The BioInsights Podcast
The BioInsights Podcast discusses the challenges of translating novel biologics from bench to clinic to market. It covers topics related to biopharmaceutical development, regulatory hurdles, and commercialization strategies. The podcast features interviews with industry experts and thought leaders.
Episodes
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
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
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.
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 ta
Formulation and delivery of RNA-based vaccines and therapeutics: addressing outstanding questions around safety and purity
In this interview, Róisin McGuigan, Editor, Nucleic Acid Insights, and Jesse Erasmus, Director of Virology at HDT Bio, discuss current challenges and opportunities in RNA safety, manufacturing, and targeted delivery, and the key ongoing obstacles facing viral and LNP-based delivery modalities.
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 a
Exploring advances in bioconjugation: nanozymes, tissue tropism, and the future of responsive systems
Lauren Coyle (Commissioning Editor, Bioconjugation Insights) speaks to Vincent Rotello (Distinguished Professor of Chemistry, University of Massachusetts Amherst) about the advantages and limitations of different nanomaterial platforms, and emerging strategies such as tissue tropism and responsive nanozymes that could advance targeted therapeutic and diagnostic delivery.
The promise of antibody-oligonucleotide conjugates for neurological diseases
Lauren Coyle, Launch Commissioning Editor, Bioconjugation Insights, speaks with Kerstin Hofer, Science and People Lead, Roche, about the evolving application of antibody-oligonucleotide conjugates in neurology. She highlights their design, delivery challenges across the blood–brain barrier, and potential to transform CNS diseases.
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.
Enhancing mRNA results through strategic RNA design and quality control
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 mR
For the many and the few: bringing ASO therapies to both mainstream and nano-rare indications
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.
Exploring challenges, opportunities and state-of-the-art tools in the lipid nanoparticle space
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.
Driving innovation in cell and gene therapy: the role of AI and robotics
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 proc
Spatial mapping: shaping the future of I-O diagnostics and treatment
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.
Pioneering quality control in biomanufacturing of cell and gene therapies
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 re
Preparing for tomorrow’s cell and gene therapies today: lessons from 30 years in the field
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
Insights into advanced therapies in the context of evolving funding and M&A environments
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
Fit for function: developing potency assays reflective of the in vivo environment
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 In
Gene therapy is having a monumental year: how can the industry keep up with supply?
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.
A deep dive in to generative AI applications in I-O
Lauren Coyle, Commissioning Editor, Immuno-Oncology Insights, speaks with André Freitas, Senior Lecturer (University of Manchester) and Research Group Leader (Idiap Research Institute/National Biomarker Centre), about the intersection of generative AI and experimental cancer treatments, with a focus on clinical trials, regulatory considerations, and leveraging emerging technologies for a transform
Developing novel radioimmunotherapy combinations for lung cancer treatment
Lauren Coyle, Commissioning Editor, Immuno-Oncology Insights, speaks to Joe Chang, Clinical Thoracic Oncologist, MD Anderson Cancer Center, University of Texas, who discusses his team’s pioneering work in combining radiation therapy with immunotherapy for lung cancer treatment. He highlights the challenges and promises of optimizing radioimmunotherapy combinations, emphasizing the importance of pe
Focusing on the fundamentals: what do and don’t we know about mRNA delivery?
As excitement around the evolving field of mRNA continues to grow, there remain somefundamental questions to be answered. David McCall, Senior Editor, Nucleic Acid Insights, spoke with Monash University’s Colin Pouton, Professor of Pharmaceutical Biology and Angus Johnston, Associate Professor, ARC Future Fellow about the key limitations and unknowns of current mRNA delivery approaches, and critic
Navigating genomics and transcriptomics in the immuno-oncology space
Lauren Coyle, Commissioning Editor, Immuno-Oncology Insights, interviews Katie Campbell, Postdoctoral Fellow, Cancer Research Institute, about her current research on genomics, transcriptomics, and spatial profiling to address challenges in the I-O field.
Avian influenza and the risk of pandemic
With the potential for avian influenza to transmit and spread amongst humans, an effective vaccine to increase pandemic preparedness is a global priority. Charlotte Barker, Editor, Vaccine Insights, speaks with Mathilde Richard, Principal Investigator & Associate Professor at Erasmus MC, about investigating antigenic evolution of avian influenza viruses, developing better vaccines, and the nee
Exploring the landscape of novel targets & pathways in immuno-oncology
Lauren Coyle, Editor, Immuno-Oncology Insights, speaks to Yvonne McGrath, Chief Scientific Officer, iTeos Therapeutics, about the current and emerging novel targets and pathways for the use of cancer therapy in the I-O field with a focus on small molecules and antibody targets.
Multiomics integration: advancing pediatric cancer immunotherapy
Lauren Coyle, Editor, Immuno-Oncology Insights, speaks with Raoul Santiago, Clinical Investigator and Associate Professor of Pediatric Hematology and Oncology, University Hospital Center, Laval University, to discuss the role of multiomics in the I-O setting and how these tools can be leveraged to improve pediatric cancer care.
Building with the patient in mind: designing a state-of-the-art facility for viral vector manufacturing
The cell and gene therapy space poses a number of unique challenges when it comes to facility design. In this episode, Róisin McGuigan, Editor, BioInsights, speaks to Yposkesi’s Louis-Marie De Montgrand and Morad El Gueddari to discuss the key considerations for designing an advanced therapy manufacturing facility that can meet the needs of future commercial demand.To read this interview and acces
Can AAV continue to deliver the promise of gene therapy?
In this episode, Charlotte Barker, Editor, BioInsights, will be discussing the future of AAV-based gene therapy manufacturing with Elie Hanania, VP of Process Development Viral Vector Technologies at Avid Bioservices, and Ratish Krishnan, Senior Strategy Consultant at Merck Life Sciences.
Expanding the potential of in vivo cell therapy with tLNP-RNAs (targeted lipid nanoparticle-RNA)
The application of lipid nanoparticles (LNPs) as a non- viral delivery system for advanced therapies, in conjunction with RNA-based medicines, is set to revolutionize the field. In this episode, David McCall, Senior Editor, BioInsights, speaks to Adrian Bot, Chief Scientific Officer and Executive Vice President of R&D, Capstan Therapeutics, about the potential of these tools to drive the burg
Investing long-term in the cell & gene therapies of the future
David McCall, Senior Editor, BioInsights, speaks to Geeta Vemuri, Founder and Managing Partner, Agent Capital, about her VC company's portfolio of advanced therapy investments, and the keys to obtaining funding in a difficult environment. (From an interview conducted on February 22nd, 2023).
Happy medium: considerations in scaling cell culture media strategies
While attractive from an initial cost perspective, performing early development in a cell culture substrate that does not match a therapy’s final manufacturing platform can have critical implications on development timelines. In this podcast, Charlotte Barker, Editor, BioInsights, speaks to Dalip Sethi, Director of Scientific Affairs, Terumo BCT, about best practices for scaling up cell culture s
Applying multiomics to novel target discovery in immuno-oncology
In this episode, Róisin McGuigan, Editor, Immuno-Oncology Insights, speaks with Eran Ophir, Chief Scientific Officer, Compugen, and Yaron Turpaz, Senior Vice President and Senior Advisor, Data and Informatics Solutions, Compugen, about the advantages of using multiomic and computational approaches for the discovery of novel targets and mechanisms of action (MoA) of novel drug candidates in immuno-
Modernizing cell therapy manufacturing to reduce vein-to-vein times
Charlotte Barker (Editor, BioInsights) speaks with Curate Biosciences’ CEO David Backer and CTO Tony Ward about the need for CAR-T cell therapy manufacturing to evolve, and how a new cell separation technique could boost efficiency.
Inducing innate immune responses with particulate adjuvants
Charlotte Barker, Editor, Vaccine Insights, speaks with Ed Lavelle, Professor, Trinity College Dublin, about our growing understanding of adjuvant mechanisms, his work on developing mucosal vaccines, and why size matters for nanoparticles’ adjuvant effects.
Navigating the complexities of biodistribution, transgene expression & vector shedding in gene therapy development
In this episode Róisin McGuigan (Editor, BioInsights) speaks to Paul Byrne (Senior Director, Genomics, ProtaGene) about the evolution of the gene therapy field, with a specific focus on the complexities posed by biodistribution, vector shedding, and transgene expression in gene therapy development.
Non-viral methods for ex vivo cell & gene therapy: is the future non-viral?
Non-viral methods for ex vivo cell & gene therapy: is the future non-viral? In this episode, Valeria Annibaldi and Andrea Toell discuss the types and benefits of non-viral methods for ex vivo cell and gene therapy in addition to the readiness of electroporation-based technologies for use in GMP manufacturing.To read this interview and access lots more content, visit the Cell and Gene Therapy I
Solving challenges in cell therapy clinical trials & effectively delivering complex studies in advanced therapeutics
Cell therapy clinical trials pose a variety of complex challenges. Logistics with cell harvesting, manufacturing, shipments back to sites, patient safety, changing standard-of-care treatments, and patient enrolment due to competing trials can all impact study timelines. In this episode, Vito Romita and Jai Balkissoon outline key obstacles for developing cell therapies in oncology, and provide thei
Shear ignorance? Think again: breaking the perception of shear within viral vector manufacturing
The tangential flow filtration (TFF) unit operation in viral vector manufacturing is a critical step on the path to commercialization. In this episode, Merck viral vector experts Ratish Krishnan and Akshat Gupta discuss best practices – and common misconceptions – when establishing process conditions and utilizing different TFF device formats.
Challenges in cryogenic storage containers for cell and gene therapy
Current options for cryogenic storage containers in cell and gene therapy are limited in their functionality as the industry continues to move towards increased scale and automation. In this episode, Sean Werner and Alex Sargent address specific challenges with current optionality, while also considering what future innovations in this area might look like.To read this interview and access lots mo
Maximizing Efficiency and Flexibility in Viral Vector Manufacturing Scale-up
Four viral vector experts from diverse groups within Pall Corporation’s gene therapy manufacturing organization – Denis Kole, Jon Petrone, Marc Bisschops and Nathan Hazi – join BioInsights to share insights in hot topics for the field, including optimizing upstream process yield and titer, full/empty/partially full capsid separation, and platform process development.
Improvement of viral vector purification using Mustang Q membrane chromatography
Saadia Zakai and Mark Schofield of Pall join Hélène Lebas of leading viral vector CDMO, Yposkesi, to discuss key current trends and challenges in AAV and lentiviral vector manufacturing, with a particular focus on the cutting edge in lentiviral vector and adeno-associated viral (AAV) vector purification tools.
Shear ignorance? Think again: breaking the perception of shear within viral vector manufacturing
The tangential flow filtration (TFF) unit operation in viral vector manufacturing is a critical step on the path to commercialization. In this episode, Merck viral vector experts Ratish Krishnan and Akshat Gupta discuss best practices – and common misconceptions – when establishing process conditions and utilizing different TFF device formats.
CAR-T cells: from cancer to autoimmunity
Professor Dimitrios Mougiakakos is the director of the Hematology and Oncology department at the Otto-von-Guericke University in Magdeburg, Germany. In this episode, he joins us to discuss the exciting potential for CAR T cell therapy for autoimmune disease and how his team has approached GMP manufacturing in the clinical setting. He explains the challenges faced in setting up cell therapy for sys
Tales, tips & teachable moments from applications support veterans
Cell and gene therapy scientists are under increasing pressure to achieve results faster and produce cells and cell products more cost-efficiently. Field applications scientists from their major suppliers can provide invaluable support, helping to optimize processes, utilize new platforms and technologies more effectively, and avoid costly errors. In this podcast, three veteran Field Applications
Access to vaccines: how can we leverage technology innovations to achieve greater vaccine equity?
Fatema Kazi works for the WHO, where she helps to assess the public health value of vaccine products and technologies in routine, campaign, and outbreak settings. We caught up with her to discuss how innovations in vaccine technology can help get vaccines to the people who need them.
De-risk & accelerate the drug development process for gene therapy
In today’s challenging financial environment, it is more important than ever to get key biotech business decisions right first time. One of the most important and topical of these is the choice of CDMO partner. Dr Kim Watanabe, General Manager and Site Head for Patheon Translational Services, a part of the Thermo Fisher Scientific pharma services contract development and manufacturing organization
Working Together to Safely Advance Cell & Gene Therapies
Drug development is a costly and time-consuming process associated with a significant attrition rate in the clinic. Safety is an important factor in this, and is a particular issue for cell and gene therapies. A panel moderated by Dr John Maher of King’s College London and Leucid Bio, and featuring Dr Alastair King, Dr Francisca Neethling, and Dr Andrea Bisso, discuss this highly topical barrier t
Learning from pediatric CAR-T development: insights from manufacturing unique patient doses
What valuable experiences from first generation cell therapies can the industry carry forward and apply to other indications, such as solid tumors? In this episode, Sean Werner and Chris Brown explore the most important lessons the industry has gleaned from pediatrics, and how they can inform the future of cell therapy manufacturing.
Insights into the editing of the human genome: where can novel non-viral polymeric delivery agents take us
Tom Foti (Vice President and General Manager of the Protein Business Unit, Aldevron) and Dr Kris Saha (Associate Professor of Biomedical Engineering and Medical History and Bioethics, University of Wisconsin-Madison) discuss ongoing work in Dr Saha’s lab to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene thera
Making the switch from autologous to allogeneic cell therapy
Accelerating cures: funding stem cell innovation & ideas in an evolving cell therapy space
The Maryland Stem Cell Research Fund (MSCRF) is a well-established US state fund aimed specifically at driving the development of new medical strategies for the prevention, diagnosis, treatment and cure of human diseases, injuries, and conditions through human stem cells. Here, we discuss the MSCRF’s specific activities and goals with Executive Director, Dr Amrithar Jaishankar, and get her take on
Insights into the editing of the human genome: where can novel non-viral polymeric delivery agents take us
Achieving better AAV vector productivity and product quality
Transient transfection of plasmids into suspension HEK293 cells is still the most commonly used method for the production of recombinant adeno-associated virus (rAAV) gene therapies – in this episode, Diane Golebiowski and Marissa Stanvick discuss ways to optimize that process.
Partnering in life sciences: what is the ‘secret sauce’ for success? PART 2
Welcome to a 2-part series in which we identify and distill some key learnings for partnering success in today's life sciences sector.Perhaps one of the most valuable take-aways from the COVID-19 pandemic response is the sheer scale of what may be achieved through effective collaboration. Over the next three episodes, we'll talk to a range of different stakeholders from across BioInsight
Partnering in life sciences: what is the secret sauce for success? PART 1: The Big Pharma perspective
PART 1: The Big Pharma PerspectiveWelcome to a 2-part series in which we identify and distill some key learnings for partnering success in today's life sciences sector.Perhaps one of the most valuable take-aways from the COVID-19 pandemic response is the sheer scale of what may be achieved through effective collaboration. Over the next three episodes, we'll talk to a range of different s
Where will tomorrow’s workforce come from? PART 4: Who are tomorrow’s cell and gene therapy workers?
PART 4: Who are tomorrow’s cell and gene therapy workers?Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?”The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade now, fuelled by long-awaited clinical successes, commercial breakth
Where will tomorrow’s workforce come from? PART 3: Innovation in staff sourcing, training and retention - what works and what doesn’t?
PART 3: Innovation in staff sourcing, training and retention - what works and what doesn’t? Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?”The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade now, fuelled by long-awaited cli
Where will tomorrow’s workforce come from? PART 2: How is the educational system responding, and how can the cell and gene therapy community at large help?
Part 2: How is the educational system responding, and how can the cell and gene therapy community at large help?Welcome to a four-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?” The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled
Where will tomorrow’s workforce come from? PART1: Framing the issue
Welcome to a 4-part series exploring a question that the entire cell and gene therapy community is struggling with at the moment: “Where will tomorrow’s workforce come from?”The cell and gene therapy field has been advancing at a breakneck speed for the best part of a decade, fuelled by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from bot
The quest for the Holy Grail in AAV chromatography: empty–full separation
Ratish Krishnan and Oliver Rammo share their thoughts on the need for a more nuanced understanding of AAV capture and empty–full separation, and the trends driving innovation in this area.
Residual DNA testing in viral vector manufacture: exploring the challenges and solutions
In this episode Ilaria Scarfone Field Application Specialist, Pharma Analytics, Thermo Fisher Scientific speaks to Mike Brewer, Director and Global Principal Consultant, BioProduction Division, Thermo Fisher Scientific about the challenges for residual DNA testing in viral vector manufacture.To read this interview and access lots more content, visit the Cell and Gene Therapy Insights website.
Precisely for CGT: automating aseptic filling for lowest volumes
In this Episode, Roisin McGuigan, Editor at BioInsights, speaks to Dr Barbara Fisher, Process Consultant at Single Use Support about automating aseptic filling for lowest volumes. Barbara works with both established pharmaceutical manufacturers and start-up companies, and has in-depth expedience in low bioburden and aseptic GMP manufacturing from downstream processing to fill and finish. To read t
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