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In this episode of Cell & Gene: The Podcast, Host Erin Harris sits down with Peter Altman, Ph.D., CEO of BioCardia, to discuss the company’s evolution from a cardiac biotherapeutic delivery firm to a developer of autologous and allogeneic cell therapies for cardiovascular and pulmonary diseases. Altman highlights BioCardia’s CardiAMP program, a precision medicine approach that pre-screens patients based on their cell profiles to improve trial outcomes and reduce costs. He explains why no cardiac cell therapy has yet received FDA approval, citing challenges in delivery, immune rejection, and arrhythmia risks. Altman outlines BioCardia’s near-term roadmap, including regulatory submissions in the U.S. and Japan and the launch of a second trial focused on patients most likely to benefit.

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In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research. Dr. Zhou highlights CRI’s focus on funding early-stage science and clinical trials to move immunotherapy toward curing all cancers. She covers the serious implications of recent U.S. Government funding cuts, including NIH budget freezes and halted grant review processes, which are already impacting biomedical research institutions, graduate programs, and clinical trials. In light of the NIH budget cuts, Dr. Zhou explains how CRI is stepping up by committing an additional $2.5 million from its reserves to fund 10 postdoctoral fellowships.

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On the 100th episode of Cell & Gene: The Podcast, Host, Erin Harris, sits down with Audrey Greenberg, Founder and CEO of AG Capital Advisors. Audrey is the award-winning executive, board director, and strategic advisor with a proven track record of launching, scaling, and successfully exiting multi-billion-dollar ventures. They explore the biggest challenges and opportunities facing CGT biotech leaders today; the funding crisis in biotech, the evolving investment landscape, and whether the traditional VC-driven model is still sustainable. They also examine what it really takes to scale a biotech company from startup to market leader, the role of AI-driven drug discovery, and how big tech’s growing influence could reshape the industry. You'll hear their discussion on leadership challenges in biotech, the need for more diverse voices at the top, and what must change to empower the next generation of women leaders in CGT, and more.

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In this episode of Cell & Gene: The Podcast, Host Erin Harris dives into the world of retinal gene therapy with Kenji Fujita, M.D., Chief Medical Officer of Atsena Therapeutics. Atsena develops treatments for inherited retinal diseases, including X-linked retinoschisis (XLRS), a rare genetic condition that currently has no FDA-approved therapy. They talk through the impact of XLRS on patients, the challenges of gene delivery to the retina, and how Atsena’s AAV vector technology is designed to overcome these hurdles. They also discuss the significance of the Fast Track designation recently granted to Atsena’s XLRS program, the role of patient advocacy in rare disease research, and the key milestones to watch for in the months ahead.

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In this episode, Host Erin Harris sits down with Dr. Simrit Parmar, Founder of Cellenkos, to explore how the company is pioneering umbilical cord blood-derived Regulatory T cell (Treg) cell therapies for autoimmune and inflammatory diseases. Dr. Parmar shares the vision behind Cellenkos, the advantages of cord blood-derived Tregs over other sources, and how their CRANE technology platform enhances precision in targeting diseases. They also discuss key findings from their Phase 1b trial for CK0804, the challenges of scaling up off-the-shelf Treg therapies, and what’s next for Cellenkos in 2025.

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Omkar Kawalekar, Ph.D., Senior Manager, NextGen Therapies Manufacturing & Supply Chain Lead, Deloitte Consulting joins Host Erin Harris to share his expert take on how distributed manufacturing models address capacity constraints and supply chain risks, the role of automation in reducing batch-to-batch variability, as well as the power of digital technologies in optimizing production processes. He also covers the key considerations for CGT companies when choosing between in-house manufacturing and CDMO partnerships, and much more.

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In this episode, Erin Harris sits down with Faraz Ali, CEO of Tenaya Therapeutics, to explore the cutting-edge world of gene therapies for heart diseases. As Tenaya makes significant strides in developing innovative treatments, Ali shares insights on Tenaya's gene therapy platform, their in-house manufacturing capabilities, and the potential impact of their therapies on prevalent heart conditions. They also discuss the complexities of commercializing gene therapies, industry-wide developments, and Tenaya's roadmap for 2025. This conversation offers a unique glimpse into the future of cardiac care and the transformative potential of gene therapies in treating heart diseases.

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Helen Sabzevari, Ph.D., President and CEO of Precigen, joins Host, Erin Harris to discuss how the company utilizes gorilla adenovirus vectors. These vectors offer significant advantages in delivering large genetic payloads, a crucial factor in developing effective gene therapies. Sabzevari also discusses Precigen's recent BLA submission for PRGN-2012, which includes Phase 1/2 pivotal study results where over 50% of patients achieved Complete Response and more than 85% experienced decreased surgical interventions.

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