Colorado Clinical & Translational Sciences Institute (CCTSI)

1. Colorado Clinical & Translational Sciences Institute (CCTSI) Overview and Vision Ronald J. Sokol, MD, Director and PI

2. Objectives • Overview of CCTSI • Goals • Mission and Vision • Structure and organization • Highlights • Evaluation and Tracking • National Consortium involvement

3. 2005 – Dr. Zerhouni, NIH Director New NIH grant program to transform clinical and translational research and training; to be started in 2006 GCRC programs (and several other NIH grants) would be phased out and encompassed in this program NIH would eventually fund 60 CTSAs Academic Health Centers that could give graduate degrees were eligible CTSA Program and NIH

4. Translational Research Clinical Investigation Clinical Trials Practice In the Community Basic Research T1 T2 Bench Bedside Trench Molecules & Cells, Animal Models Communities & Populations Patients Clinicians Population Scientists Basic Scientists Clinical Scientists

5. CTSA Program and UC Denver UC Denver obtained CTSA planning grant in 2006 Submitted full CTSA grant in Nov. 2007 Received fundable score (5th best) Grant Award announced on May 29, 2008 (2008-2013) CCTSI initiated on June 1, 2008 3rd “Class” of CTSA grants

6. 38 CSTA Awardees – as of June, 2008

7. CCTSI - Institutions Involved • UC Denver, CU-Boulder • UCD Professional Schools: SOM, CON, SOP, SOD, CSPH, Graduate School; UCD downtown faculty – Engineering, Arts & Sciences, Education • Hospitals: University of Colorado Hospital, The Children’s Hospital, Denver Health, National Jewish Health, Denver Veterans Affairs Medical Center, Kaiser Permanente Colorado

8. CCTSI at University of Colorado President of University of Colorado Affiliated Hospitals: UCH, DH, TCH, NJH, KP, DVAMC Chancellor UC-Boulder Chancellor UCDenver Vice Chancellor Of Research UCB Vice Chancellor Of Research UC Denver Vice Chancellor Of Health Affairs UC Denver UCB Schools & Colleges Downtown Denver Campus Schools & Colleges School of Medicine School of Pharmacy College of Nursing School of Dentistry School of Public Health Graduate School Institutions Encompassed by the CCTSI

9. CCTSI Community Partners • 20 Community-Academic partnerships throughout the state • Populations: Native Americans, Latinos, African American, rural groups, Nursing partnerships, Catholic churches, etc. • PACT Focus Groups: San Luis Valley, Stapleton 2040, American Indian/Alaskan Native Programs, High Plains Research Network, Kaiser Patient/provider, LUCHAR

10. Where is the CCTSI? • Institute without walls • Centralized: at Leprino Bldg, 3rd floor • Administrative Core, Adult Outpatient CTRC and Infusion Facility, Metabolic Kitchen, TCH Core Lab, ERL, other Offices • Distributed: • CTRCs at UCH, TCH, NJH and CU-B • Other Programs and Cores located across UCD AMC, downtown campus and Hospitals • Contact points (usually CTRCs) at each Hospital

11. Affiliated Institutions UCB Denver Campus NJH Denver Health Anschutz UCH & TCH VAH KP

12. Mission of Colorado CTSI Improve the health of the population of Colorado by speeding the translation of biomedical discoveries into prevention and intervention strategies in the community, and by reducing health disparities

13. Vision of Colorado CTSI Transform the current clinical and translational research and training efforts of all Schools at UCD and affiliated institutions into an innovative, interdisciplinary, integrated, collaborative campus-wide academic home for clinical and translational sciences, scientists and trainees

14. CCTSI Founding Principles • Transparency • Integrated services & efficiency • Collaboration • Interdisciplinary research • Communication • Fairness • Evaluation & Adjustments • Transformation

15. CCTSI Goals Transformation of: 1. The Institution – academic home 2. The Clinical and Translational Scientist 3. Discovery (T1) Translational Research 4. Community (T2) Translational Research and Practice

16. CCTSI Organizational Structure Chancellor of UC Denver Vice Chancellor of Research Vice Chancellor of Health Affairs Administrative Director/CFO Administrative Core CCTSI Director CCTSI Executive Committee: Director, 6 Co-Directors, CFO, Chair of IAC CCTSl Advisory Council Internal Advisory Committee External Advisory Committee Evaluation Center 6 Pillar Programs

17. CCTSI Academic Home Chancellor of UCDenver Vice Chancellor of Research Vice Chancellor of Health Affairs CCTSI PI and Director Administrative Director / CFO Admin. Core CCTSl Advisory Council Internal Advisory Committee CCTSI Executive Committee External Advisory Committee Evaluation Center 6 Pillar Programs Translational Informatics Research Informatics Integrated Core (RIIC) & Platform (RIIP) • Education & • Training • CLSC; KL2, TL1; Clinical Faculty Scholars; Career Development Discovery Translation PCIR (CTRCs); BERD; Regulatory Community Translation Community Engagement Novel Methods & Technology CO-Pilot; NeTT; Novel Methods Child & Maternal Health

18. CCTSI Co-Directors • Robert Eckel, MD Discovery Translation • Marc Moss, MD Education, Training • Andy Kramer, MD Community Engagement • Mark Geraci, MD Novel Methods and Technologies • Michael Kahn, MD, PhD Informatics • William Hay, Jr., MD Child-Maternal Health

19. Administrative Core • Tim Lockie – Admin. Director/CFO • Kristin Benn – Assoc. Admin Director • Natascha Palmer – Communications Director • Managers for each Program and Core • Holding quarterly system wide meeting of managers • Grant budget management, contact with NIH and Grants & Contracts, personnel, policies and procedures, admin. support, annual NIH reporting, etc.

20. Specific Components • Education, Training and Career Development (ETCD) • Clinical Sciences Graduate Program • KL2 (K12) Research Scholar program • TL1 (T32) Predoctoral training program • Leadership in Innovative Team Science (LITeS) • Clinical Faculty Scholars Program • Clinical Trials Training for Investigators and Coordinators (CTTIC) • K-Club

21. Specific Components • PCIR = Participant and Clinical Interactions Resource • Inpt. and outpt. CTRC facilities, Research Nursing, Core labs, Bionutrition (UCH,TCH, NJH, CUB) • Clinical Trials (UCH, TCH, NJH) • Scientific Advisory and Review Committee (SARC)

22. Specific Components • BERD: Biostatistics Epidemiology and Research Design - Colorado Biostatistical Consortium • CO-Pilot: Colorado Collaborative Pilot Grants • NeTT: Network of Translational Technologies • RIIC: Research Informatics Integrated Core • Regulatory Knowledge and Support • CMH: Child Maternal Health Program

23. Implementation Phases & Milestones • Pre-Award:-6 to 0 months • all milestones met • Transition:0 to +6 months • met milestones except did not hold retreat in September in year one, plan for 2009 • website still under development • Implementation:+6 to + 18 months • currently within this phase (GCRCs  CCTSI)

24. Tracking and Evaluation Program • Ongoing tracking of all components • Specific objectives related to each specific aim in the grant • Metrics developed • Reporting and measurements • Dashboard and feedback • Adjustments • Bonnie Walters and Kady Nearing – School of Education and Human Development, UCD

26. Major Highlights of Year One • Secured needed Space for Offices - Leprino • GCRCs reorganized into CTRC network with centralized administration • K12 and T32 programs - awardees chosen • Clinical Sciences Grad. Program enhanced • Leadership Development Program • PACT council formed and meeting • Informatics program started

27. Major Highlights of Year One - 2 • Three Pilot Project Award programs initiated - >$950,000 awarded in February, 2009 • CMH Council meeting and developing plans • UCH and TCH planning Mother/Infant hospital – using CMH program as example of cross-hospital collaboration in this arena • Evaluation & Tracking program finalized objectives, metrics and intervals, dashboard system

28. CCTSI Website • Fully operational by Spring 2009 • CCTSI.ucdenver.edu • Or “Google” CCTSI • Portal of entry for investigators, trainees, communities, the public • Information, applications, links to services, training, announcements, etc. • Membership online– opened in July 2009 • over 500 members

29. Unforeseen Challenges • Website development took longer than initially expected • RAPTOR too complicated for some – REDCap substituted • High demand for database development • Concerns about lack of Ancillary funding of CTRC protocols • up to $7,000 per year per protocol, soon to be increased further

30. National CTSA Consortium • National involvement mandatory • National Committees for each component, numerous subcommittees • Tackling important issues on national basis • Conference calls, Meetings, Initiatives • Developed Strategic Plan (CTSAweb.org) • New Society for Clinical & Translational Sciences

31. QUESTIONS