ADVISORY BOARDS

Clinical Steering Committee (CSC)

Yuman Fong, MD

Yuman Fong, M.D., an internationally recognized expert in hepatobiliary cancer and in the use of genetically modified viruses to combat malignant disease, is the chair of the Department of Surgery at City of Hope. Dr. Fong is also Associate Director for International Relations at the comprehensive cancer center.


Dr. Fong joined City of Hope from Memorial Sloan Kettering Cancer Center in New York, where he held the Murray F. Brennan Chair in Surgery while also serving as a professor of surgery at Cornell Medical College. He has been a pioneer both in the operating room and in the laboratory, crafting new surgical techniques and instruments and creating entirely new treatment methods. Especially notable is his track record of launching human clinical trials of genetically modified viruses with the potential to fight cancer.


Dr. Fong has authored more than 600 peer-reviewed articles, including more than 200 basic scientific articles, and over 350 clinically oriented peer-reviewed publications, which have appeared in Nature, New England Journal of Medicine and Journal of Clinical Investigation, among others. He has served as author and editor of 11 textbooks as well as 65 book chapters.


Dr. Fong has received grant support as a principal investigator continuously over the past 17 years, most from the National Institutes of Health (NIH), and has been awarded five patents related to his work. He has served on the editorial boards of 14 journals and has received numerous honors and awards including the Franklin Martin Faculty Fellowship from the American College of Surgery and the Shipley Award from the Southern Surgical Association. Dr. Fong recently completed a two-year term as chair of the recombinant DNA advisory committee of the NIH.

Ralph Smalling, MS

Ralph Smalling was with Amgen Inc. for over 23 years. He started with their R&D group and was responsible for cloning a number of therapeutic proteins, as well as construction and characterization of the cell bank used in the commercial production of epoetin alfa. He then joined the Regulatory Affairs Department in 1985 where he held roles of increasing importance and was ultimately named to Amgen’s most senior regulatory affairs position.


As Vice President of Regulatory Affairs and International Clinical Safety, he oversaw the development of more than 40 antibody and recombinant protein therapy projects. Ralph was responsible for US and European regulatory affairs, and for providing regulatory oversight to Canada, Australia and Japan. Under his leadership, Amgen obtained marketing authorizations, supplemental approvals and orphan drug designations in the US, EU, Canada and Australia for numerous products. Ralph was a member of the industry team that negotiated PDUFA II and drafted several of the provisions included in the FDAMA legislation passed by Congress in 1997.


Since 2005, Ralph has been an independent consultant and he continues to perform regulatory work in some of the most innovative areas of therapeutic product development including antibody drug conjugates, stem cell and gene therapies. He served as a Member of Product Development Review Committee of Circadian Technologies Ltd. and acts as an advisor to numerous biotechnology companies. Ralph graduated from Occidental College with a BA in Biology and attended California State University at Long Beach (UCSB), where he obtained his Masters Degree in Microbiology.