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Session 09B: Breakthrough Therapies
Session Chair(s)
Ramesh K. Sood, PhD
Senior Scientific Advisor (Acting), Office of New Drug Products, CDER
FDA, United States
Section 902 of the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in year 2012, provides a roadmap for expedited development and review of drugs for serious or life-threatening diseases or conditions where the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. This has provided an excellent opportunity for the pharmaceutical industry and the regulators to develop and make available medically necessary treatments to the American public. The development and approval of such therapies typically involve a rapid manufacturing development program to accommodate the accelerated pace of the clinical development.
Regulators from the Food and Drug Administration and pharmaceutical industry speakers will share their experiences, successes, and challenges faced during the development and approval process of such therapies. Presentations will be followed by panel discussions.
Speaker(s)
Breakthrough Therapy Drugs: An Industry Perspective
Brian Kelley
Genentech, A Member of the Roche Group, United States
Vice President, Bioprocess Development
An Industry Experience With Breakthrough Therapy Drugs
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC
CMC Submission Strategies for Breakthrough Therapies: Successes and Challenges - FDA Perspective
Dorota Matecka, PhD
FDA, United States
Branch Chief (Acting), Office of New Drug Products, CDER
Manufacturing Challenges for Breakthrough Therapies
Robert Wittorf
FDA, United States
Pharmacist, Office of Pharmaceutical Quality, Office of Process Facilities, CDER
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