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Cell & Gene Therapy Manufacturing & Commercialization US
September 23-26, 2024
Hynes Convention CenterBoston, MA

Nathalie Clément
Vice President of Vector Development at Siren Biotechnology, Inc.
Speaker

Profile

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.

Agenda Sessions

  • Navigating the clinical development journey of an AAV drug product: considerations for a seamless CMC from Phase I to BLA

    11:15am