Mike Fusakio has more than five years of experience in Regulatory Affairs and Project Management in both contract research organization, 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 involving 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, and initial IND documents (including IBs and M2) and IMPDs.

Prior to joining Halloran, Mike Fusakio was a Senior Specialist–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 for Medpace, a Contract Research Organization, where he was a project manager for initial INDs and an NDA submission.

Education:
Indiana University, PhD, Biochemistry and Molecular Biology
DePauw University, Bachelor of Arts, Biochemistry