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With 20+ gene therapy targets in Novartis Gene Therapies’ pipeline, President Chris Fox and her team are hyper-focused on newborn screenings as the pathway to helping more and more patients. The company's initial gene therapy, Zolgensma, for spinal muscular atrophy (SMA) has been approved in more than 40 regions and countries and has been used to treat more than 2,300 patients worldwide. Fox details what’s next on the commercialization front for the therapy, and she shares advice with Cell & Gene: The Podcast listeners about what it takes to commercialize a therapy.

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Sernova Corp. is a clinical-stage regenerative therapies company currently focused on insulin-dependent diabetes. CEO and President, Philip Toleikis, Ph.D., details the company's on-going clinical trial to treat Type 1 diabetes (T1D) as well as the very real potential to progress from simply masking symptoms to having a functional cure for T1D. Toleikis also provides his take on the near-term future of regenerative medicine.

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Emily Moran, VP of Vector Manufacturing and Avi Nandi, VP of Process Development at the Center for Breakthrough Medicines share key considerations for biotechs looking to partner with a CDMO. During this epsiode, biotechs will learn how to reduce risk, lower costs, and how to better manage expectations when it comes the biotech / CDMO relationship. 

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Dr. Carl June, an HIV gene therapy pioneer and the father of CAR-T cell therapy, joins Cell & Gene: The Podcast to discuss the current state of CAR-T therapy, what's on the short-term horizon for immunotherapy, on-going manufacturing capacity issues, an update on Emily Whitehead, the first child to receive CAR-T cell therapy on an experimental basis, and more.

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TC BioPharm's CEO Bryan Kobel explains gamma delta t cells (GDT) in depth as well as the advantages of using GDT cells as a cell therapy vehicle. He discusses why the publicly-traded, clinical-stage cell therapy company conducts and manages all clinical trials in house as well as the unique challenges and benefits that come along with doing so. 

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Poseida Therapeutics is a broad platform technology company led by CEO, Mark Gergen. During this episode, Gergen explains how and why the company is moving away from AAV delivery in favor of nanoparticle delivery. He shares some of the biggest hurdles the CGT sector faces when it comes to the development of off-the-shelf therapies as well as the manufacturing challenges Poseida has had to overcome and how they did it.

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Autologous cell therapy clinical trials and products are very complex, and the stakeholder investment is diverse. Immatics' Director, Clinical Operations, Michael Mehler, explains why new hybrid roles operate in clinical operations, clinical supply chain, strategic operations, and medical affairs to help bridge the gap between the sponsor company and the clinical site for clinical trials in an autologous setting. Mehler talks through the main aspects of a site operations lead and why the role is imperative to commercial success as well as how he sees the role evolving in the near term. He also explains what size CGT companies will benefit most from these new hybrid roles.

Cell & Gene: The Podcast is produced by Cell & Gene in partnership with Applied Biosystems by Thermo Fisher Scientific. 

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Dr. Metin Kurtoglu, COO at Cartesian Therapeutics, explains the clinical-stage biotech's autologous RNA cell therapies, Descartes-08 for Myasthenia Gravis and Descartes-11 for multiple myeloma. He also explains Descartes-25, their allogeneic RNA cell therapy and the reasons for the move to "off-the-shelf," and why the future of RNA cell therapy is not confined to rare and fatal diseases. We also discuss post-care for patients having received infusions.

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Encoded Therapeutics' Chief Manufacturing Officer Andy Stober explains the unique commercial manufacturing issues in gene therapy and how to address them. Stober also shares some of the lessons he's learned, which may educate the next generation of gene therapy scientists to accelerate future manufacturing success. We also talk about what developers need to consider regarding the ethical responsibilities in gene therapy.

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Amit Kumar, Ph.D., President and CEO at Anixa Biosciences details the company’s progress on its Phase 1 trial for ovarian cancer. We also discuss why the company’s ovarian cancer program is integral for initial proof of concept for other solid tumor indications. He covers why CAR-T therapy uses an existing hormone/hormone receptor relationship to create a targeted approach to treat ovarian cancer. Dr. Kumar shares how the field of cell therapy may evolve in the short term, and much more.

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