The newest edition of BioCentury This Week television brings together Friends of Cancer Research and FDA to explore what has to happen to make the breakthrough pathway real, how fast the transformation will take place, and how many drugs may qualify.
Driven by patient advocates at Friends of Cancer Research, Congress has created a faster regulatory pathway for drug candidates that show early exceptional promise of altering disease.
The FDA Safety and Innovation Act commits FDA to collaborate with a sponsor to accelerate product testing and development for these “breakthrough” compounds. And biopharma companies have started offering candidates for breakthrough designation.
Now FDA has to implement the breakthrough pathway, infusing a sense of urgency that the Phase I, Phase II, Phase III paradigm cannot address for sponsors or patients.
Join Washington Editor Steve Usdin’s special conversation with:
|Dr. Jeff Allen, Executive Director, Friends of Cancer Research
|Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research.