National Center for Research Resources NATIONAL INSTITUTES OF HEALTH T r a n s l a t 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 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 NATIONAL INSTITUTES OF HEALTH 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

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

NCRR 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

NCRR 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

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

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

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

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

NCRR 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)

NCRR 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

NCRR 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

NCRR 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

NCRR 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:

NCRR 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

NCRR Educational Impact of CTSA Program  Doubled the clinical and translational training workforce from  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

NCRR Educational Impact of CTSA Program (Based on 2008 Annual Progress Reports from first 24 CTSAs) 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, , Field of Training # of Investigators # of Trainees and Scholars * = includes 37 subcategories

NCRR Encouraging and Enhancing Collaboration CTSA Consortium – 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 Clinical and Translational Information Exchange Environment Informatics Pilots

NCRR 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

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

NCRR Research Networking at Harvard CTSA Harvard 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

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

NCRR NCRR/NIH Telehealth Conference June 25-26, Help determine how NCRR/NIH can partner with other agencies to accelerate research and improve healthcare

NCRR Workshop on Efficient Management and Utilization of Core Facilities July 14-15, 2009 Natcher Conference Center Building 45, Main Auditorium NIH Campus Additional information available at

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

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

NCRR RCMI at University of Puerto Rico Telepresence 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

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

NCRR Institutional Development Awards (IDeA) Northeast Cyberinfrastructure Consortium Improving Research Connectivity in the Northeast  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 Collaborative research effort in five IDeA states to provide access to nationwide research networks and resources These network upgrades will allow real time data transfer among researchers in the region.

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

NCRR Biomedical Technology Research Resources (BTRCs) Nationwide Users of BTRCs United States: 6,171 Foreign: 793 Total: 6,964

NCRR  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 Biomedical Informatics Research Network (BIRN) A shared biomedical IT infrastructure

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

NCRR 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)

NCRR ARRA Limited Competition RFA: Enabling National Networking of Scientists and Resource Discovery RFA-RR 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 

NCRR ARRA – NCRR Administrative Supplement Collaborative 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

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