Abstract

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 present some important statistical innovations that have greatly improved the efficiency of pharmaceutical development in recent years. For example, adaptive clinical trial designs have increased the success probability of product development while reducing the number of patients exposed to ineffective treatments. Biomarker assessment has enabled precision medicine and accelerated approval of drugs and vaccines. In addition, we will highlight the key leadership qualities that statisticians can bring to the collaborative research environment.