Michael Boyne, PhD. is an accomplished scientific professional. Before joining Cour, he was a Senior Consultant at BiotechLogic where he advised pharmaceutical manufacturers on drug development and CMC strategy, including drafting, reviewing, and authoring Pharmaceutical Quality/CMC sections (Module 3) of the CTD for regulatory submissions. Prior to consulting, he was a Research Chemist in the Division of Pharmaceutical Analysis at the US Food and Drug Administration where he established a laboratory developing and applying modern analytical technologies for the evaluation and regulation of complex drug products.
Michael has authored over 30 peer-reviewed publications and is an internationally recognized speaker on the application of modern analytical technologies. He is currently the chair of the 15th Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry and sits on the organizing committee for the inaugural CASSS meeting on Cell and Gene Therapies.