Scott R. Burger, MD
Principal, Advanced Cell and Gene Therapy, a consulting firm specializing in cell, gene, and tissue-based therapies. Dr. Burger works with clients in industry and academic centers worldwide, providing assistance in process development and validation, GMP/GTP manufacturing, GMP facility design and operation, regulatory affairs, technology evaluation, and strategic analysis.
Lizabeth J. Cardwell, MT (ASCP), MBA, RAC
Principal, Compliance Consulting, LLC, a private consulting business offering quality and regulatory consulting services to cell therapy, medical device, and pharmaceutical companies.
Jerry E. Cooley, M.D.
Dr. Cooley is a board certified dermatologist and diplomate of the American Board of Hair Restoration Surgery (ABHRS). He has served in leadership positions including President of the International Society of Hair Restoration Surgery (ISHRS) and co-editor of the Hair Transplant Forum, the main journal for hair transplant doctors. He has been performing hair transplants for almost 20 years.
Colleen Delaney, MD, MSc
Director of the Cord Blood Research and Transplant Program at Fred Hutchinson Cancer Research Center (FHCRC) and Seattle Cancer Care Alliance (SCCA). She is an attending physician at Seattle Children’s Hospital, Assistant Member of the Clinical Research Division of FHCRC and Assistant Professor at the University of Washington, School of Medicine.
Dayong Gao, Ph.D.
Professor of Biomedical Engineering at the University of Washington in Seattle. Dr. Gao has been actively engaged in cryopreservation research for more than 20 years, and has authored over 130 peer-reviewed journal articles on cryopreservation.
Shelly Heimfeld, Ph.D.
Director of Heimfeld Research Laboratory, Scientific Director of Cellular Therapy Laboratory, Scientific Director of cGMP Therapeutic Manufacturing Facilities, and former President of the International Society of Cellular Therapy. Dr. Heimfeld is internationally recognized for research in hematopoietic-derived stem cells and the development of cell processing technologies for improved cancer therapy.
Vice President of Clinical and Regulatory Affairs for Lone Star Heart, Inc. (formerly CardioPolymers, Inc.) since 2004. Lone Star Heart is a global developer of medical devices, small molecule, and cellular-based therapies for cardiovascular disease. Mr. Hinson is also a Director of the Company.
Edward LeCluyse, Ph.D.
Senior Research Investigator at The Hamner Institutes for Health Sciences. Dr. LeCluyse pioneered the use of HypoThermosol® and CryoStor® in improving preservation of research designated livers and derived commercial hepatocytes marketed to the pharmaceutical industry.
Aby J. Mathew, Ph.D.
Dr. Mathew was part of the founding team of BioLife Solutions, and is a co-developer of BioLife’s biopreservation media solutions. He is a co-inventor on multiple issued and pending patents related to methods, devices, and formulations for the preservation of cells, tissues, and organs. He holds a Ph.D. in Biological Sciences within the Biochemistry, Cell and Molecular Biology Program from Binghamton University and a B.S. in Microbiology from Cornell University. Dr. Mathew has been researching low temperature biopreservation since 1994, and his studies contributed to the development of BioLife’s current commercial HypoThermosol and CryoStor product platforms and intellectual property foundation. Dr. Mathew was part of the scientific team that linked cell death via apoptosis (programmed cell death) to exposure to hypothermic and/or freezing temperatures. These discoveries were integral to the development of BioLife’s improved intracellular-like biopreservation solutions, and also contributed to improvements in cryosurgical ablation of cancer. Dr. Mathew is currently active in, or previously a member of, the International Society for Cell Therapy (ISCT), AABB (formerly the American Association of Blood Banks), BEST (the Biomedical Excellence for Safer Transfusion collaborative), Tissue Engineering & Regenerative Medicine International Society (TERMIS), Society for Cryobiology , International Society for Biological and Environmental Repositories (ISBER), American Society for Cell Biology, and the Society for In Vitro Biology.
John McMannis, Ph.D.
Executive Vice President of Manufacturing at Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY). Dr. McMannis was previously the Director, Cellular Therapy Laboratory, Department of Stem Cell Transplantation, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas.
Jon Rowley, Ph.D.
Entrepreneur and Independent Consultant, formerly the Innovation Director, Cell Processing Technologies at Lonza Biosciences. Jon has been responsible for driving technology development and innovation related to commercial scale bioprocessing of therapeutic cell-based products.
Erik J. Woods, Ph.D.
President and CEO at Cook General Biotechnology, and also Director of Genome Resources, an anonymous donor and client depositor sperm bank. Both laboratories are FDA registered and CLIA compliant.