Drug Development Decision Criteria

Catalog description

Drug development is a highly regulated process with a great deal of oversight provided by both the global regulatory community and the internal management of the companies themselves. In addition to the regulatory milestones that designate a target molecule’s status, there are scientific hurdles that a drug candidate must traverse in order to gain passage to the next development phase. The pharmaceutical industry over time has systematically outlined critical junctures at which data, assumptions, models and experience are collated and reviewed by decision makers within the company, and many times in view of external experts, to decide if a compound should progress and also define the best course of action. This course reviews the critical junctures over which innovative and generic drugs are evaluated and the decision criteria used to judge performance and plan next steps. The nature of the collective data under review, the decision paths and the decision makers themselves often change depending on the stage of development. This course covers decision criteria from drug discovery through post marketing and even entertains decision points for generic drugs (pharmaceutical- and bio- equivalence). Metrics for evaluation, company and regulatory expectations and the tools used to facilitate decision (e.g., modeling and simulation techniques to generate “what-if” scenarios) making are all discussed in detail.