Business of regenerative medicine: an expert panel discussion

Written by RegMedNet

Join our experts to discuss preservation and the challenges of delivering a high quality product, regulation and the issue of comparability, and what the manufacturing facility of the future might look like.

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Join five industry experts for an open discussion on their key pain points. Topics discussed included preservation and the challenges of delivering a high quality product, regulation and the issue of comparability, and what the manufacturing facility of the future might look like.

Part two: comparability and the regulatory revolution

Part three: preservation and the supply chain

Michael May (CCRM)

Michael May completed his PhD in Chemical Engineering at the University of Toronto (ON,USA) in 1998 and was co-founder of Rimon Therapeutics Ltd (ON, USA). He is currently President and Chief Executive Officer of the Centre for Commercialization of Regenerative Medicine (CCRM; ON, USA) as well as sitting on a number of boards and advisory committees, including the Ontario Institute of Regenerative Medicine; the Centre for the Commercialization of Antibodies and Biologics; the Department of Chemical Engineering and Applied Chemistry at the University of Toronto; the Industry Committee of the International Society for Stem Cell Research; and the Executive Committee, Alliance for Regenerative Medicine (ARM). Michael is a RegMedNet leader.

Robert Preti (Hitachi Chemical Advanced Therapeutics Solutions, LLC)

Robert completed his BSc in biology at Fordham University and his MSc and PhD at New York University (both NY, USA). He was previously director of hematopoietic stem cell processing and applied research at Hackensack University Medical Center (NJ, USA) and served in several capacities with the New York Blood Center (NY, USA) from 1990 to 1997. Robert has served on the Stem Cell Banking Committee and Cord Blood Subcommittee of the New York State Department of Health (USA) and on the New Jersey State Department of Health’s Blood Bank Advisory Committee (USA) and was a co-founder of PCT Cell Therapy (NJ, USA). He is currently CEO and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC (NJ, USA) and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector.

Robert Jones (Fisher Bioservices)

Robert Jones studied at Birmingham University (UK) and worked at DuPont (DE, USA) and Kendro Laboratory Products (NC, USA) before joining Fisher Bioservices (UK) in 2003 as General Manager. He is currently Director of the Fisher Bioservices business at Thermo Fisher Scientific (MA, USA).

Carolyn Yeago (Georgia Institute of Technology)

Carolyn Yeago received her BS in Biomedical and Bioengineering from North Carolina State University (NC, USA) and her PhD in Biomedical Engineering from the Georgia Institute of Technology and Emory University (both GA, USA). After seven years with Halyard Health and Kimberly Clark Health Care (both GA, USA) where she directed research and evaluated technologies to inform new platform strategies. Carolyn Yeago is currently the Associate Director of the Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) at Georgia Tech.

Qasim Rafiq (UCL)

Qasim Rafiq obtained his Masters in Engineering at University College London (UCL; London, UK) in Biochemical Engineering before completing his PhD at Loughborough University (UK) in collaboration with Lonza. He is a Senior Lecturer (Associate Professor) in Cell & Gene Therapy within the Department of Biochemical Engineering at UCL. His research activity focuses on the biomanufacture of advanced therapeutics including cell, gene and tissue-based therapy. He is a Chartered Engineer, a Chartered Scientist and a Fellow of the Higher Education Academy and currently pursuing an MBA at Aston Business School (Birmingham, UK).