ChBE Annual Peck Lecture: Speaker Ann Lee, Developing and Manufacturing Autologous CAR-T Cell Therapy Products to Fight Cancer
Immunotherapy using chimeric antigen receptor (CAR) T cells has demonstrated high response rates in patients with B cell malignancies and offers further promise for additional hematological indications as well as potentially for solid tumors. Engineered T cells represent a new paradigm in anti-cancer therapy. CAR-T cells are generated by removing T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, which reprograms the T cells to target and destroy tumor cells. Commercializing these CAR-T therapies present numerous challenges for manufacturing and the timely delivery of the product to the patient. In particular, process and product control, vein-to-vein turnaround time, building a robust supply chain, patient tracking, and manufacturing facility design strategies are among the many technical and logistical challenges that will presented. In addition, some considerations on next generation technologies will be discussed.
Speaker Bio:
Ann L. Lee is Executive Vice President of Technical Operations, Juno Therapeutics and Head of Cell Therapy Development and Operations, Celgene. Prior to joining Juno in 2017, Ann was Senior Vice President, Genentech and Global Head of Pharma Technical Development at Roche. Her organization was responsible for technical development of biologics, small molecules, devices, drug delivery, packaging development, analytical development, QA/QC for investigational medicinal products, clinical manufacturing, clinical supply chain management, project and portfolio management, development CMO management, business excellence, and manufacturing science and technology support. Together, the organization delivered the R&D pipeline, and provided technical support for all commercial products.
Previously, Lee worked at Merck & Co., Inc., where she held several leadership positions in vaccine development in Merck Research Laboratories, and she was Vice President of Chemical Technology and Engineering in the Merck Manufacturing Division. Ann holds a BS degree in chemical engineering from Cornell University, and a Ph.D. in bio/chemical engineering from Yale University. She is a Fellow of the American Institute for Medical and Biological Engineering (1997), Member of the National Academy of Engineering (2007), and Fellow of the American Academy of Arts and Sciences (2017). She is active in numerous professional societies, was named 150 Most Influential Women in Business in Bay Area Business, is involved in company-wide diversity groups, and supports programs encouraging boys and girls to pursue science. Over the course of her career, she has contributed to the successful development and commercialization of 23 medicines and vaccines.
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