ISPE to Engage Members, Industry Leaders and Regulators in Critical Dialogue on Breakthrough Therapies at 2013 ISPE Annual Meeting

Pharmaceutical industry experts and global regulators will meet to discuss the recent draft guidance on breakthrough therapies at the 2013 ISPE Annual Meeting, 3 – 6 November in Washington, DC USA. The session, entitled “Breakthrough Therapy: Are You Ready for Approval?” will take place during the Global Regulatory and Compliance discussion sessions on Tuesday, 5 November.

“With the introduction of FDASIA last year, FDA now has the authority to make breakthrough therapy designations for certain drug products, which is clearly an area of intense interest for ISPE Members and the pharmaceutical and biopharmaceutical industry at large,” said ISPE President and CEO Nancy Berg. “ISPE embraces the opportunity to partner with the FDA and provide industry feedback on their recent draft guidance on breakthrough therapies, with the ultimate goal of collaborating with the FDA on the development of CMC regulatory expectations for review and inspection based on science, and the need to deliver important medicines to the patient. The discussions that will take place during this session will be a critical step in the process.”

The session will be led by Eric Thostesen, Senior Director, Business Support, Janssen Pharmaceutical Company and will feature talks from the 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, among other topics. 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.

Space is still available for this important discussion. Registration information can be found at www.ISPE.org/2013AnnualMeeting. Members of the media wishing to cover this event should email requests for media credentials to ISPE Membership Marketing Communications Manager Danielle Hould at dhould@ispe.org.