Public-private partnerships as driving forces in the quest for innovative medicines

In 2004, the US Food and Drug Administration (FDA) introduced the Critical Path Initiative with the intent of modernizing drug development by implementing public-private partnerships (PPP) to share data, expertise, and resources. In response to FDA’s initiative, in the following year the non-profit Critical Path Institute (C-Path) was formed. At the same time, the National Institutes of Health (NIH) Public-Private Partnership program was established. In Europe, the Innovative Medicines Initiative (IMI) supported jointly by the European Union and the European Federation of Pharmaceutical Industries and Associations was launched in 2008. These independent efforts have a common long-term objective, namely to facilitate the emergence of innovative medicines by developing new tools for drug discovery, new indicators for drug efficacy or safety, and new approaches for patient stratification. Herein, we present evidence that PPP already exert a positive impact on the drug development process.Public-private partnerships represent attractive means to leverage resources dispersed across industry, academia, and voluntary health organizations in order to address multiple challenges of drug development in an era of constrained resources and increased regulatory pressure.There are several causes of the insufficient productivity of the current drug development process, including but not limited to: [1] the insufficient integration of the results of academic research into the research and development strategy of pharmaceutical companies, [2] the insufficient interest in academic institutions in regulatory science, methods standardization and concrete applications of basic discoveries, [3] the lack of established criteria to define acceptable risk-benefit ratio for drug approval by regulatory authorities, and [4] economic considerations making the development of certain drugs unattractive from an industry standpoint. PPP can help to overcome some of these hurdles by bringing togethe