Major Areas of Research
- As an emergent scientific discipline, regulatory science and strategy applies science, laws, guidance, and best practices to foment effective and efficient innovation, strategies, and decisions that enable biologic product development
- As novel drugs and biologics are developed, an adaptive and able regulatory science team develops in step with innovative approaches, standards, and metrics that ensure safety, efficacy, and quality of regulated drug products
The Vaccine Research Center (VRC) Regulatory Science and Strategy Program (RSSP) aims to advance and support the VRC mission to discover, develop, and evaluate novel vaccines and antibody-based products. To achieve these goals, VRC regulatory scientists collaborate with the full spectrum of VRC research teams to generate scientific data and regulatory science strategies, study reports, and agency filings that consistently meet target quality criteria; satisfy federal regulations and FDA guidance; and achieve scientifically robust, compliant, and timely submissions to the FDA and other regulatory authorities.
The portfolio overseen by RSSP includes, but is not limited to, pre-Investigative New Drug (pre-IND) meeting requests and briefing documents, IND applications, IND annual reports, amendment updates on chemistry, manufacturing, and control information, nonclinical studies, pharmacology-toxicology studies, clinical protocol revisions and study information, labeling documents, and responses to FDA requests for information. RSSP leverages its members’ breadth and depth of expertise in science, quality systems, regulatory strategy and policy, manufacturing processes and procedures, data standards, electronic common document specifications, and management principles. These proficiencies potentiate the RSSP team to forge timely, compliant, and innovative regulatory science frameworks that support VRC biological products research and development, positioning these products to address public health needs.
Ms. Sandra Vázquez is director of the VRC’s RSSP. In this role, she is responsible for providing regulatory guidance and input into all VRC consideration and selection activities of candidate products for development and clinical testing. She also oversees the completion of regulatory risk analyses for VRC leadership, which guide product down-selection. Ms. Vázquez leads the preparation for and conduct of all meetings between the VRC and regulatory agencies, such as the FDA.
Ms. Vázquez’s scientific expertise is based on broad experience in biologic research and development and quality control and assurance. She worked in a variety of roles in industry that included analytical test method development, qualification, and validation; raw material inspection and batch record review; internal and external audit conduct; corrective and preventative action investigations; and nonconformance investigations. She conducted in-process, lot release, and drug product QC testing and drug product stability assays. Her experience includes a wide variety of regulatory activities from early to late-stage product development, including IND generation and maintenance, FDA meetings and briefing packages, investigator’s brochures and labeling, clinical study documentation, annual reports, and responses to FDA requests for information. Ms. Vázquez served as a regulatory scientist within the US Army Medical Research and Materiel Command, providing regulatory guidance in the development of drugs and products designed to protect US service members from field-based infectious diseases and generating requisite FDA documentation for all projects. While there, she acted as team leader and core member of the Integrated Product Team, creating regulatory strategies for late-stage infectious disease drug development and providing guidance to the project management team.
Ms. Vázquez has expertise with both US and international regulatory authorities, having interacted with the European Medicine Agency, Panama Ministry of Health, the Democratic Republic of Congo Ministry of Health in response to the 2018 Ebola outbreak, and multiple agencies across Latin America and the Caribbean during the Zika epidemic.
Ms. Vázquez earned her Bachelor of Science in Biology and Master of Science in Molecular Biology from the University of Puerto Rico. She subsequently completed a second Master of Science degree program in Bioscience Regulatory Affairs (now Regulatory Science) at Johns Hopkins University in Baltimore, MD.
Michelle Conan-Cibotti, Ph.D., RAC (U.S.), (E.U.), Senior Regulatory Scientist
Somia Hickman, Ph.D., RAC (U.S.), Senior Regulatory Scientist
Ashly Lukoskie, M.S., RAC (U.S.), Senior Regulatory Scientist
Ramya Malla, M.S., Regulatory Associate
Andrew McDougal, Ph.D. DABT, Senior Nonclinical Scientist, Pharmacology/Toxicology Regulatory Lead
Melissa Wan, Program Analyst
Diane Wycuff, Ph.D., RAC (U.S.), Senior Regulatory Scientist and Nonclinical Scientist