iPSC-based therapy dilemmas explored: overcoming hurdles for future success

As the number of iPSC-based therapies in clinical development is increasing, the industry is seeing significant advancement following decades of the industry’s iPSC development efforts. Despite these noteworthy strides, there are still many existing dilemmas to address for sustained progress and commercial viability. In this article, four esteemed industry experts delve into the critical aspects of reshaping the future landscape of iPSC-based therapies, exploring key areas such as material access and readiness, operational intricacies, technological innovations, and standardization.

Melissa Carpenter has worked on the development of cell therapies using human adult and embryonic stem cells for the last 20 years, in academia and industry, in the US and Canada. She has been involved with human embryonic stem cell (hESC) research since the field was established. Her work involves discovery research and the translation of this research into therapeutics, including developing strategies for preclinical development and navigating the regulatory issues surrounding stem cell therapies. She has held leadership positions at three of the major stem cell companies: CytoTherapeutics, Inc (StemCells, Inc.), Geron, Corp., and Novocell, Inc (Viacyte, Inc). Currently, Carpenter is President of Carpenter Group Consulting and works with early stage companies, academic groups and investors to translate discovery based research into stem cell therapies. She is credited with numerous publications and patents in the stem cell field.

Lise Munsie earned her PhD at McMaster University, Hamilton, ON, Canada, focusing on drug discovery in neurodegenerative diseases. Following this, she completed a post-doctoral research fellowship at the Centre for Applied Neurogenetics at the University of British Columbia, Vancouver, BC, Canada, where she focused on the genetic causes of Parkinson’s Disease. Lise joined CCRM, Toronto, ON, Canada, in 2015 and is currently the Vice President of the iPSC Technology Platform for CCRM, and its affiliate, OmniaBio Inc. Lise manages iPSC reprogramming, gene editing, cell banking, scale-up, and differentiation projects. Lise’s team critical focus is enabling these technologies to be manufactured to produce clinically relevant products.

Kim Raineri is the Chief Technology Officer for Aspen Neuroscience, Inc., San Diego, CA, USA. He is responsible for the manufacturing, process and analytical development, technology development, and delivery device functions of a leading autologous iPSC derived cell therapy company targeting CNS diseases. Prior to this position he was the Chief Manufacturing and Technology Officer for AVROBIO, Inc., responsible for the CMC, process and analytical development, supply chain, and external manufacturing functions of a leading gene therapy company targeting Lysosomal Storage Disorders through ex vivo lentiviral gene therapy. Prior to this role, he held various positions of responsibility in cell and gene therapy CDMO as Vice President of Operations for Nikon CeLL innovation, Business Director for Lonza Bioscience Singapore Pte Ltd., and Director of Operations for Lonza Walkersville. Raineri has a MBA from Kennesaw State University, Kennesaw, GA, USA, and BSc from the University of Miami, Coral Gables, FL, USA.

Bruno Marques is Vice President of Process and Product Development at Century Therapeutics, Philadelphia, PA, USA, with a focus on allogeneic, iPSC-derived therapies for cancer and autoimmune diseases. He is a chemical engineer by training, with a PhD from Carnegie Mellon University, Pittsburgh, PA, USA, and a BS from the Illinois Institute of Technology, Chicago, IL, USA.

Please enter your email to access content Read now