Critical Factors to Assess When Sourcing Viral or Non-Viral Engineering CMOs for Gene Modified Therapies Presented by the ISCT Business Development & Finance Committee
Sponsored by ViroCell Biologics
This webinar will provide insights on the pros and cons of different methods of gene transfer and how to pressure test potential challenges with each method in the context of therapeutics development. A panel discussion from experts in viral and non-viral vector manufacturing will explore the most typical questions that are surfaced during due diligence and vendor qualification for AAV, lentivirus or lipid nanoparticles. Additionally, we will look to explore the questions that are not asked but should be asked by clients when engaging with vector CDMOs or for investors exploring opportunities in this field.
• Gain insights on what questions to raise when sourcing a gene engineering partner be it (viral or non-viral) methods• Understand the potential bumps in the road that can impact time to clinic for the Therapeutic Company• What to expect in variability of cost impact to over COGS of a cell therapy
Jeff Liter, MBA
Farzin Farzaneh, PhD, FRCPath., FRSB
Chief Scientific Officer
Professor of Molecular MedicineSchool of Cancer & Pharmaceutical Sciences, King’s College
Having studied at the universities of Aberdeen and Sussex, Prof. Farzaneh’s postdoctoral career was supported by a Beit Memorial Fellowship for Medical Research, followed by Fellowships from the UK Medical Research Council and European Molecular Biology Organisation, at the Universities of Sussex and Amsterdam. He was appointed to the faculty at King’s College London (KCL) in 1985 and appointed to the Chair of Molecular Medicine in 1996, where he established the Rayne Cell and Gene Therapy Suite in 2001. This facility has produced the largest number of viral vectors for regulatory approved clinical studies in Europe (about 200 GMP batches of retro- and lenti-viral vectors). He was appointed the Chief Scientific Officer at ViroCell Biologics (https://virocell.com), an innovation driven CDMO, focused on the development and GMP manufacture of viral vectors. A major focus of the innovation department at ViroCell is the development of programmable vectors for targeted delivery and expression of therapeutic genes. The focus of the GMP manufacturing activities is the rapid transition of gene therapy from discovery science into clinical evaluation. Prof Farzaneh holds Honorary Chairs at University College London, Imperial College London and at the Technical University of Dresden. He has served on the Clinical Trials, Biologicals & Vaccines Expert Advisory Group of the UK Commission on Human Medicines (since 2016). He received the Distinguished Scientist Award, of the US Society for Experimental Biology and Medicine in 2016. He has published >250 scientific papers with an average citation of >50.
David Hermanson, PhD
Director of Cell and Gene Therapy Applications
David has greater than 10 years experience in using non-viral gene editing for the production of CAR T and CAR NK cells. He is currently the Director of C> Applications at Bio-Techne providing workflow solutions utilizing non-viral gene editing capabilities, specialty medias, and GMP proteins. Prior to joining Bio-Techne, he worked at BMoGen Biotechnologies advancing the TcBuster™ transposon system, now owned by Bio-Techne. David has also worked extensively with the piggyBac™ transposon system while at Poseida Therapeutics first as an R&D scientist and then as a process development scientist and manager for their CAR-T clinical candidates. He received his PhD from the University of Minnesota in medicinal chemistry before doing a post-doctoral fellowship using non-viral gene editing in iPSCs and CAR design for NK cells.
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