Indiana CTSI 101

1. Indiana CTSI 101 Indiana Clinical and Translational Sciences Institute Monday, October 18, 2010

2. Indiana CTSI Anantha Shekhar MD, PhD Indiana Clinical and Translational Sciences Institute: Its Mission in a accelerating Clinical and Translational Research

3. Bridging the Gap Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2.

4. National Institutes of Health Clinical And Translational Science Awards • In 2006, National Institutes of Health (NIH) developed the Clinical and Translational Science Award program (CTSA) led by the National Center for Research Resources (NCRR) • CTSA works together as a national consortium of 55 institutions sharing a common vision to improve human health by transforming the research and training environment to enhance the efficiency and quality of clinical and translational research – helping scientists bridge laboratory discoveries to patient treatments • When fully implemented by 2011, 60 institutions will be linked together to transform the local, regional, and national environment to increase the efficiency and speed of clinical and translational research across the country.  

5. Indiana Clinical and Translational Science Institute • BioCrossroads, IU School of Medicine, the Regenstrief Institute, Indiana University, Notre Dame and Purdue University pursued the CTSA from the NIH • In 2008, NIH awarded a $25 Million CTSA to the Indiana University, Purdue University and the University of Notre Dame to fund collaborative university-industry translational research at the Indiana Clinical and Translational Science Institute - CTSI • More than 120 collaborations throughout the US applied that year and only the top 9 earned the prestigious grant award • Awardput Indiana on the map for nationally recognized, acclaimed institutions enhancing recruiting, retention, publication and competitiveness of our universities • NIH federal dollars is supplemented by nearly $60 million from IU and Purdue, the State of Indiana, Eli Lilly and Co. and the Richard M. Fairbanks Foundation, Inc. to extend the reach of the CTSI

6. Access to National Consortium of Academic Health Centers – 55 to date

7. CTSI Today • A strong Indiana public-private partnership that extends beyond basic research and looks at specific programs to improve the health of Hoosiers and all Americans. • State-wide laboratory created to transform health sciences research and health care delivery. • Part of a National Consortium of 55 Academic Health Partners working together to accelerate biomedical discoveries across 28 states and DC.

8. Goals Improve Health of Indiana & Beyond by: • Creating Translational Research Acceleration Programs • Training a New Cadre of Translational researchers • Fostering Robust Community Engagement • Streamlining Clinical Research Resources • Leveraging Resources of the Greater Indiana Community

9. Goal 1. Translational Research Acceleration Programs Challenge: • Scientists are on multiple campuses spread across the state • Gap in communication between basic scientists making new discoveries and clinicians testing therapies in practice CTSI Solution: • Pilot Grants • Intercampus pilots are given to collaborative projects across 3 institutions on 5 campuses • IU Bloomington, IUPUI, IU School of Medicine, PU, ND • 134 applications received to date • Awarded 22 to date • Criteria – 2 campus connection. Program must be a new collaboration or new twist to existing collaboration and must generate additional funds.

10. Goal 1. Translational Research Acceleration Programs Challenge: • Need novel mechanism to engage multiple faculty, non-biomedical investigators, young researchers, and industry partners CTSI Solution: • Project development teams (PDT) • multidisciplinary clinical research team comprised of Pharmacologists, Medicinal Chemists, Study Coordinators, Public/Industry, Statistician, Clinician, Tech Transfer, Regulatory Affairs and a Principal Investigator • 8 PDTs established to date • 8+ faculty/experts @ 1 FTE salary • Each authorized up to $100K pilot funds • 2 additional PDTs established with ARRA funds

11. Current Portfolio of PDT Projects practice bedside bench Clinical Practice Delivery of Care Identification of New Clinical Questions and Gaps in Care Basic Science Research Preclinical Studies Animal Research Human Clinical Research Controlled Observational Studies Phase 3 Clinical Trials Case Series Phase 1 and 2 Clinical Trials Proof of Model Drug ConceptDev Dev Bench to Bedside Guideline Development Meta-analyses Systematic Reviews Adult Medicine Dissemination & Implementation Research Health Systems Redesign Applied Health IT Pediatric Community Trans. Research Imaging Purdue Notre Dame

12. Goal 1. Translational Research Acceleration Programs Challenge: • People find $, yet still struggle to get to the next critical step in discovery • Pre angel investment • Early stage funding • Feasibility funds CTSI Solution: Bridging the gap in taking discovery to IP • RISC Grants advance IP development • RISC (Research for Invention and Scientific Commercialization) are IP boost grants up to $25K each • First grant resulted in treatment patent that one pharma group is interested in pursuing • Connect to Venture Capital of Licensing • When ready for commercialization, provide link thru IUETC and Clarian Ventures

13. Goal 2. Training Translational Researchers Challenge: • Need to improve the infrastructure and workforce CTSI Solution: • Clinical Faculty Career Development Awards (17 awarded) • Basic Research Faculty career development awards (5 new positions) • Graduate Training (30 awarded) • NIH K30 grant provides • MS in Clinical research for MD, Nurses, Clinicians • Translational science for engineering, PhDs • MS in Translational Sciences • Program for Research coordinator certification • Undergraduate Research Fellowships (12 slots/year) • K-12; High school student program (50 students) • Project SEED • Genetics Based Science Teachers

14. Goal 3. Robust Community Engagement Challenge: • Improve clinical research availability through health literacy throughout the community and biobank CTSI Solution: • Community Health Enhancement Program (CHEP) • Over 170 active Community Partners engaged • YMCA diabetes management program • Advancing Community Engagement in Science (ACES) led by CTSI -10 other national CTSAs to develop best practices to do community based research • Community Advisory Council established • Focus areas meet monthly, entire group annually • A New mechanism developed to supplement subject recruitment similar To PDTs CTSI SUCCESS: • Indiana CTSI built a set of ‘tools’ for a national model for community engagement

15. Goal 4. Streamlining and Enhancing Clinical Research Resources Challenge: • Need to engage more patients in clinical studies • Regulatory barriers need to be shortened through contracts, IRBs • Streamline the process so research moves through the continuum quickly • Need more bricks and mortar infrastructure to do it correctly • Need a place to conduct studies faster, better

16. 3 2 4 1 5

17. Clinical Research Support Office

18. Regulatory Processes

19. Subject Recruitment Office

20. Clinical Research Resources

21. Bio-banking Program

22. Goal 5. Leverage Community Resources Academic-Industry Partnerships – Indiana is rich in academic, health and life science resources Challenge: academic and industry working in a vacuum. Industry needs cutting edge research to commercialize and academic needs to know how to take a discovery to patients. CTSI Solution: a perfect division of labor and strategic partnerships • IU Bloomington, IU Med Center, Purdue, Notre Dame, IUPUI, Minnesota • BioCrossroads, Clarian Health, Cook, Eli Lilly and Company, Richard M. Fairbanks Foundation, WellPoint, Inc., Roudebush VA Medical Center, Regenstrief Institute, Wishard Health Services, Indiana State Government • 55 National CTSA consortium partner locations, 28 states and D.C.

23. Clarian Health partnership with CTSI brings unmatched synergy to translational research Clarian is part of CTSI infrastructure - IU Health in 2011 State-wide hospital system of 20 hospitals are now mandated to: Increase patient enrollment for clinical studies Support biobank Provide a platform for the state-wide IRB Goal 5. Leverage Community Resources

24. Other Significant Results to date: Disease Modeling and Personalized Medicine Program with Eli Lilly and Company Preventive and Individualized Medicine Technology Center (PRIME TEC) with CDI/Sony DADC FDA compliant Phase I Oncology unit with commercial partner Developing “i2i” with Cook Health Economics Program with WellPoint Indiana Health Study - Fairbanks Institute for Healthy Communities conducting a longitudinal study of the Indianapolis population Goal 5. Leverage Community Resources

25. Access to National CTSA Consortium Benefits of being part of this national group • Learn best practices from anywhere in the country • Share tools and expertise developed at each of the sites • Provide a network of collaborators that can be deployed rapidly • CTSI investigator developed tool to screen, manage patients with severe delirium. CTSI quickly connected with a number of investigators at other CTSA institutions across the country. Effort resulted in national study and $9 million in funding. • IU Cardiology applied for grant, national trial for heart arrhythmia treatment across multiple sites around the country

26. IU Cardiology Clinical Trial Sites

27. Questions?