Michael Fusakio, PhD

Michael Fusakio, PhD LEAD CONSULTANT, REGULATORY AFFAIRS

Mike Fusakio has more than 5 years of experience in Regulatory Affairs and Project Management across contract research organizations, academic, and consulting settings. He has experience with regulatory strategy and project management for initial INDs and NDA submissions, ex-US projects (MHRA and EMA), and projects in the Oncology, Neurology, Rheumatology, Gastroenterology, Psychiatry, and Diabetes and Obesity therapeutic areas. Projects have involved a variety of product modalities, including small molecules, monoclonal antibodies, and cell and gene therapy. He has experience with authoring regulatory documents, including orphan applications, Pre-IND meeting requests, initial IND documents (including IBs and M2), and IMPDs. 

Before joining Halloran, Mike Fusakio was a Senior Specialist in Regulatory Affairs at Cincinnati Children’s Hospital Medical Center. At Cincinnati Children’s, Mike assisted investigators with initial INDs, Q-submissions, and IND exemptions. He also served as the regulatory expert for the Rare Disease Clinical Research Network. Before Cincinnati Children’s, Mike was a Regulatory Affairs Associate at Medpace, a Contract Research Organization, where he served as a project manager for initial INDs and NDA submissions.

Michael holds a BA in Biochemistry from DePauw University and a PhD in Biochemistry and Molecular Biology.