Brante P. Sampey
Phone: 1 919-265-3810
Dr. Brante Sampey is a board-certified toxicologist based in the Research Triangle Park, North Carolina, USA, and has been in the biotech and pharmaceutical healthcare industry for over ten years. His primary focus as a regulatory toxicologist is to support the preparation and review of nonclinical drug development strategies, carrying out gap analyses for drug or pharmaceutical products, biologics, and drug delivery systems, and conducting due diligence reviews of nonclinical data packages and/or technology platforms. He also evaluates preclinical data for authoring and preparation of regulatory submissions (e.g., INDs, CTAs, IMPDs, NDAs, MAAs) and has represented clients at meetings with regulatory agencies (US FDA, EU EMA).
Dr. Sampey also acts as a nonclinical program development manager, facilitating the design and conduct of nonclinical safety programs for a broad range of drugs and biopharmaceuticals, across several routes of administration using diverse dosing modalities. He has been involved in the design, development, and execution of protocols for nonclinical studies including general toxicology, safety pharmacology, PK/ADME, genotoxicity, reproductive and developmental toxicity, juvenile toxicity, carcinogenicity studies, as well as efficacy studies using established and novel model systems. Dr. Sampey is also responsible for study implementation and monitoring, and assuring compliance with GLP regulations and conformance to protocols and SOPs.
- Prepares nonclinical testing strategies and data gap analyses for pharmaceuticals and biologics covering a broad range of therapeutic areas.
- Manages clients, CROs, and subcontractors to oversee quality, science, timelines, and budgets for nonclinical studies.
- Analyzes and interprets toxicological data in order to integrate complex scientific concepts into client-ready documents.
- Toxicology expert for regulatory submissions.
- Represented sponsors successfully at meetings with U.S. FDA and EMA.
- Monitors nonclinical studies for scientific integrity and compliance with Good Laboratory Practices.
- Published author in the area of nonclinical drug development.
Education and Professional Qualifications
- D., Toxicology, University of Colorado Health Sciences Center
- S. in Biology, Virginia Polytechnic Institute & State University
- DABT, Diplomate of the American Board of Toxicology
- American College of Toxicology
- Society of Toxicology
- RTP Drug Metabolism Discussion Group
- British-American Business Council