Panelists:
Paris Margaritis, PhD
Chief Scientific Officer
GeneVentiv Therapeutics
Panelist
Paris Margaritis, PhD
Paris Margaritis, PhD, is a professional with over 28 years of experience in AAV gene therapy for hemophilia. A key focus of his work has been treating hemophilia patients with inhibitors.
He earned his doctorate from the University of Oxford and has worked at the Children’s Hospital of Philadelphia and the University of Pennsylvania. His expertise lies in connecting coagulation factor biochemistry with transgene engineering and in vivo AAV delivery using various animal models. He has also managed ocular AAV gene therapy programs, one of which is currently in the clinical phase. In his current role, he provides scientific direction and supports business development of GeneVentiv’s gene therapy portfolio towards clinical applications and commercialization.
Jacob Smith
Head of Technical Development & CMC Strategy
Viralgen
Panelist
Jacob Smith
Jacob Smith is Head of Technical Development & CMC Strategy at Viralgen, having previously served as the company’s Head of Manufacturing. Jacob came to Viralgen in 2023 from AskBio, where he served as VP of Process Development and Manufacturing for six years, and where he led the development of the Pro10
manufacturing system. His industry experience includes roles at Pfizer, Bamboo Therapeutics, and UNC Chapel Hill Gene Therapy Center & Vector Core. He has extensive experience in molecular biology and virology, with special expertise in natural product isolation and identification, DNA sequencing and analysis, and AAV vector design and production, as well as manufacturing process development, implementation, and technology transfer.
- Time:
The US Food and Drug Administration’s Office of Therapeutic Products (OTP) convened a public listening session on September 18, 2025, asking the cell and gene therapy (CGT) community how prior knowledge can be leveraged to accelerate the development and streamline the review of cell and gene therapy (CGT) products. But what does that mean for developers, regulators, and external partners who are tasked with developing effective, safe therapies?
In this GEN webinar, an outstanding panel of CGT experts will unpack some of the key themes raised during the recent FDA Listening Session and examine their implications for the future of product development and regulatory strategy. They will discuss the role of prior knowledge across chemistry, manufacturing, and controls (CMC), nonclinical, clinical, and manufacturing contexts and its potential to inform efficiency, safety, and innovation. Webinar attendees will learn:
- What types of data are most valuable to share and where the boundaries should be.
- How sponsors and CDMOs can navigate data leveraging across partnerships and the product lifecycle.
- Strategies for integrating knowledge across disciplines to strengthen development and risk assessment.
A live Q&A session will follow the presentations, offering you a chance to pose questions to our expert panelists.
Produced with support from:
The post What Comes Next? Industry Takeaways from FDA’s Cell and Gene Therapy Listening Session appeared first on GEN – Genetic Engineering and Biotechnology News.
