Clinical Study Project Manager
Managing Director, Global BioClinical
Neil R. Mucci is a biotech executive with over 25 years of strategic, operational, and commercial experience in molecular diagnostics and clinical research. He has a successful track record of building, growing, and managing clinical research operations within multi-national biotech companies to support regulatory authority submission and in vitro diagnostic product approval.
In 2008 Mr. Mucci established Global BioClinical (GBC) a contract consulting and clinical research organization (CRO) based in Seattle, Washington, with core expertise in clinical trial planning and execution, human biospecimen services, in vitro diagnostic medical device testing, and clinical project management.
He has supported numerous US, European, and Asian biotech companies with clinical research studies, including Curetis GmbH for validation of a multiplex PCR-based rapid pathogen detection diagnostic test. Prior to Curetis Mr. Mucci served as the Head of Clinical Study Management at Epigenomics AG where he oversaw numerous clinical studies enrolling over 10,000 subjects for the validation of a blood-based diagnostic test for colorectal cancer.
Prior to Epigenomics, Mr. Mucci was a founder of the human tissue services company Asterand PLC where he served as Director of Laboratory Operations, Director of Quality Assurance, and Director of Strategic Alliances. At Asterand Mr. Mucci was responsible for establishing and managing biospecimen collection programs at over 100 institutions in over 10 countries around the world.
Prior to joining Asterand, Mr. Mucci supervised the Prostate Cancer Tissue Core Facility at the University of Michigan Specialized Program of Research Excellence (UM Prostate SPORE) where he co-authored scientific articles on tissue procurement, tissue microarrays, surrogate end-point biomarker development, and telepathology.
Mr. Mucci has supported the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program for the development and Emergency Use Authorization (EUA) of new SARS-CoV-2 PCR and antigen tests. He has supported the National Cancer Institute (NCI) with the Clinical Proteomics Tumor Analysis Consortium (CPTAC) Project and The Cancer Genome Atlas (TCGA) Project, as well as support the National Human Genome Research Institute (NHGRI) with the Genome Tissue Expression (GTEx) Project. He has worked with the NCI Office of Biorepositories and Biospecimen Research (OBBR) to develop the foundation for the Cancer Human Biobank (caHUB) and the Biospecimen Research Network (BRN) initiatives.