Dr. Brian T. Welsh is a Senior Scientist with ToxStrategies, Inc., in Austin, TX, where he 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. Dr. Welsh specializes in overseeing and developing toxicology monographs for manufacturing-process impurities and excipients in drugs (large and small molecules), as well as evaluating the potential risk, infectivity, and pathogenicity of microbiological organisms used in agriculture. Dr. Welsh is also skilled in using systematic review as a tool to evaluate hazard data and ultimately formulate both qualitative and quantitative conclusions for toxicology monographs. This 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 also oversees the study design/protocol development, conduct, data interpretation, and report finalization of pharmacokinetic, general toxicology, and reproductive and developmental toxicity studies in various animal species, including rodents, rabbits, and nonhuman primates. In addition, he works directly with clients and serves as the project toxicologist for different projects in various indications, including oncology and orphan drug indications. He also has experience in generating various regulatory documents for biopharmaceutical/pharmaceutical products, including Investigational New Drug (IND) and Biologic License Applications (BLA). Dr. Welsh has developed systematic review 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.