Engineering Off-the-Shelf Cell Therapies for Cancer & Autoimmune Disease with Ernexa Therapeutics' Sanjeev Luther
We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn
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What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago
We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn
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Inside CRISPR-GPT with Yuanhao Qu
We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn
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Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D.
We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn
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Defining Product Roles and Navigating FDA Approval with Monika Swietlicka
We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube Visit my website: Cell & Gene Connect with me on LinkedIn
Cell & Gene, the most valuable online resource for delivering in-depth content from authoritative authors and sources to professionals in the CGT sector, introduces Cell & Gene: The Podcast. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to industry and academic leaders about their current initiatives and how they are moving the sector forward.
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