The new members are:
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.
John McMannis, Ph.D., Executive Vice President of Manufacturing at Mesoblast Limited. 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., Innovation Director of Cell Processing Technologies at Lonza Biosciences, responsible for driving technology development and innovation related to commercial scale bioprocessing of therapeutic cell-based products.
Mike Rice, BioLife Chief Executive Officer, commented on the expansion of BioLife's SAB by stating, "We're thrilled that Drs. LeCluyse, McMannis, and Rowley have joined our Scientific Advisory Board. Each is a very highly thought of opinion leader in their respective fields. We look forward to their contributions to our strategies for continually improving our quality environment and products and services offering."
These new members join the founding members of BioLife's SAB, who are:
Scott M. Burger, M.D., principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell, gene, and tissue-based therapies.
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.
Colleen Delaney, M.D., 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.
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, having authored over 130 peer-reviewed journal articles on cryopreservation.
Shelly Heimfeld, Ph.D., is the Director, Heimfeld Research Laboratory, Scientific Director, Cellular Therapy Laboratory, and Scientific Director, cGMP Therapeutic Manufacturing Facilities at the Fred Hutchinson Cancer Research Center. 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 joined the Board in February 2007. He is currently the Vice President for Clinical and Regulatory Affairs for LoneStar Heart, Inc., a developer of proprietary biopolymer, small molecule and cellular-based therapies to effectively treat heart failure and other cardiac conditions. Mr. Hinson has diverse experience in the cell and gene therapy markets and extensive experience with regulatory and clinical trial issues for new therapies for cardiac, neurologic, and gastrointestinal applications.
Darin Weber, Ph.D., is a leading regulatory expert for cellular and tissue based products, and a former FDA cellular therapy reviewer. He is currently the Executive Vice President, Global Regulatory Affairs at Mesoblast Limited. Dr. Weber's knowledge of the regulatory landscape for cell and gene therapy is extensive and directly relevant to the Company's business since its biopreservation media products are a critical process component in numerous active clinical trials for new cellular therapy products.
Erik J. Woods, Ph.D.,Co-Founder, CEO of General Biotechnology, LLC, and Laboratory Director of The Genesis Bank, a private umbilical cord blood bank. Dr. Woods is the current president of the Society for Cryobiology.