Ralph Smalling

Biography

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.

Research Interest

Medical Devices