The Academic–Industrial Complexity: Failure to Launch

摘要

The pharmaceutical industry has long known that ～80% of the results of academic laboratories cannot be reproduced when repeated in industry laboratories. Yet academic investigators are typically unaware of this problem, which severely impedes the drug development process. This academic–industrial complication is not one of deception, but rather a complex issue related to how scientific research is carried out and translated in strikingly different enterprises. This Opinion describes the reasons for inconsistencies between academic and industrial laboratories and what can be done to repair this failure of translation. Trends The drug development process has historically thrived on results of basic research in academic laboratories that are then refined in industry laboratories and translated to clinical studies. Academic laboratories increasingly participate in applied research directed toward disease, as a result of funding pressures from granting agencies to focus on clinically relevant investigations. Recent experience and retrospective studies have demonstrated that the process is frequently flawed, with as many as 70–90% of academic laboratory findings not being reproduced when repeated in the industry setting. Start-up companies are positioned in the middle of the discovery process, with expertise in the drug and the experimental models, yet subject to the financial and time pressures of industry. The result is slowing and inefficiency in drug development, leading to a drying up of pipelines.