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CCTSI 2.0: Expanding Research Under Fiscal Challenges January 16, 2014

CCTSI 2.0: Expanding Research Under Fiscal Challenges January 16, 2014. Ronald J. Sokol, MD, Director and PI. WELCOME TO COLORADO. WELCOME TO COLORADO. External Advisory Committee.

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CCTSI 2.0: Expanding Research Under Fiscal Challenges January 16, 2014

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  1. CCTSI 2.0: Expanding Research Under Fiscal Challenges January 16, 2014 Ronald J. Sokol, MD, Director and PI

  2. WELCOME TO COLORADO

  3. WELCOME TO COLORADO

  4. External Advisory Committee • Rob Califf, MD Vice Chancellor for Clinical Research, Director of Duke Translational Medicine Institute, Division of Cardiology, Duke SOM • Rex Chisholm, PhDVice Dean Scientific Affairs and Graduate Education, Northwestern University Feinberg SOM • Joe “Skip” Garcia, MD Sr. Vice President for Health Sciences, University of Arizona

  5. External Advisory Committee • Jennifer Puck, MD Professor of Immunology and Pediatrics, UCSF School of Medicine • Larry W. Green, DrPH, MPH Professor of Epidemiology and Biostatistics, UCSF • Doris Rubio, PhD Professor of Medicine, Biostatistics, Nursing and Clinical and Translational Sciences, Director of Center for Research on Health Care Data Center, Co-Director of Institute for Clinical Research Education, University of Pittsburgh

  6. NCATS Project Officer • Mary Purucker, MD, PhD Division of Clinical Innovation, NCATS, NIH Internist, Pulmonary & Critical Care Medicine

  7. This Year’s Format for EAC Meeting • Overview, Challenges, Progress and Plans • Report from Each Pillar Program • Key Core Presentations • New Programs • Dinner Presentation – CTR Resources & Services and our Program Income System • Closed EAC Session • Feedback Session

  8. This Year’s Format for EAC Meeting • Specific Aims in new Grant • Governance • Approach • Progress and Metrics • Response to last year’s EAC Critiques • National CTSA Consortium Involvement • Is this important any more? • Questions for the EAC

  9. Overview of CCTSI: Expanding Research Under Fiscal Challenges

  10. History of UC Denver CTSA First Grant Award (2008-2013) $76.2 million 3rd “Class” of CTSA grantees Received 4 ARRA and 1 NICHD supplements in 2009 – $3.4 M Received $2.2 M unobligated balance in 2010 Close out supplement in 2013 = $6.8 M Total NIH Funds for CCTSI 1.0 ~ $89 million

  11. History of UC Denver CTSA • “Renewal” (New) Grant application submitted on Jan. 8, 2013 • Overall Impact Score = 14 (3rd best among 29 grants) • NOGA received September 2013 • Included a 3.5% Sequestration Cut • Initially included another 10% cut that was later re-instated • Total Award = $51,656,921 for 4 yr and 7 mo.

  12. CCTSI – “Collaboratory” of Institutions • Three Universities UC Denver • Anschutz Medical Campus: SOM, CON, SOP, SOD, CSPH, Graduate School • Downtown – 7 colleges– Engineering, Arts & Sciences, Business, others CU Boulder • 4 colleges Colorado State University – newest partner 2013 • 8 colleges

  13. CCTSI – “Collaboratory” of Institutions • Six Affiliated Hospitals and Health Care Organizations • University of Colorado Hospital - UC Health System • Children’s Hospital Colorado • Denver Health • National Jewish Health • Denver Veterans Affairs Medical Center • Kaiser Permanente Colorado

  14. Affiliated Institutions UCB CSU UCD Denver Campus NJH Denver Health Anschutz UCH & CHCO VAH 2016? KP

  15. University of Colorado Health System • 2011-12 UCH formed joint non-profit system with Poudre Valley Health System (2 hospitals in Ft. Collins) • 2012 UCH, CU SOM and Children’s were approved by Colorado Springs City Council to lease and operate Memorial Hospital (60 years) – October 2012 . - New Branch SOM campus in CO Springs (2016) • 2013 Ivinson Memorial Hospital, Laramie, WY UC Health: 5 Hospital Front Range Health System • largest in the state, all on Epic EMR - huge potential for clinical research, outcomes and clinical trial expansion • NOT OWNED BY UNIVERSITY OF COLORADO

  16. UC Denver and Partner Institutions • CU Denver and CU Boulder are separate institutions • Each Hospital partner is a separate, private, not-for-profit institution (except for the VA), none of which are owned by Univ. of Colorado (including Univ. of Colorado Hospital and UC Health System) • Thus, most large decisions are negotiations, collaborations and shared decisions

  17. CCTSI Community Partners • 20 Community-Academic partnerships throughout the state, multiple PBRNs • Populations: • Native Americans, Latinos, African Americans, 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

  18. CCTSI Members January 2, 2014 Total 3,192

  19. UC HealthSystem

  20. Total Grant Expenditures - UC DenverMillions

  21. Total Grant Expenditures - UC DenverMillions CCTSI

  22. Total NIH Grant Expenditures - UCDMillions

  23. Total NIH Grant Expenditures - UCDMillions CCTSI

  24. Growth of Research Funding

  25. Growth of Research Funding • FY 2013 Total Award Expenditures • UC Denver G&C $414 million [NIH funding 184 million (grants only)] • AMC Campus 395 million • SOM 327 million NIH funding 162.8 million (50%) • Clinical Depts. 226 million • Basic Science Depts. 41.3 million • Centers/Institutes 57.8 million

  26. Growth of Research Funding • NIH Funding – FY 2013Rank • SOM $162,763,023 24 (10 public) • Dept. of Medicine 52 million 20 • Dept. of Pediatrics 43 million 1 • Dept. of Psychiatry 11 million 21 • SOPharm $10,610,483 3 • CSPH $ 4,969,302 27 • CON $ 768,923 44

  27. Enter NCATS and CTSA RFA • Despite this success in growing our research portfolio, funding and national rankings… • NCATS new formula for new CTSA grant funding changed our funding model and so began our fiscal constraints • Most recently – following IOM report NCATS • disbanded Steering Committee and all other committees, formed new SC run by NCATS, initiated 3 priority Working Groups, encouraged unofficial consortium collaborations (removed support)

  28. CTSA 2012 RFA Budget Calculation • Target Funding level (for year 5) • Total NIH funds available to each CTSA applicant = 3% x total NIH funding in year 2011 to CTSA institution and all their partners • New budget must be in place during grant year 5 • Can maintain our current budget for year 1 • Reduce budget each year to reach target in yr. 5 • Reductions should average a straight line • Budget plan must be approved in writing by Project Officer prior to application

  29. Year 5 - CCTSI 1.0 Funding Level • Our Year 5 NIH budget is $15.1 million/yr • $12,391,531 Direct costs • $2,769,564 F&A

  30. 2011 NIH FundingOriginal Institutions • UC Denver $179,354,215 + 822,639 • CU Boulder 45,590,534 • National Jewish 29,006,839 • Denver Health 571,097 • CHCO and UCH 0 • TOTAL $253,345,324 Colorado State Univ. $34,350,686

  31. NIH Calculation for Year 5 Budget • Total NIH Grant Support (2011) for CCSTI $253,345,324 x 3% = $7,600,359 + $1,030,320 Addition of CSU 8,630,879 Reduction of $6.5 million for yr. 5 budget 43% Reduction

  32. Budget Strategies • Increase EfficiencyNew Quality and Process Improvement Program (QPIP) David West, PhD New Operations Director – Janine Higgins, PhD 2. Increase Institutional Support UCH, CHCO, SOM, CSU, Chancellor, Others 3. Program Income System - Charge backs for services Wendy Kohrt, PhD • Protect trainees and young investigators • Institute CTRC MicroGrants & BERD Seeds 4. Philanthropy

  33. CCTSI Budget 20013-2018

  34. NIH Goals of “New” CTSA Program • Promote an institutional environmentthat enhances quality, safety, efficiency, and cost effectiveness of clinical and translational research for all conditions • Provide resources and servicesto support and speed the planning and implementation of clinical and translational research across the entire range of research and communities • Facilitate the training and career development of a robust translational research workforce

  35. Key Concepts of CCTSI 2.0 • Streamline processes • Break down barriers • Insure quality and safety • Increase speed and efficiency • Become more cost effective • Enroll and complete studies • Support NIH multi-site studies

  36. Specific Aims - Overall Goal 1: Further enrich and expand our integrated statewide academic home for clinical and translational sciences across the entire translational research spectrum Goal 2: Institute new Clinical Research Management strategies to strengthen quality, safety, efficiency, cost-effectiveness and innovative team science throughout our research enterprise Goal 3: Centralize and enhance the delivery of our resources, services and technologies to promote innovation and quality science

  37. Specific Aims - Overall Goal 4: Infuse key concepts of community engagement into the full spectrum of translational research Goal 5: Increase the translational research workforce capacity through a broad curriculum of education and training opportunities

  38. Re-Alignment of Org. Structure to New RFA Priorities • Major emphasis on Research Environment • Quality, Efficiency, Effectiveness, & Safety • Less emphasis on specific resources and cores, but on Resources and Services as a unit (P.I.S) • Strong emphasis on Pilot Grant Awards Program, Translational Informatics and Education Training and Career Development • Breadth of T1 through T4

  39. CCTSI 2008-13 CTRCs BERD Regulatory, Research Ethics Pilot Projects NeTT New Methods

  40. CCTSI 2013-18

  41. Operations Director

  42. Operations Director

  43. New CCTSI Organizational Structure

  44. New Partner – Colorado State University • Top Veterinary Medicine College, Infectious Disease research program, UC Cancer Center, NORC, CSPH, Advanced animal imaging, GMP facilities for therapeutics and vaccine development, Comparative Pathology • Many ongoing partnerships and collaborations • Only 60 minutes by car to the North • CU-CSU CCTSI Summit held July 2013, two more planned in 2014

  45. CSU and CCTSI • Value added to CCTSI • Clinical Trials in Animal Models • naturally occurring cancers and other diseases with similar biology – dogs, cats, etc. • Target identification, biomarker development, diagnostics, imaging and drug development, therapeutic trials (“One Medicine”) • PK/PD/PG center • Joint Pilot grant projects – “T 0.5” translation • GMP facility – BSL3

  46. New Core: Practical Trials-Dissemination/Implementation Core Strategy: Leverage resources with training infrastructure at COHO/COR Progress since October: • Convened 2-Day D&I Training Workshop • Planning follow-up Pragmatic Trials & Methods Training Workshop for 2014 • Submitted R25 proposal for national training program – Pragmatic Trials & Methods using the RE-AIM framework

  47. Intro to D&I Training Workshop Trainees: • 60+ attendees • 68% were members of CCTSI; 32% new to CCTSI (largest groups: 32% SOM, 19% CSPH) • 84% were new to D&I science and/or had a basic understanding of D&I … but felt they needed more to be competitive in grant applications and/or to be successful in implementation practice. Survey Response: Day 1 attendees, 50% (n= 34); Day 2 attendees, 86% (n= 12)

  48. Intro to D&I Training Workshop Feedback: >90% agreed/strongly agreed they were satisfied 100% agreed/strongly agreed the workshop increased their overall knowledge in D&I science. 90% agreed their knowledge increased “some” to “a lot” in: a) D&I theory and definitions, b) D&I programs/interventions, and c) evaluating D&I programs/interventions. Survey Response: Day 1 attendees, 50% (n= 34); Day 2 attendees, 86% (n= 12)

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