UAMS CENTER FOR CLINICAL & TRANSLATIONAL RESEARCH (CCTR )

1. UAMS CENTER FOR CLINICAL & TRANSLATIONAL RESEARCH (CCTR) Center OverviewUNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCESuams.edu/cctr Curtis L. Lowery, MDCCTR Director 501-686-5847

2. Clinical and Translational Science Awards (CTSAs) Led by the National Center for Research Resources (NCRR) at the National Institutes of Health (NIH). Working as a national consortium, CTSA institutions share a common vision to improve human health by transforming the research and training environment. Team science partnerships-Collaboration-Connectivity-Breaking down institutional barriers

3. T1/T2 Summary • T1- Bench (lab) science to subject testing • Animals • Test tubes • Human subjects (controlled or < 1,000) • T2: Taking it to the streets • Real world use by every day practitioners • Population-based results • Community involvement

4. National CTSA Organizational Chart

5. CTSA Consortium History • Consortium launched in 2006 with additions each year • 46 current member institutions (60 at full implementation) • UAMS first applied in October 2007 • Score = 196 • Second application in October 2008 • Score = 147 • 7th best in the country

6. Current CTSA Locations

7. Consortium Committees • Leadership Committees • Steering – PIs of each CTSA • Child Health Oversight • Strategic Goal Committees • National Clinical and Translational Research Capability • Training & Career Development of Clinical/Translational Scientists • Enhancing Consortium-Wide Collaborations • Enhancing the Health of Our Communities • T1 Translational Research

8. Consortium Key Function Committees Administration Biostatistics/Epidemiology/Research Design Clinical Research Ethics Clinical Research Innovation Communications Community Engagement Education and Career Development Evaluation Informatics Public-Private Partnerships Translational

9. UAMS CCTR Goal The CCTR’s overarching goal is to transform the pace, effectiveness, and quality of translational research among UAMS and its partners, resulting in better health for all Arkansans.

10. CCTR Location • Currently Reynolds Institute on Aging • Recovery Act: Core Facility Renovation, Repair, and Improvement (G20) • Renovate • Central Building: 4 B, C, and D • Central Building ground floor: Metabolic Kitchen • Barton: 3rd floor • Includes • CRC • Informatics • Administration • Research Support Center • Other

11. Required Program Components-All CTSAs Regulatory Knowledge and Support Participant and Clinical Interaction Resources Research Design, Biostatistics, and Clinical Research Ethics Biomedical Informatics Research Education, Training, and Career Development Novel Methodologies & Pilot and Collaborative Studies Translational Technologies and Resources Community Engagement

12. Special Strength Program Components at UAMS Health Services Research Behavioral Research Epidemiology Plus Overall and Governance Tracking and Evaluation

13. Overall and Governance • Director • Curtis Lowery, MD • Co-Directors • Cornelia Beck, PhD, RN, FAAN • Lawrence Cornett, PhD • Co-Investigators • Warren Bickel, PhD • Peter Emanuel, MD • James Raczynski, PhD • Elie Al-Chaer, PhD • Aubrey Hough, MD

14. Executive Steering Committee

15. Regulatory Knowledge and Support • Director • Thomas G. Wells, MD • Overall Goal • To optimize performance of the support services for each step of a clinical trial in order to insure research subject safety and compliance with federal regulations.

16. Regulatory Knowledge and Support • Navigators • Help researchers/staff navigate system and receive timely, appropriate support • CRIMSON • ARIA • IRB • Writing • Portal Administrator • Recruitment Specialist • Assists in • appropriate study design • recruitment and retention of participants • minority recruitment • interfacing with recruiting outlets and • website (portal) design. • Assures • ethical practices are used and • recruiting rates are acceptable • Works with the Minority Recruiting Center

17. Novel Methodologies & Pilot Studies • Co-Directors • S. Michael Owens, PhD • Sudhir Shah, MD, FACP • Overall Goal • To create a UAMS research environment that • focuses scientific and clinical researchers on applying innovative ideas and knowledge to benefit patients and communities • brings new talent to clinical and translational sciences • facilitates interdisciplinary research by population, clinical, and laboratory-based sciences to increase the pace of medical discovery • identifies and manages barriers to bringing important discoveries to patients’ bedsides and the community.

18. Rainmakers Forward thinking, proven scientists from a broad array of disciplines, departments, and colleges charged with fostering collaborative interactions and nurturing investigators in development of novel ideas • S. Michael Owens, PhD, Co-director (COM, Pharmacology & Toxicology) • Sudhir V. Shah, MD, FACP, Co-director (COM, Nephrology) • Mary Aitken, MD, MPH (COM, Pediatrics; COPH) • Cornelia Beck, PhD, RN (CON, COPH, COM) • Warren Bickel, PhD, (COM, Psychiatry) • Marie Chow, PhD (COM, Microbiology & Physiology) • Michael Douglas, PhD (UAMS BioVentures) • Martin Hauer-Jensen, MD, PhD (COP, COM)

19. NovelMethodologies&PilotStudies Awards for Innovative Clinical and Translational Research • Funding • $200,000 CTSA grant award • $200,000 ACH • $600,000 UAMS • Investigator-Initiated Pilot Award (up to $50,000/award) • Collaborative Research Award (up to $100,000/award) • High Impact Award (up to $150,000/award)

20. Biomedical Informatics • Acting Director • Alan VanBiervliet, PhD • Associate Directors • Thomas Kieber Emmons, PhD • David Nelsen, MD • Laura Hutchins, MD • Overall Goal • To develop, implement, and evaluate a biomedical knowledge grid accessible to CCTR investigators that will improve clinical and research integration and interoperability with data quality.

21. Research Education, Training, and Career Development • Co-directors • Robert McGehee, PhD • Katharine Stewart, PhD, MPH • Robert Safirstein, MD • Overall Goal • To transform existing loosely structured educational components at UAMS into training and career pathways for clinical and translational research professionals.

22. Research Education, Training, and Career Development • Pathfinder Committee • Key UAMS faculty members who are top leaders and among the most active researchers • Ensure trainees consistently receive outstanding mentorship and guidance • K12 Scholar-type program • Mentored career development • Post- MD, PhD, PharmD, DDS education and training • Grant supports two trainees, UAMS supports up four additional trainees • Award aims to increase T32, K, and F funding

23. Translational Technologies and Resources • Director • Philip Mayeux, PhD • Overall Goal • Maintain high-quality, cost-efficient, state-of-the-art core facilities • Regular review and periodic retooling to deliver state-of-the-art services in a reliable, cost-efficient manner. • Assist in securing extramural and intramural funding for new technologies and new core facilities

24. Community Engagement • Director • Paul Greene, PhD • Associate Directors • Mary Kathryn Stewart, MD, MPH • Mark Mengel, MD, MPH • Overall Goal • To develop complementary service and research infrastructures for a translational research environment in which communities can examine, understand, and change factors contributing to chronic illness and health disparities.

25. Design, Biostatistics, and Clinical Research Ethics • Director • Paula Roberson, PhD • Co-directors • Chris Hackler, PhD • D. Micah Hester, PhD • Overall Goal • To generate feasible, well-designed protocols which produce reliable data to be translated into communities to improve public health

26. Epidemiology • Co-directors • Fred Kadlubar, PhD • Martha Phillips, PhD • Overall Goal • To provide the expertise, techniques, and tools for state-of-the-art epidemiologic methods for clinical and translational research. The ultimate goal is to improve the health of all Arkansans.

27. HealthServicesResearch • Co-directors • Glen Mays, PhD, MPH • Bradley Martin, PharmD, PhD • Overall Goal • Study social, behavioral, and epidemiologic research methods in order to study the organization, financing, and delivery of health care • Create a forum for multiple stakeholders to share ideas and resources and work collaboratively

28. Participant and Clinical Interaction Resources • Director • Peter Emanuel, MD • Associate Program Director • Aubrey Hough, MD • Overall Goal • To expand participation of UAMS faculty in clinical and translational research, leading to an environment of scholarship and inquiry for clinical and translational research.

29. Behavioral Research • Director • Warren Bickel, PhD • Overall Goal • To provide the expertise, techniques, and tools for state-of-the-art behavioral science in clinical and translational research, with the ultimate goal of improving the health of all Arkansans.

30. CCTR Component Program Managers Acts as administrative leader for each component Ensures projects involving multiple program components are integrated within the CCTR Communicates improved procedures to other components, needs for resources