R&D Process

The process of pharmaceutical R&D is long and challenging. It begins with the basics of scientific exploration into the roots of disease. If a compound proves promising after years of testing, it continues through regulatory approval, launch and the commercial life cycle. Even a medicine that successfully makes it to market and is meeting the health needs of patients and doctors will still be a focus of further study.

Few promising compounds survive the tough process of research, development and testing to finally become medicines. Using a sports analogy, we compare the strategy for overcoming these long odds to taking “shots on goal”, where many shots have to be taken in order to score a single success.

Pharmaceutical R&D involves a sequence of distinct activities. ‘Target identification’, ‘lead finding’ and ‘lead optimization’ comprise the drug discovery process and make up the ‘research phase’ of a prospective medicine's life.

The “D” in R&D involves formulation, analysis, process development and bioanalytical identification. To complete the R&D phase, regulatory documentation and technology transfer are provided to the commercial site.
’Development’ involves the early and later phase clinical trials essential for assessing a medicine's efficacy and safety in humans and to prepare data for registration and marketing.