Lisa Sauer has served as our Senior Vice President, Regulatory Affairs and Quality Assurance since September 2023. Prior to joining us, she was with Exelixis, Inc. where she served most recently as Senior Vice President, Regulatory Affairs and Quality Assurance. During her seventeen-year tenure at Exelixis, she provided leadership for the development and execution of global regulatory strategies for cabozantinib from first-in-human through approval. She successfully led marketing applications for Cometriq® and Cabometyx® in the US and EU, utilizing regulatory pathways such as Breakthrough Therapy Designation and Real Time Oncology Review with FDA and Accelerated Assessment in the EU. Additionally, she supported worldwide applications and approvals of Cabometyx through commercial partners. Prior to Exelixis, Ms. Sauer worked at SuperGen, Inc. (now Astex Pharmaceuticals) where she supported several abbreviated new drug applications through approval as well as the initial NDA filing for Dacogen®. Ms. Sauer earned her BS in Environmental Economics and Policy from UC Berkeley.
