Delia Bethell, Ph.D.
Clinical Trials Consultant & Regulatory Specialist
Dr. Bethell is bringing over 25 years of scientific/management experience and her regulatory expertise in product research, development, clinical study evaluation and manufacturing to the GHS as a Regulatory/Clinical Studies Specialist. For six years as Vice President of Clinical Development for Ventria Bioscience (Sacramento, CA) she planned and executed human clinical studies for medical foods and prepared both regulatory strategies and filings with the Center for Food Safety and Applied Nutrition for these products. Additionally, as the Director of Research and Regulatory Affairs for Bioseparations, Inc. she led the research team developing early-stage products and their manufacturing protocols. As the Director of Research and Development for Genzyme Diagnostics Dr. Bethell also managed all aspects of products lines, the development, clinical validation and regulatory filings/approvals for Point of Care in vitro diagnostics. She has extensive experience in seeking regulatory approvals from the FDA and CLIA, QA/QC, IND and NDC filings in addition to her research and development management history.