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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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