General Session 4: Pharmacogenomics

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General Session 4Pharmacogenomics

• Organizers Estelle Russek-Cohen (FDA), Alex
  Bajamonde (Genentech), Sue-Jane Wang
  (FDA)Session Chairs Gene Penello (FDA), Alex
  Bajamonde (Genentech)

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Speakers

• Michael Ostland (Genentech)
• Javier Cabrera (Rutgers)
• Sue-Jane Wang (FDA)

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Background

• Holy grail of drug development
• Personalized medicine
• Expose those and only those patients with the
  best risk/benefit ratio
• More pragmatic best ? advantageous
• This is not new ...
• Tamoxifen for breast cancer ER/PR patients

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Background

• More recent examples
• Herceptin HER2 () breast cancer
• Gleevec KIT () GIST Philadelphia chromosome
  () CML
• These may have been the more straightforward
  cases
• Mechanism of action for these drugs were
• Relatively well-understood
• Directly measurable

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Background

• Many challenges for statisticians
• Microarrays genes, SNPs, etc.
• Multiplicity
• Modeling of biological processes
• Incorporation of markers in drug development
  programs
• Manufacturing considerations
• Regulatory perspectives
• Etc