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On episode 112 of Cell & Gene: The Podcast, Michael Quigley, Ph.D., Chief Scientific Officer and Global Head of Research at Sanofi talks to Host Erin Harris about the establishment of Sanofi’s dedicated Genomic Medicine Unit (GMU). Dr. Quigley emphasizes in vivo delivery and process optimization to improve patient experience, scalability, and global access. They discuss the importance of partnerships with academia, industry, and regulators, and Dr. Quigley discusses how advances in AI are accelerating research efficiency, molecule optimization, and experimental design across Sanofi’s portfolio. He also points to the breakthroughs likely to revolutionize immunology and gene therapy, such as solutions to pre-existing immunity barriers, improved tissue-specific delivery, regulated and reversible gene therapies, and more precise gene editing. 

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On episode 111 of Cell & Gene: The Podcast, Host Erin Harris talks to Ernexa Therapeutics' President and CEO, Sanjeev Luther, about how the company is advancing cell therapy innovation for cancer and autoimmune disease through engineered induced pluripotent stem cell-derived mesenchymal stem cells (iMSCs). Luther shares how Ernexa’s synthetic, standardized, off-the-shelf iMSCs are designed to overcome historic hurdles in MSC therapy, including variability, scalability, and manufacturing complexity, by leveraging master cell banks, precise gene editing, and novel product engineering. He also shares insights into the process of developing pro- and anti-inflammatory iMSCs for oncology and autoimmunity.

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This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development. From the impact of leadership changes and evolving policy directives to the role of funding allocations and public health priorities, Drago sheds light on what CGT developers and sponsors should be watching most closely. She explores regulatory modernization trends, including digital health integration, real-world evidence, and decentralized trial models, and offers practical guidance on how companies can best prepare for potential regulatory shifts while maintaining alignment with FDA expectations for safety, efficacy, and manufacturing rigor.

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In this episode of Cell & Gene Podcast episode, Host Erin Harris talks to Stanford School of Medicine Ph.D. student, Yuanhao Qu, about his work developing CRISPR-GPT, an AI-driven multi-agent system designed to automate genetic experimental design and data analysis, making CRISPR experiments more efficient and accessible, even for non-experts. Qu explains how CRISPR-GPT addresses key challenges such as guide design, delivery methods, off-target prediction, and protocol generation, and shares how collaborations with Princeton helped shape the tool’s architecture and evaluation. Qu also discusses Biomni, a general-purpose biomedical AI agent aimed at supporting a broad range of life science applications, and how the two systems complement each other as building blocks toward an "AI scientist" capable of accelerating discovery across biomedicine. Qu emphasizes the importance of rigorous evaluation, productivity gains, and ethical guardrails to ensure these tools are powerful yet safe for the future of biomedical research.

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This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine and Chief Regulatory Officer for ISCT, a leading expert at the forefront of pediatric cell and gene therapy. Dr. Grilley shares her wealth of experience and unique perspective on the most pressing barriers to accessing transformative treatments for children, from logistical and financial challenges faced by families, to systemic and regulatory hurdles in getting therapies from the lab to the clinic.

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Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and gene therapies. Their conversation covers the importance of defining a therapy’s intended role (curative, chronic, or adjunctive) early in development, the different regulatory expectations based on disease context and patient population, and the crucial impact of unmet medical need on regulatory flexibility. Swietlicka emphasizes the necessity of a clear, scientifically sound regulatory narrative, especially when precedent is lacking, and advocates for early, robust investment in CMC to minimize risks. They also explore the complexities of using surrogate endpoints, planning for long-term patient follow-up under uncertainty, and the value of integrating commercial considerations from the outset. Swietlicka calls for cell and gene therapy developers to adopt a commercial mindset and proactive regulatory engagement to achieve clinical and commercial success.

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In Episode 109 of Cell & Gene: The Podcast, Host Erin Harris talks to Will Chou, M.D., CEO of Passage Bio about the promise and challenges of developing gene therapies for frontotemporal dementia (FTD), a neurodegenerative disease with strong genetic underpinnings. Dr. Chou discusses the biological basis of FTD and the complex scientific, manufacturing, and regulatory hurdles that come with targeting the brain. They discuss the latest interim results from the upliFT-D study of Passage Bio’s PBFT02, including safety and tolerability findings, dose cohort comparisons, and the evolving strategies around immunosuppression. Dr. Chou also highlights upcoming milestones for PBFT02 and what they could mean for advancing gene therapies in neurodegenerative diseases.

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This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the importance of early and continuous engagement with regulatory authorities, especially through structured meetings like INTERACT and pre-IND sessions. Harris and Spratt cover CMC readiness, filing for RMAT/CIT, BLA approvals and regulatory expectations, and more. 

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Cell & Gene: The Podcast Host, Erin Harris, talks to Orca Bio CEO and Co-Founder Nathaniel Fernhoff as he recounts the company’s origins and evolution, tracing its roots to pioneering stem cell research at Stanford University and Dr. Irv Weissman's lab. Seeking to create safer, more effective cures for blood cancers such as AML, ALL, and MDS, Orca Bio developed high-precision cell therapies that utilize purified regulatory T cells and stem cells to minimize complications, such as graft-versus-host disease. Orca Bio spun out of academia to establish its own scalable production platform and clinical pipeline, and Fernhoff explains Orca's flagship product, Orca T, which recently achieved a pivotal milestone by outperforming standard stem cell transplants in a Phase 3 trial.

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On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Ralf Schmid, Ph.D., Associate Director of Preclinical Research at Novartis Biomedical Research, about the evolving use of large animal models in gene therapy development. Dr. Schmid discusses the current reliance on non-human primates (NHPs), their growing logistical and ethical challenges, and the emerging interest in alternatives like genetically engineered pigs and sheep. He outlines key considerations around safety, biodistribution, and immunogenicity that still necessitate large-animal testin —particularly for CNS-targeted AAV therapies — and emphasizes the need for thoughtful study design, responsible sourcing, and diversification in model systems. Dr. Schmid also previews his participation in the upcoming Next Generation Gene Therapy Vectors Summit and reflects on the future of preclinical safety testing in a landscape aiming to balance innovation, rigor, and compassion.

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