ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana CTSI 101 Indiana Clinical and Translational Sciences Institute Monday, October 18, 2010

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Indiana CTSI Anantha Shekhar MD, PhD Indiana Clinical and Translational Sciences Institute: Its Mission in a accelerating Clinical and Translational Research

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2. Bridging the Gap

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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. National Institutes of Health Clinical And Translational Science Awards

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 –Award put 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 Indiana Clinical and Translational Science Institute

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Access to National Consortium of Academic Health Centers – 55 to date

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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. CTSI Today

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Improve Health of Indiana & Beyond by: 1.Creating Translational Research Acceleration Programs 2.Training a New Cadre of Translational researchers 3.Fostering Robust Community Engagement 4.Streamlining Clinical Research Resources 5.Leveraging Resources of the Greater Indiana Community Goals

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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. Goal 1. Translational Research Acceleration Programs

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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+ 1 FTE salary –Each authorized up to $100K pilot funds 2 additional PDTs established with ARRA funds Goal 1. Translational Research Acceleration Programs

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

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 Goal 1. Translational Research Acceleration Programs

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 Goal 2. Training Translational Researchers

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 Goal 3. Robust Community Engagement

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 Goal 4. Streamlining and Enhancing Clinical Research Resources

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Clinical Research Support Office

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Regulatory Processes

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Subject Recruitment Office

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Clinical Research Resources

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Bio-banking Program

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 1.IU Bloomington, IU Med Center, Purdue, Notre Dame, IUPUI, Minnesota 2.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 3.55 National CTSA consortium partner locations, 28 states and D.C. Goal 5. Leverage Community Resources

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH Other Significant Results to date: 1.Disease Modeling and Personalized Medicine Program with Eli Lilly and Company 2.Preventive and Individualized Medicine Technology Center (PRIME TEC) with CDI/Sony DADC 3.FDA compliant Phase I Oncology unit with commercial partner 4.Developing “i2i” with Cook 5.Health Economics Program with WellPoint 6.Indiana Health Study - Fairbanks Institute for Healthy Communities conducting a longitudinal study of the Indianapolis population Goal 5. Leverage Community Resources

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH 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 Access to National CTSA Consortium

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH IU Cardiology Clinical Trial Sites

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