The BioInsights Podcast

In the last few years, mRNA has moved to the fore in the vaccine and cell and gene therapy fields, and as a result, its successful production for these downstream applications has never been more crucial. In this podcast episode, Róisin McGuigan, Editor, Nucleic Acid Insights, speaks to Ryan Lahr, Senior R&D Scientist, CELLSCRIPT, about design, production, and quality control of synthesized mRNA for translation in cells.

Roisin McGuigan, Commissioning Editor, Nucleic Acid Insights, speaks to Stanley Crooke, Chairman, Founder and CEO, n-Lorem, about his long career and pioneering role in the antisense oligonucleotide (ASO) space, how RNA-targeting therapies are set to enter the mainstream, and his latest focus: making personalized, free-for-life ASO therapies available to nano-rare patient populations.

Róisin McGuigan, Commissioning Editor, Nucleic Acid Insights, speaks to Ketaki Deshmukh, Senior Scientist, Novo Nordisk, about advanced characterization tools for LNPs, challenges in extrahepatic delivery, scalability issues, and the potential impact of AI and machine learning (ML) on future LNP development.

Jokūbas Leikauskas, Editor, Cell & Gene Therapy Insights, speaks with OmniaBio Inc.’s Kenneth Harris, Chief Strategy Officer and Head of AI, Mitchel Sivilotti, President and CEO, and Anthony Rotunno, Senior Vice President and General Manager/Site Head, about the innovative advancements in cell and gene therapy, focusing on how AI, automation, and robotics are revolutionizing manufacturing processes by reducing costs, increasing production capacity, and ultimately, improving patient outcomes in the rapidly evolving cell and gene therapy field. 

Lauren Coyle, Commissioning Editor, Immuno-Oncology Insights, speaks with Banafshé Larijani, Director of the Centre for Therapeutic Innovation, University of Bath, about the development and application of a novel spatial mapping technology designed to improve cancer diagnostics and personalize treatment planning.

Lauren Coyle, Commissioning Editor, speaks with Dhruv Sareen, Executive Director at Cedars-Sinai Biomanufacturing Center, and Johnathan Rodriguez, Quality Control Manager at Cedars-Sinai Biomanufacturing Center, about the roles of in-process controls, method validation, risk management, and automation in biomanufacturing. They will highlight strategies to ensure product safety, consistency, and regulatory compliance for cell and gene therapy products.

For the first time in history, cell and gene therapy products are reaching the market in waves rather than in one’s and two’s, creating unprecedented challenges for pharma/biotech and healthcare sector stakeholders alike. David McCall, Senior Editor, BioInsights, speaks to Eric Faulkner, President and Chief Strategist, Passage Health Associates, about the chequered history of market access in the advanced therapies field, and what lessons can be taken forward to ensure a successful and sustainable commercial future for the sector. 

David McCall, Senior Editor, BioInsights, spoke to Lee Brown, Healthcare Sector Global Team Leader, Third Bridge Group, on Tuesday, February 6, 2024 to gain his insights into the fast-moving market landscape of advanced therapies. The discussion outlines key recent news and strategic moves from prominent pharma and biotech companies in the field, as well as the prospects for specific technologies such as CRISPR-based genome editing and next-generation CAR-T therapies.

Translating the therapeutic promise of cell and gene therapies into clinical reality relies on robust potency assays. However, designing assays that accurately reflect the complex mechanisms of these therapies can feel like chasing a moving target. Here, Charlotte Barker, Editor, Cell & Gene Therapy Insights, speaks with Giorgio Zenere, CMC technical project lead in the Global QC Technology Innovation Team, Kite Pharma, and Dirk Windgassen, Director of Analytical Development, Miltenyi Biotec, to discuss best practices and future trends in developing potency assays for cell and gene therapies.

Lauren Coyle, Commissioning Editor, Cell & Gene Therapy Insights, talks with Suman Subramanian, Head of Commercial Operations, Catalent Cell and Gene Therapy, to discuss the major achievements in the gene therapy market in 2023, with a focus on reliable manufacturing processes and strategies to enhance predictability while reducing waste in gene therapy manufacturing.