ISPE Will Discuss Breakthrough Therapies at 2013 ISPE Annual Meeting - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

ISPE Will Discuss Breakthrough Therapies at 2013 ISPE Annual Meeting



Untitled Document

Pharmaceutical industry experts and global regulators will meet to discuss the FDA’s recent draft guidance on breakthrough therapies at the 2013 ISPE Annual Meeting, held on Nov. 3-6 in Washington, DC.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.

Source: ISPE

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
29%
Breakthrough designations
10%
Protecting the supply chain
43%
Expedited reviews of drug submissions
10%
More stakeholder involvement
10%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here