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The new frontier: regulatory implications for cell and gene therapies with Kimberley Buytaert-Hoefen

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Manage episode 400555425 series 1258384
Content provided by Taylor & Francis Group and Francis Group. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Taylor & Francis Group and Francis Group or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
In the first episode of this series, we spoke to Executive Director and Global Head of Regulatory Services Kimberley Buytaert-Hoefen about her experience with cell and gene therapy (CGT) approvals and the barriers to getting these important therapeutics to the patient. Kim advises early regulatory interaction and collaboration to improve the success rate of applications and emphasizes the importance of global harmonization of regulatory standards. We discuss key barriers to CGT approvals including manufacturing and immunogenicity and Kim voices her excitement for the newly approved CRISPR-Cas9 technology to treat sickle cell disease.
  continue reading

290 episodes

Artwork
iconShare
 
Manage episode 400555425 series 1258384
Content provided by Taylor & Francis Group and Francis Group. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Taylor & Francis Group and Francis Group or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
In the first episode of this series, we spoke to Executive Director and Global Head of Regulatory Services Kimberley Buytaert-Hoefen about her experience with cell and gene therapy (CGT) approvals and the barriers to getting these important therapeutics to the patient. Kim advises early regulatory interaction and collaboration to improve the success rate of applications and emphasizes the importance of global harmonization of regulatory standards. We discuss key barriers to CGT approvals including manufacturing and immunogenicity and Kim voices her excitement for the newly approved CRISPR-Cas9 technology to treat sickle cell disease.
  continue reading

290 episodes

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