General Session 4: Pharmacogenomics PowerPoint PPT Presentation

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Title: General Session 4: Pharmacogenomics


1
General Session 4Pharmacogenomics
  • Organizers Estelle Russek-Cohen (FDA), Alex
    Bajamonde (Genentech), Sue-Jane Wang
    (FDA)Session Chairs Gene Penello (FDA), Alex
    Bajamonde (Genentech)

2
Speakers
  • Michael Ostland (Genentech)
  • Javier Cabrera (Rutgers)
  • Sue-Jane Wang (FDA)

3
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

4
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

5
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
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