Cell & Gene: The Podcast – Détails, épisodes et analyse

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Episode 115 of Cell & Gene: The Podcast features Host Erin Harris' talk with Aliya Omer, Vice President and Global Head of Hematology and Cell Therapy at AstraZeneca. Omer shares valuable insights from her rich experience leading cell therapy development across multiple top companies. She highlights the critical importance of collaboration by breaking down silos across research, manufacturing, regulatory, and commercial teams to deliver innovative therapies efficiently. She also discusses AZ’s diverse and ambitious cell therapy portfolio, encompassing autologous CAR-T, TCR-T, in vivo gene therapies, and regulatory T-cell therapies. She candidly addresses current challenges in manufacturing scalability, patient access, and healthcare system readiness and describes how AZ is prioritizing fast manufacturing platforms and ecosystem-wide partnerships to surmount these hurdles. 

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On episode 114 of Cell & Gene: The Podcast, Host Erin Harris talks to Brian Culley, CEO of Lineage Cell Therapeutics, about advancing cell therapy beyond oncology and into transformative treatments for conditions such as spinal cord injury and blindness. Culley shares how Lineage’s allogeneic, off-the-shelf approach, anchored by its OPC1 program, aims to replace lost or damaged cells to restore function, starting with patients who have plateaued after chronic spinal cord injury. He details the DOSED study’s innovative delivery device and thaw-and-inject formulation, both designed to simplify administration, enhance safety, and improve patient access. Harris and Culley also explore Lineage's broader vision for commercial viability in cell transplantation and its collaborative work with the Christopher & Dana Reeve Foundation to drive awareness, research, and investment in spinal cord injury therapies.

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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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BlueSphere Bio's CEO Dr. David Apelian explains the difficulties associated with treating solid tumor cancers as well as what the CGT sector needs to get right in the short term and why.

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Cue Biopharma's Anish Suri, Ph.D., explains why the clinical-stage biopharma is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the body to transform the treatment of cancer.

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REGENXBIO's VP of Regulatory and Science Policy, Nina Hunter, Ph.D., shares potential solutions to gene therapies' regulatory roadblocks and why the accelerated approval pathway is so pertinent. 

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Selecta Biosciences' President and CEO Dr. Carsten Brunn details the company's ImmTOR platform, which can mitigate unwanted immune responses that cause immune-related toxicities that impose significant treatment challenges with current therapies.

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Cellevolve Bio's founder and CEO. Dr. Derrell Porter shares his experience with starting up a cell therapy company and why we, as an industry, need to advocate for more Black leaders and leaders of color in the biotech industry.

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Dr. Michael Singer, CSO at Cartesian Therapeutics, details why RNA has advantages over other cell therapies, the company's three RNA trials, and the therapeutic benefit of multiple modifications.

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Vor Biopharma's CEO Dr. Robert Ang explains the company's lead engineered hematopoietic cell (eHSC) product candidate, genome engineering of HSCs, and the cell manufacturing process needed to leverage genome engineering technologies for the cells they're creating.

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