Come dive into one of the curiously delightful conversations overheard at National Geographic’s headquarters, as we follow explorers, photographers, and scientists to the edges of our big, weird, beautiful world. Hosted by Peter Gwin and Amy Briggs.
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The new frontier: regulatory implications for cell and gene therapies with Kimberley Buytaert-Hoefen
MP3•Laman utama episod
Manage episode 400555425 series 1258384
Kandungan disediakan oleh Future Science Group. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Future Science Group atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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
280 episod
The new frontier: regulatory implications for cell and gene therapies with Kimberley Buytaert-Hoefen
MP3•Laman utama episod
Manage episode 400555425 series 1258384
Kandungan disediakan oleh Future Science Group. Semua kandungan podcast termasuk episod, grafik dan perihalan podcast dimuat naik dan disediakan terus oleh Future Science Group atau rakan kongsi platform podcast mereka. Jika anda percaya seseorang menggunakan karya berhak cipta anda tanpa kebenaran anda, anda boleh mengikuti proses yang digariskan di sini https://ms.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
280 episod
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