The digital revolution: Technological innovations to enable automation in cell therapy manufacturing

Dr. Sean Chang, Ph.D. is an R&D Team Leader in the Cell and Gene Therapy business unit at Thermo Fisher Scientific and is working on the integration and automation of cell therapy manufacturing workflow. Prior to this role, he was a Process Development Scientist, leading manufacturing process optimization of an allogeneic CAR-T product. Sean also gained extensive experiences in new product development in his previous career role as an R&D Scientist, where he identified novel T cell genome editing and non-viral delivery solutions, and worked on new closed modular instruments. Sean received his Ph.D. in Integrative Molecular and Biomedical Sciences from Baylor College of Medicine, where he focused on the mechanisms underlying therapeutic resistance of breast cancer.

Dr. Krishnendu (Krish) Roy received his undergraduate degree from the Indian Institute of Technology (Kharagpur, India) followed by his MS from Boston University and his PhD in Biomedical Engineering from Johns Hopkins University. After working for 2 years at Zycos Inc., a start-up biotechnology company, Dr. Roy left his industrial position to join the Biomedical Engineering Faculty at The University of Texas at Austin in 2002, where he was most recently Professor and Fellow of the Cockrell Chair in Engineering Excellence. He left UT-Austin in July of 2013 to move to Georgia Tech. where he is now the Robert A. Milton Chaired Professor in Biomedical Engineering. At Georgia Tech, he also serves as the Director of the newly established NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT) and The Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) – as well as the Director of the Center for ImmunoEngineering. He is also the Technical Lead of the NIST/AMTech National Cell Manufacturing Consortium (NCMC), a national public-private partnership, focused on addressing the challenges and solutions for large scale manufacturing of therapeutic cells. Dr. Roy’s research interests are in the areas of scalable cell manufacturing, Immuno-engineering, stem-cell engineering and controlled drug and vaccine delivery technologies, with particular focus in biomedical materials. In recognition of his seminal contributions to these fields, Dr. Roy has been elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE) and Fellow of the Biomedical Engineering Society (BMES). In addition, Dr. Roy has received numerous awards and honors including Young Investigator Awards from both the Controlled Release Society (CRS) and The Society for Biomaterials (SFB), NSF CAREER award, Global Indus Technovator Award from MIT, the CRS Cygnus Award etc. He is also the recipient of Best Teacher Award given by the Biomedical Engineering Students at UT-Austin and the best advisor award given by bioengineering students at Georgia Tech. He serves as a member of the Editorial Boards of the Journal of Controlled Release, the European Journal of Pharmaceutics and Biopharmaceutics, and the Journal of Immunology and Regenerative Medicine. He is a member of the Forum on Regenerative Medicine of the National Academies of Science, Engineering and Medicine (NASEM) and a Board Member of the newly established Standards Coordinating Body (SCB) for Cell and Regenerative Therapies.