Statistical Innovation for Next-Generation Pharmaceutical Development

The Duke-Industry Statistics Symposium (DISS) is organized by the Department of Biostatistics and Bioinformatics, Duke University School of Medicine and several industry and non-profit partners. The first symposium was established in 2013 to discuss challenging issues and recent advances related to the clinical development of drugs, biologics and devices and to promote research and collaboration among statisticians from industry, academia, and regulatory agencies.
The symposium (DISS2024) to be held April 3-5, 2024 under the theme “Statistical Innovation for Next-Generation Pharmaceutical Development“, will explore the forefront of statistical innovation in next-generation clinical research for pharmaceutical products. The advances in biomedical technology, big data science, and artificial intelligence have created a myriad of development opportunities in drug developments. This has prompted a need for integrating multiple cutting-edge tools and approaches into clinical trials research, including machine learning and artificial intelligence, the utilization of electronic health records, implementation of pragmatic trials, patient-centered trial designs, master protocols, adaptive trial design methodologies, and the effective utilization of historical controls and real-world evidence. In contrast to traditional clinical development, these innovative methods require systematically gathering insights from data collected from ongoing clinical trials and external sources, utilization of machine learning and AI algorithms, analysis of high-dimensional clinical, genomics and imaging data as biomarkers for the development of next-generation pharmaceutical products.
The first day of the in-person symposium will be devoted to short courses. The following day and a half will consist of keynote speeches, parallel sessions, and poster lightning talk sessions. The Organizing Committee is actively working to finalize the schedule, the topics of various sessions, and invited speakers.