Christopher Kim (Amgen Thousand Oaks)
“The increasing importance of real-world data across the globe and drug development life cycle”
Real world data (data gathered from non-clinical trials of standard healthcare practice) is growing in importance across the entire drug development lifecycle. Across geographies and stakeholders, there has been an increase in available data (including new data types), new analytic approaches, and increased interest from stakeholders (e.g., regulators, payers) which has enabled innovative uses for RWD across the drug development lifecycle. To be discussed will be several case examples of using innovative approaches with real world data to answer important topics such as use of historical study data to lead to drug approvals with non-randomized clinical trials, evaluate drug safety related to patient race differences, and contextualizing Phase 1b and Phase 2 clinical trials with real world data in the hematology therapeutic area
Background
An epidemiologist at Amgen in the Center for Observational Research (CfOR) currently serving as a Therapeutic/Product Area Lead for the Hematology therapeutic area, leading and managing a team of 5, focused on conducting real world evidence (RWE) studies to demonstrate unmet need, to provide context to single arm clinical trials by identifying external historical control groups, designing post-marketing safety commitment studies (PMC/PMR), evaluate risk management minimization plans (RMM/RMP), compare effectiveness of drugs/regimens, identify treatment trends, and contribute to understanding the epidemiology of various diseases for the development of molecules and drugs post-marketing authorization for 5 approved products and the Hematology pipeline.
Prior to Amgen, formerly a post-doctoral fellow at National Institutes of Health/National Cancer Institute in the Division of Cancer Epidemiology and Genetics. Graduate from the Epidemiology and Public Health department at Yale University (PhD) and Biology department at Boston University (BA).