Geoff Goodfellow, Ph.D., DABT, ERT
Dr. Goodfellow is the Director of Toxicology at Intrinsik Health Sciences. Geoff is a board-certified toxicologist and has been a consultant for over 12 years to the biotechnology, pharmaceutical, and healthcare industry. His primary focus as a toxicologist and preclinical development manager is to facilitate the development and conduct of nonclinical safety programs for a broad range of drugs and biopharmaceuticals. Dr. Goodfellow has been involved in the design, development, and execution of protocols for hundreds of studies including general toxicology, safety pharmacology, PK/ADME, genotoxicity, reproductive and developmental toxicity, and carcinogenicity studies.
Dr. Goodfellow also assists companies by preparing or reviewing preclinical drug development strategies, carrying out gap analyses for drug or pharmaceutical products, biologics, drug delivery systems, and natural health products, and conducting due diligence reviews to evaluate preclinical data and/or technology platforms. Geoff is acknowledged as a professional writer in the area of toxicology. As a regulatory toxicologist, he evaluates preclinical data for authoring and preparation of regulatory submissions (e.g., INDs, CTAs, IMPDs) and has represented clients at meetings with regulatory agencies (US FDA, Health Canada). Geoff is a full member of the Society of Toxicology and the American College of Toxicology.
- 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.
- Monitors nonclinical studies for scientific integrity and compliance with Good Laboratory Practices.
- Analyzes and interprets toxicological data in order to integrate complex scientific concepts into client-ready documents.
- Toxicology expert for regulatory submissions.
- Published author in the area of nonclinical drug development.
- Represented sponsors successfully at meetings with the FDA and Health Canada.
Education and Professional Qualifications
Ph.D., Pharmacology, University of Toronto
M.Sc., Pharmacology, University of Toronto
B.Sc. (Honours) in Life Sciences, Queen’s University
DABT, Diplomate of the American Board of Toxicology
ERT, European Registered Toxicologist