BU CTSI Update

2018

BU CTSI UPDATE

Accelerating Discoveries Toward Better Health

Clinical & Translational Science Institute 1

A MESSAGE FROM

the Associate Provost for Translational Research and Director of the Boston University Clinical and Translational Science Institute Greetings, I am pleased to present this report from the Boston University Clinical and Translational Science Institute (BU CTSI) for 2018. As you will read in the following pages, the BU CTSI has left its footprint in almost every aspect of translational research since we were first funded by the National Institutes of Health in 2008.

Our original goal was to build a translational science infrastructure that supports standard research practices and funds new and novel ideas from BU and BMC scientists.

At every stage, we have attempted to bridge the gaps across disciplines, schools and departments to encourage the very best science. Our programs range from pilot and team science funds through the creation of a clinical trials network to help clinical researchers efficiently navigate the regulatory and recruitment barriers (our Clinical Trials Express).

To note a few highlights: Our team of dedicated community researchers have developed a program to help identify patients in our community ready to participate in clinical research, and along the way were recognized by a prestigious NCATS CTSA Collaborative Innovation Award for navigating treatments of patients with breast cancer from low socio-economic status to help eliminate the disparities in outcomes essentially translating research into practice (TRIP).

DAVID CENTER

Principal Investigator

HELIA MORRIS Executive Director

We formed the only CTSA sponsored training program (TL1) in regenerative medicine in the nation, which uses its unique expertise in inducible pluripotential stem cells (iPSC) to train the next generation of organ regeneration scientists and which provides iPSC derived from well characterized patients to any scientist in the world for their research in drug discovery.

This regenerative medicine program created a collaboration with the Framingham Heart Study to derive iPSC from highly characterized subjects.

We created an RNA-based drug discovery and repurposing tool (OpenSESAME) and an all purpose storage and curation system to link patient information from the Electronic Health Records to patient genome data.

We have a renowned faculty development program to mentor and support junior PhD and MD researchers sustain careers in translational science, along with several highly successful grant writing assistance programs.

I am certain you will find something of interest in the following pages, and please use them to connect with new and better suggestions for enriching our translational research environment.

David M. Center, MD

Associate Provost for Translational Clinical Research, BU CTSI Chief of Pulmonary, Allergy and Critical Care Medicine Gordon and Ruth Snider Professor of Pulmonary Medicine Professor of Medicine and Biochemistry

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BU CTSI leadership: David M. Center, MD, Director David T. Felson, MD, MPH, Co-Director George O’Connor, MD, MS, Co-Director

OVERALL VISION AND AIMS

A local and national catalyst for clinical and translational research The overall vision of the BU CTSI is to explore and solve new challenges in translational science by developing and deploying new tools, methods and processes for our hub and the CTSA Network. To do this, we created strong multidisciplinary, multi-cultural collaborative team that combines expertise from diverse programs. This approach actively engages in continuous and vigorous dialogue within our own hub, with other CTSA hubs, and with NCATS to identify opportunities to catalyze clinical and translational research locally and nationally.

Our visions are shaped by the relationship of the BU CTSI at the interface of two special environments: a long caring and scientific relationship with an ethnically diverse patient population encompassing the entire lifespan, and a rich scientific enterprise within BU. As noted by the Institute of Medicine’s 2013 report on The CTSA Program at NIH, “translating the results of basic and clinical research into clinical and community practice has been slow and cumbersome, and many years may pass before the benefits of basic science discoveries and clinical investigations reach individual patients and communities.”

We believe that incremental, local solutions to the inefficiencies in translational science are less likely to succeed than solutions developed, and implemented coordinated multi-disciplinary team approaches, especially those implemented at the level of the national CTSA network. BU CTSI and our hub of academic and health care institutions contribute to these solutions through the following overall aims: AIM 1 | Discover, demonstrate, deploy and disseminate novel training methods that will enhance our entire translational science workforce.

AIM 2 | Effect meaningful research relationships with all communities and stakeholders that empower bi-directional contributions to strengthen translational research across the lifespan.

AIM 3 | Use our unique full spectrum (T0-T4) research strengths to discover, develop and disseminate improved treatments and diagnostics that address the problems of our community and nation.

AIM 4 | Share innovative best practices with other hubs in the national CTSA network, and join with other hubs in the conduct of coordinated, multi-center, translational research.

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OUR PARTNERS & AFFILIATES

We have selected partner and affiliate institutions based on their commitment to clinical and translational research and their ability to contribute to the visions and goals of our hub and of the CTSA network. We define Partner as a stakeholder that participates actively in all or most of the Hub Programs. Affiliates are institutions that actively engage in selected Hub Programs based on their ability to contribute.

Boston Medical Center Health System PARTNER INSTITUTION

BMC is a powerful CTSI partner in clinical informatics, clinical research and patient care improvement and safety, having been named a Top Hospital for 2012-17 by the Leapfrog Group. All BMC attending physicians hold academic appointments at BU. BMC has just partnered with three other Accountable Care Organizations (ACO’s) to create the largest ACO Health System in Massachusetts. BU and BMC share an Office of Technology Development, a GCRU, all research regulatory oversight (IRB, IACUC, IBC), research space and centers (e.g. The Center for Regenerative Medicine).

Boston HealthNet

AFFILIATE INSTITUTION

The Boston HealthNet network consolidates the resources of the 14 Community Health Centers (CHCs) of Boston. They are “partnered” with BMC for central inpatient resources, radiology service and Informatics/EHR, and with BU School of Medicine for faculty appointments, degree work and student, resident and research fellow training. The Boston HealthNet brings the BU CTSI a connection with 400,000 patients >80% from diverse underserved ethnicities, twice the size of BMC.

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Veterans Administration Boston Healthcare System (VABHS) AFFILIATE INSTITUTION

The VABHS consolidated facility consists of campuses in Jamaica Plain, West Roxbury and Brockton. The system includes 448 acute hospital beds and serves several million outpatient visits per year. VABHS is a major teaching hospital affiliated with BU School of Medicine and Harvard Medical School, and staff physicians hold academic appointments at either institution. The VABHS provides BU CTSI with exceptional faculty and facilities for our mentorship programs, access to unique databases, and a large enrollment base for BU-initiated clinical trials.

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA AFFILIATE INSTITUTION

This long-term care facility brings strengths in geriatric and psychiatric care to the BU CTSI. The hospital’s Geriatric Research Education Clinical Center (GRECC) has been at the forefront of geriatric research and clinical care since 1975 and provides us expertise in geriatric lifespan research. The GRECC provides a highly integrated system of research, education and clinical care to the geriatric veteran population.

HealthCore/New England Research Institutes, Inc. AFFILIATE INSTITUTION

NERI, a private Clinical Research Organization (CRO) located in Watertown, MA, has been an affiliate since 2015. NERI brings a public-private partnership with resources for enrollment of human subjects including unique pediatric and geriatric populations, as well as expertise in use of social media for recruitment and trial management.

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PROGRAM CLUSTERS

DAVID CENTER, MD

Principal Investigator

CLINICAL RESEARCH George O'Connor, MD, MS

Clinical Informatics

Bill Adams, MD

Community Engagement

Translational Workforce Training

David Felson, MD, MPH Mary-Tara Roth, RN, MSN, MPH

KL2 Career Developement

Tracy Battaglia, MD, MPH

David Felson, MD, MPH

Biostatistics, Epidemiology & Research Design

TL1 NSRA

Howard Cabral, PhD, MPH

Regulatory Knowledge

John Ennever, MD, PhD, CIP

Integrating Special Populations (ISP)

Megan Bair-Merritt, MD

Participant and Clinical Interactions (PCI) General Clinical Research Unit (GCRU) Research Recruitment & Retention (R3)

George O'Connor, MD, MS 6

WORKFORCE DEVELOPMENT David Felson, MD, MPH

Darrell Kotton, MD

INNOVATION INCUBATOR David Center, MD

Collaboration & Multidisciplinary Team Science

EVALUATION & CONTINUOUS IMPROVEMENT, QUALITY & EFFICIENCY Deborah Fournier, PhD

Katya Ravid, PhD, DSc Jonathan Rosen, PhD, MBA

Pilot, Translational & Clinical Studies

Frederick Ruberg, MD

Framingham Heart Study iPsc

Darrell Kotton, MD Andrew Wilson, MD

Translational Bioinformatics Program

Avi Spira, MD, MSc Marc Lenburg, PhD Adam Gower, PhD

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CLINICAL RESEARCH

ALL OF US RESEARCH PROGRAM In the fall of 2016, BU CTSI leaders George O’Connor, MD (Director, Clinical Research), William Adams, MD, MPH (Director, Informatics), and Tracy Battaglia, MD, MPH (Director, Community Engagement), in collaboration with colleagues at Partners HealthCare, were awarded funding from NIH’s Precision Medicine Initiative to establish the New England Hub for the All of Us Research Program (AoURP). The existing collaboration among these leaders was crucial to the success of this application for funding, as clinical research and recruitment experience, expertise in informatics and a strong community engagement program were required by the NIH. The AoURP is a historic nationwide effort to enroll one million volunteers willing to share their health information and blood and urine samples to create a resource for research on the prevention, diagnosis, and treatment of many health conditions, with the ultimate goal of speeding up health research and medical breakthroughs. The New England Hub of the AoURP will enroll patients over five years at BMC, the Partners HealthCare hospitals and health centers affiliated with the two organizations.

Enrollment began in October 2017, and 2,200 patients of BMC and affiliated health centers enrolled within the first 11 months, along with another 3,300 at Partners HealthCare. The research infrastructure and programs of the BU CTSI have been crucial to AoURP’s success at BMC. The General and Clinical Research Unit (GCRU) has provided the venue for most enrollment visits and has worked with the BMC AoURP team to adapt GCRU procedures to the high volume of visits required. The CTSI’s Informatics Program has taken the lead in electronic health data sharing for the AoURP, and the CTSI’s Community Engagement Program has been instrumental in establishing a community advisory panel, enhancing communication skills of research assistants, and other aspects of community engagement.

REMOVING DATA ROADBLOCKS TO PROVIDE BETTER HEALTH FOR PATIENTS The BU Clinical and Translation Science Institute is actively engaged with informaticians across the CTSA national network to enact solutions that enable researchers to have realtime access to shared longitudinal clinical data and opportunities to collaborate on multi-site research.

William G. Adams, MD, Professor of Pediatrics, is leading the way to implementing a set of solutions to increase interoperability between 60+ institutional hubs across the CTSA national network. The solutions aim to increase data integration and sharing that enable researchers to better explore and understand diverse patient populations that then lead to the identification of better hypotheses and study protocols to more effectively accelerate and disseminate discoveries. The solutions focus on eliminating data roadblocks that impede the translation of research by improving data access and sharing, data and metadata standards, data quality, data security and training in the use of informatics tools.

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DID YOU KNOW? In the past year, the GCRU staff implemented a total of 2,242 visits during 5,075 hours, of which 2,233 visits were clinical trial studies.

Our Clinical staff has assisted with the collection of 5,939 samples and our Laboratory has processed and/or aliquoted 10,711 samples.

GENERAL CLINICAL RESEARCH UNIT The General Clinical Research Unit (GCRU) at CTSI provides resources to faculty at BUMC, including a controlled and optimal setting for clinical investigators, career development programs and training for health professionals.

The GCRU is currently the setting for a large number of active protocols; it is also part of a national network of 62 academic medical institutions across the country that offer infrastructure and clinical investigation resources.

Examples of resources provided by the GCRU include: • The ability to conduct pharmacokinetic studies in a controlled environment with both adult and pediatric inpatients and outpatients • Resources for timed collection of specimens and other specialized testing (bone density, CT scan, etc.)

• A private environment to explore patterns of behavior • A primary location for the education of future physicians, scientists and nutritionists in patient-oriented research CTSI offers resources to investigators in medicine and dentistry funded by various sponsors including federal, non-federal and industry, as well as those conducting innovative clinical research pilot studies, prior to requesting funding. Experienced medical professionals help by facilitating the day-to-day research activities for physicians, trainees, and participants. The GCRU boasts a highly trained research staff of eight who support inpatient and outpatient, adult and pediatric, medical and dental studies that discover the cause, progression, prevention, control, and cure of human diseases.

The GCRU is home to more than 81 studies, including the All of Us Research Program, the CTE study and the Patisiran for Amyloidosis protocol. GCRU provides resources to the Boston University and Boston Medical Center communities. It is a controlled and optimal setting for clinical investigators, career development programs and training for health professionals.

Active protocols require a variety of services including: clinical support (infusions, PK sampling, phlebotomy, ECG, CT and DXA bone densitometry, etc.), laboratory processing and shipping, storage in our monitored and alarmed bio-repository, budget and IRB consultations.

New Services Offered Special consideration is given to studies where it is physically impractical for participants to come to the Evans building. In these cases, services are offered through our “GCRU without walls,“ where GCRU staff can go to your participant to provide requested services.

For more information, please contact the Director of Clinical Research Operations, Ridiane Denis, at ridianed@bu.edu or call 617-358-7558.

CPR certification and Phlebotomy training are now available.

CPR new certification is $75, and offered on the 2nd and 4th Wednesday of every month, 9:30-11:30 a.m.

Phlebotomy new certification threeday training is $350, and offered on the 3rd week of every month, Wednesday-Friday, 9-11:30 a.m.

The GCRU provides a web-based application and scheduling system for study personnel. They also offer flexible and accommodating early morning, evening and weekend research visits.

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CLINICAL RESEARCH COMMUNITY ENGAGEMENT

The goal of the BU CTSI Community Engagement (CE) program is to provide national leadership in developing, delivering and disseminating innovative approaches to community engagement that meaningfully impact health.

Led by Dr. Tracy Battaglia, the CE program offers support to researchers and community members as they learn how to work together effectively.

The CE team provides support to those looking to learn about, participate in, and deepen their commitment to Community Engaged Research (CEnR). Services include: • capacity building trainings for researchers, community members, and anyone with a stake in improving research • guidance in creating community or patient advisory boards • specific pilot grants for Community Engagement • support for researchers striving to communicate their science to a lay audience • consultation to any developing or established partnership Translating Research into Practice The past year has been a productive and exciting one for the BU CTSI Community Engagement (CE) program.

One of the CE team’s longest running partnerships resulted in an innovative new project. The Community Engagement program is one of the founding members of the Boston Breast Cancer Equity Coalition (BBCEC). The Coalition includes breast cancer survivors, doctors, patient navigators, policy makers, advocates, and researchers.

Their mission is to eliminate the persistent disparity between Black and White women with breast cancer here in the city of Boston.

Together, the BBCEC and the four Massachusetts CTSAs (BU, Harvard, Tufts and UMass) designed a study called “Translating Research into Practice” or TRIP (1U01TR002070-01, Battaglia). In September 2017, these partners received funding to implement a coordinated care delivery model in six area hospitals to promote quality breast cancer care among vulnerable patients.

TRIP aims to address barriers to care and reduce delays in treatment for African American women in Boston. The ultimate goal is to eliminate city-wide racial disparities in breast cancer care and outcomes, and to serve as a national model for other health problems.

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Boston Health Equity Research Network In 2017, the CE team took a major step forward in creating a “Practice-Based Research Network” (PBRN), a group of primary care practices that partner in research to improve care. The team convened a planning committee with members from Boston Medical Center and several community health centers.

At the end of this process, the committee launched the “Boston Health Equity Research Network” (BHERN).

BHERN's mission is to promote research that improves the health and well-being of our patients and their communities. To date, BHERN includes 7 practices and community health centers. Over the coming year, BHERN will develop the infrastructure and tools necessary to support the needs of members and research partners.

Workshops and Trainings The CE team builds the capacity of stakeholders to partner in research through two types of trainings: Connecting Community to Research (CCR) • CCR is a two-hour introduction to research for community members and patients interested in partnering in research.

• The training uses storytelling to demonstrate how life experiences can improve research.

• To date, the team has trained 100+ community members, more than half of whom serve as active research partners and/or receive a quarterly newsletter with opportunities.

• In 2017, the team launched a toolkit so that anyone can do a CCR training in their community. The toolkit is available at is.gd/CCRToolkit. Over 70 practitioners have downloaded the toolkit across 22+ states!

Communication Workshops • In 2017, the team created another workshop that trains researchers and community members how to effectively communicate complex research topics.

• The four-hour workshops feature improvisational theater exercises.

• Researcher and community stakeholders find better ways of discussing science topics and communicating as partners.

• To date, more than 80 researchers and community members have trained together.

• Watch a one-hour preview the team presented at the UMass Center for Clinical and Translational Science Community Engagement and Research Symposium. >>

bit.ly/2JLnfJK

The Community Engagement program plans to continue to build on the momentum of the past year and expand our services to support community-academic partnerships.

For more information, please reach out to the team at CCR@bmc.org.

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CLINICAL RESEARCH CTSI Tools and Services Biostatistics, Epidemiology & Research Design (BERD) BERD program provides researchers with comprehensive support in conceptualizing and carrying out research at the design, implementation and analysis stages. BERD has generated a portfolio of solutions for the most common needs to ensure participation in the earliest stages of study development. >> Learn more at bit.ly/2SBHCgx

Informatics for Integrating Biology and the Bedside (BU i2b2) The BU i2b2 is an NIH-funded effort to provide a standardized data architecture and informatics capabilities to combine clinical patient data with demographic, biologic and genomic data for use in clinical research projects. An easy-to-use aggregate data query tool, i2b2 is accessible via the internet using the i2b2 web client. >> Learn more at bit.ly/2SzNua1

Bioinformatics Consultation Service The BU CTSI Translational Bioinformatics Core provides bioinformatics analyses in support of translational research projects at Boston University. These consultations have primarily involved analysis of microarray projects processed by the Boston University Microarray and Sequencing Resource (BUMSR), providing assistance to hundreds of investigators and resulting in at least 50 publications since 2010. Bioinformatics consultations can also be provided for the analysis of gene expression data not generated by the BUMSR, including publicly available microarray and RNA sequencing datasets. >> Learn more at bit.ly/2RHqtSL

Boston University Profiles BU Profiles is a software tool that supports research networking and expertise searches that enables individuals (either internal or external to BU) to locate researchers by subject matter, name, institution, department, division, faculty, etc. >> Learn more at bit.ly/2CqKTvc

Clinical Research Resources Office (CRRO) The CRRO provides regulatory consultations for PIs and research staff at any point during the life of a research study. CRRO helps with IRB applications before and after submission to the IRB and advise on FDA regulations and the IND and IDE applications. The office also provides a number of trainings on the conduct of human research. >> Learn more at bit.ly/2CmlHpD

Community Engagement The BU CTSI Community Engagement program offers assistance and advice to researchers around forming patient and community advisory groups; communicating about science in everyday language; hosting Science CafĂŠs, or small discussion events to deliver research results back to the community; and consultation on a variety of community engagement topics. >> Learn more at bit.ly/2GLoK98 | ccr@bmc.org

Clinical Research Informatics & Technology Consults (CRITIC) CRITIC consultations help BMC/BU researchers identify, develop and implement the effective and efficient use of information technology and informatics in clinical studies. >> For a free one-on-one consultation, contact Christopher Shanahan, MD, MPH, at christopher.shanahan@bmc.org.

ClinicalTrials.gov ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. >> Learn more at bit.ly/2L7dibg

General Clinical Research Unit The GCRU provides resources for protocol implementation across BUMC, BMC and the CRC. >> Learn more at bit.ly/2oBtzKq

CReM iPSC Culture Course The CReM iPSC Core was created to expedite the use of iPSC technology by providing essential services and support to on-campus investigators and the broader scientific community. >> Learn more at bit.ly/2pIwORT

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Grant Writing & Editing Services

Non-BUSM Investigators: Grant writing, editing and formatting services for NIH and other federal applications are provided as part of a CTSI collaboration with Boston Medical Center’s Development Department.

BUSM: The OPD (Office of Proposal Development) is pleased to offer grant writing and editing assistance. In addition to providing copyediting services for investigators, they will guide new and non-native English-speaking principal investigators in developing and writing grant submissions. In addition to technical assistance in all aspects of the writing process, from conceptualizing specific aims, to developing successful submission strategies and guiding investigators in building compelling scientific narratives. To request one or all of these services, please fill out this form: bit.ly/2Ta3pNw. >> Learn more at bit.ly/2Eek1if and request services at bit.ly/2CnWPOo

openSESAME openSESAME (Search of Expression Signatures Across Many Experiments) is a search engine that uses patterns of gene expression to discover relationships between experimental conditions, diseases, or biological states based on expression patterns alone without the need for prior knowledge of experimental groups or phenotypes. This powerful approach has the potential to reveal common molecular etiologies of diseases and to aid in drug repurposing. >> Learn more at opensesame.bu.edu

Protocol Builder Protocol Builder is a secure, cloud-based technology that provides step-by-step guidance for developing research protocols. This new protocol writing technology can help you write investigator-initiated protocols that adhere to IRB and regulatory standards in less time with less hassle. It provides organization, guidance and collaboration tools for your observational or interventional research protocols. >> To request access to Protocol Builder, visit bu.edu/ctsi/tools

REDCap: Research Electronic Data Capture REDCap is a secure, HIPAA compliant, web-based electronic data capture application for building and managing online surveys and databases. REDCap may be used for research purposes by the entire BU community. >> Learn more at bit.ly/2Cm1TCK

Research Job Connection Research Job Connection was initiated to help connect researchers with temporary staffing needs. This tool helps employees that may be facing a job lay-off or looking to fulfill practicum requirements find jobs. The employee pool is made up of research professionals who are already familiar with BMC/BU systems and policies and have proper GCP credentials. >> Learn more at bit.ly/2SBA2CH

Research Recruitment and Retention Program (R3) Research Recruitment and Retention Program (R3) helps researchers succeed in efficiently meeting participant recruitment goals for clinical and translational research studies, including randomized clinical trials. R3 assists both investigator-initiated and industrysponsored research. >> Learn more at bit.ly/2t4Boy7

StudyFinder StudyFinder is a medical campus website that lists research studies for public view, both for purposes of recruitment and/or general publicity/collaboration. >> Learn more at bit.ly/2F6TZhC

Trial Innovation Network (TIN) TIN is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC) - that seek to address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. >> Learn more at bit.ly/2EUgOG6

Trialspark Trialspark is a data-driven recruitment strategy utilizing online advertising campaigns to target specific research populations.

BU CTSI is piloting this service to determine university-wide interest and will subsidize the cost of creating a platform. Once the recruitment material is IRB approved and ready to go live, each study is then responsible for monthly costs associated with using Trialspark. Costs are based on individual study needs. >> To learn more, email Jill MacRae at jmacrae@bu.edu.

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WORKFORCE DEVELOPMENT TL1 REGENERATIVE MEDICINE TRAINING PROGRAM The BU CTSI’s Regenerative Medicine Training Program has completed another year of successfully training the next generation of regenerative medicine translational researchers.

Launched in 2015, our TL1 Regenerative Medicine Training Program (RMTP) is unique: we are the only TL1 program in the nation entirely focused on stem cells and regenerative medicine. With six predoctoral and four postdoctoral trainees each year, the TL1 RMTP offers comprehensive training from mentored laboratory research to formal coursework in stem cell biology and an exciting seminar series run by our Center for Regenerative Medicine.

Since the inception of our program the national need for training translational regenerative medicine scientists has continued to grow at an impressive pace, propelled by new discoveries in gene editing, stem cell biology and tissue engineering. This growing need is most concretely reflected in the 21st Century Cures Act, passed by Congress in 2016, which established regenerative medicine as one of four national research areas in urgent need of clinical translation.

Aligned with these national priorities, our RMTP launched as one of three integrated CTSI-funded components at Boston University focused on advancing regenerative medicine: 1) a TL1-funded RMTP, 2) a CTSI module to establish a bank of nationally shareable pluripotent stem cells from the BU-led Framingham study participants, and 3) a BU-led consortium of four CTSA hubs dedicated to providing training modules and 1,000 pluripotent stem cell lines for the CTSA network.

Having successfully established all three of these components, the RMTP has become a marquee program of Boston University.

PREDOCTORAL TRAINEES TRAINEE

MENTOR

OUTCOME/ CURRENT ROLE

Kristine Abo

Darrell Kotton

Graduate student

Benjamin Blum

Andrew Wilson

Graduate student

Kerri Dame

Laertis Oikonomou

Graduated with PhD Postdoctoral fellow at US Food and Drug Administration

Elissa Everton

Valerie Gouon-Evans

Graduate student

Richard Giadone

George Murphy

Graduate student

Anjali Jacob

Darrell Kotton

Awarded an F31 HL134274 Return to Year 3 of Medical School

Delia Lopez

Herbert Cohen

Graduate student

Whitney Manhart

Gustavo Mostoslavsky

Graduate student

Timothy A. Norman

Alan Fine

Awarded an F31 HL136126 Graduate student

Yuliang Sun

Darrell Kotton

Graduate student

POSTDOCTORAL TRAINEES TRAINEE

MENTOR

OUTCOME/ CURRENT ROLE

Beth Bragdon

Louis Gerstenfeld

Awarded K99 AR068582 New faculty member at BU

Dar Heinze

Gustavo Mostoslavsky

Postdoctoral fellow

Amira Hussein

Louis Gerstenfeld

Postdoctoral fellow

Esak Lee

Christopher Chen

Awarded a Lymphatic Education and Research postdoctoral fellowship Postdoctoral fellow

Sara Lewandowski

Oikonomou, Laertis

Postdoctoral fellow

Hua Liu

Valerie Gouon-Evans

Postdoctoral fellow

Amalia Capilla Villanueva

Gustavo Mostoslavsky

Postdoctoral fellow

Zhongyan Wang

David Sherr

Postdoctoral fellow

Chih-Sheng Yang

Bob Varelas

Senior Scientist at AbbVie

K GRANT WRITING COURSE Launched in spring of 2016, the K Grant Writing Course seeks to increase the number of submitted and funded career development awards across BUMC and BU. The course, led by Drs. Megan Bair-Merritt and Richard Wainford, is open to early career research faculty.

The competitive application process is based on the applicant’s promise as an independent scientist, mentoring team, and published papers.

To date, the course has accepted 22 faculty, of which 11 have been awarded grants upon completion of the program, four are awaiting funding scores and six are preparing to submit grants this coming year.

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KL2 - Mentored Career Development A key institutional strength, CTSI’s KL2 program is a mentored career development program for BU’s most promising junior faculty translational researchers. The KL2 program provides salary support up to $100,000/year for up to two years and also provides financial support for additional training, lab costs and travel.

KL2 scholars are invited to participate in the following programs or activities: • Independent multidisciplinary research projects involving researchers from at least two diverse disciplines and mentors from two disciplines • K to R Transition Support Program (PRIME) • Training in grant writing • Faculty development seminars

Current and past KL2 Scholars 2018-2019 Sanjib Chowdhury, PhD, MS 2018 KL2 Fellowship "Cohesin SA-1 Polymorphisms and Racial Disparities in Colorectal Cancer" Mentors: Hemant Roy, MD, Lindsay Farrer, PhD, and Lynn Rosenberg, DSc

Tehnaz Boyle, MD, PhD 2018 Institutional Early Career Development Award "Improving Prehospital Emergency Care for Children With Telemedicine" Mentors: James Feldman, MD, FACP, and Megan Bair-Merritt, MD, MSc

2017-2019 Louis Awad, PhD, PT “Wearable Sensors For Measuring Propulsive Force Generation During Walking After Stroke” Mentors: Terry Ellis, PhD, PT, and Ken Holt, PhD, PT

Christopher Salas-Wright, PhD “Toward the Prevention of Substance Use and Violence Among Latino Youth” Mentors: Julia Dickson-Gomez, PhD, and Lena Lundgren, PhD

Tae Woo Park, MSC, MD “Distress Tolerance and Benzodiazepine Discontinuation in Opioid Agonist Therapy”

Traci N. Bethea, BA, MPA, PhD “An Assessment of Whether Aspirin Improves Breast Cancer Outcomes in Black Women and Modifying Effect of Genetic Variants” Mentors: Julie Palmer, SCD, MPH, and Tracy Battaglia, MD, MPH

Ji Yi, PhD "Optical Phenotypes of Genetic Cancer Syndromes Using iPSC Organoids" Mentors: Irving Bigio, PhD, and Darrell Kotton, MD

Julie Morgan Frieman, MD "A Novel Apporach to Hepatitus C Testing in Resource-limited Settings"

Mentors: Robert Horsburgh, MD and Benjamin Linas, MD, MPH

2016-2018 Hong-Phuong Thi Vo, MD “Weight Gain, Respiratory Infections and Asthma in Infants with Bronciolitis” Mentors: Megan Bair-Merritt, MD, and Carlos Camargo, MD

Allison Dennis, PhD “Monitoring Tumor Biomarker Evolution with Multiplexed Tissue-Dept Imaging”

Christine K. Liu, MD, MS “Decreasing Risk Factors for Falls in Older Hemodialysis Patients” Mentors: Roger Fielding, PhD, Allan Jette, PT, PhD, and Janice Weinberg, ScD

Joshua D. Campbell, MD “Single-cell RNA Sequencing of Bronchial Epithelium of Smokers and Lung Tumors” Mentors: Avrum Spira, MD, and William Johnson, PhD

2015-2016 Devyani Misra, MD “Evaluating Synovitis as a Link Between Knee Osteoarthritis and Muscle-related Morbidities” Mentors: David T. Felson, MD, MPH, and Roger Fielding, PhD

Julia Xu, PhD “Potential Role of Adipocyte AMPK in Obesity-related Cardiomyopathy” Mentors: Wilson S. Colucci, MD, and Konstantin Kandror, PhD

Katrina Traber, MD, PhD “The Role of Oncostatin-M in Pneumonia”

Mentors: Lee J. Quinton, PhD, and Darrell N. Kotton, MD

Mentors: Catherine Klapperich, MD, Tyrone Porter, MD, and Sam Thiagalingam, MD

Mentors: Richard Saitz, MD, and Michael Otto, PhD

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WORKFORCE DEVELOPMENT

MENTORING MATTERS BU CTSI maximizes the mentor-mentee relationship by offering training on developing an effective mentoring relationship, effective communication, fostering independence, aligning expectations and understanding cultural difference. Empowering the mentee helps emerging clinical and translational investigators navigate the complexities of the mentoring dynamic.

Train the Mentor Skill development for mentors

PRIME Program

BEST Program Career Exploration, Seminars and Career Coaching

Faculty K Awardees Career Development KR2

Research Support Consults

TL1 Program

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KL2 Program

Mentored Career Development Training

CREST Program Clinical Research Training for MD Fellows

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Grant Workshops F, K and R Grant Workshop Series

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BU CTSI Infrastructure Development and Integration through Mentoring

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Funding Early- and Mid-Career Team Projects

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Career Projects

Predoc & Postdoc Training in Regenerative Medicine

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Informatics, Regulatory, Biostats & Research Design

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ARCs

Funding Affinity Research Collaborative team projects

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Grant Writing Consults Consults and Services

Pilot Program Funding Interdisciplinary Pilot Projects

There are different types of mentoring relationships, including: DYAD MODEL One-on-one relationship; mentor-mentee setup COORDINATED NETWORK MODEL Multiple mentors who work as a team to support the mentee’s development MULTI-MENTOR MODEL Multiple mentors who work independent of each other to support the mentee’s development Mentorship of our faculty is a cornerstone of all our programs, which ensures that fellows, early career and mid-career faculty are supported every step of the way.

For more information on the ontology of Boston University mentoring, visit: bit.ly/2C0NxpV

PRIME PROGRAM PRIME (Pathways to Research Independence and Mentoring Excellence) is a research career support program for faculty. Directors Tuhina Neogi, MD, PhD, FRCPC, and Richard Wainford, PhD, launched PRIME in October 2017 with a cohort of 20 scholars.

The goal of the program is to develop a supportive research environment, community and peer cohort, and mentoring culture for BUMC NIH K-funded investigators.

PRIME has been modeled on successful programs at other leading institutions that have shown high success rates in transitioning K investigators to independent R01 funding. The PRIME Program is designed to help faculty successfully transition to independent funding, aiming for stronger and earlier grants. The program offers an interdisciplinary peer-supported network; peer-led and reviewed work-in-progress sessions to optimize work; and interactive presentations and research resources to boost faculty efforts for successful transition from K funding to independent R01 funding.

Bi-monthly meetings feature interactive presentations of direct relevance to scholar research endeavors. The third Tuesday of each month is set aside for work-in-progress reviewed by PRIME peers and directors for constructive interdisciplinary feedback; including abstracts, papers, posters, presentations, and importantly, review of scholar grants’ specific aims and other sections. Mock grant review panels are scheduled at least six weeks before intended NIH submission deadline, with insightful feedback by seasoned faculty. Each session has time built in to provide a “safe space” for scholars to brainstorm and troubleshoot with PRIME peer network about the challenges and issues that faculty face in their research trajectory.

PRIME scholars will continue to be part of an engaging supportive network supporting their activities and know-how to locate and navigate access to research resources through the BU CTSI. The PRIME directors will continue to provide support, and anticipate that scholars will be able to help mentor the next generation of early career researchers through the same process.

VIEW COHORT 1 bit.ly/2Oskyyr

VIEW COHORT 2 bit.ly/2JJnCWi

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WORKFORCE DEVELOPMENT SUCCESS STORIES

K GRANT WORKSHOP SUCCESS The K Grant Writing Workshop a CTSI Workforce development program has proven to be highly successful. Launched in the fall of 2016, offering 2 sessions per year, a total of 22 faculty have completed the program to date. In 2018 the program was extended to include accomplished Post-doctoral students and Fellows. We are thrilled to announce that 11 of the participants have been awarded funding. See all awardees here: bit.ly/2QkPC9b

TRACI N. BETHEA, PhD, MPA

CHRISTOPHER P. SALASWRIGHT, PhD, MSW

Traci N. Bethea received a 2017 KL2 scholarship for “An Assessment of Whether Aspirin Improves Breast Cancer Outcomes in Black Women and Modifying Effect of Genetic Variants.”

On September 1, 2017, Dr. Christopher P. Salas-Wright received a KL2 fellowship for his research on “Preventing Alcohol and Other Drug Use and Violence among Latino Youth.” Exactly one year later, he is now the Principal Investigator of a K01 Mentored Research Scientist Development Award, a five-year project funded by the National Institute on Alcohol Abuse and Alcoholism. Dr. Salas-Wright’s K01 award supports his career development and research activities through 2023, allowing him to conduct research and receive advanced training in the areas of qualitative research, intervention adaptation, and prevention implementation and outcomes research.

Subsequentially, Dr. Bethea was funded by the NIH for a K01 Career Development Award. Her award provides an opportunity to receive training in cancer survivorship and in molecular epidemiology. The research focus of her K01 award will be on breast cancer survivors in the Black Women’s Health Study (BWHS).

Dr. Bethea’s K01 research focuses on two modifiable exposures – aspirin/nonsteroidal anti-inflammatory drug use and vitamin D status – that may influence breast cancer outcomes and considers potential interaction with genetic factors, which will be instrumental in identifying populations that may benefit from pharmaceutical intervention.

During her K01 award, she will continue her research on breast cancer subtypes, ovarian cancer, and neighborhood socioeconomic status in African American women and will contribute to research endeavors in the BWHS. In the next few years, she would like to develop new research directions to complement her K01 award. As a K awardee, she was invited to join the first cohort of the CTSI PRIME program, where she will continue to be supported on her path to an R01.

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Dr. Salas-Wright’s K01 research will focus on adapting the “keepin’ it REAL” curriculum—a widely-used, school-based substance use prevention program— to include an emphasis on preventing youth violence. Given that we know substance use and youth violence are often connected, this approach is an efficient and cost-effective way to address problem behaviors affecting youth. The current project builds upon Dr. Salas-Wright’s recent book on drug use and crime, as well as his extensive research in the areas of adolescent substance use, violence, and risky behavior.

Dr. Salas-Wright’s research and commentary have been featured in numerous national news and pop culture outlets, including: ABC News, NBC News, CBS News, National Public Radio, USA TODAY, The Washington Post, The Los Angeles Times, The Dallas Morning News, Huffington Post, Vox, Politifact, The Academic Minute, Cosmopolitan, Teen Vogue and Conan.

RESEARCH PROFESSIONALS NETWORK The BU Medical Campus/BMC Research Professionals Network (RPN) was launched in December 2016, with support from the BU CTSI and with the goal of enhancing the quality of human research by supporting the professional development of the institutions’ clinical research support staff.

RPN membership is open to all research personnel involved in coordinating clinical/human research at BMC and BU. Members of the RPN have enthusiastically embraced the network, and in a recent survey of the RPN, over half attributed their membership in the RPN as a key reason for their improvements in conducting study procedures, documentation, communicating with the study team, developing new research connections, handling study-related challenges, demonstrating leadership, knowledge of regulations and policies.

Our peer-led, competency-based workshops were one of the more significant RPN offerings in 2017. The content for these novel workshops are based on the Joint Task Force (JTF) recommendations for essential competencies to conduct safe, ethical, and high-quality clinical research, as well as identification of coordinator needs. The workshops include a didactic presentation, as well as a workshop activity for attendees to work on together, which helps reinforce learning. The peer-led aspect of the workshops provides a unique opportunity for coordinators to learn from one another and share expertise.

The teaching experience allows the workshop peer leaders to further their knowledge and expertise in a specific research topic area and to hone their presentation skills.

New in AY 2018/19 is a collaboration with CTSI and the University of Vermont (UVM), who is modeling its own RPN based on BU’s. Sessions will be attended and taught by members of BU/BMC as well as UVM through use of Zoom videoconferencing technology to facilitate collaborating from afar.

Another important focus for the coming year will be on career development, with new initiatives to include a mentoring program, professional certification preparation support, and creation of standardized job descriptions to define a career ladder at BMC and BU. For more information regarding this program, please contact Gina Daniels at gdaniels@bu.edu.

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WORKFORCE DEVELOPMENT RESOURCES

BEST Program: Broadening Experience in Scientific Training exposes trainees to a variety of career paths they might not have considered by identifying the needs of the current and future biomedical workforce and helping trainees match with an engaging and satisfying career. Open to all biomedical graduate and postdoctoral trainees. >> Learn more at bit.ly/2ROi1RH TL1 Regenerative Medicine Program: The overarching goal of this program is to recruit and train outstanding scientists in the dynamic fields of stem cells and regenerative medicine. Trainees are provided with an innovative and integrated training curriculum that supports translational team science interactions with both PhD and MD scientists and clinicians. >> Learn more at bit.ly/2zQqpJv CREST: The Clinical Research Training (CREST) Program is an interactive mentored training program targeted at postdoctoral fellows and scientists, which focuses on the essential tools and competencies that scientists need to conduct clinical or translational science. >> Learn more at bit.ly/2zUqUSJ Research Professional Network (RPN): The RPN has an overarching goal to enhance the quality of human subjects research on campus through an effective network of research professionals. Membership is open to all research personnel involved in coordinating clinical/human research on campus. >> Learn more at bit.ly/2SGJu7Z Regulatory Training: This training covers key topics and concepts to ensure human/clinical research professionals at BMC and BUMC are able to successfully conduct research study activities. >> Learn more at bit.ly/2L8EHcW Biostatistics, Epidemiology & Research Design (BERD): The BERD program provides researchers with comprehensive support in designing and carrying out research at the design, implementation and analysis stages. BERD has generated a portfolio of solutions for the most common needs to ensure participation in the earliest stages of study development. >> Learn more at bit.ly/2SBHCgx Grant Writing Consults: CTSI provides writing and editing assistance for all aspects of the grant writing process, from conceptualizing specific aims, to developing successful submission strategies, and guiding investigators in building compelling scientific narratives. >> Learn more at bit.ly/2Eek1if Affinity Research Collaboratives (ARCs): ARCs consist of faculty and trainees from different disciplines across campuses, who are organized around the foci of common research interests. Support and development of ARCs create opportunities for interdisciplinary approaches to both research and training in biomedical research. >> Learn more at bit.ly/2G6QCsI 20

Early–Career Projects: PhD candidate Tim Norman was awarded an F31 from NHBLI for his research that focuses on the origin, maturation and regeneration of pulmonary lymphatic endothelium. >> Learn more at bit.ly/2EnZYPd K Grant Workshop: This course, offered twice a year, seeks to increase the number of submitted and funded career development awards across BU/BUMC. Participants prepare all sections of their K award, critique previously submitted K awards and engage in a mock study section with senior faculty. >> Learn more at bit.ly/2QpY6Mg KL2 Career Development: KL2 is a mentored career development program for promising junior faculty translational researchers. It provides salary support up to $100,000 a year (for up to two years) and provides financial support for additional training, lab costs and travel. Additionally, each KL2 scholar has one career mentor and two research mentors from different disciplines (clinical and nonclinical backgrounds). >> Learn more at bit.ly/2QpxR8s Mid-Career Projects: Cara Stepp, a former KL2 Scholar and Pilot awardee, developed a tool that uses an acoustic measure of small changes in people’s voices, called relative fundamental frequency (RFF) that will make estimating laryngeal tension easy, noninvasive, reliable and affordable. >> Learn more at bit.ly/2C0WuzM PRIME K to R Transition Program: Pathways to Research Independence and Mentoring Excellence (PRIME) is a career support program for faculty, designed to help them successfully transition to independent funding, aiming for stronger and earlier grants. PRIME offers an interdisciplinary peer-supported network, peer-led and reviewed work-in-progress sessions to optimize work and research resources for successful transition from K funding to independent R01 funding. >> Learn more at bit.ly/2SBZcB5 R Grant Workshop: Participants learn about the process of submitting an R01 research grant to the National Institutes of Health. It overviews the NIH study section review process and a general structure to follow when writing a R01 grant, as well as the necessary steps to submit a NIH proposal through Boston University’s Office of Sponsored Programs. >> Learn more at bit.ly/2ONOfdl

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INNOVATION INCUBATOR CTSI SYMPOSIUM

co-sponsored by the Grayken Center for Addiction The Boston University Clinical and Translational Science Institute and The Grayken Center for Addiction co-sponsored the Seventh Annual Translational Research Symposium in Memory of David C. Seldin, MD, PhD (1957-2015) on May 3, 2018. The event was held in the Hiebert Lounge, located in the Boston University School of Medicine Instructional Building, and was attended by over 200 guests.

The symposium, titled “Addiction Medicine 2018: Translational Science at the Cutting Edge,” highlighted several guest speakers who discussed the ongoing opioid crisis accompanied by research-based presentations. The symposium also featured 32 e-poster boards containing various topics relating to addiction medicine.

Featured speakers included Executive Director of the Grayken Center Michael Botticelli; Dean of the Boston University School of Public Health Sandro Galea; Commissioner of the Massachusetts Department of Public Health Monica Bharel; Dean of the Boston University School of Social Work Jorge Delva; and Director of the Division of Clinical Innovation for the National Center for Advancing Translational Sciences (NCATS) Michael G. Kurilla.

Keynote speaker and Director of the National Institute on Drug Abuse, Nora D. Volkow, presented in length about the potential relationship of translational science among the opioid crisis.

Volkow’s PowerPoint presentation was titled “Addressing the Opioid Crisis: A Key Role for Translational Science.”

Senator Ed Markey attended the symposium, providing the closing remarks about the positive contributions and efforts of the professionals at the Boston University School of Medicine and the Grayken Center on issues involving the opioid crisis and addiction. The Senator reminded those in attendance to encourage those in need to find a pathway to treatment.

For those unable to attend in person, the CTSI held a YouTube livestream that totaled 175 views. On Twitter, the hashtag #AddictionSymposium2018 was posted 161 times, with a unique reach of 236,293 people. More information from the symposium, including presentation slides and video playlist can be found at bit.ly/2L8bmxF. Dr. Seldin will be remembered for organizing the annual Translational Science Symposium and we are indebted to him for his vision and contributions.

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HOSPITAL-BASED OPIOID TREATMENT With overdose being the most common cause of accidental death in the United States, the HBOT program, or Hospital-based Opioid Treatment, is an important, attainable step in helping those who suffer from Opioid Use Disorder (OUD).

This program specializes in helping patients who suffer from OUD by providing them with both inpatient and outpatient treatment, despite being admitted to the hospital for a reason unrelated to OUD. BMC was able to create a successful HBOT program in the form of Addiction Specialty Consultation Service (ACS) that resulted in a much greater percentage of admittance for treatment, because patients were able to receive what they needed within the same facility, and were not recommended elsewhere for potential treatment.

BMC has been working to implement this programming for several years, despite a national push back. The next steps are to integrate the programming into hospitals at a national level to stop the opioid crisis and use hospitalization to limit the amount of relapses and further decline in people who suffer with OUD. The approach of this program is to use HBOT as a stepping stone in research among hospitalized and medicated patients.

With three aims in place (a written guide, an extensive evaluation, and a data-driven improvement process), the HBOT program should provide enough research and information to kick start it in hospitals around the country.

BIOINFORMATICS CONSULTATION SERVICE The BU CTSI Translational Bioinformatics Core provides bioinformatics analyses in support of translational research projects at Boston University.

These consultations have primarily involved analysis of microarray projects processed by the Boston University Microarray and Sequencing Resource (BUMSR), providing assistance to hundreds of investigators and resulting in at least 50 publications since 2010.

Bioinformatics consultations can also be provided for the analysis of gene expression data not generated by the BUMSR, including publicly available microarray and RNA sequencing datasets.

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INNOVATION INCUBATOR INDUCED PLURIPOTENT STEM CELL (iPSC) Boston University has established a CTSA collaboration with UPenn, Beth Israel Deaconess, and University of Chicago. The collaboration creates a national IPS cell network with deep phenotyping for translational research that will enable advanced disease modeling using >1,000 existing normal and disease specific human cell lines including lines representing second generation participants of the Framingham Study.

The consortium institutions will collectively maintain an Open-Source gene editing tool box, comprised of the cells, reagents, and protocols needed for CTSA investigators to manipulate the human genome in iPSCs. The consortium plans to develop the infrastructure necessary to facilitate advanced disease modeling or genotype-phenotype interactions using the CTSA network of large iPSC repositories.

The ultimate goal of the iPSC consortium is to facilitate the translational capacity of iPSC technology through dissemination of cells and associated tools and knowledge required to maximize their utility. In addition to sharing iPSCs with outside investigators, the network is meant to disseminate protocols and reagents that we have collectively developed with significant investment over time, to decrease the need for duplicative effort by other investigators.

An additional component of this infrastructure is the establishment of an annual, hands-on course in iPSC culture, differentiation, and manipulation. This course is taught by CTSA hub project participants on a rotating basis, with core competencies covered each year supplemented by additional skill sets specific to each center. The first iteration of this course was held April 24-28, 2017, at the Boston University School of Medicine CReM with 10 course participants, the second installment of the course occurred in May 14-18, 2018, at the University of Pennsylvania.

The Framingham Heart Study iPSC Repository is a partnership between the CReM and the Framingham Heart Study to bank reprogrammable blood samples from 6,200 FHS participants. To date ~2,500 Gen2/Omni 1 cohort samples have been collected and 2,213 of 3,700 Gen3/Omni 2/NOS samples have been collected during ongoing Exam 3, with an anticipated completion by March 2019. 70 iPSC lines have been generated to date from FHS participant samples.

Following the first year of the course, the consortium developed a series of planned educational video modules based on the course content. These include the didactic lectures that were included as part of the course covering a variety of core and specialized topics including: 1

iPSC reprogramming concepts and methods;

2

Practical aspects of iPSC culture and Sendai virus reprogramming;

3

ESCs and the embryo: pluripotency and endodermal differentiation;

4

Editing the genome of pluripotent stem cells;

5

CRISPR design for iPSC targeting;

6

Directed differentiation of PSCs to definitive endoderm and lung progenitors;

7

Mycoplasma policies and SOPs for prevention, detection, and response;

8

Characterization of pluripotent stem cells.

These video lectures are available for free streaming on:

ď„ˆ BU CTSI website: bit.ly/2pIwORT

ď…Ś

BU CTSI YouTube channel: bit.ly/2RDztaS

In addition, an iPSC culture instructional manual is included on the Boston University CTSI site for free download. Views and downloads of these videos and the instructional manual are being tracked with content from other sites associated with this consortium.

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TEAM SCIENCE The Evans Center for Interdisciplinary Biomedical Research (ECIBR) and BU Interdisciplinary Biomedical Research Office (BU IBRO), partnering with the BU CTSI, supports Affinity Research Collaboratives (ARCs) to enhance team science.

The ARCs consist of faculty and trainees from different disciplines across campuses who are organized around the foci of common research interests. They are built from the bottom up, from investigator initiated common research interests.

From left: M. Dangeti, C. Scheftic, Dr. Alan Fujii, BMC NICU Director, E. Sridhar with the NVM Prototype, and N. Leung

Learn more about the ARCs and what they've accomplished in their publication:

BU BRIDGE BUILDERS

bit.ly/2zdapkh

BU Biomedical Engineering and BU CTSI have established a new collaborative program, the Biomedical Bridge BUilders Initiative. It is designed to accelerate the commercialization of clinician-inspired medical device innovations by partnering with graduate engineering biodesign and product development student teams.

Bridge BUilders invites physicians, dental clinicians and other members of the BU Medical Campus to submit a short (one page or less) description of a medical device clinical challenge. These descriptions can be an early product idea or a project that is already underway that could benefit from a team of graduate biomedical engineers trained in the biodesign product development process. The graduate students selected for each project work part-time under the guidance of a Clinical Advisor while they complete their Masters Graduate studies at the BU College of Engineering. Each project develops innovative IP and resulting patents are assigned to Boston University or BMC under current university patent policies.

This program was initiated during the Fall 2016 semester with a neonatal monitoring project under the guidance of Dr. Alan Fujii (shown above). During its first year, this project completed the initial phase of verification testing, submitted and received IRB approval, and conducted the first series of clinical studies.

The second project is developing a robotic retraction system under the guidance of Dr. Karl Karlson, that will facilitate the exposure of the IMA during open-heart surgical procedures.

Dr. Keith Davies is the Clinical Advisor for a project that will redefine the cranial support system for pediatric neurosurgery. The Bridge BUilders Initiative is now exploring clinical challenges for the next cycle of collaboration.

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INNOVATION INCUBATOR

INTREGRATED PILOT PROGRAM BU CTSI Integrated Pilot Grant Program serves as a principal means to facilitate clinical and translational scientific collaborations across traditional barriers of school or research discipline. Over the past ten years, the success of this program has been enabled through broad support from the university and its respective schools, affiliated hospitals, and other partners. By encouraging new team-science partnerships, the Pilot Grant program has supported a portfolio of projects that have forged novel lines of investigation resulting in over $30 million in externally funded awards to date.

In general, funded projects fall within the broad spectrum of clinical and translational research in the prevention, diagnosis, and management of human disease. Specific areas include: • T1 research that develops novel treatments and interventions by expediting the movement between basic research and patient-oriented research leading to new or improved scientific understanding or standards of care.

• T2 research that tests the efficacy of interventions through patient-oriented research and population-based research leading to better patient outcomes, the implementation of best practices, and improved health status in communities.

• T3 research that promotes dissemination and implementation of research for system-wide change through movement of evidence based-guidelines into clinical practice.

• T4 research that promotes discoveries in population science.

Funding Partners and Research Support Navigating the various funding opportunities available to researchers at BMC/BU can be challenging and time consuming.

By partnering with the diversity of schools, clinical programs, and hospitals in our extended community, the Pilot Grant program serves as a central repository for seed grants that connects researchers to sponsors and leverages resources to support the scientific process.

Partners include hospitals such as Boston Medical Center and the Boston Veteran’s Affairs Medical Center, schools such as the School of Medicine, Goldman School of Dental Medicine, and School of Public Health, departments including the Department of Medicine, research centers including the BU-BMC Cancer Center, the Grayken Center for Addiction, the Evans Center for Biomedical Research, and the Evans Center for Implementation and Improvement Science, and BU-wide resources including the Office of Technology Development. Prospective and funded researchers are connected to the array of services offered by the CTSI to support the proposed investigation from inception, though implementationn, interpretation, and dissemination.

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RESEARCHER Q&A WITH

CASEY T. TAFT, PhD Staff Psychologist, National Center for PTSD, VA Boston Healthcare System; Professor, Department of Psychiatry, Boston University School of Medicine

"Trauma-Focused Partner Violence Intervention: A Pilot Study " Describe the project. What are the aims and goals and why is it important?

The goal of this project is to pilot test the "Strength at Home" group therapy program to end intimate partner violence within a civilian population. Our prior randomized controlled trials demonstrating the effectiveness of the intervention have been with military populations.

How has the pilot impacted research?

The pilot was invaluable because this is a difficult area of research with little outside funding available. The pilot data will help bolster applications for future funding for a larger randomized controlled trial. Without such pilot data, we would have little chance of external funding.

What were the outcomes and its translational impact?

We do not have the longer-term outcomes for this study. However, we have shown that the program translates very well from the military to civilian population. The program was well-received by the participants and little adaptation needed to be made. The project also allowed us to obtain all of the necessary approvals and certifications, which were considerable, for us to be able to offer these clinical services and conduct the research.

Any plans for expanding your research based on the results?

We are excited to submit applications for a larger randomized controlled trial that builds on this important pilot work. The potential impact of such a study is enormous in our view because to date, no other intimate partner violence intervention program has been shown to be effective via randomized controlled trial. This research may ultimately pave the way for the implementation of more effective violence prevention interventions that can save many lives.

INTEGRATED PILOT PROGRAM SUMMARY 2008-2016 $3,325,975 pilot funding

$41,402,621 in grants

88 publications

supported 169 projects

10 provisional IP filings

resulting in:

5 patent applications

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RESEARCH JOB CONNECTION EMPLOYEE POOL

MISSION To connect PIs with temporary staffing and provide temporary work for employees in need of more hours, in need of practicum, or facing job lay-off.

LAUNCHED IN

Comprised of research professionals familiar with BMC/BU systems and policies who have proper GCP credentials.

46 employees have applied with 20 matches to date.

6 matches

have resulted in full or

part-time employment DECEMBER 2017

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17 PIs have applied since launch and 100% have

matched with at least one employee.

LEARN MORE AT bit.ly/2Qm9IeZ

     

HAVE WE HELPED YOU LATELY? Here are just some of the ways BU CTSI can help your research!

451 INVESTIGATORS

use regulatory consultation services for improving IRB protocols

450 INVESTIGATORS use consultations for biostatistics and research design

89 INVESTIGATORS

assisted with recruiting participants into their studies

22 FACULTY

7 FACULTY

$3.3M+ IN PILOT AWARDS to faculty to

take K Grant Writing Workshop Series to write competitive K proposals & all submit proposals

GRANTS, 88 PUBS, 5 PATENTS, & 10 PROVISIONAL IPS

7 NEW

32 TYPES

join KL2 Career Mentored Program that helps them get 6 external awards to date

catalyze translational research led to $41.4M+ IN

16 PREDOCS AND POSTDOCS

in the TL1 Training Program in Regenerative Medicine with 7 completing the program & continuing in research in academics & industry

informatics tools available & informatics consults offered

of training workshops support research skill building



216 RESEARCH STAFF in the Research Professional Network

220 INVESTIGATORS

form 12 Affinity Research Collaboratives (ARCs) to chart new directions using novel interdisciplinary approaches & catalyze

421 publications & 122 grants

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MILESTONES & MORE  = Launched

 = Ongoing

$ = Funded

2015

• Accessible Research Commons for Health  • BERD: Biostatistics, Epidemiology & Research Design  • CIIS – Center for Implementation and Improvement Sciences  • Continuation of CREST  • CTSI funded $ • First Regional Shared Mentoring Symposium  • Fundamentals of GCP Training • Initiation of Framingham iPSC Bank, CTSI Module 1  • Integrated Pilot Program $ • KL2 Scholars Funded $ • Mentoring the Mentors Seminar  • Mini Sabbatical Award $ • PCORI BU-CTSI joined • REDCap  • Regulatory Consultation  • Regulatory GCP Training  • Thrombosis and Hemostasis in Health and Disease ARC  • TL1 Fellowships $

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2016

• Annual Symposium in Honor of David Seldin  • BU Bridge Builders  • CCR (Connecting Community to Research) Trainings  • CTSI Grant Writing Service  • External Advisory Board  • K Grant Writing Course  • New Website  • Research Professionals Network  • Research Recruitment and Retention Core  • Science Cafes  • Strategic Executive Committee  • Thrombotic Microangiopathy and Clinical Trial  • U01 (iPSC networked repository funded CRC-based Digital Health Initiative) $ • WebCAMP 

2017

• “2 BE CLEAR” Training  • AAHRPP accreditation with Distinction in Community Engagement • All of Us Network - BU and Boston HealthNet  • BHERN (Boston Health Equity Research Network) PBRN • BU Profiles upgraded  • ClinicalTrials.gov  • Communication Workshops - Community Engagement  • Community Engagement: Toolkit  • CReM Training Course - iPS Culture Course  • CTSI joins ACT Network • I2B2 Info Session  • Informed Consent Translational Program  • Joined New England CTSA IRB Working Group  • Newsletter  • PRIME  • Research Professionals Network Workshops  • TEC - Translational Epidemiology and Comparative Effectiveness Center  • Trial Innovation Network  • U01 “Translating Research into Practice” (TRIP) $

2018

• CMD Center for Molecular Discovery Collaboration  • Community Engagement Newsletter  • • • • •

IBRO - Technology Wonders Symposium Protocol Builder  Research Job Connection  Trialspark  Voucher Program for Core Facilities 

2018-2019 Academic Year • Pilot RFA • CTSI 8th Symposium • 4th Annual Regional Shared Mentoring Symposium • GCRU - CPR and Phlebotomy Training

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Clinical & Translational Science Institute CTSI Administration

Helia Morris, MSM | Executive Director, CTSI

hmorris@bu.edu

Hubert Wong | Assistant Director of Finance and Operations

hswong@bu.edu

Licia Holman | Finance & Operations Coordinator

lmh@bu.edu

ClinicalTrials.gov

Karla Damus, PhD, MSPH, MN, RN, FAAN Administrator, ClinicalTrials.gov and Clinical Research Education

damusk@bu.edu

Clinical Trial Network (Trial Innovation Network TIN)

Point of Contact: Helia Morris, MSM

hmorris@bu.edu

Communications

Sharon Tomlinson, BS | Training Program & Communications Manager

stomlin@bu.edu

Alyssa Kenny, BA | Communications & Social Media Coordinator

amkenney@bu.edu

Community Engagement

Nicole Spencer, MSW, MPH | Community Project Manager

Nicole.Spencer@bmc.org

General and Clinical Research Unit (GCRU)

Ridiane Denis, RN | Director, Clinical Research Operations

ridianed@bu.edu

Human Research Quality Assurance

Fiona Rice, MPH | Human Research Quality Manager

fionar@bu.edu

Abdalla Abdussamad, MD, MA | Human Research Quality Manager

abdallaa@bu.edu

Integrated Pilot Funding

Deborah Rebelo | Pilot Program Coordinator

ctsipilots@bu.edu

Program Evaluation

Deborah Fournier, PhD | Assistant Provost for Institutional Research & Evaluation; Director, CTSI Evaluation Program

fournier@bu.edu

Regulatory Consultations

Mary-Tara Roth, RN, MSN, MPH | Director, Clinical Research Resources Office

mtroth@bu.edu

Research Professionals Network (RPN)

Gina Daniels, BS | Human Research Quality Manager

gdaniels@bu.edu

Research, Recruitment & Retention

Jill MacRae, MS/CCRP | Project Manager

jmacrae@bu.edu

CTSI Website, WebCAMP, REDCap

Tasha Coughlin | Data Manager

tawatson@bu.edu

Training and Education

Sharon Tomlinson, BS | Training Program & Communications Manager

stomlin@bu.edu

Sign up for CTSI Funding & Event Communications bit.ly/2EwYeCg

CITE & SUBMIT

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Continue our support by citing our grant number in relevant publications:

1UL1TR001430

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