Handing over the baton: connecting medicinal chemistry with process R&D

Abstract

The pharmaceutical industry, as virtually any other industry, is continuously striving to become more effective and efficient. This demand for improving business processes is focused on all parts of the organization-from R&D and manufacturing to marketing and sales. Specifically from an R&D perspective, there are two areas that stand out as having caught more attention than others: attrition and timelines. While the former, so far, has seen relatively small changes for the better, the latter has reached clear targets in reducing the overall time required for the various activities conducted during drug discovery and development phases. For process R&D-the unit accountable for the design and optimization of small-molecule synthetic routes as well as delivery of active substance (API) for clinical and toxicological testing-the key contribution in this respect has been the shortening of lead times for supply of the first batch of material on scale. Thus, applying a work model based on balanced frontloading has shown that this crucial task can be taken off the critical path, and instead of delivering required API amounts several months post candidate drug nomination, the availability can now be guaranteed at or even ahead of reaching this milestone. The paradigm shift that has been necessary in order to reach this goal is the subject of this article.