Alex May is a US lead on the regulatory policy team at Genentech. He previously served as Director of Regulatory Science, Policy, & Intelligence at CSL Behring, where he led regulatory policy for North America. He served as co-chair of the National Organization for Rare Disorders (NORD) Regulatory Affairs Working Group and continues to co-chair the Biotechnology Innovation Organization (BIO) FDA/Sponsor Meetings Task Force. Prior to CSL, Alex served as Director of Science & Regulatory at BIO, where he led the manufacturing/quality and pediatrics portfolios. He also represented BIO at the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as Coordinator and supported the PDUFA VII reauthorization process. Before BIO, Alex worked as a consultant at US FDA, leading projects in CDER and CBER. Alex earned a MS in Physiology & Biophysics at the Virginia Commonwealth University School of Medicine. He earned his BS in Neuroscience at the College of William & Mary.