Recent clinical successes in cell therapy and gene therapy have shown how fast this field is advancing. While the clinical outcomes are leading the developments in this field, the chemistry, manufacturing, and control (CMC) are struggling to meet development needs, global regulatory compliance and timelines.
The intricacies of these advanced therapies represent many challenges. From cell source to the final product, sponsors are continuously addressing gaps to improve the product quality and deliver a safe and efficacious product. In this webinar, we will focus on the main CMC challenges in cell and gene therapy development in the EU and US and their integration as part of the overall product development.
Key takeaway message:
- Present specific quality considerations for cell and gene therapies
- Identify and take into account the CMC challenges during product development in order to minimize CMC hurdles
- Provide insight on commonalities and differences between EU and US
About the presenters:
Alexandra Beumer Sassi, Director, CMC & Quality
Alexandra is responsible for providing CMC and regulatory consulting services to clients to help them take their products from early clinical phases to marketing authorization, particularly for biologicals. Alex has over 16 years of experience in the pharmaceutical/biopharmaceutical industry and consulting services.
François Gianelli, Director, CMC & Quality
As a CMC & Quality Director, François is involved in different projects for biologicals regulatory and CMC support. François is involved in authoring and reviewing CMC content (IMPD/IND and MAA/NDA/BLA), and performs gap-analysis of CMC development.
Valérie Pimpaneau, Vice President, CMC & Quality
Valerie Pimpaneau is responsible for the management of projects involving the development of CMC, bio-analytical and quality strategies for Drugs, Biologics, Gene and Cell Therapy. She heads up the activities of the regulatory CMC group built to provide assistance to product development with a staff combining strong technical background with good regulatory expertise. Her experience in the Biopharmaceutical industry allows Valerie to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the product development phases.