Allison Hubel, PhD is Professor of Mechanical Engineering and Director of the Biopreservation Core Resource (BioCoR), 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 30 years of 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 (UMN) where he holds the American Red Cross Chair in Transfusion Medicine. He is the Medical Director of Molecular & Cellular Therapeutics, the cGMP facility of the UMN, and the Laboratory and Medical Director of the M Health Clinical Cell Therapy Lab. He served as the PI for the most recent NHLBI-sponsored PACT (Production Assistance for Cellular Therapies) contract, and he was the co-PI of the UMN's NIH R25 training program in cell therapy. He is the program director for the fellowship in Transfusion medicine as well as the newly opened fellowship in Cell Therapy and Regenerative Medicine. Dr. McKenna is a member of the International Society for Cellular Therapy, the American Association of Blood Banks and a Scientific Member and Team Co-Leader of the BEST Collaborative Cellular Therapy Team. His interests include QA/QC in cellular therapy and translational research/clinical scale-up of biotherapeutics.
Ian M Pope, PhD, MBA, BSc is a thought leader and acknowledged expert in cryogenic and ultra-cold storage and transport. As the current Chief Commercial Officer for IC Biomedical, Ian oversees the company's sales, marketing, and research and development strategy. Together with fellow industry experts, the IC Biomedical leadership team is leveraging their collective 100 years of experience in the industry to build the market-leading cryogenic storage and transport manufacturing company and create a paradigm shift within the cryo/bio market. Building on a 64-year foundation with the acquisition of International Cryogenics and the Taylor-Wharton line manufactured by Worthington's Life Sciences Group, IC Biomedical is bringing new life to the cryogenic equipment market. With a long career in cryotechnology and biomedical engineering, Ian first worked in the area of cryogenic storage as a director of Planer PLC the world’s foremost manufacturer of controlled rate freezers and as Vice President of the Biomedical division of Chart Industries. Ian has experience working with Core Cryolab in Toronto, Cryo Associates Group, and Brooks Life Sciences Cryo Solutions Group. Originally from the United Kingdom, Ian graduated from the Royal Society Chemistry in London with a bachelor of science in chemistry and an holds an MBA from Henley Management College in Henley, UK.
Rui Li, PhD is cryobiologist and strategic generalist dedicated to bridging across organizations and empowering innovators in advanced therapies with adaptive preservation toolsets. With a PhD in Biomedical Engineering from the University of Minnesota, she has led R&D initiatives across academia, start-up, and corporate settings and has been instrumental in industry working groups shaping the future of advanced therapy manufacturing. As the founder of EastWind CryoWorks, she currently consults for startups, non-profits and corporations developing cutting-edge cellular and cold chain technologies while navigating the evolving regulatory landscape.
Vaibhav Patel is a seasoned quality assurance professional with over 13 years of experience in drug development. As the director of quality assurance and regulatory affairs at the University of Minnesota, he excels in managing quality systems for clinical productions and ensuring FDA compliance. His career covers various biopharmaceutical domains, including radiopharmaceuticals, nanomedicine, cell and gene therapy products, and monoclonal antibodies. He is certified as a Quality Auditor (ASQ CQA) and in Regulatory Affairs (RAC-US). Vaibhav holds a Master’s degree in Pharmaceutical Manufacturing from Stevens Institute of Technology and a Bachelor’s degree in Pharmacy from Rajiv Gandhi University of Health Sciences. Vaibhav's expertise includes developing phase-appropriate quality management systems, leading QA teams, and managing IND product releases, as well as managing CDMOs in the US, China and India.