Dr. Brian T. Welsh specializes in evaluating hazards and risks associated with exposures to a wide variety of biopharmaceutical and pharmaceutical products, food ingredients and additives, herbal supplements, and industrial chemicals. He has expertise in risk assessment and toxicology, working with both large and start-up companies in the biopharmaceutical/pharmaceutical industry, and he works directly with clients, serving as the project toxicologist for various indications and therapies, including those for oncology, enzyme replacement, neurological disorders, and orphan diseases. Dr. Welsh oversees the study design, protocol development, conduct, study monitoring, data interpretation, and report finalization of pharmacokinetic, in vitro genotoxicity, general toxicology (GLP and non-GLP), and reproductive and developmental toxicity studies in various animal species, such as rodents, rabbits, dogs, and nonhuman primates. He has experience reviewing and analyzing digital data sets from nonclinical toxicology studies (i.e., Standard for Exchange of Nonclinical Data [SEND]). In addition, Dr. Welsh is the author of various regulatory documents for biopharmaceutical and pharmaceutical products, including Investigator Brochures (IBs), Investigational New Drugs (INDs,) and Biologic License Applications (BLAs). Dr. Welsh also specializes in overseeing and developing toxicology monographs for manufacturing-process impurities and excipients in drugs (large and small molecules).
Dr. Welsh is skilled in using systematic review as a tool to evaluate hazard data and ultimately formulate both qualitative and quantitative conclusions for toxicology monographs. This work involves implementing search strategies for both public and proprietary databases (e.g., PubMed and Embase), literature review and data extraction, and individual study assessment for bias and quality. Dr. Welsh has developed protocols that address key elements of the systematic review process, such as defining the analytic framework, outlining conflicts of interest, evaluating risk of bias, and designing strategies for evidence integration. During implementation of these reviews, Dr. Welsh has particular expertise with various software tools and databases used to conduct, track, and report on literature searches and screening. Additionally, he tracks and summarizes longer-term changes and updates to bodies of literature to report on trends.
Dr. Welsh’s areas of expertise extend to neuroscience, neuropharmacology, and protein biomarkers. He has eight years of experience in the biotechnology industry, working in various roles, including process development of vaccines and experimental therapeutics, business development, and analysis of biomarker data. Biomarker projects focused on analysis of internal data sets for normal species-specific values (e.g., human, murine, canine, etc.), as well as substantial experience with disease-specific markers and data sets for Alzheimer’s, Parkinson’s, and other neurodegenerative illnesses. Dr. Welsh earned his Ph.D. in Neuroscience from the University of Texas at Austin; his research focused on the molecular sites of action of alcohol and inhaled anesthetics on ligand-gated ion channels, using electrophysiological techniques at both the whole-cell and single-channel levels. Dr. Welsh is a co-author of numerous meeting abstracts and peer-reviewed publications.