NCI Workshop on Phase

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NCI Workshop on Phase 0 TrialsRationale and
Goals

• Reduce the FDAs Exploratory IND to practice New
  process for investigators interested in early
  phase cancer therapeutics. Designed for pilot
  studies from Academia and Pharma.
• When appropriate? When not?
• How to apply it? Who can help you?
• What are pitfalls? What has been learned?
• Can it speed up the development timeline?
• GOAL Provide primer on a new mechanism for
  testing novel therapeutic and imaging molecules

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NCI Workshop on Phase 0 TrialsFormat

• Introductory lectures and overviews in the
  morning. Coffee and Lunch on your own.
• Hands-On panels and Think-Tank question and
  answer sessions in the afternoon Will provide
  you with question cards that will be picked up
  after the morning session so that they can be
  addressed after lunch. Please identify yourself
  when speaking.
• Informal Focus on providing information that
  will assist you in the conduct of very early
  phase cancer clinical trials

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The Next Speaker isDr. David Jacobson-Kram