Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidne - PowerPoint PPT Presentation

1 / 14
About This Presentation
Title:

Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidne

Description:

National Institutes of Health and Department of Health and Human Services. THE ... Extramural: Deputy Director/NIDDK. Collaborator. Authorized Signatory. 14 ... – PowerPoint PPT presentation

Number of Views:61
Avg rating:3.0/5.0
Slides: 15
Provided by: techdevN
Category:

less

Transcript and Presenter's Notes

Title: Office of Technology Transfer and Development National Institute of Diabetes and Digestive and Kidne


1
Office of Technology Transfer and
DevelopmentNational Institute of Diabetes and
Digestive and Kidney DiseasesNational Institutes
of Health and Department of Health and Human
Services
  • THE CRADA PROCESS
  • 12 South Drive, MSC 5632, Bethesda, MD
    20892-5632
  • Tel (301) 451-3636 ? Fax (301) 402-7462
  • http//TechDev.NIDDK.NIH.gov

2
CRADA - Cooperative Research and Development
  • Exchange of Intellectual Contribution

3
CRADAs
  • Cooperative Research and Development Agreements
    are authorized under U.S. Statute (15 U.S.C.
    3710a)
  • Require Intellectual Exchange between
    Collaborator and NIDDK/NIH
  • For Collaborator contributions of only
    proprietary material, (preferably not
    commercially available) see M-CRADAs also known
    as Materials CRADAs)
  • Provide Industry Collaborator with option to
    license inventions made solely or jointly by
    NIDDK/NIH investigator during performance of
    Study or Trial
  • May be used for Clinical Trials
  • Allow for industry funding of all or part of a
    Study
  • Submitted to the CRADA sub-committee of the NIH
    Technology Transfer Policy Board for approval
    before Institute can execute agreement

4
CRADAs
  • The CRADA is not a grant, procurement contract,
    or other funding mechanism
  • The government laboratory is prohibited
  • from transferring Congressionally-appropriated
    funds
  • to a CRADA Collaborator, under the CRADA

5
CRADA Process
  • Selection of the Collaborator
  • Fair Access / Conflict of Interest
  • Arranging the Agreement
  • Appendix A The Research Plan
  • Appendix B Financial and Staffing Contributions
  • Appendix C Modifications to the CRADA template
  • NIH review of CRADAs
  • Execution by the Parties

6
CRADA ProcessSelection of the Collaborator
Fair Access
  • Fair Access requirements
  • By law, special consideration given to 1)
    small business firms and 2) businesses located in
    the U.S.
  • In accordance with policy, fair access for
    collaborative opportunities provided to all
    outside organizations
  • Compliance with Fair Access requirements
  • Collaborators proprietary technology, unique
    expertise, or unique facilities
  • Public announcement of the CRADA opportunity

7
CRADA ProcessSelection of the Collaborator
Conflicts of Interest
  • Conflicts of Interest (that can prevent a CRADA!)
  • NIH PI owns stock above threshold amount in the
    prospective Collaborator company
  • NIH PI is a paid consultant with the Collaborator
    company
  • NIH PI is on the Board of Scientific Advisors at
    the Collaborator company
  • Negotiating official or signatory at the
    prospective Collaborator company is a former NIH
    employee within the past 12 months

8
CRADA ProcessArranging the CRADA
  • PHS Model CRADA (legal terms) available at
    http//TechDev.NIDDK.NIH.gov at CRADA.pdf
  • NIH CRADA Policy accessible at
    http//TechDev.NIDDK.NIH.gov at techtrans.htm
  • Appendix A The Research Plan
  • Appendix B Financial and Staffing Contributions
  • Appendix C Modifications to the CRADA legal
    terms
  • Addition of provisions for Clinical Trials
  • Negotiated modifications

9
CRADA ProcessArranging the CRADA - The
Research Plan (Appendix A)
  • Specific Goals
  • Introduction (background of the technology) and
    expertise of the Parties
  • Workscope
  • Responsibilities of the Parties
  • Detailed description of the scope of the research
    Prenegotiated field of use for the license is the
    scope of the research plan Model Licenses
    available at http//TechDev.NIDDK.NIH.gov at
    forms.htm
  • List of publications, patents, patent
    applications, prior agreements

10
CRADA ProcessArranging the CRADA Financial
and Staffing Contributions (Appendix B)
  • Contributions of materials, facilities,
    equipment, and staff to be committed by each
    Party
  • Funds (if any) provided by the Collaborator
  • CRADAs are not intended to be primary source of
    funds to the government labs
  • nor to provide a pair of hands for the
    collaborator

11
CRADA ProcessArranging the CRADA
Modifications to the Legal Terms (Appendix C)
  • Certain terms in the agreement restate statutory
    law and regulations -- These cannot be modified
  • Certain terms reflect NIH policy and can be
    modified
  • NIDDK Office of Technology Transfer and
    Development, in consultation with the NIH Office
    of Technology Transfer and the NIH Office of
    General Counsel may modify certain terms
  • Other terms can be negotiated to accommodate the
    unique needs of each collaborator

12
CRADA ProcessNIH Review of the Agreement
  • NIDDK
  • Technology Development Specialist
  • Director, Technology Transfer and Development
  • Principal Investigator(s) and Lab Chief
  • Ethics Coordinator (for Conflicts of Interest)
  • Scientific Director and/or Director or Deputy
    Director/NIDDK
  • NIH
  • CRADA Subcommittee
  • meets monthly submission deadline usually
    first Friday of each month
  • Includes representatives from
  • NIH Office of Technology Transfer
  • NIH Office of the General Counsel
  • NIH Scientists
  • Office of the Director

13
CRADA ProcessExecution of the CRADA
  • NIDDK
  • Intramural Scientific Director
  • Extramural Deputy Director/NIDDK
  • Collaborator
  • Authorized Signatory

14
NIDDK Collaborative Opportunities and Novel NIH
Technologies
  • NIDDK Technology Transfer and Development website
    at http//TechDev.NIDDK.NIH.gov
  • NIH Office of Technology Transfer website at
    http//ott.od.nih.gov/db/tech.asp
  • Federal Register at http//www.fedreg.gov
  • Federal Business Opportunities (formerly Commerce
    Business Daily) at http//www.fedbizopps.gov
  • TechEx at http//www.techex.com
  • Knowledge Express at http//www.knowledgeexpress.c
    om
  • International Conferences
  • Publications
Write a Comment
User Comments (0)
About PowerShow.com