The Brookings Institution is holding a day-long series of broadcasted panel discussions on Breakthrough Designation with the FDA. It’s running from 9:15 a.m. to 4:30 p.m. EDT.
It’ll talk about the criteria that qualifies companies in the biopharma industry for breakthrough therapy designation – a status launched in 2012 by the FDA that helps expedite approval of drugs and biologics that address unmet needs.
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Here’s the discussion guide.
It largely features FDA analysts discussing Breakthrough Designations over the past two-and-a-half years, though it also brings in biopharma execs. David Kerstein, medical director of Ariad Pharmaceuticals, and Eric Rubin, a vice president at Merck, will talk on using breakthrough status in oncology.
Merck regulatory exec Robert Kowalski will speak about breakthrough designations’ implications in neurology; regulatory execs Anne-Virginie Eggimann of Bluebird Bio and Andrew Gustafson of GSK will speak on hematological disease; and Janssen Pharmaceuticals regulatory head Karin Van Baelen will discuss the topic in summary.