ADVISORS
Scott R. Burger, MD
Principal of 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
Compliance Consulting for Cell Therapy and Biotechnology. Ms. Cardwell has provided Quality Assurance and Regulatory consulting for start-up cell therapy and biotechnology companies since 2005. Prior to August 2005, Ms. Cardwell held the position of Director of Regulatory Affairs and Quality Assurance at Xcyte Therapies. Through June of 2003, Ms. Cardwell was Vice-President for Quality Assurance and Quality Control at Dendreon Corporation. In the over 5 years at Dendreon, she built and established departments to manage the quality systems required to manufacture, test and release Cell Therapy products across different laboratories, to release a class III (PMA) medical device, and a recombinant protein.
Colleen Delaney, MD, MSc
Dr. Delaney is the 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. Dr. Delaney's research interests include hematopoietic stem cell regulation and the development of novel and clinically feasible ex vivo expansion systems for hematopoietic progenitor cells. Her goal is to improve the outcome of patients in need of a cord blood transplant. Dr. Delaney is principal investigator on five FHCRC clinical trials investigating the use of single or double unrelated donor umbilical cord blood grafts as an alternative source of stem cells for hematopoietic cell transplant, including a multi-center protocol investigating the use of single versus double unrelated donor umbilical cord blood grafts as source of stem cells for hematopoietic cells.
Dayong Gao, Ph.D.
Dayong Gao, Ph.D, is a 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, having authored over 130 peer-reviewed journal articles on cryopreservation.
Shelly Heimfeld, Ph.D.
Shelly Heimfeld, Ph.D, is the Director of the Cellular Therapy Laboratory at the Fred Hutchinson Cancer Research Center in Seattle, and also the 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.
Andrew Hinson
Andrew Hinson joined the Board in February 2007. He is currently the Vice President for Clinical and Regulatory Affairs for Symphony Medical, Inc., a developer of proprietary biopolymer and cellular-based biologic therapies to effectively treat chronic and post-operative atrial fibrillation and other cardiac conduction abnormalities. Mr. Hinson has diverse experience in the cell and gene therapy markets and extensive experience managing clinical trials for new biologic based therapies for cardiac, neurologic, and gastrointestinal applications.
Darin Weber, Ph.D.
Darin Weber, Ph.D, is a leading regulatory expert for cellular and tissue based products, and a former FDA cellular therapy reviewer. Dr. Weber’s knowledge of the regulatory landscape for cell and gene therapy is extensive and directly relevant to our business since the Company’s preservation solutions are a critical process component in several active clinical trials for new cellular therapy products.
Erik J. Woods, Ph.D.
Co-Founder, CEO and Laboratory Director of The Genesis Bank, a private cord blood bank, and also Director of Genome Resources, an anonymous donor and client depositor sperm bank. Both laboratories are FDA registered and CLIA compliant.