BIO X302 - Preservation of Cellular Therapies
Description
Currently 1.2 million patients are receiving treatment from regenerative medicine products produced by 171 companies with a capital value of ~$4.7 billion. Most molecules, cells and tissues are collected at a given time and location for use at a later time. Therefore, our ability to stabilize biological properties (e.g. viability, biomarkers) during transportation and long-term storage is a critical technology.
The preservation of cellular therapies is the central focus of this professional short course. Come learn about fundamentals of preservation, protocol development, design of a storage facility, regulatory issues associated with preservation of cell therapies, clinical issues and more.
Lecturers
Allison Hubel, PhD: Dr. Hubel, BioCoR Director, is currently a Professor of Mechanical Engineering at the University of Minnesota. She is also a former faculty member in the Department of Laboratory Medicine and Pathology at the University of Minnesota. For almost 20 years, Dr. Hubel has studied both basic science and translational issues behind cell and tissue preservation (liquid storage and cryopreservation). Her research focuses on development of protocols for cell and tissue preservation, develoment of tools to improve preservation, and understanding molecular mechanisms of damage and education/training in the field of preservation. She has published numerous articles related to cell and tissue preservation and has been awarded three patents related to cell preservation technology.
Diane Kadidlo received her B.S. from Iowa State University. She has over 19 years experience in cell and tissue manufacturing, regulation and quality assurance. She has served as the Supervisor for the University of Minnesota Medical Center Clinical Cell Therapy Laboratory since 1996 overseeing the production of cell and tissue products in support of the University of Minnesota's Blood and Marrow Transplant Program. Currently she is the Director of th UMN's Molecular and Cellular Therapeutics Facility and plays a key role in coordinating the transfer of cell and tissue engineering methods from the laboratory bench to clinical trial while ensuring compliance with the FDA's Good Manufacturing Practices/Good Tissue Practices.
David McKenna, M.D. recently joined the faculty of the University of Minnesota and is Associate Professor of Lab Medicine & Pathology and Medical Director of the Clinical Cell Therapy Lab. He is actively involved with the NHLBI-sponsorsed PACT (Production Assistance for Cellular Therapy) group. Dr. McKenna is a member of the International Socieity for Clelular Therapy and the American Association of Blood Banks and an Associate Scientific Member of the BEST Cellular Therapy Team. His interests include umbilical cord blood research, QA/QC in cellular therapy, and translational research/clinical scale-up of biotherapeutics.
Ian M Pope, PhD, MBA, BSc: Director of Business Development, Cryo Associates, Gaithersburg MD. Ian has worked in the area of cryogenic systems for over 25 years, initially as managing director of Planer PLC, the original manufacturer of controlled rate freezers. He later ran the BioMedical Division of MVE/Chart, the worlds largest provider of cryogenic storage freezers and liquid distribution systems and co-owned Core Cryolab a unique biorepository, cord blood bank and international consulting group in Toronto, Canada. Ian works with and consults for many of the major repository operations in the US and abroad and sits on the ISBER standards and accreditation committee. His expertise lies in the area of the practical application of cryogenics to the storage and preservation of biological materials, the design, operation, accreditation, validation and best practices of bio-repositories and in the environmental and sustainability aspects of cold space provision.
Fran Rabe has over 20 years of experience working in the areas of tissue and cell quality assurance and regulatory compliance. She currently oversees the quality assurance aspect of operations at the University of Minnesota Molecular and Cellular Therapeutics (MCT) Facility, a GMP facility that manufactures standard and IND hematopoietic products, pancreatic cellular products and active pharmaceutical ingredients. Fran has extensive experience with audits, having performed in excess of 50 GMP audits at multiple U.S. and international institutions. She also has extensive experience with FDA IND submissions and working direclty with FDA as it relates to the regulation of cellular and tissue products. In addition to holidng a Masters Degree in Manufacturing Systems, Ms. Rabe is an American Society for Quality (ASQ) Certified Quality Manager.