We are pleased to announce that Dr. Andrea Weir has joined ToxStrategies, Inc. as a Senior Consultant and will be based in the Washington, DC area. Dr. Weir is a board certified toxicologist with 28 years of experience in toxicology, primarily in drug development. She has worked in both the contract research industry and at the U.S. Food and Drug Administration (USFDA).
Prior to joining ToxStrategies, Dr. Weir was a regulatory toxicologist at the USFDA for approximately 12 years, working primarily in the Center for Drug Evaluation and Research (CDER). During this time, Dr. Weir served as a pharmacology/toxicology reviewer and was responsible for critically reviewing the nonclinical sections of regulatory submissions such as INDs, NDAs, and BLAs. Dr. Weir actively participated in meetings (e.g., pre-IND meetings) advising pharmaceutical and biopharmaceutical companies regarding their nonclinical development plans, particularly the study design and data interpretation, as well as addressing toxicities and other challenges encountered in nonclinical studies. She was also actively involved in several internal FDA/CDER subcommittees. Following the USFDA, Dr. Weir was a Senior Scientific Advisor at Charles River Laboratories. She actively participated on numerous scientific advisory committees within the pharmaceutical and biopharmaceutical industry, which were held to obtain expert advice on various aspects of the nonclinical drug development process.
Dr. Weir has extensive experience with biopharmaceuticals such as monoclonal antibodies and fusion proteins, and with chemically-synthesized molecules. Her experience extends to a variety of clinical indications including rheumatoid arthritis, oncology and rare diseases, as well as multiple routes of administration including oral, intravenous, dermal, and ocular. Dr. Weir also has extensive experience in the design and interpretation of nonclinical toxicology studies (GLP and non-GLP) and in applying data from such studies to the overall drug development process. Dr. Weir has co-authored numerous journal articles and book chapters relating to drug development, and served as co-editor of a text titled Assessing Ocular Toxicology in Laboratory Animals.
To read more about Dr. Andrea Weir and get her contact information, please visit her company web page.