Opportunities of Statistics for Precision Medicine in Drug Development

The overarching mission of the pharmaceutical industry is to develop medical products that can improve human health. Scientific discoveries and innovations in research and development are very critical in the success of developing new medical products such as drugs, vaccines, and medical devices. Working closely with scientists and clinical researchers, statisticians play a key role in solving real problems in the drug development process, from basic discovery to clinical trials and post marketing surveillance. In this presentation we will provide some perspectives and opportunities for precision medicine in drug development from statistical perspectives. We will discuss how statistics and analytics can be utilized to detect signals and analyze biomarker data from discovery to clinical trials. For example, machine learning methods are used to identify subgroups of patients that are more likely to benefit from the medical treatment. Statistical analytic methods can be used to develop biomarkers that can enrich the clinical trial design. Finally, examples will be used to illustrate the utility of some of these methods. Depth Regression with Application to Functional Data