Purpose: The objectives of this session are to introduce how use of precision medicine is captured and investigated to support multiple use cases utilizing real-world data (RWD).

Description: Advances in precision medicine have led to the development of targeted treatments specific to an individual’s disease, often resulting in improved patient outcomes compared with standard of care. Use of genomic testing to understand disease etiology, inform drug development and impact treatment decisions drive precision medicine. These test results, in connection with clinical records have created robust, longitudinal clinicogenomic datasets with immense potential. This session will review the landscape of genomic RWD focusing on availability of data, utilization practices, hurdles and limitations.

This session will start with a quick introduction of the history of precision medicine, from the bench to the bedside to the cloud. The exponential growth and increasing inclusion and limitations of genomic information in a patient journey will be explored (7 minutes, Nguyen). Next, the workshop will examine genomic RWD sources ranging from electronic medical records to laboratory datasets to commercial patient or provider-initiated results. Difficulties in data completeness, types of data (example transcriptome v WGS), and challenges with various data linkages will be discussed (Brenton 17 minutes). The session will then shift to describe how genomic data is being applied to the entirety of the drug discovery and development life cycle. Real world clinicogenomics data is driving drug discovery, improving the probability of technical success for clinical trials, and enabling modern value-based access strategies (Webster, 17 minutes). Finally, best practices and algorithms implemented to generate RWE using independent and linked genomic data will be shared (Nguyen, 7 minutes). The session will conclude with a discussion between audience and panel members (12 minutes). This session may benefit stakeholders who already or intend to utilize, generate, or interpret genomic RWE.