Clinical and Translational Science Awards (CTSAs): Building Connections

1. National Center forResearch Resources A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e NATIONAL INSTITUTES OF HEALTH Clinical and Translational Science Awards (CTSAs): Building Connections Federation of American Societies for Experimental Biology May 31, 2009 Barbara Alving, MD, MACP Director National Center for Research Resources

2. National Center for Research Resources Accelerating research from basic discovery to improved patient care animal model resources community engagement science education Pre-clinical Improved patient care Community imaging & informatics advances research capacity & training Clinical clinical research support

3. Impetus for the CTSA Program To ensure new discoveries lead to improved public health, clinical science must evolve to better: • Implement biomedical discoveries • Develop, test and bring new prevention strategies into medical practice more rapidly • Catalyze change - lower barriers between disciplines • Encourage creative and innovative approaches www.CTSAWeb.org

4. Broad Mandates for the CTSAs • Educate the next generation of clinical and translational researchers to work in interdisciplinary teams • Improve clinical research management through: informatics, communication with potential participants, development of IRB reciprocity • Build diversity in leadership • Forge partnerships with private and public health care organizations • Develop community outreach; enhance public trust

5. WA ME MT ND VT OR MN NH WI ID NY MA SD WY RI MI NJ PA IA NE NV OH MD IN DE IL UT CO WV KS VA CA MO KY NC TN OK AZ AR SC NM GA AL MS LA TX AK FL HI PR CTSA: Building a National Consortium Currently 39 CTSA Sites Across the Country CT Participating Institutions Members Newest Member

6. = CTSA Institutions = East Coast Consortium = Midwest Consortium = West Coast Consortium CTSA – Creating Regional Partnership Opportunities Mayo Clinic College of Medicine Universityof Iowa University of Washington University of Chicago University of Wisconsin Oregon Health & Science University University of Rochester Yale University University of California, Davis Weill Cornell Medical College Columbia University University of California, San Francisco Rockefeller University Albert Einstein College of Medicine Stanford University The Scripps Research Institute Washington University in St. Louis

7. CTSA – Providing Local Leveraging Opportunities Indiana Clinical and Translational Sciences Institute Purdue University Regenstrief Institute Biocrossroads Indiana School of Medicine Indiana State Government Clarian Health Partners Fairbanks Institute for Healthy Communities Cook Group, Incorporated Richard M. Fairbanks Foundation Eli Lilly and Company

8. Kaiser Permanente Georgia CDC Yerkes National Primate Research Center Emory University Georgia Tech Morehouse School of Medicine Children’s Healthcare of Atlanta Complex Carbohydrate Research Center at U Georgia Atlanta VAMedical Center Georgia Research Alliance Georgia Bio CTSA – Providing Local Leveraging Opportunities Atlanta Clinical and Translational Science Institute (Atlanta-CTSI) at Emory University

9. CTSA National Strategic Plan Priorities Goal 1: Enhancing National Clinical and Translational Research Capability • Clinical research management • Research infrastructure • Phenotyping – human and preclinical models Goal 2: Enhancing Training and Career Development of Clinical and Translational Investigators Goal 3: Enhancing Consortium-Wide Collaborations • Social networking • Inventory of resources • Data sharing Goal 4: Enhancing the Health of Our Communities and the Nation • Community engagement • Public health policy (i.e. comparative effectiveness research)

10. CTSA National Strategic Plan Priorities: Goal 5 (Adopted April 21, 2009) The CTSA consortium will focus on three components for this goal: • Education and training requirements for T1 investigators • Collaborative demonstration projects to develop and implement the infrastructure to conduct proof-of-concept studies in humans across the different CTSA sites • Innovative and novel models of technology transfer to advance translational projects Goal 5: To enhance strategies and resources for the efficient movement of T1 translational discoveries and knowledge into clinical testing

11. Public-Private Partnerships (PPP) Key Function Committee Goals • Share best practices across the CTSA consortium in the area of PPPs • Implement policies and procedures to facilitate PPPs across the CTSA consortium • Provide assistance with new or established partnerships to identify partners and partnership models Mission To facilitate the implementation of partnerships with industry, other academia and patient advocacy groups to support and conduct medical research, research training and the dissemination of information

12. Public-Private Partnerships (PPP) Example:The West Coast Licensing Partnership • Adds value by bundling related technologies over individual tools and technologies • Strengthens inter-institutional relationships between member partners • Increases global access to research tools by promotion of non-exclusive licensing • Provides simple one-stop licensing of technologies from multiple institutions • Saves time and money from negotiating multiple license agreements Oregon CTSA is part of a group of institutions willing to designate a subset of their technologies for marketing and licensing purposes

13. CTSA Consortium – Building Connections with Business Schools • Develop business plans, design, and implement community surveys • Create innovative cross-educational programs • Develop case studies to pilot programs • Collaborate with international colleagues • Prepare cost analyses • Protect CTSA-developed patents • Form industry partnership programs CTSA are partnering with business schools to:

14. Cultivating Networks: The National Consortium Working together as a Consortium, the NIH and CTSA Institutions have established a committee structure to execute the vision and goals of the CTSA Program

15. Educational Impact of CTSA Program • Doubled the clinical and translational training workforce from 2006 - 2008 • Increased the number of regional training interactions among consortium sites • Awarded a supplement to develop a National CTSA Educational Resource Program (NCERP) that will: • Identify, catalog and assess training modules in clinical and translational research • Enhance and broaden training opportunities for clinician scientists across the CTSA consortium

16. # of Investigators # of Trainees and Scholars Field of Training 272 29 50 10 9 16 7 20 10 18 5 5 8 10 7 37 513 Clinical Disciplines * Pediatric Disciplines Public Health Stats, Res Methods, Informatics Genetics Allied Health Immunology Nursing Bioengineering Neuroscience Psychology, non-clinical Physiology Microbiology and Infect Diseases Pharmacology Molecular Biology Other Total 3,948 516 317 176 134 121 115 110 108 108 93 77 69 61 53 250 6,256 Educational Impact of CTSA Program(Based on 2008 Annual Progress Reports from first 24 CTSAs) * = includes 37 subcategories

17. Encouraging and Enhancing Collaboration CTSA Consortium – Informatics Pilots Clinical and Translational Information Exchange Environment Informatics Pilots • Implementation and development of tools for clinical investigators to facilitate small- and medium-sized research studies • Enhance the collection and management of data in small and medium sized studies • Requirements • At least three CTSA must collaborate • Data and software sharing • Must incorporate institutional database support that is flexible, secure and easily accessible on demand

18. Informatics Pilot Projects PhysioMIMI at Case Western Reserve University • Includes investigators from Marshfield Clinic, University of Wisconsin and University of Michigan • Collects, manages and analyzes diverse data types across institutions • Allows secure, safe and regulated transfer of information from clinical care systems and research databases Sharing Clinical Data at University of Washington • Includes investigators from University of California, San Francisco and University of California, Davis • Allow researchers to access large shared datasets • Assist with designing research studies and generating hypotheses Research Electronic Data Capture (REDCap) at Vanderbilt • Includes investigators from Oregon Health and Sciences University and Mayo Clinic • Provide an easy way for researchers to develop a secure, web-based application for collecting, managing and sharing of their clinical and translational research data • Create secure and flexible interoperability between REDCap and external data systems thus ensuring data quality in information exchange

19. Informatics Pilots University of Washington WA ME MT ND MansfieldClinic University of Wisconsin– Madison Oregon Health & Science University VT OR MN NH WI ID NY MA SD University of Michigan CT Mayo Clinic College of Medicine WY RI MI NJ PA IA University of California, Davis NE NV OH MD IN DE IL UT Case Western Reserve University CO WV University of California, San Francisco KS VA CA MO KY Vanderbilt University NC TN OK AZ AR SC NM GA AL MS LA TX AK FL HI PR

20. Research Networking at Harvard CTSAHarvard Catalyst The Harvard Catalyst is a shared enterprise of Harvard University, its ten schools and its18 Academic Healthcare Centers, as well as numerous public, private and community partners

21. Encouraging and Enhancing Collaboration NIH Opportunities • Emergency Medicine • Sleep Research Network • Critical Care • Neurology • Neuroimaging CTSA Thematic Research Networks/CTSA Interest Groups

22. NCRR/NIH Telehealth ConferenceJune 25-26, 2009 Help determine how NCRR/NIH can partner with other agencies to accelerate research and improve healthcare http://events.internet2.edu/2009/NIH/index.html

23. Workshop on Efficient Management and Utilization of Core Facilities July 14-15, 2009 Natcher Conference CenterBuilding 45, Main AuditoriumNIH Campus Additional information available at http://www.ncrr.nih.gov/Core_Facilities/

24. CTSAweb.org Resources for Researchers Building Connections e-Newsletter Communication Toolkit

25. Research Centers in Minority Institutions (RCMIs)18 Centers in 10 states, the District of Columbia, and Puerto Rico City College CUNY Hunter College CUNY Morgan State University, MD Howard University, DC Charles R. Drew University, CA Meharry Medical College, TN Clark Atlanta University, GA Morehouse School of Medicine, GA University of Texasat El Paso Florida A&M University Tuskegee University, AL Jackson State University, MS University of Hawaii at Manoa University of Puerto Rico, Medical Sciences Campus University of Texas at San Antonio Texas Southern University Universidad Central del Caribe, PR = RCMIs Ponce School of Medicine, PR = RCMI/RCMI Clinical Research Centers

26. RCMI at University of Puerto RicoTelepresence in Endoscopy RCMI Center for Information Architecture in Research Transmits Live Multicast Video of Endoscopic Procedures Simultaneously to Four Institutions via Internet2. • Transmission site: • Experimental Surgery Lab, UPR School of Medicine • Receiving sites: • National Library of Medicine, NIH • Rochester Institute of Technology • Johns Hopkins Hospital • University of Michigan School of Medicine Technologies: H.323 and Conference XP http://rcmi.rcm.upr.edu/rcminews/news0809/endo08

27. WA ME MT ND VT OR MN NH WI ID NY MA SD CT WY RI MI NJ PA IA NE NV OH MD IN DE IL UT CO WV KS VA CA MO KY NC TN OK AZ AR SC NM GA AL MS LA TX AK FL HI PR Institutional Development Award (IDeA)Increasing research capacity in 23 states and Puerto Rico Montana State University Universityof Idaho • Lariat Project: • High Speed internet connectivity • Bridging digital divide University of Wyoming University of Nevada, Reno Universityof Hawaii Universityof Alaska = Lariat Project: encircling institutions with connectivity = IDeA-eligible states

28. Institutional Development Awards (IDeA) Northeast Cyberinfrastructure Consortium Improving Research Connectivity in the Northeast Collaborative research effort in five IDeA states to provide access to nationwide research networks and resources • Enhances the connectivity of networks at research institutions in underserved states can participate in data-intensive science applications • Enhance participation in NCRR programs at IDeA institutions located in these five states • Facilitates multi-institution research collaborations across the northeast These network upgrades will allow real time data transfer among researchers in the region.

29. Imaging Technology MRI Image-guided therapy PET CAT Ultrasound Biomedical Technology Research Centers (BTRCs) • 50 Centers in 5 Broad Areas • Scope: from basic discovery to clinical research • Scale: from molecule to organism • Informatics • Resources • Genetics • Modeling of complex systems • Molecular dynamics • Visualization • Imaging informatics • Optics & Laser • Technology • Microscopy • Fluorescence spectroscopy • In Vivo diagnosis • Technology for • Structural Biology • Synchrotron x-ray technologies • Electron microscopy • Magnetic resonance • Technology for • Systems Biology • Mass spectrometry • Proteomics • Glycomics & glyco-technology • Flow cytometry www.ncrr.nih.gov/BTcenters

30. Biomedical Technology Research Resources (BTRCs) Nationwide WA ME MT ND VT NY MN OR NH MA WI ID SD MI WY RI PA CT IA NJ NE IN NV DE OH MD UT WV IL CO VA CA DC KS MO KY NC TN OK ` AR SC AZ NM AL MS GA LA TX FL AK PR HI Users of BTRCs United States: 6,171Foreign: 793Total: 6,964

31. Biomedical Informatics Research Network (BIRN) A shared biomedical IT infrastructure • Collaboration between groups with different expertise and resources (technical, scientific, social and political) • Shared infrastructure to support collaboration (designed to be extensible to other biomedical communities) • Open access and dissemination of data and tools (i.e. Open Source) • Bringing transparent GRID Computing to Biomedical Research

32. American Recovery and Reinvestment Act (ARRA) Budget Components Other HHS (AHRQ) to also transfer ARRA appropriated $10 Billion (B) directly to NIH $8.2 B $1.0 B $0.5 B $0.3 B $0.4 B Extramural Scientific Research (All ICs, OD) Extramural Construction (NCRR) Intramural Repair & Improvement & Constr. (B&F) SIG & Other Cap Equip (NCRR) Comparative Effectiveness Research (OD) Financial & Employment Reporting

33. NCRR Funding through ARRA • $1.0 Billion for construction, repair and renovation • RFA for Extramural Research Facilities Improvement Program (C06) • RFA for Core Facility Renovation, Repair and Improvement (G20) • $300 Million for shared instrumentation and other capital research equipment • RFA for Shared Instrumentation Grant (SIG) • RFA for High End Instrumentation (HEI) • $310 Million for scientific research • Supplements to existing resource programs (IDeA, RCMI, CTSA BTRC and ABMR)

34. ARRA Limited Competition RFA: Enabling National Networking of Scientists and Resource Discovery • RFA-RR-09-009 • Purpose: • To develop, enhance, or extend infrastructure to facilitate national discovery of individuals and resources to support biomedical research • Includes a diversity of institutions (in size, technology sophistication, geography, racial/ethnic culture) ensuring broad use and impact • Distributed (non-centralized) approach • Mechanism of Support: • Resource-Related Research Projects Cooperative Agreement (U24) • Funds Available • $30 million over two years • www.ncrr.nih.gov/recovery/rfa-rr-09-009

35. ARRA – NCRR Administrative SupplementCollaborative Community Engagement Research • Examples: • Develop, expand, and/or evaluate telehealth networks linking academic health centers and health care providers in rural and other medically underserved areas • Leverage HRSA, VA, FCC, and/or USDA telehealth programs • Increase community capacity for clinical and translational research, risk assessment, biosurveillance, emergency preparedness and disaster recovery www.ncrr.nih.gov/recovery/supplements/details

36. NCRR ARRA Homepage http://www.ncrr.nih.gov/recovery