ROUNDTABLE Overcoming Barriers to iPSC Market Readiness: Part II
Wednesday, May 31, 2023 10:45 AM - 11:45 AM
Room 242A
COGS & Business Models
Roundtable
How to harmonize Quality Control requirements without impacting safety?
Moderator
Xiaokui Zhang, PhD, Chief Scientific Officer, Aspen Neuroscience, Inc., USA
Panelists
Kapil Bharti, PhD, Senior Investigator, National Institutes of Health, USA
Michael Kuo, MT(ASCP), Senior Vice President of Manufacturing, Vita Therapeutics, USA
Bruno Marques, PhD, Executive Director, Process & Product Development, Century Therapeutics, Inc., USA
Jacqueline Barry, PhD, Chief Clinical Officer, Cell and Gene Therapy Catapult, UK
Session Description
The last decade has seen tremendous progress in utilizing human iPSC technology in disease modelling, drug development and basic research. It remains a long journey for realization of the huge potential of developing iPSCs as cell replacement therapies. One of the largest challenges in the field is how to ensure that manufacturing process for iPSC-derived cell therapy can be industrialized at an affordable cost for a large number of patients with consistent quality, safety and efficacy.
In this Roundtable session, we will discuss QC requirements and COGs management to bring iPSC-based therapies from the bench to patients within the current regulatory and commercial environment.
Learning Objectives
Moderator
Xiaokui Zhang, PhD, Chief Scientific Officer, Aspen Neuroscience, Inc., USA
Panelists
Kapil Bharti, PhD, Senior Investigator, National Institutes of Health, USA
Michael Kuo, MT(ASCP), Senior Vice President of Manufacturing, Vita Therapeutics, USA
Bruno Marques, PhD, Executive Director, Process & Product Development, Century Therapeutics, Inc., USA
Jacqueline Barry, PhD, Chief Clinical Officer, Cell and Gene Therapy Catapult, UK
Session Description
The last decade has seen tremendous progress in utilizing human iPSC technology in disease modelling, drug development and basic research. It remains a long journey for realization of the huge potential of developing iPSCs as cell replacement therapies. One of the largest challenges in the field is how to ensure that manufacturing process for iPSC-derived cell therapy can be industrialized at an affordable cost for a large number of patients with consistent quality, safety and efficacy.
In this Roundtable session, we will discuss QC requirements and COGs management to bring iPSC-based therapies from the bench to patients within the current regulatory and commercial environment.
Learning Objectives
- What are the regulatory considerations to clinical entry for iPSCs-derived cell therapies, including selection and characterization of donor source and iPSC lines, reagent quality, CMC?
- How to effectively bring a benchtop process to commercial readiness? What decisions can we make during early development to prepare for success?
- What are the strategies for managing high cost of goods associated with manufacturing and QC testing of iPSCs-derived cell therapies?
Bruno Marques PhD
Executive Director, Process & Product Development
Century Therapeutics, Inc.
Panelist
Executive Director, Process & Product Development
Century Therapeutics, Inc.
Panelist