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Michael Groaning

PhD, Prostate Cancer Global Medical Affairs Lead
Amgen
Michael Groaning PHD Headshot

Dr. Groaning attended Colorado State University until 2000 when he moved to Zurich, Switzerland for his post-doctoral studies at the Swiss Federal Institute of Technology (ETH). Dr. Groaning started his career in the pharmaceutical industry at F. Hoffmann – La Roche in Basel, Switzerland in their Discovery Chemistry group before transferring to Boulder, Colorado as a process research chemist where he optimized the production of a key intermediate for Tamiflu. He finished out his career with Roche back in Basel before taking a job with Endocyte in West Lafayette, Indiana. While at Endocyte, Dr. Groaning completed the first total synthesis of Tubulysin B which became the warhead of two lead small molecule drug conjugates in Endocyte’s portfolio.

Dr. Groaning later moved into regulatory affairs where he was the primary author of the CMC sections (Modules 3 and 2.3) for three conditional MAAs which were given a positive opinion by the CHMP before taking over as program lead for their PSMA-targeted small molecule drug conjugate. It was through this program that Endocyte developed its expertise in prostate cancer and lead to the in-license agreement with ABX for PSMA-617. Once PSMA-617 was acquired and the pivotal VISION study was started, Dr. Groaning continued leveraging his relationships with KOLs around the world to build a network of experts to develop the clinical plan for PSMA. In late 2019 he transitioned into his current role as US Medical Advisor – Prostate Cancer.

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