FDA and the University of Pennsylvania have signed a five-year MOU to work on advancing (among other things) drug/device co-development, companion diagnostics, translational medicine and new clinical trial models.
All good things.
The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs. Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products? That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.
The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.
Particular congrats go out to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
All good things.
The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs. Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products? That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.
The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.
Particular congrats go out to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
