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Regulatory Challenges in Global CAR T Cell Therapy Development



Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and Israel, of which more than 140 are focused on cell therapies. Around the world, there were 452 clinical trials of genemodified and cell-based immunooncology therapies under way at the end of 2019 (1). Of these, 215 are in Phase II trials and 15 have progressed to Phase III trials.

Despite the bustle of research activity, only two CAR T cell therapies are on the market today, both targeting the CD19-expressing target cells, and clinical experience remains limited (2).

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About the authors


Dr Brian Marks BSc, DC, has worked in clinical research for more than 20 years, and his extensive background covers the spectrum from single-site studies to large, multinational trials. He joined Premier Research in 2018 to oversee the oncology programme team, ensuring progress according to client and Premier Research requirements and driving courses of action to keep each programme on track. Brian received a Doctor of Chiropractic degree as well as a Bachelor of Science in Human Biology from Logan College of Chiropractic, US. He also holds a Bachelor of Arts in Psychology from the State University of New York, US.

Ashley Jones MSc joined the Premier Research team as a Senior Project Manager in 2017. Prior to her tenure with Premier Research, she worked for Quintiles for seven years. Ashley was integral in the creation of the Stem Cell Center of Excellence at Quintiles and currently helps develop strategies for CAR T and other immuno-oncology opportunities at Premier Research. Ashley’s therapeutic expertise includes Phase I-III oncology studies conducted in the US and globally, with a special interest in paediatric haematopoietic stem cell transplantation and graft versus host disease, as well as Phase I and II acute lymphoblastic leukaemia studies and advanced malignancies.
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