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

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

2020 ISPE Biopharmaceutical Manufacturing Virtual Conference
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.

The International Society for Pharmaceutical Engineering (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,” said Tim Howard, PE, CPIP, President & CEO, ISPE. “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 Bryan, MD, Director, Office of Tissues and Advanced Therapies, FDA/CBER
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, FDA/CDER
Dr. Hughes will share regulatory considerations of innovations in sterile manufacturing and will also join the closing Fireside Chat.

Richard Friedman, Deputy Director, Science & Regulatory Policy, FDA/CDER
Friedman will provide updates on sterile products and change management.

Raj Puri, MD, PhD, Director, Division of Cellular & Gene Therapies, FDA/CBER
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

To explore the educational agenda and to register, please visit ISPE.org/Bio20.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, 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 and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.

For more information, contact:
Amy Henry
Marketing Communications Manager
International Society for Pharmaceutical Engineering (ISPE)
Email: ahenry@ispe.org
ISPE.org

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ISPE
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Patricia Hughes, PhD, Branch Chief, Division of Microbiology Assessment, FDA/CDERWilson Bryan, MD, Director, Office of Tissues and Advanced Therapies, FDA/CBERRichard Friedman, Deputy Director, Science & Regulatory Policy, FDA/CDERRaj Puri, MD, PhD, Director, Division of Cellular & Gene Therapies, FDA/CBER