Managing risks in drug discovery: reproducibility of published findings

Abstract

In spite of tremendous advances in biopharmaceutical science and technology, the productivity of pharmaceutical research and development has been steadily declining over the last decades. The reasons for this decline are manifold and range from improved standard of care that is more and more difficult to top to inappropriate management of technical and translational risks along the R&D value chain. In this short review, major types of risks in biopharmaceutical R&D and means to address them will be described. A special focus will be on a risk, i.e., the lack of reproducibility of published information, that has so far not been fully appreciated and systematically analyzed. Measures to improve reproducibility and trust in published information will be discussed.

Keywords: Reproducibility; Research and development; Risk management; Technical risk; Translational risk.

Fig. 1

a “Eroom’s law” of declining R&D productivity in the pharmaceutical industry. The straight line denotes a decrease by a factor of 2 every 9 years. Data taken from Scannell et al. (2012), supplementary information. b Annual biopharmaceutical R&D spending by PhRMA member companies. Data from Phrma.org (2015). c Number of new molecular entities (NMEs) approved by the FDA for the years between 2001 and 2015. Horizontal gray bars denote the mean for the respective 5-year periods. Data from Phrma.org (2015) and fda.gov