Cell & Gene: The Podcast

We love to hear from our listeners. Send us a message. Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) within the Food and Drug Administration (FDA) sits down with Cell & Gene: The Podcast host Erin Harris to discuss the most anticipated areas of innovation in clinical development, and he offers recommendations to companies in their engagement with the FDA...

We love to hear from our listeners. Send us a message. Shoreline Biosciences' Chief Scientific Officer Dr. Robert Hollingsworth shares his insight on intelligently designed allogeneic off-the-shelf, standardized, and targeted iPSC-derived natural killers (NK) and macrophage cellular immunotherapies. He explains the company's preclinical testing on a potential NK cell therapy for acute my...

We love to hear from our listeners. Send us a message. BlueRock Therapeutics' President and CEO Seth Ettenberg, Ph. D. talks to Cell & Gene: The Podcast listeners about the company's Phase 1 Clinical Trial for Advanced Parkinson’s Disease. Ettenberg also covers the most promising therapeutic applications for iPSCs currently in development as well as the major regulatory challenges th...

We love to hear from our listeners. Send us a message. Orgenesis' CEO, Vered Caplan explains the business model behind providing cell and gene therapies that may be manufactured at the point of care. She details how working with hospitals and healthcare providers to enable them to participate in CGT development on their sites and providing these therapies in-house by adapting them to closed s...

We love to hear from our listeners. Send us a message. Capstan Therapeutics' CEO, Laura Shawver, Ph. D., talks us through the company's in vivo CAR therapies and what led to the in vivo cell engineering breakthrough that has been decades in the making. Shawver explains the promise of harnessing mRNA and targeted LNP delivery to train a patient’s body to make CAR-T cells in vivo. She also...

We love to hear from our listeners. Send us a message. PepGen, a Cambridge, MA-based biotech, is advancing oligonucleotide therapeutics with the goal of transforming the treatment of severe neuromuscular and neurologic diseases has focused on delivery. SVP Head of Clinical Development Dr. Michelle Mellion explains PepGen's trial of PGN-EDO51, the company’s lead product candidate for the treat...

We love to hear from our listeners. Send us a message. On the heels of Congress' reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act, BridgeBio's Chief Regulatory Affairs Officer, Adora Ndu, explains the Commitment Letter, the programs that may be rolled out under PDUFA VII, why right-sizing CBER will help the cell and gene sector going forward as well as how spon...

We love to hear from our listeners. Send us a message. Arrowhead Pharmaceuticals is a biopharmaceutical company based in Pasadena, CA that develops medicines that treat intractable diseases by silencing the genes that cause them. Javier San Martin, Arrowhead's CMO, talks to Cell & Gene: The Podcast listeners about the similarities and differences between RNAi and CRISPR. He also explains...

We love to hear from our listeners. Send us a message. Will Junker, Head of Manufacturing Quality at Kite Pharma, talks to Cell & Gene: The Podcast listeners about the challenges associated with capacity planning, whether to partner with a CDMO, and why it's important to prioritize inventory over time-to-market. We also discuss why developing a better understanding of the vector manufactu...

We love to hear from our listeners. Send us a message. 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...

We love to hear from our listeners. Send us a message. 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 f...

We love to hear from our listeners. Send us a message. 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 relation...

We love to hear from our listeners. Send us a message. 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 exp...

We love to hear from our listeners. Send us a message. 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 doi...

We love to hear from our listeners. Send us a message. 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 t...

We love to hear from our listeners. Send us a message. 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...

We love to hear from our listeners. Send us a message. 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...

We love to hear from our listeners. Send us a message. 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...

We love to hear from our listeners. Send us a message. 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 relationshi...

We love to hear from our listeners. Send us a message. Celyad Oncology’s CMO, Dr. Charlie Morris, shares the benefits and challenges of the allogeneic approach versus the autologous approach and why a non-gene edited shRNA approach may result in better efficacy and safety for CAR-T therapies. Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gene Connect with me...

We love to hear from our listeners. Send us a message. Rocket Pharmaceuticals CEO Dr. Gaurav Shah offers his take on why gene therapy developers have been plagued by clinical holds, whether the FDA’s AAV-focused CTGTAC meeting's takeaways will hold up throughout 2022, and more. Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gene Connect with me on LinkedI...

We love to hear from our listeners. Send us a message. BlueSphere Bio's CEO Dr. David Apelian explains the difficulties associated with treating solid tumor cancers as well as what the CGT sector needs to get right in the short term and why. Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

We love to hear from our listeners. Send us a message. Cue Biopharma's Anish Suri, Ph. D., explains why the clinical-stage biopharma is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body to transform the treatment of cancer. Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gene Conn...

We love to hear from our listeners. Send us a message. REGENXBIO's VP of Regulatory and Science Policy, Nina Hunter, Ph. D., shares potential solutions to gene therapies' regulatory roadblocks and why the accelerated approval pathway is so pertinent.  Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gene Connect with me on LinkedIn

We love to hear from our listeners. Send us a message. Selecta Biosciences' President and CEO Dr. Carsten Brunn details the company's ImmTOR platform, which can mitigate unwanted immune responses that cause immune-related toxicities that impose significant treatment challenges with current therapies. Subscribe to the podcast! Apple   |  Spotify |  YouTube Visit my website: Cell & Gen...