Kim Fabrizio, B.A.,
Chief Operating Officer

Mrs. Fabrizio joined the Institute for  Neurodegenerative Disorders in April 2021 as Chief Operating Officer.   Mrs. Fabrizio has 20+ years of experience in clinical research and drug development and held numerous executive leadership roles in both small and mid-size pharmaceutical research organizations, including Bayer  Pharmaceuticals, Clinical Data, Molecular NeuroImaging, Invicro and most recently On Target Laboratories.  She received her BA from Quinnipiac  College and has focused her career within the Regulatory Affairs and  Quality Assurance arenas, which has included experience in multiple therapeutic areas including neuroscience, radiopharmaceuticals,  oncology, anti-infective and CNS.  Mrs. Fabrizio has regulatory leadership and strategy experience in early clinical research (Pre-IND)  through to commercialization.  She has successfully brought over 75  novel compounds into human investigation and led over 11 NDA/sNDA teams to successful review of marketing applications with the FDA CDER  Division, as well having in depth experience in 21 CFR Part 11 and GDPR  compliance. Her leadership breadth has spanned leading teams in GMP, GCP and System Validation Compliance areas to support clinical research.   Her Quality Assurance leadership has included the implementation of  Quality Management Programs at several startup companies, and she has successfully hosted health authority inspections from regulators of the  FDA, DEA, NRC, and DEA.