FDA Leaders to Speak at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference

13 May, 2020
2020 ISPE Biopharmaceutical Manufacturing Virtual Conference Banner

ISPE announced featured presenters representing the Food and Drug Administration (FDA) at the 2020 ISPE Biopharmaceutical Manufacturing Virtual Conference. Taking place 1–2 June 2020, this first of its kind fully interactive digital event features timely and topical presentations and panel discussions from 40+ global experts representing FDA, GSK, Kite Pharma, Novartis, Roche, and more.

Featured FDA presenters will provide updates on regulatory expectations, considerations, and perspectives on biotechnology and biological products.

ISPE drives industry wide clarity of new regulations and guidance, advising on potential impact and facilitating practical solutions, seeking harmonization of regulatory expectations where desired and possible, It's vital that the biopharmaceutical industry pay close attention to what the regulators have to say and that we continue to develop constructive relationships.

FDA Presenters:

Wilson W. Bryan, M.D.
Director, Office of Tissues and Advanced Therapies

Dr. Bryan’s keynote presentation will provide insights into current developments in regenerative medicine, future trends, and challenges.

Patricia Hughes, PhD
Branch Chief, Division of Microbiology Assessment

Dr. Hughes will share regulatory considerations of innovations in sterile manufacturing and will also join the closing Fireside Chat.

Richard L. Friedman
Deputy Director, Science & Regulatory Policy

Friedman will provide updates on sterile products and change management.

Raj K. Puri, MD, PhD
Director, Division of Cellular & Gene Therapies

Dr. Puri will participate in the closing Fireside Chat featuring global regulatory and industry leaders who are working to frame the strategy for the era ahead.

In addition to regulatory insights, industry experts will share their knowledge and lessons learned on critical topics, including:

  • Cell and gene therapies
  • Emerging technologies
  • Supply chain challenges
  • Aspects of automation and digitalization in biomanufacturing
  • Challenges facing vector-based gene therapies
  • Harmonization

Learn More & Register