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

General Session 4:
Pharmacogenomics
Organizers: Estelle Russek-Cohen (FDA),
Alex Bajamonde (Genentech), Sue-Jane Wang (FDA)
Session Chairs: Gene Penello (FDA),
Alex Bajamonde (Genentech)
Speakers
• Michael Ostland (Genentech)
• Javier Cabrera (Rutgers)
• Sue-Jane Wang (FDA)
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
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
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