Michael Hageman

Prior to joining the Department of Pharmaceutical Chemistry at The University of Kansas as a Distinguished Professor in 2017, I spent 30+ years working in the Pharmaceutical Industry. I have extensive experience in physicochemical characterization and preclinical assessment of new chemical entities (NCE), including proteins, peptides, oligonucleotides, protein drug conjugates, prodrugs, and other small molecule based therapeutics. I have been directly involved in the Discovery process with chemical lead selection, chemical lead optimization, and drug candidate selection for transition into clinical development. Those preclinical experiences include drug delivery research for both parenteral and oral dosage form design, with particular emphasis on designing specialized formulation strategies to overcome poor drug stability and poor aqueous solubility, with the ultimate goal of enhancing developability and commercialization. I have extensive experience, and resulting patents, on the generation of solublilzed dosage forms for administration, parenteral and oral, of both immediate release and controlled release dosage forms. Similarly, critical experience in factors which influence processing technologies, such as lyophilization and spray drying for both biologics and small molecule NCE, provides a window to later phase manufacturing challenges. In depth lab work utilizes a materials characterization approach to understand the fundamental role of both physicochemical and physicomechanical properties in both the chemical and physical stability within these amorphous systems, which dictate the resulting bioperformance of these systems. I have expertise at understanding the role of polymers and excipients in both the dissolution behavior of these solid dispersion systems and their ability to produce and maintain supersaturated drug concentrations to enhance oral absorption. My background in industrial R&D, my experience in physical analysis, formulation screening, and developability assessment of numerous different drug modalities, will all provide me the background necessary to support the practical delivery aspects of this project in a way which has a line-of-sight to clinical evaluation and a potential product..