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Key CMC and NC considerations for cell and gene therapy development

Post thumbnail Key CMC and NC considerations for cell and gene therapy development

ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US, represent the fastest growing arena in today’s global biotechnology and biopharmaceutical sectors. Despite a slow start, there were at the end of Q1 2023 approximately 20 cell and gene therapies (CGTs) based on viral vectors approved in the EU/US, and the tendency for the future is towards exponential developments. Regardless of region, such innovative products face specific challenging CMC and nonclinical hurdles which were reviewed and regrouped as part of a benchmark approach considering approved CGTs.

In this webinar, VCLS regulatory science experts analyzed the global cell and gene therapy development landscape, NC and CMC related challenges in regard of developing this type of products and the resulting trends and tendencies.

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    Featured Speakers

    Carlo Chiavaroli
    Carlo Chiavaroli, PhD
    Senior Director, Nonclinical & Early Clinical Development
    As Director, Nonclinical, and Early Clinical Development, Carlo is responsible for leading projects for which strategic considerations are particularly challenging.…
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    Jennifer Woods PhD VCLS director CMC
    Jennifer Woods, PhD
    Director, CMC
    As a Director, Chemistry, Manufacturing and Controls (CMC) at VCLS, Jennifer is responsible for providing CMC and regulatory consulting services…
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