The Jobs Of R&D Presidents Are Hard, and getting harder by the day. To guide their labs toward the most promising avenues of research, they have to keep up with the rapid pace of scientific progress. At the same time, as the chief executives of complex, technology-driven (and frequently international) organizations, they are involved in many non-scientific operational and organizational issues. R&D presidents—and frequently the leaders of discovery, pre-clinical, and development—wear two hats. They're chief science officers (CSO) and chief operating officers (COO).
The situation is exacerbated by the fact that, in many biopharmaceutical R&D organizations, responsibility for operations is fragmented among many executives. This makes it difficult to conceive and implement comprehensive solutions. Yet, given the unrelenting pressure to bring new therapies to market rapidly and at reasonable prices, R&D organizations can no longer afford to focus on science to the exclusion of operations. To launch new therapies ahead of competitors, they need to excel at both.Managing Operations Several factors make R&D operationally complex. One is R&D's intense use of technology. Today's labs are permeated with high-throughput screening, interactive voice response systems, electronic data capture, computational chemistry, compound library management systems, laboratory information systems, and many other similar tools. The future promises even greater use of technology, including biomarkers, dynamic simulation tools for modeling human physiology, and predictive toxicology assays.
A second factor is the increasingly stringent regulatory climate. Clinical trials have become significantly larger and more complex over the last decade, and regulatory considerations have been a major contributor to the trend. New regulatory requirements, such as Part 11 compliance, also have had a direct impact on operations.
Third, as biopharmaceutical companies have worked to reduce costs by moving operations, such as data management or lead optimization, to faraway places, they have expanded their R&D footprints. They also have significantly increased the number of countries in which they conduct clinical trials, in order to gain access to investigators and patients.
Finally, the movement away from traditional blockbuster drugs to more personalized medicine means that R&D portfolios include a larger number of drugs.
Large, global labs may consider replicating this structure one level down and appoint COOs for discovery, pre-clinical, and development to support the COO of R&D. Labs that look to significantly improve their performance, or that are experiencing rapid growth, will benefit the most from this approach.