Omkar Kawalekar, Ph.D., a Senior Manager and NextGen Therapies Manufacturing & Supply Chain Lead at Deloitte Consulting, dives into the future of cell and gene therapy manufacturing. He discusses how distributed manufacturing models can tackle capacity issues and supply chain threats. Omkar emphasizes the role of automation in minimizing variability between batches and the significance of digital technologies in optimizing production. He explores vital decisions for CGT companies regarding in-house versus CDMO partnerships, providing insights on efficiency and innovation.

We love to hear from our listeners. Send us a message.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.Subscribe to the podcast!Apple | Spotify | YouTube

Helen Sabzevari, Ph.D., President and CEO of Precigen, shares insights on innovative adenovirus-based therapies. She discusses the promising use of gorilla adenovectors, which enhance the delivery of large genetic payloads for effective gene therapies. Sabzevari reveals exciting results from Precigen's recent BLA submission, with over 50% of patients achieving Complete Response in pivotal studies. She also highlights the company's groundbreaking work in treating recurrent respiratory papillomatosis and the potential for broad applications in immuno-oncology and beyond.

We love to hear from our listeners. Send us a message.Christopher Horan, Chief Technical Operations Officer, Artiva Biotherapeutics joins Cell & Gene: The Podcast Host, Erin Harris, to discuss the advantages natural killer (NK) cells have offer over T cells in terms of safety and efficacy for autoimmune disease. They take a deep dive into the key factors that make NK cells promising for ‘off-the-shelf’ cell therapy products. They cover Artiva's "manufacturing first" approach to enabling scalable NK cell production, and much more.Subscribe to the podcast!Apple | Spotify | YouTube

Christopher Choi, Ph.D., is an expert in cell and gene therapy manufacturing and the Director of the GMP Facility at Roswell Park Comprehensive Cancer Center. In this discussion, he reveals plans for a new Cell and Gene Therapy Hub set to open in 2025, aimed at advancing cancer treatment. Choi emphasizes the critical role of automation in manufacturing and shares valuable advice for emerging biotech firms on quality management, project coordination, and the importance of a quality by design approach to improve market readiness.

We love to hear from our listeners. Send us a message.Cell & Gene: The Podcast Host Erin Harris talks to Lothar Roessig, M.D., SVP, Integrated Product Team Lead, Congestive Heart Failure at Asklepios BioPharmaceutical, Inc. (AskBio) about the biggest challenges in developing gene therapies for cardiovascular diseases, specifically congestive heart failure (CHF). They discuss AB-1002, the gene therapy the company is developing for the treatment of CHF and why a gene therapy approach is significantly different from traditional therapies.Subscribe to the podcast!Apple | Spotify | YouTube

Dr. Amit Rhakit is the Chief Medical Officer at BlueRock Therapeutics, where he focuses on cutting-edge cell therapies for Parkinson's disease. He delves into how their therapy, bemdaneprocel, restores dopamine-producing neurons, contrasting it with conventional treatments. The discussion highlights the significant benefits these advancements could have on patient quality of life. Rhakit also shares insights on the personal stories of those living with Parkinson's, emphasizing the transformative potential of innovative therapies in managing symptoms.

We love to hear from our listeners. Send us a message.Rita Johnson-Greene, COO at Alliance for Regenerative Medicine (ARM) joined Cell & Gene: The Podcast Host, Erin Harris, on site during 2024 Meeting on the Mesa to record their discussion. Johnson-Greene shared information about the Joint Clinical Assessment (JCA) in Europe and its potential impact on cell and gene therapies, how globalization impacts patient access, an update on ARM's Grow Internship Program, as well as a few key takeaways from the event that sector professionals can anticipate impacting the CGTs in the next 12 months and beyond.Subscribe to the podcast!Apple | Spotify | YouTube

Dennis Williams, Senior Vice President of Late Stage Development at Adaptimmune, dives into the revolutionary world of TCR T-cell therapies. He shares insights on the TECELRA trial, which achieved FDA approval for Tecelra, a groundbreaking engineered T-cell therapy for solid tumors. The conversation highlights the intricacies of developing therapies for synovial sarcoma and the unique challenges in this field. Williams also compares TCR and CAR T-cell therapies, shedding light on their distinct advantages and the complexities of off-target effects in treatment.

Miguel Forte, CEO of Kiji Therapeutics and President of ISCT, shares his insights on iPSC-MSC therapy for inflammatory diseases. He discusses Kiji's innovative approach to tackling conditions like graft-versus-host disease, inflammatory bowel disease, and psoriasis through advanced clinical trials. The conversation highlights the significance of strategic funding and global collaboration in biotechnology. Forte also reflects on the opportunities presented at ARM's meeting and the importance of networking for future technological advancements.