Indiana Clinical and Translational Sciences Institute: A statewide Laboratory for accelerating Clinical and Translational Research Anantha Shekhar MD, PhD Indiana CTSI

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

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.   This slide is historical perspective does it need a title?

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

Indiana CTSI Partners – Providing Leveraging Opportunities Throughout the State Biocrossroads Clarian Health Partners Eli Lilly and Company Richard M. Fairbanks Foundation Indiana University Notre Dame Purdue University Cook Group, Inc Wellpoint, Inc. Atlanta CTSI An inter-institutional partnership between Emory University, Morehouse School of Medicine, Children’s Healthcare of Atlanta, and Georgia Tech. The ACTSI focus is on community engagement, training C&T investigators, and reducing health disparities. The goal is to extend the CTSA philosophy of interdisciplinary interactions and connectivity to generate partnerships and collaboration beyond the consortium to organizations involved with health care throughout the nation. It is through multiple partnerships that CTSAs will transform clinical and translational research and bring new scientific advances to health care. Roudebush VA Medical Center Regenstrief Institute Wishard Health Services Indiana State Government

Indiana 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. This slide is “who we are”

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

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.

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

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

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

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

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

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

More than 1 million admissions & outpatient visits Statewide Impact of IU Health - 2011 More than 20 hospitals, health centers, partners, affiliates & joint venture operations More than 19,000 employees More than 1 million admissions & outpatient visits ~ 4,200 patients participating in ~ 2,600 clinical trials ~ 60% of Indiana doctors trained at IUSM, thus have spent time in Clarian facilities.

Hospital Reach Participation includes: 68 hospitals (27 health systems) 5 payors Long-term care facilities Immediate Care centers Free-standing labs and imaging centers State and local public health agencies Copyright 2010 Indiana Health Information Exchange, Inc.

Patients Over 12 million unique patients Almost 4 billion structured results Ratio of patients in INPC to population (2007 census)

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Clinical Research Support Office

Regulatory Processes

Subject Recruitment Office

Clinical Research Resources

Bio-banking Program

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 academia needs to know how to take a discovery to patients Indiana CTSI Solution: a perfect division of labor and strategic partnerships IU Bloomington, IU Med Center, Purdue, Notre Dame, IUPUI, University of 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.

Goal 5. Leverage Community Resources 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