Why Rare Disease Drug Developers Need Regular Interaction with the FDA

RARECast

Despite accelerated pathways for the development and approval of rare disease therapies, significant challenges remain for companies wishing to bring new treatments to market. Mallory Factor, CEO of IntraBio, recently testified at a U.S. Senate Subcommittee hearing and argued that the programs in place today fail to address the needs companies like his have for timely and early interactions with the U.S. Food and Drug Administration when developing therapies for diseases afflicting small populations of patients. We spoke to Factor about his recent testimony, the issues companies like his face, and what he’d like to see done to address the problem.