Managing raw material changes in cell & gene therapy: ensuring compliance and consistency

Jessica King-Hart has 20 years in manufacturing and quality in regulated industries including tissue banking, birth tissue, medical devices, and cell therapy. She holds certifications from the American Society of Quality (ASQ) including Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), and Certified Supplier Quality Professional (CSQP). She is currently a Sr Manager, Supplier Quality Engineer in the Cell Therapy division at Bristol-Myers Squibb.

Michael Mendicino, PhD is a multi-disciplinary cell & gene therapy subject matter expert with over 25 years’ experience, educated in molecular/cellular biology/genetics, immunology, and regulatory science. Michael founded Hybrid Concepts International (HCI) as a niche consultancy and advisory firm in the fields of cell therapy, gene and gene-modified cell therapies, gene editing, oncolytic viruses, xenotransplantation, tissue engineering, and other advanced therapies/regenerative medicines. Michael previously worked at numerous biotech companies and/or consulted, all within the aforementioned fields, covering areas such as CMC, strategic regulatory affairs, regulatory meetings & submissions, R&D, commercial, and product & technology due diligence activities.

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.

Xiao joined Thermo Fisher Scientific in 2024 in the Life Sciences Solutions Group. Her primary role is to serve as the regulatory lead on new product introduction teams, supporting both product development and customer use of the Cell Therapy Systems™ (CTS™) products. Xiao began her career as a research scientist in drug discovery and later as QC manager in GMP labs. She then transitioned into regulatory affairs where she focused on Chemistry, Manufacturing and Controls (CMC) of biologics and vaccines before bringing her skills to Thermo Fisher customers. She holds a PhD in Biochemistry from the University of Iowa.