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

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

Induced pluripotent stem cell (iPSC)-based therapies offer advantages in their potential to address clinical applicability and scalable manufacturing to meet patient demand. As the number of iPSC-based therapies in clinical development is increasing, the industry is seeing significant advancement following decades of development efforts. Despite these noteworthy strides, there are still many existing dilemmas to address for sustained progress and commercial viability.

In the pursuit of exploring the complexities within iPSC-based therapies, OmniaBio, a cell and gene therapy CDMO with deep iPSC expertise and capabilities, brings together a distinguished panel of industry experts. The panel aims to dissect the ever-evolving landscape of iPSC technology, highlighting crucial elements impacting efficient and effective clinical translation of these cell therapies. The panel aims to explore key areas such as material access and readiness, operational intricacies, technological innovations, and standardization. Join us as we delve into these critical aspects to reshape the future landscape of iPSC-based therapies.

Explore strategies to expedite therapy development and accelerate speed to market
Evaluate the existing licensing and royalty stacking paradigm in iPSC technology and discuss innovative approaches to address challenges and opportunities
Examine existing product characterization best practices and avenues for enhancing standardization across the sector
Debate the necessity of clean room environments and the impact on manufacturing efficiency and product quality

Lise Munsie

Vice President, iPSC Technology Platfrom at OmniaBio | CCRM

Lise Munsie earned her PhD at McMaster University 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 where she focused on the genetic causes of Parkinson’s Disease. Lise joined CCRM in 2015 and is currently the Vice President of the Induced Pluripotent Stem Cell (iPSC) Technology Platform. 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

CTO at Aspen Neuroscience

Mr. Raineri is the Chief Technology Officer for Aspen Neuroscience, Inc. 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 Contract Manufacturing and Development Organizations (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. Kim has a Master’s of Business Administration from Kennesaw State University and Bachelor’s of Science from the University of Miami.

Melissa Carpenter

President at Carpenter Consulting Corporation

For the last 20 years, Dr Carpenter has worked on the development of cell therapies using human adult and embryonic stem cells, in academia and industry, in the United States 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 major stem cell companies: CytoTherapeutics, Inc (StemCells, Inc), Geron, Corp., and Novocell, Inc (Viacyte, Inc). In 2019, Dr Carpenter joined ElevateBio as the Chief Scientific Officer of Regenerative Medicine. At ElevateBio, she built PSC technology platforms and therapeutic programs focused on accelerating PSC-derived products to patients. This work included the development of clinical iPSC lines for therapeutic products. Currently Dr Carpenter is President of Carpenter Consulting Corporation 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.

Bruno Marques

Vice President, Process & Product Development at Century Therapeutics

Bruno Marques is Vice President of Process and Product Development at Century Therapeutics, with a focus on allogeneic, iPSC-derived therapies for cancer and autoimmune diseases. His responsibilities span the adaptation of Research protocols, process scale-up, technology transfer into GMP manufacturing facilities, and supply to Clinical sites. Prior to joining Century in 2019, Bruno spent 14 years developing and commercializing biopharmaceutical products at Merck and GlaxoSmithKline (GSK). At GSK, he held leadership roles in process development and portfolio management, contributing to the launch of several biological products such as Benlysta® and Nucala®. He eventually joined GSK’s Cell & Gene Therapy platform as Director of Manufacturing Strategy in support of autologous immunotherapies. Bruno serves as scientific advisor to academic (NovaCell, CMU’s Biotechnology & Pharmaceutical Program) and industrial (Andson Biotech) institutions. He is a Chemical Engineer by training, with a PhD from Carnegie Mellon University and a BS from the Illinois Institute of Technology.