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									National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




CTSA Public-Private Partnership Steering
              Committee




           Meeting at National Institutes of Heath
                      (Bethesda, MD)
                       June 6, 2007
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




               Agreed Overarching Objective:

 “Identify shared PPP issues and opportunities
CTSA members would like to develop, but which
   would require a Consortium Alliance effort”
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH     Accelerating   and enhancing research from basic discovery to improved patIent care




                                Strategy for the Day:

        Establish topic prioritization, set goals,
     propose workgroups to PI Steering Committee

            Presentations from Gov representatives:
                                  NIH PPP, NIH OTT, FDA

          Presentations from CTSA representatives:
                     Current PPP Scope and Activities
                                Future Vision
                              Issues Identified
              Efforts possible via a consortium alliance effort
     National Center for
     Research Resources
     NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




      CTSA PPP STEERING COMMITTEE WORKGROUP TOPICS

1)    AGGREGATE IP
           Create a searchable database (IP and research portfolios)
           Facilitate collaborations
           Evaluate use of Synapse
           Evaluate linkages to gap funding mechanisms

2)    AGREEMENTS AND CONSENT FORMS
           Standardize across CTSA’s (confidentiality, IP, MTA’s, IAA’s, consent)
           Framework will need to evolve to leverage a CTSA community
           Develop tracking (eg; Consent form tracking; sample sharing, disposition)
           Aim to encourage sharing
     National Center for
     Research Resources
     NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




       CTSA PPP STEERING COMMITTEE WORKGROUP TOPICS

3)      INVENTORY RESOURCES
             Across CTSA’s
             Across NIH (eg; IC’s, Roadmap, Clinical Center)
             Data and specimen samples (requires harmonization of consent
              components)

4)      ASSESS EDUCATION RESOURCES
             Inventory existing curriculum and programs at CTSA’s and NIH
             Determine existing/future consortium needs
             Develop a sharing and dissemination plan
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




  CTSA PPP STEERING COMMITTEE WORKGROUP TOPICS

 5)     ADDRESS THE TECHNOLOGY & FUNDING GAP
              Seek to partner resources (CTSA’s, NIH, FDA)
              Co-develop funding strategies


 6)     DEVELOP SHARED EDUCATION RESOURCES
              Programs to develop entrepreneurial awareness and skill
               sets in clinical researchers
                •       Start-up creation
                •       Drug discovery
                •       Regulatory
                •       Finance
National Center for
Research Resources
NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




  CTSA PPP STEERING COMMITTEE WORKGROUP TOPICS
 7)     ALIGN BEST PRACTICES
              Public policy
                •     Clinical Trials
                •     FDA collaboration
                •     Regulatory: (Drug approval endpoints, Risk-benefit assessment)
                •     Marketing standards
                •     Infrastructure (cGMP for cell, biological, small mol. therapeutics)
              Master Agreements
                •     Preclinical/ Clinical Research between CTSA’s
                •     Industry agreements
              Conflict of Interest Management
              Consenting
                •     OHRP issues for IRB approvals
    National Center for
    Research Resources
    NATIONAL INSTITUTES OF HEALTH   Accelerating   and enhancing research from basic discovery to improved patIent care




                                       MEETING ACTIONS



     Select WorkGroup Topics
           Edit and Refine Topics within PPP Steering Committee
           Prioritize Topics for WorkGroup assignment:
            (Clear Deliverables, CTSA interest, Cross Workgroup Interest)
           Advance to PI Steering Committee Discussion & Feedback

     Appoint CTSA Representatives Chair

								
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