Pharmaceutical

Although similar to other industries, the types of pharmaceutical activities considered R&D are different due to the nature of testing procedures required to meet regulatory requirements. The time taken from the earliest research stages on a particular drug to market is usually in the order of a decade. And only a small percentage of promising compounds identified in early research end up with regulatory approval.

R&D in the pharmaceutical industry typically takes place in four stages:

• Drug discovery

This phase is concerned with the identification of promising new chemical entities.

• Pre-clinical trials

Pre-clinical trials are concerned with the non-human testing of compounds. Compounds that are identified as promising at the pre-clinical trial stage move into clinical trials.

• Clinical trials

Clinical trials go through three phases, they could generally be described as toxicity tests (phase 1), preliminary efficacy tests (phase 2) and comparative efficacy and tolerability tests (phase 3). Work in these first 3 stages will likely be considered R&D. This will likely include work on applying to and responding to the regulator, and work on doing further testing as requested by the regulator. Most of the work involved in making an application to the regulator would involve work that directly contributes to the resolution of technological uncertainty and would therefore qualify as R&D.

• Post-launch

The post-launch phase occurs when a product has been licensed. Thus this phase involves post-marketing confirmatory studies, special interest studies, longer-term efficacy, tolerability etc. Work in this phase would generally not be considered R&D unless the work involved a scientific or technologically advanced uncertainty.

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