The 2024 Rising Stars of the Profession: Mike Fusakio

Mike Fusakio is a Lead Consultant of Regulatory Affairs for Halloran Consulting Group based in Boston, Massachusetts. With over seven years of experience across contract research organizations, academic and consulting settings, Mike specializes in regulatory strategy and project management. His expertise spans from initial INDs to NDA submissions, ex-US projects (MHRA and EMA), and in various therapeutic areas. Mike excels in various product modalities and is proficient in authoring various regulatory documents such as orphan applications, nonclinical summaries and Pre-IND meeting requests. Mike holds a pivotal role in regulatory affairs, leveraging his comprehensive experience to drive successful outcomes for clients. Mike received his Ph.D. in Biochemistry and Molecular Biology from Indiana University School of Medicine.