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

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Office of Technology Transfer and
DevelopmentNational Institute of Diabetes and
Digestive and Kidney Diseases

• MISSION
• TO PROMOTE THE DEVELOPMENT, DISSEMINATION AND
  
• COMMERCIALIZATION OF INNOVATIVE TECHNOLOGIES
• THROUGH COLLABORATIONS WITH ACADEMIA AND
  INDUSTRY
• FOR THE BENEFIT OF THE PUBLIC HEALTH
• Office of Technology Transfer and Development
• National Institute of Diabetes and Digestive and
  Kidney Diseases
• Of the National Institutes of Health and the
  Department of Health and Human Services
• 12 South Drive, MSC 5632, Bethesda, MD
  20892-5632
• Tel [phone] ? Fax [phone]
• http//TechDev.NIDDK.NIH.gov

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Objectives

• PROMOTE DEVELOPMENT OF NEW TECHNOLOGIES FROM
  NIDDK INTRAMURAL RESEARCH
•  
• PROMOTE TRANSFER OF NEW TECHNOLOGIES FROM NIDDK
  INTRAMURAL RESEARCH ACTIVITIES TO INDUSTRY
•  
• PROMOTE COLLABORATIONS BETWEEN NIDDK INTRAMURAL
  INVESTIGATORS AND INDUSTRY
•  
• PROMOTE COLLABORATIONS BETWEEN NIDDK EXTRAMURAL
  PROGRAMS AND INDUSTRY
•  
• PROMOTE COMMERCIALIZATION OF NEW TECHNOLOGIES FOR
  THE BENEFIT OF THE PUBLIC HEALTH

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Technology Transfer

• Government, Academia and Industry collaborating
  for the public benefit

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Collaboration - Intramural

• University Collaborators
• Industry Collaborators

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Materials Transfer

• Material Transfer Agreement (MTA)
• See Material Transfer Agreements and Simple
  Letter Agreement
• If exchange involves ONLY proprietary material
  (preferably not commercially available) from
  Industry, and resultant data from NIDDK/NIH, a
  materials CRADA may be appropriate
• If materials are transferred from NIDDK/NIH to
  Industry, a License may be required
• For additional information on MTAs, see MTAs
  the Process

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CRADA - Cooperative Research and Development

• Exchange of Intellectual Contribution

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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
• For additional information on CRADAs, see CRADAs
  the Process

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Clinical Trial Agreement

• Publication
• Data (e.g. for regulatory filings)

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Clinical Trial Agreements (CTAs)

• Primary Purposes
• Establishes drug or device supply
• Amount
• Distribution
• Placebo
• Establishes data rights and data flow
• Data may be provided to Industry Collaborator
• Pre-print of publication
• Data for Regulatory Filings, if applicable
• Summary Data, in some circumstances
• Personally Identifiable Data under certain
  limited circumstances
• Data may be required of Industry Collaborator by
  NIDDK
• Cross-referencing FDA files if NIDDK holds IND
  for the Protocol
• Investigators Brochure
• For additional information on Clinical Research,
  see the NIDDK website

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Extramural Multi-Center Trials

• Cooperative Group
• Group of Investigators having central operations
  and statistical offices for supporting
  administrative requirements of the common
  research, and for performing central data
  collection and analysis
• Steering Committee
• Committee of PIs from each funded Clinical
  Center in the Cooperative Group and
  representatives from NIDDK.

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Confidential Disclosure Agreements(CDAs)

• Establishes agreement concerning
• Exploratory discussions exchanging proprietary
  information between NIDDK/NIH investigators and
  potential Collaborators
• Patentable inventions
• Protocols
• Investigators Brochures
• Sharing of information amongst cooperative
  agreement members (extramural multi-center
  trials)
• .

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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