The BioInsights Podcast

The BioInsights Podcast

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The BioInsights Podcast episodes

  • Making the Move to AAV producer cell lines: comparability, bridging studies and regulatory considerations

    Lauren Coyle (Editor, BioInsights) speaks with Lonza's Laura Sands (Head of Regulatory Affairs), Ramesh Koukuntla (Director of R&D), Wenling Dong (Head of Upstream Process Development), and Vijetha Bhat (Subject Expert of Platform Technologies) about:

    • Key regulatory considerations when transitioning to AAV producer cell lines 
    • Comparability and bridging strategies to support a successful transition 
    • Approaches to managing manufacturing and regulatory risk 
    • Considerations for enabling scalable AAV production
    29 min
  • From one target to many: how high‑plex ddPCR is changing CGT from development to analytics

    Lauren Coyle, Editor, BioInsights, speaks with Christian Overgaard, Senior Field Application Scientist, Bio‑Rad Laboratories, about the technical and practical evolution of droplet digital PCR (ddPCR) and high‑plex multiplexing, covering assay design challenges, vector integration analysis, biodistribution studies, and the emerging role of digital PCR in cell and gene therapy characterization and clinical development.

    16 min
  • Beyond one and done: engineering durable, redosable cell‑based gene therapies

    The one‑and‑done model has defined gene therapy for a generation. Chris Hopkins thinks it is time to move on. At ASGCT 2026, Abi Pinchbeck spoke with the Co‑founder and CEO of Glafabra Therapeutics on redoseable cell‑based gene therapy, a platform spanning Fabry, Pompe, and Gaucher diseases, and what durable, if not permanent, treatment could mean for patients. A podcast version of this discussion is also available.

    19 min
  • Precision by design: engineering site‑specific ADCs with machine learning

    Lauren Coyle, Launch Commissioning Editor, Bioconjugate Insights, speaks with Weston Kightlinger, CEO, Ridge Bio, about the challenge of DAR heterogeneity and site specificity in ADC development, Ridge Bio’s ML‑driven enzyme and linker engineering platforms, and what site‑specific conjugation means for the future of ADCs as the field moves beyond oncology.

    25 min
  • Crossing the ADC inflection points: what separates clinical success from failure

    Lauren Coyle, Launch Commissioning Editor, Bioconjugate Insights, speaks with Antoine Yver, Board Chair, Ona Therapeutics, with more than three and a half decades of experience shaping global cancer drug development. In this conversation, they explore what determines whether an ADC successfully crosses the critical threshold and how teams should rethink dose finding, toxicity, and what it truly takes to set a program up for long-term success in the clinic. 

    31 min
  • Advancing nucleic acid therapeutics with circular RNA

    In this podcast episode, Jokūbas Leikauskas, Editor, BioInsights, speaks to Trevor Hallam, who served as Chief Scientific Officer of Sail Biomedicines until July 2025. The interview, recorded in June 2025, explores advances in RNA therapeutics, particularly circular RNA (circRNA or eRNA) technologies, and how they may help overcome current limitations in delivery, durability, and specificity for applications such as CAR-T cell therapies and autoimmune disease treatment.

    34 min
  • From innovation to access: bridging gaps in scalability and cold chain precision logistics for advanced therapies

    Jokūbas Leikauskas, Editor, BioInsights, speaks to Rohin Iyer, Senior Director, Global Cell and Gene Therapy Operations, Marken, about addressing the complex logistics of cell and gene therapies through global infrastructure, precision, and advanced technologies. They also discuss evolving cold chain needs, regulatory and geopolitical challenges, and the need for scalability. 

    20 min

About The BioInsights Podcast

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The BioInsights Podcast: discussing the challenges of translating novel biologics from bench to clinic to market.