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

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Presentation on theme: "General Session 4: Pharmacogenomics Organizers: Estelle Russek-Cohen (FDA), Alex Bajamonde (Genentech), Sue-Jane Wang (FDA) Session Chairs: Gene Penello."— Presentation transcript:

1 General Session 4: Pharmacogenomics 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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