Leveraging Platform Processes for Developing and Accelerating Novel Gene and Cancer Therapeutics

Date: December 5, 2024
Time: 11:00am ET

This year, the long-awaited FDA draft guidance for Platform Technology Designation Program was released. This critical guidance enables drug developers to leverage Platform Technology data in approved drugs if similar “platforms” are used, thereby accelerating the approval process and improving access to therapies for patients.

In this webinar Catalent’s George Buchman will discuss Catalent’s approach to platform processes as well as securing an integrated supply chain.

Siren’s Nathalie Clement will share insights on Siren’s exciting work on combining two transformative therapeutic technologies – AAV gene therapy and cytokine immunotherapy – into a single, powerful new treatment modality to fight cancer. She will also explain how partnering with Catalent has accelerated the development of these offerings.

• Advantages of platform processes for developing and accelerating novel Gene Therapies
• Catalent’s approach to platform processes as well as securing an integrated supply chain with a focus on critical starting materials
• Siren’s pioneering work in combining AAV gene therapy with cytokine immunotherapy to fight cancer
• Value of strong partnerships to ensure patient access for curative gene therapies

SPEAKERS

Dr. Clément has 25+ years of experience in the field of Gene Therapy, with industry leading expertise in adeno-associated virus (AAV) viral vectors manufacturing. At the Powell Gene Therapy Center of the University of Florida, Gainesville, she led AAV process development and manufacturing for R&D POC, IND-enabling Toxicology and IND studies. During this time, she oversaw the manufacturing, release testing and stability campaigns for more than eight AAV INDs, including QC assay qualifications and CMC preparations. Her lab’s research focused on developing scalable GMP-ready platforms using the HSV and the transfection systems in suspension. Dr. Clément joined the large CDMO, National Resilience, as the Director of the Process Development for Viral Vaccines and Gene Therapy, where she oversaw multiple industry-sponsored manufacturing programs, at scale up to 200L in suspension and adherent bioreactor formats. Since January 2022, Dr. Clément holds the role of Vice President of Vector Development at Siren Biotechnology Inc., a San Francisco startup focused on combining the promise of two transformative therapeutic technologies, AAV gene therapy and cytokine immunotherapy, into a single, powerful new treatment modality to fight cancer. At Siren, Dr. Clément leads CMC operations to bring Siren’s clinical candidates to patients.

Dr. Buchman joined Catalent through its acquisition of Paragon Gene Therapy in 2019. He has more than 35 years of experience in the biotech industry and has held roles at companies including Life Technologies (now Thermo Fisher), Celera Genomics and GeneLogic. Dr. Buchman obtained a bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and a doctorate in biochemistry from University of Maryland.