The impact of COVID-19 on cell therapy supply and manufacture
The effects of the COVID-19 pandemic are being felt across all industries, including the life science sector. The already complicated cell therapy supply chain and production process has been feeling the strain, as manufacturers work to ensure that they have access to raw materials and therapies for patients.
In this panel discussion, experts in the field discuss the challenges to cell therapy manufacturing processes and supply chains as a result of the pandemic, along with the strategies put in place to ensure quality of raw materials and time- and cost-effective cell therapy manufacture.
What will you learn?
- Current obstacles in the cell therapy supply chain
- Measures put in place to ensure safety and quality in autologous and allogeneic raw materials
- Advances in technology to support manufacturing and logistical requirements
- The future of cell therapy manufacture and supply
Who may this interest?
- Cell and gene therapy (CGT) supply chain
- CGT QA/QC personnel
- Pharmaceutical companies
- Process development teams
- CGT manufacturers
Chair: Heidi Elmoazzen
Canadian Blood Services’ Stem Cell Program
Dr Heidi Elmoazzen is currently the Director of Canadian Blood Services’ (Ontario, Canada) Stem Cell Program, which includes Canadian Blood Services’ Cord Blood Bank, Stem Cell Registry, Stem Cell Manufacturing programs and Cord Blood for Research Program. She obtained her PhD in Medical Sciences from the University of Alberta (Canada) with a concentration in cryobiology. She went on to do a post-doctoral fellowship at Harvard Medical School and Massachusetts General Hospital (both MA, USA). Following her fellowship, she became an instructor at Harvard Medical School and an Assistant in Bio-engineering in the Department of Surgery and Obstetrics and Gynecology. Her area of research was focused on fertility preservation and developing novel biopreservation techniques for stem cells and reproductive cells.
Her main areas of expertise and experience include biopreservation, stem cell banking and translational medicine. She has published two book chapters on stem cell preservation as well as over 30 journal papers. She has hundreds of contributed and invited presentations at various national and international meetings.
Senior Product Manager
Be The Match BioTherapies®
Joy Aho is the Senior Product Manager at Be The Match BioTherapies® (MN, USA), where she develops innovative products and best-in-class services for the cell and gene therapy industry. Prior to joining the team, she worked in product development and management at Bio-Techne (MN, USA) for 13 years designing pioneering clinical and discovery tools for the development of cell and gene therapies. Aho received her PhD in Molecular, Cellular, and Developmental Biology & Genetics from the University of Minnesota (USA), and her research led her to studying the role of TGFβ family proteins during embryonic development utilizing stem cells and developmental models.
Alliances Manager, Cell and Gene Therapy
Bill Shingleton is a biological scientist with a research background in inflammation, biology of aging and connective tissues. His work in these areas has helped advance studies in autoimmunity, degenerative diseases and oncology. Bill has gained experience in academia at the Universities of Cambridge and Newcastle-upon-Tyne (UK), combined with 15 years in industry with Unilever R&D (Colworth, UK) and GE Healthcare Life Sciences, now Cytiva (Amersham, UK). Recently, he has been supporting cell therapy development through the application of in vivo imaging to enable safety, efficacy and mechanism of action studies and develop tools and technology for manufacturing and cryopreservation. Currently, Bill is focused on providing input into the Advanced Therapy Treatment Centre consortium, which aims to deliver cell and gene therapies to the UK’s National Health Service.
Associate Scientist in the department of Neurology at Henry Ford Health System
Adjunct Associate Professor at Oakland University, Scientific Consultant at NeurExo Sciences (all MI, USA)
Dr Buller is an Associate Scientist in the Department of Neurology at Henry Ford Health System in Detroit and he serves as an Adjunct Associate Professor at Oakland University and as a consultant at NeurExo Sciences, developing therapeutics using exosomes. He also served as Chief Scientific Officer at Forever Labs (MI, USA). Dr Buller has been pivotal in demonstrating the role of exosomes in the delivery of microRNAs to treat stroke and traumatic brain injury.
Principal Manufacturing and Supply Chain Consultant
Global OT/IT Quality Services
Robert currently is a Manufacturing and Supply Chain Consultant with Global OT/IT Quality Services (NJ, USA), specializing in regenerative medicine including cell and gene therapy and tissue engineering with leading organizations. He has a diversified background in pharmaceuticals and biotechnology with companies such as Pfizer (NY, USA), Merck (NJ, USA) and Hoffmann-La Roche (Basel, Switzerland). His operational and project work experiences include manufacturing, supply chain, engineering and technical services, operational excellence, automation and information systems. He is certified as a Master Black Belt in Lean Six Sigma, Project Management Professional, Certified in Production and Inventory Management, Certified Pharmaceutical Industry Professional and Certified Supply Chain Professional. He has degrees in chemical engineering, technology management, pharmaceutical science and quality assurance/regulatory affairs. He is also an adjunct professor at the New Jersey Institute of Technology (USA) in the Chemical Engineering department teaching pharmaceutical engineering.