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The BioInsights Podcast

Author: BioInsights

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