Past, current, and future safety and efficacy trends in the drug industry

In view of the enormity of the subject on which I have been asked to speak, I consider it advisable, prudent, and pragmatic to attempt to focus the scope of my discussion on the area of my immediate expertise. In my lecture, I shall attempt to survey "the past" via a very brief discussion of some of the methods used for the determination of both safety and efficacy as well as the results achieved. With respect to "current practices," I intend to present an overview of the scope of safety and efficacy evaluation with new drugs, emphasizing both the pros and cons as perceived from the vantage point of a pharmaceutical scientist dedicated to the discovery and development of new therapeutic agents that will ameliorate disease states and human suffering while, at the same time, returning profit to the industry that has generated such drugs, so as to permit continued expansion of our therapeutic armamentarium by continued research efforts.