Enhancing the value delivered by the statistician throughout drug discovery and development: putting statistical science into regulated pharmaceutical innovation

With the dawn of the 21st century, the pharmaceutical industry faces a dram atically different constellation of business and scientific predictors of s uccess than those of just a few years ago. Significant advances in science at the genetic, molecular and cellular levels, combined with progress demon strated around the globe with drug regulations, have increased business and competitive opportunities. This has occurred in search of better and cheap er medicines that reach patients with unmet medical needs as quickly as pos sible. Herein lie new opportunities for those who can help business and reg ulatory leaders make good decisions about drug development and market autho rization as quickly and efficiently as possible in the presence of uncertai nty. The statistician is uniquely trained and qualified to render such valu e. We show how the statistician can contribute to the process of drug innov ation from the very early stages of drug discovery until patients, payers a nd regulators are satisfied. Indeed, the very nature of regulated innovatio n demands that efficient and effective processes are implemented which yiel d the right information for good decision making. The statistician can take the lead in setting a strategy that directs such processes in the directio n of greatest value. This demands skills that enable one to identify import ant sources of variability and uncertainty and then leverage those skills t o make decisions. If such decisions call for more information, then the sta tistician can render experimental designs which generate the right informat ion needed to make the decision in an efficient, timely manner. To add valu e to the enterprise, statisticians will have to become more intimately asso ciated with business and regulatory decisions by building on their traditio nal roles (for example, numerical analyst, tactician) and unique skill sets (for example, analysis, computation, logical thought and work process, pre cision, accuracy). Business and regulatory savvy, coupled with excellent co mmunication and interpersonal skills, will allow statisticians to help crea te the knowledge needed to drive success in the future. Copyright (C) 2001 John Wiley & Sons, Ltd.