CRADAs, Clinical Trials

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NIH Technology Transfer and Ethics
Pat Lake, Deputy Director Extramural Technology
Transfer NIDDK, NIH FLC Mid Atlantic Regional
Meeting, Rocky Gap, Maryland September 15, 2005
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National Institutes of Health

• Mission The National Institutes of Health is the
  steward of medical and behavioral research for
  the Nation.
• 27 Institutes, Centers and Divisions
• 18,000 employees
• Total FY 2004 budget 27 billion dollars

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NIH IC Offices of Technology Transfer

• Evaluates new inventions generated by scientists
• Assists in marketing Institute patents/
  inventions to industry
• Assists scientists in implementing transactional
  agreements, i.e. Material Transfer Agreements
  (MTAs), Confidential Disclosure Agreements (CDAs)

4
NIH IC Offices of Technology Transfer (Contd)

• Assists scientists in setting up collaborations
  with profit and not for profit entities through
  CRADAs and Clinical Trial Agreements (CTAs)
• Acts as a resource to our scientists for a wide
  variety of technology transfer intellectual
  property matters

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CRADAs Ethics
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NIH CRADA Review Process

• Institute Collaborator PIs develop Research
  Plan
• Institute performs actual negotiations with
  CRADA Collaborator
• NIH Office of Technology Transfer, IC Ethics
  Office and Office General Counsel review the
  CRADA
• Internal NIH CRADA Subcommittee reviews and makes
  the recommendation for approval

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Conflict of Interest Fair Access Review

• COIFA Form
• PIs complete and Ethics Office reviews
• Questions include Financial or Personal
  relationships PI has with CRADA Collaborator
• Fair Access Issues-why was this Collaborator
  chosen

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Other Case Studies\Examples
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Royalties going directly to a Charity

• Sorry! According to HHS OGC not possible
• Royalties must go directly to inventor
• Inventor can then make arrangements with a
  charity of choice

10
Employee Owned Inventions

• New employee hired by NIH from European research
  institute
• He personally was prosecuting his own patent
  application
• Wanted to continue research in this area covered
  in patent
• PI assigned IP rights to NIH who assumed patent
  prosecution costs

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Sponsored Travel

• Sponsored travel is handled differently amongst
  the NIH institutes.
• Some Institutes dont allow their scientists to
  accept sponsored travel from industry without a
  one year cooling-off period before a
  collaboration can begin.
• Since sponsored travel is technically a gift to
  the Institute and not the scientist, it is not a
  conflict. This is a policy issue for the
  institutes.

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Recap of NIHs New Ethics Rules

• No consulting in personal capacity
• Scientist are encouraged to consult with industry
  in their official capacity!!!
• See our ethics website for summary of new rules.
• Http//www.nih.gov/about/ethics/summary_ammendment
  s

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Please feel free to contact

• Pat Lake
• Deputy Director
• Extramural Technology Transfer
• NIDDK, NIH
• Office of Technology Transfer and Development
• 6707 Democracy Plaza, Suite 906B, MSC 5343
• Bethesda, MD 20892-5343
• Ph. 301-594-6762
• Fax [phone]
• Email LakeP_at_mail.nih.gov