ICYMI: Q1 2024's Cell & Gene Live And Cell & Gene: The Podcast
By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1
With Q1 of 2024 coming to close, I wanted to take this opportunity to make sure you’ve read, heard, or viewed some of insightful content we’ve created for our readers since the start of the year. Below, you’ll find a list of some of the Cell & Gene: The Podcast episodes that aired in Q1, featuring industry leaders discussing the topics that regularly impact your role. You’ll also find links to our recent Cell & Gene Live events during which we covered topics including how to reduce batch-to-batch variation in cell therapy manufacturing and an outlook for this year’s regulatory landscape with FDA's Drs. Peter Marks And Nicole Verdun. The entire full-length presentations are available, but don’t sleep on the video clips. For your convenience, we’ve broken down each 60-minute Cell & Gene Live into short videos segmented by topic. The links will take you to the full-length presentation as well as the video segments.
Stay tuned for what’s to come in Q2 and beyond as we bring you more detailed information covering the most important topics impacting the cell and gene therapy space.
Cell & Gene: The Podcast
Life Biosciences' CSO, Sharon Rosenzweig-Lipson, Ph.D., and I talk about the Boston-based biotech's cellular rejuvenation therapies for the treatment of age-related diseases. We cover Life Biosciences' lead program, a gene therapy called OSK that is being advanced in two optic neuropathies – a rare eye disease of aging called non-arteritic anterior ischemic optic neuropathy (NAION) and glaucoma. And we talk through the why behind gene therapy as a modality, as well as Life Biosciences' partnership with Forge Biologics to manufacture AAV for cellular rejuvenation technology.
Rare Disease Day was February 29, 2024. In honor of this important day, I sat down with Jackson Laboratory’s (JAX) Rare Disease Translational Center (RDTC)'s VP, Cat Lutz to discuss RDTC's mission, the specific qualifications that make up a rare disease, how the study of rare diseases can potentially advance progress in common diseases, and more.
Inside Yescarta's Reduced Median Turnaround Time with Kite, a Gilead Company's Christopher McDonald
On this episode of Cell & Gene: The Podcast, Christopher McDonald Global Head of Technical Operations at Kite, a Gilead Company, and I talk about Kite's recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. We discussed the most significant steps Kite took to reach this approval, lessons learned from having worked with the FDA, scaling up technologies for cell therapy manufacturing, and more.
Pricing, Value, And Access of CGTs With The Dedham Group's Jennifer Klarer, M.Sc.Eng.
The Dedham Group's Jennifer Klarer, M.Sc.Eng., Partner and Head of Cell & Gene Therapy, joined me on this episode of Cell & Gene: The Podcast for a deep dive into pricing and value for CGTs. Klarer shared a detailed breakdown of the most misunderstood aspects of cell and gene therapy pricing, value, and affordability. She also explained how manufacturers can get ahead of addressing time-to-treatment issues typically experienced at launch.
Cell & Gene Live
How To Reduce Batch-to-Batch Variation in Cell Therapy Manufacturing
As the patient’s immune cells are the starting materials, inherent biological variability leads to CAR-T manufacturing. Additional critical raw materials such as plasmids, viral vectors, lipid nanoparticles, etc. also have batch-to-batch variability, which means the entire production process is a constant balancing act of adjusting the manufacturing process to create a standardized manufacturing. I welcomed Donna Rill, Chief Technology Officer at Triumvira Immunologics and Omkar Kawalekar, Ph.D., Senior Manager, Deloitte Consulting for a discussion on practical ways to overcome the challenges associated with batch-to-batch variation.
2024 Regulatory Outlook with FDA's Drs. Peter Marks and Nicole Verdun
For this record-breaking Cell & Gene Live, I welcomed Dr. Peter Marks, Director, CBER, FDA and Dr. Nicole Verdun, Super Office Director, CBER, FDA for a discussion on the evolving regulatory landscape in 2024 for cell and gene therapies. During the discussion, we covered improving communication with sponsors, increasing speed availability of cell and gene therapies by enabling manufacturing processes and standards development, and much more.