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

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

3. 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?

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

5. 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

6. 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”

7. 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

8. 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.

9. 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+ 1 FTE salary
Each authorized up to $100K pilot funds
2 additional PDTs established with ARRA funds

10. 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

11. 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

12. 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

13. 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

14. 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

15. More than 1 million admissions & outpatient visits
Statewide Impact of IU Health
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.

16. 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.

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

18. 3 2 4 1 5

19. Clinical Research Support Office

20. Regulatory Processes

21. Subject Recruitment Office

22. Clinical Research Resources

23. Bio-banking Program

24. 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.

25. 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