Pharmaceutical industry experts and global regulators will meet to discuss the FDA’s recent draft guidance on breakthrough therapies at the 2013 ISPE Annual Meeting, held on Nov. 3-6 in Washington, DC. The session, entitled “Breakthrough Therapy: Are You Ready for Approval?” will take place during the Global Regulatory and Compliance discussion sessions on Tuesday, Nov. 5.
The session will be led by Eric Thostesen, senior director, business support, Janssen Pharmaceutical and will feature talks from FDA’s Tara Gooen, Steve Kozlowski, and Sarah Pope Miksinski, as well as Earl Dye of Genetech, John Groskoph of Pfizer, and Patricia Hurter of Vertex Pharmaceuticals. Presentations will cover the FDA’s recent draft guidelines on breakthrough therapies and industry considerations related to the development process challenges associated with reduced filing time and global regulatory submissions. The goal of the session will be to align industry and FDA expectations on the breakthrough therapy designation and discuss next steps for moving forward with the draft guidelines.