Research and development in the pharmaceutical industry is a complex process that involves basic and applied science, market analysis, engineering, information technology, local and international law, intellectual property protection, regulatory affairs, economics, pharmacoeconomics, company background and culture, business administration, and so on. Much of this has been discussed in preceding courses. These strands are brought together in course PHPH9126 with emphasis on the administrative decisions that determine the various GO/NO GO steps in the process of developing and introducing a new medicine. The course consists of five main sections: (a) background to factors underlying corporate decisions in drug development including overview or the R&D process (discovery, time scales, GO/NO Go decision trees), interacting perspectives (senior management, clinical, regulatory, commercial) law, standards, safety and efficacy, structures of the world and Australian pharmaceutical industries, medicines in a changing environment; etc.; (b) processes involved in the discovery of new medicines including in vitro and in vivo screening, combinatorial chemistry; bioinformatics and data-mining; structure-based design, computer-based design, genomics, proteomics; etc.; (c) selection and advancement of candidate molecules including design and validation of in vitro and animal test systems to ensure meaningful results, development of time scales for full testing programme, deciding choice of formulation and development and validation for scale-up procedures, development of clinical trial protocols and identifying investigators and contract research organizations, ensuring all laws and codes of conduct are observed; (d) protection of intellectual property (IP) including overview of IP regimes, aspects of IP regimes relevant to the pharmaceutical industry (copyright, designs, trade marks, patents), Australian legislation; (e) selection of therapeutic area, planning for the full development of a pharmaceutical product including preparing the plan, executing the plan, developing and putting in place in-house or outside procedures and contracts for toxicological programmes, implementing and monitoring clinical studies, process improvement, training, crisis management, exit strategies. This course is compulsory for programmes 5504, 5511 and 9060.