Shelly Heimfeld, PhD
Advisory Board Chair and Executive Vice President, Manufacturing and Research
Shelly Heimfeld is a Full Faculty Member at Fred Hutchinson Cancer Research Center and serves as Scientific Laboratory Director for the cGTP Cellular Therapy Laboratory and cGMP Therapeutic Manufacturing Facilities. These facilities are responsible for all minimally and more extensively manipulated cell components used for treatment of patients at the Center. His primary responsibilities are to ensure the safety, quality, and effectiveness of each product, but also include implementation of new technologies, translation of basic science procedures into appropriate clinical protocols, product development, process improvement, and regulatory compliance.
Shelly is internationally recognized for his research in hematopoietic-derived stem cells and the development of cell processing technologies for improved cancer therapy. His long-term goals have a direct therapeutic focus, many involving the “engineering” of transplant products to improve clinical outcomes. Pre-clinical translation activities include identification of better markers for characterization of hematopoietic stem and progenitor cells, improvements in isolation/purification technologies, and development of ex vivo manipulation strategies that can enhance the therapeutic potential of cells such as T-cell-based immunotherapy for treatment of various diseases.
Shelly is a Past-President for International Society of Cellular Therapy (ISCT), and is a leading authority in the FDA regulations and lab practices needed for clinical cell therapies, including Good Laboratory Practice (GLP), Good Tissue Practice (GTP), and Good Manufacturing Practice (GMP). Shelly continues to work with the FDA and other organizations to facilitate the exchange of ideas and best practices in the rapidly evolving area of Cell Therapy.
Shelly received his PhD in Cell Differentiation from the University of California, Irvine and completed postdoctoral studies with Dr. Irving Weissman at Stanford before going into industry to work as a founding scientist at SyStemix and later at CellPro, Inc., the first company to develop an FDA-approved device for CD34+ cell enrichment.