by these UTHSC faculty were being contracted, there had previously been no way for it to receive credit for industry-sponsored trials its faculty conducted.

CTN2 allows for the aggregation of research expenditures, improving our ranking and reputation.

CTN2 has experienced tremendous growth in its four short years of existence, and has added approximately $14 million to the bottom-line growth of UTHSC research grants and contracts, since its creation. Because of its tremendous impact on the health of Tennesseans and economic development and job creation for the state, CTN2 is in the governor’s budget to receive $6 million for operations over the five year period beginning in fiscal year 2023.

CTN2 DIRECTORS

Phil Cestaro Executive Director 32

Frank McGrew, MD Regional Medical Director Stern Cardiovascular Foundation, Memphis

Geoffrey Smallwood, MD Giuseppe Pizzorno, PhD, PharmD Regional Medical Director Regional Medical Director St. Thomas Health, Nashville Erlanger Health System, Chattanooga

PARTICIPATING NETWORK INSTITUTIONS •

Regional One Health

•

West Cancer Center

•

UT Health Science Center

•

Baptist Clinical Research Institute

14

PARTNERS

Hospitals and practice plans

45

CTAs

Clinical Trial Agreements executed

•

Memphis Veterans Affairs

•

University Clinical Health

•

Saint Thomas Health

•

Semmes Murphy Clinic

•

UT Medical Center

•

Erlanger Health System

•

Campbell Clinic

•

Stern Cardiovascular Foundation

•

Mays & Schnapp Neurospine and Pain

•

Olive Branch Medical Center

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CLINICAL TRIALS

Offered to UTHSC investigators

$12.2

MILLION

Contract value credited to UTHSC

2.5

MILLION

Tennessee patients de-identified data

CTN2 TRIALS UNDER CONTRACT

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REAPING THE HARVEST

In FY21, the results of all the initiatives undertaken from the OSPR-1 bore dramatic fruit. UTHSC reached an historic high point in grants and contracts.

In FY16, UTHSC, grant and contract awards for UTHSC as an institution stood at $84.3 million. By the end of FY21, annual grants and contracts had risen to $126.6 million. This 50% increase positions the Office of Research well to achieve its goal of doubling research awards and contracts over the 10-year period initially set by the UT Board of Trustees and UT President in 2016.

FY21 NUMBERS •

Total Awards FY21: $126, 599,214

•

Total Prime Federal Awards: $67,276,286

•

Total Federal Sub-awards: $12,473,946

•

Total Federal Support (all sources): $79,750,232

•

NIH Prime Awards: $53,576,268

•

NIH Sub-awards: $6,769,585

•

Total NIH: $60,345,853

Of the nearly $127 million, $80 million is federal awards (prime plus sub-awards). Federal support represents 62% of the total awards. NIH awards alone total $60.3 million, equal to 47% or almost half the total award dollars.

UTHSC as an institution has done a phenomenal job over the last five years. We are proud of all our accomplishments. As we look to the future, the Office of Research hopes to continue moving the university’s institutional research mission forward by amplifying our efforts statewide. We are committed to strengthening and growing research funding through strategic initiatives that unify the engagement and collective participation of all colleges and campuses.

A success story such as this is built on the combined commitment of the UTHSC chancellery, deans, faculty, staff, postdoctoral fellows, and students. The Office of Research applauds our UTHSC faculty whose work and creativity led to this success, and looks forward to continuing to support their efforts in the future.

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COMING ATTRACTIONS

OSPR-2, FY22-26 With the period covered by the first strategic plan coming to a close in FY21, a new committee was charged in late 2020 to update, revise, and extend OSPR-1, and create an operational strategic plan for research for the next five years.

Once again, research faculty leaders came together and developed an institutional document with direction and initiatives critical to research success. Built on the foundation of OSPR-1, the new OSPR-2 covers FY22-26. It retains as a priority and central theme the need to collaborate statewide across departments, colleges, campuses, and external entities.

The strategic components and operational recommendations of OSPR-2 again stem from areas of excellence identified by the committee. The new plan contains seven areas of excellence, four of which were carried over from the original plan (cancer; obesity, diabetes, and disorders of metabolism; cardio-renal and vascular disease; and nervous system disorders) and three of which are new: infection, inflammation, and immunity; regenerative science and stem cell-based technologies; and women’s health.

The Office of Research is excited to implement the second phase of expanding UTHSC research. We look forward with much anticipation to supporting the UTHSC Research community in the performance of cutting-edge biomedical research across the state of Tennessee.

AREAS OF EXCELLENCE •

Cancer

•

Obesity, diabetes, and disorders of metabolism

•

Cardio-renal and vascular disease

•

Nervous system disorders

•

Infection, inflammation and immunity

•

Regenerative medicine and stem cell-based technologies

•

Women’s health.

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THE UTHSC IMPACT The University of Tennessee Health Science Center (UTHSC) was founded in 1911. Our vision is to be the preeminent public research and teaching university linking the people of Tennessee to the nation and the world.

UTHSC improves human health through education, research, clinical care and public service. Offering a broad range of postgraduate and selected baccalaureate training opportunities, the main campus is located in the heart of the Memphis Medical District and includes six colleges – Dentistry, Graduate Health Sciences, Health Professions, Medicine, Nursing and Pharmacy. UTHSC educates and trains cohorts of medicine, pharmacy and health professions students – in addition to medical residents and fellows – at its campuses in Knoxville, Chattanooga, and Nashville. Patient care, professional education, and research also are carried out at more than 100 clinical and educational sites across Tennessee.

OFFICE OF RESEARCH 910 Madison Avenue, Suite 608 | Memphis, TN, 38163 phone 901.448.7125 | fax 901.448.7133 | research@uthsc.edu uthsc.edu/research/

The University of Tennessee is an EEO/AA/Title VI/Title IX/Section 504/ADA/ADEA institution in the provision of its education and employment programs and services.