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
Program Description
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.
For information or questions please contact VRCRSSPStaff@mail.nih.gov.
Research Group
- Somia Hickman, Ph.D., RAC (U.S.), Senior Regulatory Scientist
- Ramya Malla, M.S., Regulatory Associate
- Andrew McDougal, Ph.D. DABT, Senior Nonclinical Scientist, Pharmacology/Toxicology Regulatory Lead
- Diane Wycuff, Ph.D., RAC (U.S.), Senior Regulatory Scientist and Nonclinical Scientist
- Selva R Murugesan, Ph.D., Sr. Scientific Program Manager
- Pooja Nagarajan, M.S., M.B.A., Senior Regulatory Submissions Manager