The drug development process in Pharma/Biotech is governed by Research and Development (R&D).  The R&D pipeline involves various phases that can broadly be grouped into 4 stages of lateral processes: discovery, pre-clinical, clinical trials and marketing (or post-approval). Each phase has defined deliverables with Go/NoGo decision points.  During the drug development process, the drug developer works closely with the regulatory authorities on the approval process. Most pharmaceutical companies usually have several compounds in their pipelines at multiple stages in development.

The  drug discovery and development process is one of the most challenging and difficult human endeavors, for it has to balance efficacy in health benefits with safety at an appropriate therapeutic index, the efficacy versus safety is first tested in pre-clinical models and then translated to first in human.

The process is interdisciplinary, involves clinicians, biologists, medicinal and synthetic organic chemists, X-ray crystallographers, structural biologists, computational experts among others working collaboratively and synergistically with defined strategies and resources, aspects of the process are continuously re-evaluated by management and modified accordingly for optimized productivity and cost.  Around nine out of every ten drug candidates fail to win approval, with huge implications for the overall cost of drug development.