Cell & Gene: The Podcast

We love to hear from our listeners. Send us a message. In episode 137 of Cell & Gene: The Podcast, Host Erin Harris talks with Sylke Poehling, Ph.D., SVP and Global Head: Therapeutic Modalities, pRED; Roche Gene Therapy Center of Excellence about how the company selects the optimal modality by starting with disease biology. Dr. Poehling explains how an integrated Center of Excellence brings together discovery, safety, manufacturing, and development expertise to reduce technical risk and accelerate progress. She outlines where AI is already creating value versus where caution is warranted. She also explains why genomic medicines will become mainstream when, for common diseases, physicians can offer them as routine options and patients can choose them with confidence. 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. On episode 136 of Cell & Gene: The Podcast, Host Erin Harris welcomes back Dr. Panteli Theocharous, FIBMS, M.S., Ph.D., FRCPath to discuss why autoimmune CAR T is moving rapidly from an emerging concept toward a potentially transformative treatment approach. They talk about the very different benefit-risk calculus in autoimmune disease compared with oncology, the patient and caregiver burden of conditioning, apheresis and long-term monitoring, and the need to rethink clinical trial endpoints around meaningful outcomes. They explore the potential of in vivo CAR T and circular RNA to eliminate some of the biggest barriers in the current treatment pathway, while discussing the scientific and durability questions that remain. 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. In Episode 135 of Cell & Gene: The Podcast, Host Erin Harris talks to Sonal Gupta, MD, PhD, Chief Medical Officer of CoRegen, about the company's novel approach to treating solid tumors by engineering regulatory T cells (Tregs) rather than conventional effector immune cells. Dr. Gupta explains how CoRegen's investigational cell therapy, CRG150, targets the upstream regulator SRC3 to simultaneously influence multiple immune checkpoint pathways. She also discusses the scientific rationale behind the platform, the transition into first-in-human clinical studies, the biomarkers and translational questions the company hopes to answer, and why manufacturing, CDMO selection, and chain-of-identity capabilities are foundational to the future success of autologous cell therapies. 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. Episode 134 of Cell & Gene: The Podcast features Host Erin Harris' discussion with Shannon Boye, PhD, Founder and CSO of Atsena Therapeutics. Dr. Boye shares how the company is approaching Stargardt disease with a differentiated gene therapy strategy built around delivery, dual-vector design, and a disciplined go/no-go framework. Their conversation also explores what Atsena’s broader clinical experience is teaching the team as it advances new programs and works toward the clinic. 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. Episode 133 of Cell & Gene: The Podcast features Host Erin Harris' discussion with Aprea Therapeutics' CEO, Dr. Oren Gilad. They cover the evolution of precision oncology, the science of synthetic lethality, and how Aprea is developing next-generation therapies that target cancer's unique genetic vulnerabilities while improving safety and efficacy. Dr. Gilad also shares insights into biomarker-driven drug development, where precision medicine is headed as researchers pursue more effective treatments for patients with difficult-to-treat solid tumors, and more. 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. Episode 132 of Cell & Gene: The Podcast features Host, Erin Harris' conversation with Diakonos Oncology's President and COO, Jay Hartenbach. Together, they explore how the company is advancing a patient-derived dendritic cell therapy designed to generate a stronger immune response against difficult-to-treat solid tumors, including glioblastoma, pancreatic cancer, and refractory melanoma. Their discussion also covers early clinical signals, outpatient administration, and the manufacturing and automation steps needed to make personalized cell therapies more scalable for broader CGT audiences. 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. For episode 131 of Cell & Gene: The Podcast, we’re sharing a recent "Better Biopharma" roundtable that Erin Harris had the opportunity to join alongside her Life Science Connect editorial colleagues. Hosted by Tyler Menichiello, this conversation brings together chief editors from across the Life Science Connect network to take a midyear look at what’s shaping the pharmaceutical and biotech landscape in 2026. Featuring perspectives from Katie Anderson, Jeff Buguliskis, Ben Comer, Ray Dogum, Rachel Grabenhofer, Dan Schell, Anna Rose Welch, and Harris, this is a valuable listen for anyone looking to better understand where the industry is headed, and how CGT fits into that broader trajectory. https://www.bioprocessonline.com/solution/better-biopharma 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. In Episode 3 of our in vivo-focused special series of Cell & Gene: The Podcast, Ascidian Therapeutics' Founder, President, and CEO Mike Ehlers, M.D., Ph.D., explains how the company is advancing a new class of genetic medicines built on RNA exon editing to durably correct disease at the transcript level without permanently altering DNA. He also shares why in vivo therapies still need to prove precision, durability, and predictability before they become mainstream, and why the field must move beyond proof of concept to reproducible clinical performance across patients and diseases. He discusses the importance of patient selection, tissue specificity, and matching editing efficiency to biological thresholds, and much more. 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. In episode 2 of this four-part in vivo-focused special series of Cell & Gene: The Podcast, Host Erin Harris sits down with Gopi Shanker, Ph.D., Chief Scientific Officer at Beam Therapeutics, for an in-depth conversation on the rapidly evolving landscape of in vivo gene editing and precision genetic medicines. Dr. Shanker discusses how next-generation base editing technologies are advancing beyond traditional CRISPR approaches by enabling precise single-base changes without creating double-stranded DNA breaks. They discuss the growing momentum behind in vivo delivery strategies, including targeted LNP technologies designed to reach tissues beyond the liver, as well as the operational and patient-centric advantages these approaches may offer compared to ex vivo therapies. 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. In episode 130 of Cell & Gene: The Podcast, Dr. Naji Gehchan, Chief Medical and Development Officer at Kyverna Therapeutics, joins Host Erin Harris to outline the company’s mission to apply CAR T-cell therapy beyond oncology to treat severe autoimmune diseases, highlighting promising Phase 2 data from its investigational therapy, Miv-cel, in stiff person syndrome (SPS). Dr. Gehchan explains that Miv-cel works by deeply depleting pathogenic B cells and enabling a broad immune reset, differentiating it from conventional therapies that require ongoing management. As Kyverna advances a rolling BLA submission, Dr. Gehchan positions this milestone as potentially historic, both for SPS patients and for the broader cell therapy field, signaling an inflection point where CAR T could transform autoimmune disease care in the same way it has oncology. 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. This is Episode 1 of a four-episode in vivo-focused special series of Cell & Gene: The Podcast. Host Erin Harris speaks with Cassie Gorsuch, Ph.D., CSO at Precision Biosciences, about the rapid evolution of in vivo gene editing and the scientific, translational, and regulatory hurdles shaping the field. Dr. Gorsuch discusses how Precision Biosciences approaches in vivo therapeutic development through its Arcus platform, with programs targeting chronic hepatitis B and Duchenne muscular dystrophy. They cover the broader challenges facing in vivo gene editing, including delivery limitations outside the liver, balancing specificity and efficiency, mitigating off-target risks, and translating promising preclinical in vivo data into clinical success. 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. In episode 129 of Cell & Gene: The Podcast, Host Erin Harris reconnects with Zachary Roberts, M.D., Ph.D., EVP of Research & Development and Chief Medical Officer at Allogene Therapeutics, to explore how allogeneic CAR-T is evolving from a scalability promise into an earlier-line, potentially curative intervention. Their conversation centers on the ALPHA3 trial, where MRD-guided treatment is redefining when and how CAR-T can be deployed, alongside broader implications for diagnostics, patient access, and the shift toward off-the-shelf therapies in community settings. 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. In episode 128, Host Erin Harris talks to Tatyana Matveeva, Ph.D., Director of cGMP Operations at George A. "Doc" Lopez, MD Laboratory for Regenerative Cell Therapy, Harvard Medical School and Massachusetts General Hospital, about leading cGMP operations within an integrated ecosystem, where manufacturing, research, and neurosurgery coexist. Dr. Matveeva highlights key operational challenges in scaling autologous therapies, particularly around technology transfer, process reproducibility, and regulatory readiness, emphasizing the need for early collaboration between research and GMP teams. Their conversation also explores rigorous approaches to chain of identity and custody, the importance of extensive simulation runs to ensure robustness, the unique sensitivities of manufacturing cells for neurological applications, and more. 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. On Episode 127 of Cell & Gene: The Podcast, Carlos Buesa, Ph.D., Founder and Chairman of the Board at Oryzon talks to Host Erin Harris about how targeting LSD1 is unlocking new treatment approaches across oncology, CNS disorders, and sickle cell disease, with promising early clinical data and a strategy grounded in precision epigenetics. 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. On episode 126 of Cell & Gene: The Podcast, Host Erin Harris welcomes Catriona Jamieson, M.D., Ph.D, Director of the UC San Diego Sanford Stem Cell Institute and Professor of Medicine at the School of Medicine. They explore how shifting the medical mindset from “common horses” to rare “zebras” is unlocking earlier detection and more effective treatment of diseases like myelofibrosis. Dr. Jamieson explains how subtle, often overlooked symptoms can mask serious underlying conditions, and how advances in genomic testing are enabling clinicians to identify disease-driving mutations sooner. They cover groundbreaking progress in targeted therapies, which aim to stop cancer progression and overcome treatment resistance. 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. On episode 125 of Cell & Gene: The Podcast, Host Erin Harris talks to Halloran Consulting Group's Monika Swietlicka to discuss how the FDA is increasing flexibility in cell and gene therapy development without lowering evidentiary standards, emphasizing a risk-based, holistic approach. They also explore what this means for developers, from platform strategies and global regulatory divergence to the growing role of patient advocacy and the need for early, integrated planning. 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. On episode 124 of Cell & Gene: The Podcast, Aurora Therapeutics' CEO Dr. Edward Kaye discusses the company’s strategy for translating CRISPR gene editing into scalable, commercially viable medicines for rare diseases. Aurora is initially targeting phenylketonuria (PKU) using a platform approach that leverages shared components, such as lipid nanoparticles and base editors, while customizing guide RNAs for specific mutations. Dr. Kaye explains how trials, regulatory flexibility, and optimized manufacturing could make it possible to treat many genetic variants efficiently and cost-effectively. Ultimately, Aurora aims to build a repeatable model that expands gene editing access to larger rare-disease populations while keeping patients at the center of development. 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. In episode 123 of Cell & Gene: The Podcast, Host Erin Harris talks to Dr. Panteli Theocharous, FIBMS, M.S., Ph.D., FRCPath, about the patient journey in cell therapy trials. They pinpoint key friction points, such as delayed referrals, unpredictable vein-to-vein timelines, and burdensome long-term follow-up, while sharing actionable strategies for simplification. These strategies range from upstream trial design and streamlined consent processes to standardized logistics, hybrid monitoring models, honest risk communication, and engaging patients as true partners in real-world evidence generation. 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. In episode 122 of Cell & Gene: The Podcast, Host Erin Harris talks to Paul Romness, CEO of OS Therapies, to learn the company’s mission to address the severe unmet need in pulmonary metastatic osteosarcoma (PMO), a rare pediatric cancer with no established standard of care once it metastasizes. Romness explains how OS Therapies’ off-the-shelf HER2-targeted immunotherapy aims to significantly improve outcomes by stimulating a robust immune response with minimal side effects. He highlights results from a multicenter Phase 2B trial showing markedly improved overall survival rates compared to historical outcomes, details the company’s constructive regulatory interactions with the FDA, and underscores the value of comparative canine biomarkers in development. 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. In episode 121 of Cell & Gene: The Podcast, Host Erin Harris talks to Scribe Therapeutics' CEO and Co-Founder Benjamin Oakes about building next‑generation CRISPR and epigenetic editing tools to move genetic medicine beyond rare disease into common cardiometabolic indications. Oakes shares Scribe’s engineered CasX platform and epigenetic silencers, preclinical data from its various programs, and why exquisite specificity and low-dose LNP delivery are essential to treating patients safely. They also explore Scribe’s partnerships with Sanofi and Lilly, the company’s cardiometabolic-first strategy co-developed with Dr. Jennifer Doudna, and Oakes’ conviction that genetic medicines can fundamentally reshape healthspan and the future of preventive cardiovascular care. Subscribe to the podcast! Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn