indiana clinical and translational sciences instituteaccelerating clinical and translational...

ACCELERATING CLINICAL AND TRANSLATIONAL RESEARCH

www.indianactsi.org

Indiana Clinical and Translational Sciences Institute

A statewide Laboratory for accelerating Clinical and

Translational Research


www.indianactsi.org

State-wide laboratory created to transform health sciences

research and health care delivery.

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.

Part of a National Consortium of 60 Academic Health Partners working together to accelerate biomedical discoveries across 30 states and DC.

Indiana CTSI Today

Presenter

Presentation Notes

This slide is “who we are”


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Indiana CTSI Partners – Providing Leveraging Opportunities Throughout the State

Purdue University

Indiana University

Regenstrief Institute

IU Health

Roche Diagnostics

Indiana State Government

Cook Group, Inc

Richard M. Fairbanks

Foundation

Eli Lilly and Company

Wishard Health Services

Roudebush VA Medical Center

BioCrossroads University of Notre Dame

Presenter

Presentation Notes

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.


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Existing Programs Programs of the Indiana CTSI application Key function 'Section' of the RFA that is met by this

section (Assuming these required elements stay)

1. Administration (Shekhar) 1. Overview 2. Governance (Shekhar) 2. Governance 3. Novel Translational Methodologies and Pilot Studies Lead: Dr. Denne

3. Novel Translational Methodologies and Pilot Studies

4. Biomedical Informatics Lead: Dr. Tierney

4. Biomedical Informatics

5. Biostatistics, Epidemiology and Research Design (BERD) Lead: Dr. Hui

5. Design and Biostatistics

6 & 7. Bioethics, Regulatory Affairs and Subject Safety (BRASS) Lead: Dr. Meslin

6. Regulatory Knowledge and Support

8. Participant and Clinical Interaction Resources (PCIR) Lead: Drs. Shekhar and Denne

7. Participant and Clinical Interaction Resources (PCIR)

9. Community Health Engagement Program (CHEP) Lead: Drs. Marrero and Miller

8. Community Engagement and Research

10. Translational Technologies and Resources (TTR) Lead: Dr. Cornetta

9. Translational Technologies and Resources (TTR)

11. Research Education, Training and Career Development (including disease modeling) Lead: Dr. Kroenke

10. Research Education, Training and Career Development

12. Tracking and Evaluation Lead: TBN and Shekhar

11. Tracking and Evaluation

13. Implementation Plan and Milestones Lead: Dr. Shekhar

12. Implementation Plan and milestones

14. Biomedical Engineering and Nanotechnology Lead: Dr. Wodicka

Optional section


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Renewal Strategy

15. Personalized Therapeutic Program (partnership with Institute for Personalized Medicine, Bioinformatics)

Optional section; New Dr. Flockhart to lead

16. Targeted Molecules and Diagnostics Program (partnership with relevant centers at IUSM, Purdue, ND and IUB)

Optional section; New Drs. Zhang and Ratliff to lead

17. Global Health Program (partnership with Center for Global Health)

Optional section; New Dr. Inui and TBN from ND to lead

18. Health Implementation and Innovation Program (in partnership with proposed Innovation and Implementation Sciences Institute, IUH, Wishard, IHIE, etc.)

Optional section; New Drs. Boustani and Beyt to lead


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Improve Health and Economy of Indiana 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

Mission and Goals


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PDT projects

T1 Basic Science

T2 Human Clinical Research

T3 Implementation and Outcomes Research

142 197 20

Presenter

Presentation Notes

We are putting mechanisms in place to pull forward and/or investigate back – research efforts from our center… how is in the next slide.


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Challenge: • Need to Create Innovative Training Programs and develop future

workforce CTSI Solution: 1. Clinical Faculty Career Development Awards (12 awarded in 2011) 2. Basic Research Faculty career development awards (5 in 2011) 3. Graduate Training (20 awarded) 4. Masters Degrees

– MS in Clinical research for MD, Nurses, Clinicians – MS in Translational Sciences just started this year

5. Program for Research coordinator certification (RCCP) 6. Professional, Undergraduate, and high school Medical Research

Fellowships 7. Developing: International Translational Research Programs (Kenya,

Australia, others)

Goal 2. Training Translational Researchers


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Significant Results to date: 1. 3 K awardees obtained their R01s this year

(1 got 2 R01s) 2. Starting an MD, MS program 3. Planning a DDS, MS program

Goal 2.


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Challenge: • Improve clinical research access through health literacy,

research participation and Biobanking in the community • Increase collaboration among community and research partners

throughout Indiana to improve research, health and healthcare CTSI Solution: • Community Health Enhancement Program (CHEP) • Over 280 active Community Partners engaged Community • Community Advisory Council (CAC) established

• Focus areas meet monthly, entire group annually • A New mechanism developed to supplement subject

recruitment similar To PDTs

Goal 3. Robust Community Engagement


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Challenges: • Regulatory barriers need to be shortened

through contracts, IRBs • Need to engage more patients in clinical studies • Need a place to conduct pivotal studies

faster, better • Need to establish a statewide Biobank

Goal 4. Streamlining and Enhancing Clinical Research Resources


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4

1

2 3

5


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Regulatory Processes


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Significant Results to date: 1. Contract time Reduced to <21 days 2. IRB – working on improvements –

Currently around 53 (84) days

Goal 4.


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Subject Recruitment Office


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Clinical Research Resources


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Bio-banking Program


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1. We now have >4000 annotated samples 2. We have identified have targeted patients

with unique phenotypes: a. 30 years of medical records seen last year (6,700) b. 5 years of full pharmacy records (6,000).

Goal 4. BioBank

HTN (Hypertension) 4699 79.44 DM (Diabetes Mellitus) 2265 38.29 CHF (Congestive Heart Failure) 661 11.17 CAD (Coronary Artery Disease) 838 14.17 RAD (Reactive Airway Disease) 2417 40.86 CVA (stroke) 492 8.32 Renal Disease/Failure 223 3.77 MI (Myocardio Infarction) 829 14.02 Cancer 459 7.76 Liver Problem 162 2.74


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Clinical and Translational Science Volume 4, Issue 2, pages 80-83, 4 APR 2011

Goal 5. Leverage Community Resources

Presenter

Presentation Notes

The schematic diagram represents the concept of the translational circle beginning from the bench, progressing through to the bedside, then community and eventually coming back as new knowledge for further research. Also shown are the four exemplary public–private partnerships of the Indiana CTSI at each of these steps. © This slide is made available for non-commercial use only. Please note that permission may be required for re-use of images in which the copyright is owned by a third party.

http://onlinelibrary.wiley.com/doi/10.1111/cts.2011.4.issue-2/issuetoc

http://onlinelibrary.wiley.com/doi/10.1111/j.1752-8062.2011.00274.x/full


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Other Significant Results to date: 1. Developed “i2i” with Cook; Now

developing system wide device trial capability

2. Indiana Health Study - Fairbanks Institute for Healthy Communities conducting a longitudinal study of the Indianapolis population

Goal 5. Leverage Community Resources

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