Preservation of Cellular Therapies - Lecturers
Allison Hubel, PhD is Professor of Mechanical Engineering and Director of the Biopreservation Core Resource (BioCoR, www.biocor.umn.edu), a national resource in biopreservation. Dr. Hubel has studied both basic science and translational issues behind preservation of molecules, cells and tissues. Her research focuses on development of fit-for-purpose protocols for preservation, development of technology to improve preservation/processing of cells, and understanding molecular mechanisms of damage during preservation. She has developed and offered professional short courses on preservation of cell therapies and biospecimens. She has several patents in the area of preservation, some of which are being commercialized. She is a co-principal investigator for the NIH–funded REACH program that helps faculty commercialize their research at the U of MN. She is a fellow of ASME and AIMBE and a National Blood Foundation Scholar. She has been honored recently with the Outstanding Achievement in Biobanking Award from ISBER. She has published numerous articles related to preservation and is a former deputy editor of Biopreservation and Biobanking.
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. is a Professor of Laboratory Medicine & Pathology at the University of Minnesota where he holds the American Red Cross Chair in Transfusion Medicine. He is the Scientific and Medical Director of Molecular & Cellular Therapeutics, the cGMP facility of the University of Minnesota, and the Laboratory and Medical Director of the M Health Clinical Cell Therapy Lab. He is actively involved with the NHLBI-sponsorsed PACT (Production Assistance for Cellular Therapies), serving as the PI at Minnesota, and he is the co-PI of the NIH R25 training program in cell therapy. Dr. McKenna is a member of the International Society for Cellular Therapy, the American Association of Blood Banks and a Scientific Member and Team Leader of the BEST Collaborative Cellular Therapy Team. His interests include QA/QC in cellular therapy and translational research/clinical scale-up of biotherapeutics.
G. John Morris did his PhD on the cryobiology of T cells within the MRC division of Cryobiology at the Clinical Research Centre, Harrow, UK in the 1970’s. Since then he has published over 100 papers in peer reviewed journals on the science of cryobiology. After gaining is PhD he worked for 8 years as a research scientist with the Natural Environment Research Council in Cambridge UK, where is was responsible for the establishment of the first cryopreserved biobank of algae and he carried our research on the basic mechanisms of freezing injury and tolerance in extreme environments such as polar and alpine
He then co-founded Asymptote ltd, a Cambridge based SME, initially the company acted as a consultancy working on freezing and solidification problems ranging from ice cream, freeze drying of pharmaceutical products and control of gas hydrate formation in the oil industry. In the last 10 years the focus of Asymptote has been on the exploitation of Stirling cryocoolers combined with technical engineering to develop GMP compliant cryopreservation equipment for the field of regenerative medicine. Uniquely the company combines world leading research into the science of cell freezing with engineering expertise to create pioneering, liquid nitrogen-free cryochain technology for advanced medicines. In April 2017 it was acquired by GE healthcare “to fill a critical gap in GE Healthcare’s end-to-end ecosystem of products and services for cell therapy production, and will be an important piece of the portfolio enabling the industrialization of these life-saving therapies.”. The company currently has 30 employees who are a mix of biologists, with extensive experience of cryopreservation, engineers and physicists with backgrounds in product development, software engineers and technicians.
Ian M Pope, PhD, MBA, BSc is the Global Director of Cryo Solutions at Brooks Life Sciences. 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.