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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 09B: Breakthrough Therapies

Session Chair(s)

Ramesh K. Sood, PhD

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)

Brian  Kelley

Breakthrough Therapy Drugs: An Industry Perspective

Brian Kelley

Genentech, A Member of the Roche Group, United States

Vice President, Bioprocess Development

John  Groskoph, MBA

An Industry Experience With Breakthrough Therapy Drugs

John Groskoph, MBA

Pfizer Inc, United States

Executive Director, Global CMC

Dorota  Matecka, PhD

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

Robert  Wittorf

Manufacturing Challenges for Breakthrough Therapies

Robert Wittorf

FDA, United States

Pharmacist, Office of Pharmaceutical Quality, Office of Process Facilities, CDER

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