Ronald J. Sokol, MD Director Colorado Clinical and Translational Sciences Institute

1. What’s New in Research at the Anschutz Medical Campus:Colorado Clinical Translational Sciences Institute Ronald J. Sokol, MD Director Colorado Clinical and Translational Sciences Institute Professor and Vice Chair Department of Pediatrics, SOM Oct., 2007

2. CTSA Objectives: Speed Discoveries to Improved Patient Care • Develop a distinct discipline for clinical and translational science at institutions • Provide opportunities and resources for original research on novel methods • Develop translational technologies and a knowledge base for the full spectrum of clinical and translational science • Synergize partnerships with industry, foundations, and community physicians • Train the interdisciplinary teams who will conduct the clinical and translational research of the future

3. Bidirectional Translational Research Clinical Investigation Clinical Trials Practice In the Community Basic Research T1 T2 Bench Bedside Trench Molecules & Cells, Animal Models Patients Community & Population

4. NIH CTSA Awards: A Home for Clinical and Translational Science Trial Design Industry Clinical Research Ethics Advanced Degree-Granting Programs Biomedical Informatics CTSA HOME Other Institutions Clinical Resources Participant & Community Involvement Biostatistics Regulatory Support Housed in a Department, Center or Institute

5. CSTA – Reorganizes Current UCDHSC Infrastructure • CTSA will subsume GCRC grants (M01), K30 grant – will end in 2010-11 • These programs will be integrated into CTSA • Must develop a K12 program • Optional – new predoctoral T32 program • Adds many new programs • NIH to award 60 CTSA grants by 2011

6. Ten CTSA Key Functions(New Organization - NIH) • New translational and clinical methods development • Regulatory knowledge and support • Design, biostatistics and clinical research ethics • Translational technologies and resources

7. Ten CTSA Key Functions • Pilot and collaborative translational and clinical studies • Participant and Clinical Interactions • Translational informatics • Community Engagement • Research Education, Training and Career Development • Evaluation and Tracking

8. Why a Colorado CTSA? • Must be part of CTSA national program to have a voice in CTS research, shape national programs • Ability to attract and retain outstanding faculty, trainees and physicians at all affiliated institutions and campuses • Provision of essential infrastructure, support and improved training • Be eligible for special NIH funding (RFAs)

9. Current CTS Research and Training Strengths at UCDHSC and CU • Many successful collaborative Translational research efforts across campuses • Outstanding clinical research facilities (two General Clinical Research Centers and two satellites) and core resources • Excellent community research programs (including Native American Health) • One of first Clinical Science PhD and Masters programs in U.S. • Strong Child Health Research Programs

10. Progress toward CTSA Application 1. CTSA Planning Grant awarded in 2006 • Funded – $150,000 direct costs $231,000 total costs • Major critiques: • Expand scope to include more collaboration with CU Boulder – Physiology, bioengineering, etc. • Evaluation process to assess outcomes resulting from infrastructure changes 2. New Colorado CST Institute (CCTSI) approved by Regents in Aug. 2007 3. Grant application – Nov. 7, 2007 deadline

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

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

13. Goals of Colorado CTSI • Transformation of the Institution: UCDHSC will create the CCTSI as a visible, integrated and interdisciplinary statewide academic home for the disciplines of clinical and translational sciences and research that will remove barriers and obstacles and promote successful careers

14. Goals of Colorado CTSI 2. Transformation of the Clinical and Translational Scientist: The CCTSI will enhance, integrate and transform training of translational scientists to develop a new generation of investigators with advanced degrees, interdisciplinary and collaborative skills and a team approach to scientific investigation

15. Goals of CCTSI 3. Transformation of Discovery Translational Research: The CCTSI will transform the performance of discovery translational research (bench-to-beside research) by providing new resources and infrastructure, integrating current and developing new innovative research tools and methodologies, catalyzing new interdisciplinary research programs and removing barriers to efficiency

16. Goals of CCTSI 4. Transformation of Community Translational Research and Practice. The CCTSI will transform community and population-based research by enhancing, extending and integrating community-based participatory research into programs that will engage community participation and develop novel methodologies for translation of scientific discoveries into clinical practice

17. Colorado CTSI Academic Home Multi-Institutional Collaboration Collaborative Investigative Teams Biomedical Discoveries Graduate Degree Programs Education, Training Career Development Basic and Engineering Sciences Discovery Translation Interdisciplinary Research Programs Improved Community Health Community Translation Clinical Trials Novel Methods & Technology Patient Oriented Research New Generation of Trainees Child and Maternal Health Research Teams and Leaders of The Future Community And Population Sciences Community Physician Outreach Evaluation And Improvement Disadvantaged Populations

18. CCTSI Institutional Members • UCDHSC Schools of Medicine, Nursing, Dental, Pharmacy, Graduate School, Public Health • CU Boulder, UCDHSC Denver Campus (e.g. Bioengineering), • Affiliated hospitals - UCH, TCH, DH, NJMRC, VAH, Kaiser Permanente • Graduate Training Programs

19. CCTSI Organizational Structure and Governance Chancellor of UCDHSC Vice Chancellor of Research Vice Chancellor of Health Affairs Director CCTSI CFO CCTSI Advisory Council Executive Committee: Director, 5 Co-Directors, CFO, Chair of IAC Internal Advisory Committee External Advisory Committee

20. Chancellor of UCDHSC Vice Chancellor of Research Vice Chancellor of Health Affairs Director CCTSI Sokol CFO Executive Committee FIVE PROGRAMS Training and Education Discovery Translation Community Translation Novel Methods & Technology Child & Maternal Research Eckel Kramer Geraci Steiner Hay

21. ACADEMIC HOME Director Sokol Steiner Eckel Kramer Geraci Hay Training and Education Discovery Translation Community Translation Novel Methods & Technology Child & Maternal Research Community Engagement & Research Integrate Programs Throughout TCH and other Facilities Predoctoral Post-doc Jr. Faculty Career Development K30, T32, K12 CTRCs Clinical Trials CPC Pharmaceutical development Design, Biostatistics, Research Ethics Regulatory Novel Methods Development Pilot Projects Translational Technology Cores Informatics

22. Timetable • Working Groups for each key function for past 10 months • External Advisory Committee meeting July 23, 2007 • Working Groups – final drafts submitted • Executive Committee finalizing and editing • Application Deadline: November 7, 2007

23. Summary • CTSA application is a exceptional opportunity to transform andcatalyze clinical and translational research and training across campuses of University of Colorado, Affiliated Hospitals and Organizations • Will take a University-wide and Hospital-wide partnerships • Will require broad faculty and institutional commitments

24. Contact • Sokol.ronald@tchden.org • Phone: 720 777-6669 • Pager: 303-890-7744 • http://ctsa1.uchsc.edu