To Facilitate Introduction Of New Treatment/Technology More Rapidly, How Can Industry And Regulatory Agencies Work Together More Effectively?

A THE ONUS IS ON INDUSTRY TO ENHANCE COLLABORATION. Regulatory agencies provide a multitude of guidance documents and make public review information that sponsors should scrutinize for determining how best to present new treatments. Recognizing there are many gray areas where clarification is required represents the missing link. Current communication is limited to formal meetings at critical junctures, which are inadequate to facilitate effective collaboration. If the sponsor and each agency committee had a representative individual whose responsibility it was to make sure that the requirements were well understood and addressed during the entire development program, much time could be saved. The sponsor and agency roles would make excellent internship opportunities for the many universities offering advanced degrees in drug development.

MARY ROSE KELLER is VP clinical operations at Heron Therapeutics. She has 30+ years of industry experience in clinical development strategy.