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 institutionsDevelop a distinct discipline for clinical and translational science at institutions Provide opportunities and resources for original research on novel methodsProvide opportunities and resources for original research on novel methods Develop translational technologies and a knowledge base for the full spectrum of clinical and translational scienceDevelop translational technologies and a knowledge base for the full spectrum of clinical and translational science Synergize partnerships with industry, foundations, and community physiciansSynergize partnerships with industry, foundations, and community physicians Train the interdisciplinary teams who will conduct the clinical and translational research of the futureTrain the interdisciplinary teams who will conduct the clinical and translational research of the future

3. BasicResearch ClinicalInvestigation Clinical Trials Practice In the Community T1 BenchBedsideTrench Bidirectional Translational Research Molecules & Cells, Animal Models Patients Community & Population T2

4. NIH CTSA Awards: A Home for Clinical and Translational Science Trial Design Advanced Degree-Granting Degree-GrantingPrograms Participant & Community Involvement RegulatorySupport Biostatistics Clinical Resources Biomedical Informatics ClinicalResearchEthics CTSAHOMECTSAHOME Industry OtherInstitutions Housed in a Department, Center or Institute

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

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

7. Ten CTSA Key Functions Pilot and collaborative translational and clinical studiesPilot and collaborative translational and clinical studies Participant and Clinical InteractionsParticipant and Clinical Interactions Translational informaticsTranslational informatics Community EngagementCommunity Engagement Research Education, Training and Career DevelopmentResearch Education, Training and Career Development Evaluation and TrackingEvaluation and Tracking

8. Why a Colorado CTSA? Must be part of CTSA national program to have a voice in CTS research, shape national programsMust 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 campusesAbility to attract and retain outstanding faculty, trainees and physicians at all affiliated institutions and campuses Provision of essential infrastructure, support and improved trainingProvision of essential infrastructure, support and improved training Be eligible for special NIH funding (RFAs)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 campusesMany successful collaborative Translational research efforts across campuses Outstanding clinical research facilities (two General Clinical Research Centers and two satellites) and core resourcesOutstanding clinical research facilities (two General Clinical Research Centers and two satellites) and core resources Excellent community research programs (including Native American Health)Excellent community research programs (including Native American Health) One of first Clinical Science PhD and Masters programs in U.S.One of first Clinical Science PhD and Masters programs in U.S. Strong Child Health Research ProgramsStrong Child Health Research Programs

10. Progress toward CTSA Application 1. CTSA Planning Grant awarded in 2006 Funded – $150,000 direct costs $231,000 total costsFunded – $150,000 direct costs $231,000 total costs Major critiques: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 1.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 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 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. Basic and Engineering Sciences Community And Population Sciences Patient Oriented Research Clinical Trials Disadvantaged Populations Collaborative Investigative Teams Interdisciplinary Research Programs New Generation of Trainees Academic Home Multi-Institutional Collaboration BiomedicalDiscoveriesBiomedicalDiscoveries Research Teams and Leaders of The Future Research Teams and Leaders of The Future Colorado CTSI Discovery Translation Community Translation Education, Training Career Development Child and Maternal Health Evaluation And Improvement Graduate Degree Programs Improved Community Health Improved Community Health Community Physician Outreach Novel Methods & Technology

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

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

20. Chancellor of UCDHSC Vice Chancellor of Research of Research Director CCTSI Sokol Executive Committee CFO Vice Chancellor of Health Affairs of Health Affairs Training and EducationDiscoveryTranslationCommunityTranslation Novel Methods & Technology Child & Maternal Research Steiner EckelKramerGeraci Hay FIVE PROGRAMS

21. Training and EducationDiscoveryTranslationCommunityTranslation Novel Methods & Technology Child & Maternal Research SteinerEckelKramerGeraciHay DirectorSokol Predoctoral Post-doc Jr. Faculty Career Development K30, T32, K12CTRCs Clinical Trials CPCPharmaceutical development development Design, Biostatistics, Research Ethics Regulatory Community Engagement & Research Informatics Novel Methods Development Pilot Projects Translational Technology Cores IntegrateProgramsThroughout TCH and other Facilities ACADEMIC HOME

22. Timetable Working Groups for each key function for past 10 monthsWorking Groups for each key function for past 10 months External Advisory Committee meeting July 23, 2007External Advisory Committee meeting July 23, 2007 Working Groups – final drafts submittedWorking Groups – final drafts submitted Executive Committee finalizing and editingExecutive Committee finalizing and editing Application Deadline: November 7, 2007Application 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 OrganizationsCTSA 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 partnershipsWill take a University-wide and Hospital-wide partnerships Will require broad faculty and institutional commitmentsWill require broad faculty and institutional commitments

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