Pharmacovigilance and Regulatory Policy Consultant
Bruce received his doctorate in pharmacology from The Ohio State University with a focus on neuropharmacology / neuroscience. Although starting out in academics, Bruce has spent the majority of his career in the pharmaceutical industry, working in several therapeutic areas involving pre-clinical pharmacology & toxicology, regulatory affairs, and clinical research. For almost 30 years, Bruce has had roles in various US and global pharmacovigilance positions for Pfizer, Johnson & Johnson, and Genentech/Roche. His focus now is primarily on the evaluation and regulatory policies of new technologies and data sources, such as potential applications of machine learning and use of real world data, to enhance the identification and assessment of drug-related adverse events. Some recent publications to support these efforts include: A Study on the Application and Use of Artificial Intelligence to Support Drug Development, Clin Ther (2019); Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety, Ther Innov Regul Sci (2019); Advancing Nonclinical Innovation and Safety in Pharmaceutical Testing, Drug Discovery Today (2019); Pharmacovigilance is Everyone’s Concern: Let’s Work It Out Together, Clin Ther (2018); A New Erice Report Considering the Safety of Medicines in the 21 st Century, Drug Saf (2017)