CLINICAL DRUG DEVELOPMENT

Kenneth B. Klein, MD.

Endpoint

This chapter addresses the range of tasks involved in getting a compound from the laboratory to the pharmacy, highlighting both common pitfalls and methods that work consistently. The discussion will center on clinical development of a new chemical entity, that is, a unique molecule with potential as a medicine. The development of biologicals (e.g. monoclonal antibodies) in general follows similar lines; vaccines and medical devices are developed differently and are outside the scope of this chapter.

The earlier stages of clinical development are emphasized since these are most relevant to the entrepreneur. Since the Entrepreneur's Guide to a Biotech Startup is directed primarily toward an American audience, the focus will be on FDA requirements. Note, however, that most promising compounds should be developed with worldwide regulatory approval and marketing in mind.