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.

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 transformative impact in I-O. 

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 personalized treatment approaches and collaboration across disciplines to improve patient outcomes.

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 critical areas for further research and innovation to propel the field forward.

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.

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 need for proactive measures to ensure global preparedness in the face of evolving influenza threats.

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.

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.

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 access lots more content, visit the Cell and Gene Therapy Insights website.

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. 

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 burgeoning in vivo cell therapy space in particular, and the broader gene medicine field in general.

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).

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 substrate.

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-oncology.

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.

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.

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? 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 Insights website

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 their insights on overcoming them in order to increase patient access and design safer trials.To read this interview and access lots more content, visit the Cell and Gene Therapy Insights website

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.  

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 more content, visit the Cell and Gene Therapy Insights website

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.

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. 

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.  

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 systemic lupus erythematosus (SLE), and the future of cell and gene therapy in different indications.

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 Scientists from Corning Life Sciences - Austin Mogen, Catherine Siler, and Chris Suarez - share their expertise and lessons learned over decades of experience. 

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.

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 organizational arm, joins BioInsights to share her advice and insights into optimizing outsourcing strategy.

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 to the further clinical and commercial success of the field.

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.

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 therapy manufacture. 

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 how best to develop collaborative research programs and promote commercialization of stem cell technologies.

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. 

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 BioInsights' fields of focus, asking them to pass on their tips for what works and what doesn't in this crucial aspect. Abi Pinchbeck, Assistant Editor, Immuno-oncology Insights, speaks to Arjun GoyalIn PART 2,  Arjun Goyal, co-founder and managing director of US-based life sciences venture capital firm Vida Ventures, provides a venture capitalist's perspective on licensing and partnering within immuno-oncology.

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 stakeholders, asking them to pass on their tips for what works and what doesn't in this crucial aspect.In this first episode, Dr Marianne De Backer, a Member of the Executive Committee and Executive Vice President of Strategy, Business Development & Licensing, and Open Innovation at Bayer Pharmaceuticals, shares her experience as a driving force behind Bayer's significant recent moves in the cell and gene therapy area. 

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 breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovation comes the fundamental challenge of developing a sufficiently large and skilled workforce to support and maintain the sector. In this final episode, we look to the future of the cell and gene therapy workforce, exploring the motivations, skills, goals, and priorities of three individuals who are at various early stages of their careers in the sector – PhD student Tiffany Hood, recent Masters graduate Lihi Livne, and Sebastian Rudden, who is in his final year as an undergrad at University College London. 

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 clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovation comes the fundamental challenge of developing a sufficiently large and skilled workforce to support and maintain the sector. In episode 2, we looked predominantly at how the educational system is evolving to meet the specific training and skills requirements of the burgeoning advanced therapies field. In this third episode, we turn the spotlight onto the cell and gene therapy industry and how it is approaching staff development and retention – a crucial area that has been made all the more challenging by the current high level of competition for talent in the field, as well as the evolving mindset of workers relating to their career development and pathway that has been wrought by the Covid-19 pandemic, amongst other things. So what are the keys to ensuring a cell or gene therapy company can keep hold of its brightest stars and help them to flourish and grow? Hear the thoughts of Sven Kili, James Miskin, Michael Lehmicke, Qasim Rafiq and Emily Hopewell.

 Episode 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 by long-awaited clinical successes, commercial breakthroughs, and a related startling increase in activity from both investors and big pharma. But with this relentless pace of growth and innovation comes the fundamental challenge of developing a sufficiently large and skilled workforce to support and maintain the sector. In this second episode, we look at some of the ways in which the academic and industry communities are responding today, as well as important focus areas for future initiatives, with Sven Kili, James Miskin, Michael Lehmicke, Qasim Rafiq, Emily Hopewell, Frank Barry and Parviz Shamlou.

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 both investors and big pharma. But with this relentless pace of growth and innovation comes the fundamental challenge of developing a sufficiently large and skilled workforce to support and maintain the sector.In this first episode, we will frame the scale and nature of the issue through the eyes of cell and gene therapy leaders including Sven Kili, James Miskin, Michael Lehmicke, Qasim Rafiq, Emily Hopewell, Frank Barry and Parviz Shamlou.

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.