"From Discovery to Drug” - Selected Topics on Drug Development and its Pitfalls

The process of drug development from inception of the idea to drug approval encompass a series of specialized activities involving many different professionals. Drug development is typically divided into three major steps: discovery, preclinical development, and clinical trials. While the transition from discovery to preclinical development is a continuum the limit between preclinical development and clinical trial is sharply defined by the IND filing.

Although covering the same process, drug development in small companies or start ups has its specific constraints and pitfalls. The adage “Begin with the end in mind” cannot be more certain than in pre-clinical development and specially in small companies where choosing resource allocation can determine success or failure. It is essential thus, to plan carefully all the different steps to reach the goal – FDA approval and commercialization of a new drug.

Development of in house capabilities or Contract organizations, number of synthesis steps versus lead optimization to reduce them, when to enter GLP and GMP, pre-formulation, early DMPK or whether to use and in what extent predictive software are some of the critical steps that many companies face. We would like to provide some information, based in our experience, about these steps and their importance in the drug development process.