Janet Woodcock gave an excellent overview of the resurgence in novel treatments getting the FDA approval. The years of effort to validate drug targets based on disease mechanisms is now yielding important, first in class products are paying off. There is still a lot of room for increased productivity, particularly in the area of orphan drug development and molecular diagnostics. But it is clear that the model of development Dr. Woodcock envisioned when she lead the Critical Path Initiative is paying off.
Imagine what industry and the FDA could do if it expanded on that model by creating more Critical Path Institutes, for example.
And imagine how these breakthrough products will languish if CER holds up or delays access.
You can read Dr. Woodcock's testimony here:
Testimony of Dr. Janet Woodcock, July 7, 2011
Imagine what industry and the FDA could do if it expanded on that model by creating more Critical Path Institutes, for example.
And imagine how these breakthrough products will languish if CER holds up or delays access.
You can read Dr. Woodcock's testimony here:
Testimony of Dr. Janet Woodcock, July 7, 2011