Guest: Real-World Data in Drug Development
Brian is a leading global expert in pharmacoepidemiology and the use of real-world data (RWD) to generate credible real-world evidence (RWE). His knowledge and expertise span 20+ years, with senior leadership roles in industry and academia.
At Amgen, Brian leads a global organization comprised of 150+ epidemiologists, biostatisticians, database and statistical programmers and data scientists. His team works closely with internal stakeholders and external collaborators to generate high-quality RWE that can enable decision-making and support Amgen's mission to serve patients. Brian and his team have conducted pharmacoepidemiologic research using RWD from various countries across the globe including the United States, the United Kingdom, Denmark, Hong Kong, Japan, and Taiwan. A large proportion of that work has included post-marketing commitment studies and post-authorization safety studies from global regulators to address drug safety questions. In recent years, this work has expanded to include effectiveness and comparative effectiveness studies to support new drug applications and label expansions.
He oversaw the development and implementation of Amgen's global RWD platform, which currently houses data on >350 million lives across the globe. His team uses these data to answer questions across the drug development lifecycle, from incidence and prevalence to disease burden to comparative effectiveness and safety. In 2016, his team successfully integrated the FDA Sentinel System modular programs into the RWD platform, established an export, transfer and load processes to translate between the Observational Medical Outcomes Partnership and the Mini-Sentinel common data models, and now use the system routinely to support Amgen's product safety surveillance efforts.
Brian is also an Adjunct Professor of Epidemiology at the University of California, Los Angeles, where he teaches a course on Pharmacoepidemiology. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, cardiovascular, kidney and bone disease epidemiology, and methods for controlling confounding-by-indication in drug safety studies.