Summary

Title: Panel discussion: bioanalysis for the development and regulatory approval of cell and gene therapies

Date: Tuesday 5 September 2023

Time: 07:00 [PDT] 10:00 [EDT] 15:00 [BST]
Alternative time zones

As of July 2023, 32 cell and gene therapies have been approved and many more are awaiting approval. The wide variety of cell and gene therapies in the bioanalytical space urges a discussion into their regulation and support. Our expert panel dissect current modalities and their unique analytical challenges, the platforms currently being utilized to facilitate cell and gene therapy development and the primary regualtory challeneges standing in the way of the approval of such therapies. 

Find out more information about approved cell and gene therapy products here: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products

What will you learn?

  • Learn about the cell and gene therapies currently available, as well as their benefits and drawbacks
  • Better understand the platforms currently being utilized to support cell and gene therapies
  • Review what needs to be considered to facilitate cell and gene therapy approval
  • Consider the role of the bioanalytical scientist in the future of cell and gene therapy development.

Who may this interest?

  • Laboratory managers
  • Contract research organizations
  • Bioanalytical scientists
  • Individuals in the cell and gene therapy space

Speakers

Presenter
Kimberley Buytaert-Hoefen
Executive Director and Global Head of Regulatory Services
QPS Holdings, LLC (DE, USA)
View Biography
Presenter
Xiaobin Xhang
Principal Scientist
Takeda Pharmaceuticals (Tokyo, Japan)
View Biography
Presenter
Eric Feeley
Senior Field Applications Scientist
Gyros Protein Technologies (Uppsala, Sweden)
View Biography

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