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

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

PR Newswire

TAMPA, Fla., Oct. 22, 2013

TAMPA, Fla., Oct. 22, 2013 /PRNewswire-USNewswire/ -- 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experts and global regulators will meet to discuss the recent draft guidance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feedback on their recent draft guidance on breakthrough therapies, with the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 Members of the
media wishing to cover this event should email requests for media credentials
to ISPE Membership Marketing Communications Manager Danielle Hould at

About ISPE

ISPE, the International Society for Pharmaceutical Engineering, is the world's
largest not-for-profit association serving its Members through leading
scientific, technical and regulatory advancement throughout the pharmaceutical
lifecycle. The 20,000 Members of ISPE are building solutions in the
development and manufacture of safe and effective pharmaceutical and biologic
medicines and medical delivery devices in more than 90 countries around the
world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida,
USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit for more information.

For more information contact:
Danielle Hould
ISPE Membership Marketing Communications Manager
Tel: +1-813-960-2105, ext. 277


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