Michael Werner, Co-Founder and Senior Policy Counsel for the Alliance for Regenerative Medicine (ARM), says the FDA “has moved very, very quickly to implement statutory language from the Cures bill.”
Industry groups BIO, the Alliance for Regenerative Medicine and the International Society for Cellular Therapy (ISCT), as well as biopharma companies Gilead and Biocom, are seeking clarity from the US Food and Drug Administration (FDA) on guidance related to its relatively new Regenerative Medicine Advanced Therapy (RMAT) designation, according to comments submitted last week.
Debate over about ‘how to price a cure’ entered the pharma industry lexicon when Gilead Sciences Inc. priced its highly effective hepatitis C drug Sovaldi (sofosbuvir) at $84,000 per treatment course.
The number of new clinical trials in the regenerative market space continues to grow, says Cryport, which will provide global logistics support for TiGenix’s upcoming Phase Ib/IIa study.
The superlatives were flowing for the continuing progress of the regenerative medicine sector at the Alliance for Regenerative Medicine’s (ARM) state of the industry briefing on cell and gene therapies presented at the recent Biotech Showcase 2018 conference. Speaking to a packed audience of pharma and biotech company delegates as well as industry analysts and media, Robert Preti, chairman of ARM and president and CEO of Hitachi Chemical Advanced Therapeutics Solutions, proclaimed that 2017 represented a truly breakthrough year for the sector in his opening remarks of the event.
