Strategic raw material selection for cell therapy commercialization

With over fifteen years of experience, Kasey Kime is a seasoned professional in global quality and regulatory affairs within the Life Sciences sector. She presently holds the role of Director of Regulatory Affairs at Thermo Fisher Scientific, where her focus is centered on technology and tools essential for cell and gene therapy manufacturing. Kasey's specific interests lie in areas such as CMC (Chemistry, Manufacturing, and Controls), advanced manufacturing, and companion diagnostics. Her education comprises a bachelor’s degree in medical laboratory science, complemented by post-graduate degrees in Medical Microbiology, Quality Systems Management, and Business Administration. Beyond her role at Thermo Fisher Scientific, Kasey remains actively engaged by contributing to the industry, notably through her roles in the Australia and New Zealand ISCT Regulatory Committee and the Alliance for Regenerative Medicine (ARM) CMC Advisory Group.

Dr Lili Belcastro is a Senior Principal Scientist at Bristol-Myers Squibb. She leads the Material Sciences group in Cell Therapy Development. Lili has over fifteen years of experience in preclinical and clinical cancer biology, cell and gene therapy product development, and method development working with a variety of complex biological molecules, small molecule inhibitors, ancillary materials, starting materials, and gene editing materials. Lili holds a PhD in cancer biology from a joint program with the University of the Sciences and The Wistar Institute in Philadelphia.