Development of new medicines: history and philosophy of development of new medicines. Process of discovery: screening/molecular modeling resulting in identification of lead compounds. Refinement of lead compounds, biological testing in laboratory animals, tissues or tissue components. Choice of chemical entity for further development and identification of back-up compounds. Preclinical studies of selected compound: the value and limitations of animal models in predicting clinical efficacy and potential adverse effects: mechanism of action, screening for total biological effects, toxicology. Factors involved in choosing compounds for clinical development: scientific merit, medical utility, uniqueness, commercial value, compatibility with company strategies, facilities available for development. Selection of back-up compound. Project management: identification of commercial/medical objectives, pre-clinical issues, clinical development strategies. Company strategies: decision path analyses, resources, and time-lines. Clinical trial programme: phases 1, 2, 3 and 4. Clinical research plan: time-lines, study designs, dose-ranging, choice of test populations, indications, trial locations, and data treatment. Go/No Go criteria.
Note: The course is compulsory for programmes 7370, 5504, and 9060.