Clinical and Translational Science Awards (CTSAs): Building Connections

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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
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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
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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
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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

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CTSA Building a National Consortium
Currently 39 CTSA Sites Across the Country
CT
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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
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CTSA Providing Local Leveraging
Opportunities Indiana Clinical and Translational
Sciences Institute
Purdue University
Biocrossroads
Regenstrief Institute
Indiana School of Medicine
Clarian Health Partners
Indiana State Government
Cook Group, Incorporated
Fairbanks Institute for Healthy Communities
Richard M. Fairbanks Foundation
Eli Lilly and Company
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CTSA Providing Local Leveraging Opportunities
Atlanta Clinical and Translational Science
Institute (Atlanta-CTSI) at Emory University
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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)

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CTSA National Strategic Plan Priorities Goal 5
(Adopted April 21, 2009)
Goal 5 To enhance strategies and resources for
the efficient movement of T1 translational
discoveries and knowledge into clinical testing

• 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

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Public-Private Partnerships (PPP) Key
Function Committee
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

• 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

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Public-Private Partnerships (PPP) ExampleThe
West Coast Licensing Partnership
Oregon CTSA is part of a group of institutions
willing to designate a subset of their
technologies for marketing and licensing purposes

• 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

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CTSA Consortium Building Connections with
Business Schools
CTSA are partnering with business schools to

• 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

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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
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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

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Educational Impact of CTSA Program (Based on
2008 Annual Progress Reports from first 24 CTSAs)
includes 37 subcategories
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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

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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

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Informatics Pilots
University of Washington
WA
ME
MT
ND
Mansfield Clinic University of
Wisconsin Madison
Oregon Health Science University
VT
OR
MN
NH
WI
ID
NY
MA
SD
CT
University of Michigan
Mayo Clinic College of Medicine
WY
MI
RI
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
MS
AL
LA
TX
AK
FL
HI
PR
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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
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Encouraging and Enhancing Collaboration
NIH Opportunities
CTSA Thematic Research Networks/CTSA Interest
Groups

• Emergency Medicine
• Sleep Research Network
• Critical Care
• Neurology
• Neuroimaging

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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
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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/
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CTSAweb.org

• Resources for Researchers
• Building Connections
• e-Newsletter
• Communication Toolkit

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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 AM 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
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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
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Institutional Development Award (IDeA)Increasing
research capacity in 23 states and Puerto Rico

• Lariat Project
• High Speed internet connectivity
• Bridging digital divide

Lariat Project encircling institutions with
connectivity IDeA-eligible states
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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.
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Biomedical Technology Research Centers (BTRCs)

• 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

www.ncrr.nih.gov/BTcenters
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Biomedical Technology Research Resources (BTRCs)
Nationwide
Users of BTRCs United States 6,171Foreign
793Total 6,964
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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

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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. (BF)
SIG Other Cap Equip (NCRR)
Comparative Effectiveness Research (OD)
Financial Employment Reporting
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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)

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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

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ARRA NCRR Administrative SupplementCollaborativ
e 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
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NCRR ARRA Homepage
http//www.ncrr.nih.gov/recovery