Director of Chemistry, Manufacturing & Controls
Overland Park Kansas                        UNITED STATES
Michael holds a Bachelor of Science in Chemistry from Rockhurst University and an Interdisciplinary Ph.D. in Pharmaceutical Science and Organic Chemistry from the University of Missouri-Kansas City. Michael has been involved in consulting associated with regulatory affairs, drug substance/drug product, biological, device, and dietary supplement development programs. He has directed the preparation of regulatory submissions for the US, EU, and most international Health Authorities including Drug Master Files, Investigational New Drug Applications, New Drug Applications, and Abbreviated New Drug Applications. He has developed global regulatory strategies for synthetic and biologic products and has extensive scientific development experience in biologic products (including monoclonal antibodies, proteins, gene therapies/Car-T, oligonucleotides, synthetic peptides, cell- and tissue-based products)