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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.

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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.

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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.

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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.

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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. 

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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.

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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.

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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.

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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.

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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.

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Welcome to episode 120 of Cell & Gene: The Podcast. Host Erin Harris is joined by Rachel Haurwitz, CEO of Caribou Biosciences, to discuss the company’s progress in developing CRISPR-edited, off-the-shelf CAR-T therapies for hematologic malignancies. Their conversation centers on Vispacell, Caribou’s allogeneic CD19 CAR-T for second-line large B-cell lymphoma. Haurwitz explains how Caribou has systematically optimized its allogeneic platform using clinical and translational data. They also cover pivotal Phase 3 trial planning, regulatory considerations, and what to expect next from Caribou’s broader pipeline, including its BCMA-targeted program in multiple myeloma.

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