1. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Anantha Shekhar MD, PhD Indiana University School of Medicine Indiana Clinical and Translational Sciences Institute Indiana Clinical and Translational Sciences Institute A Statewide Laboratory for Accelerating Clinical and Translational Research

2. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org National Consortium of 60 Academic Health Centers

3. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Indiana CTSI is a multi-partner Institute

4. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org 1.Creating a Home for Translational Research 2.Building Resources to Accelerate Research 3.Training a New Cadre of Research Workforce Mission To Improve Health and Economy of Indiana by:

5. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Summary of the Indiana CTSI Structure

6. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org 4 1 2 3 5 Progress: Building Research Support Infrastructure

7. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Progress: Engaging Researchers statewide

8. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Progress: ROIs on Grant Mechanisms

9. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Progress: Increased Statewide collaborations

10. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Next 5 years of focus: Programs that help move academic innovations out into real world impact in three major areas

11. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org CIIS will develop Research and Discovery Units (RDUs) in our health care partners Also develop training programs Provide ‘laboratories’ for a different type of scientists It is expected to roll out in Q4 of 2013 11 CHIIS Innovations in Clinical Practice Next 5 years: Health Care Partners Center for Health Implementation and Innovation Sciences (CHIIS) Improved Patient Outcomes Improved Reimbursement

12. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org 5/14/2015 File name/location 12 Jan 14Feb 14 March 14 April 14 May 14 Jun 14 Will create a single point of entry for all Clinical Trials Focused on efficient service to sponsors Key metrics will be a) first contact to first patient enrolled in trial; b) full accrual of trials Completing a lean six-sigma process to reorganize all clinical trials across IU and IUH under the new IU CRO (timeline below) Next 5 years: Industry Partners Creating efficient IU Clinical Research Office (CRO)

13. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org o The MTP is a distributed network of therapeutics development infrastructure within the CTSI o It will provide project mapping and assistance to investigators o It will create therapeutic target teams by identifying expertise necessary to facilitate therapeutic development. 13 Molecular Therapeutics Next 5 years: University Partners Develop an Indiana Molecular Therapeutics Program (MTP)

14. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org o Ready to open A commercial grade Phase-I CTSI clinical research unit with Covance o We are in the final steps of business agreements and a press release will be coming out very soon o Several potential studies are already being planned for Q1 of 2014 IU – Covance Phase I unit Next 5 years: Private Sector Partnerships Partnership with Covance on Phase I unit at IUH

15. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Strategic Pharma and Academic Research Consortium (SPARC) A Midwest based discovery consortium conceived by Lilly and Indiana CTSI Now includes Takeda as the second industry partner and five other Midwest CTSAs It is expected to roll out the call for proposals in Q4 of 2013 15 SPARC Midwest CTSA Consortium Next 5 years: Private Sector Partnerships SPARC – Midwest consortium

16. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org Over the next 3 years, the CTSI will focus on comprehensive health improvements in two communities: a)rural - Clinton county b)urban - Indianapolis 16 Community Outreach Next Steps: Public Sector and Philanthropy Partnerships Expand Community Engagement in Health Outcomes

17. ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH www.indianactsi.org For more information https://www.indianactsi.org17