Clinical pharmacology and therapeutics
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Clin. Pharmacol. Ther. · May 2010
ReviewThe Biomarkers Consortium: practice and pitfalls of open-source precompetitive collaboration.
Precompetitive collaboration is a growing driver for innovation and increased productivity in biomedical science and drug development. The Biomarkers Consortium, a public-private platform for precompetitive collaboration specific to biomarkers, demonstrated that adiponectin has potential utility as a predictor of metabolic responses to peroxisome proliferator-activated receptor (PPAR) agonists in individuals with type 2 diabetes. Despite the challenges overcome by this project, the most important lesson learned is that cross-company precompetitive collaboration is a feasible robust approach to biomarker qualification.
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Clin. Pharmacol. Ther. · May 2010
ReviewThe Critical Path Institute's approach to precompetitive sharing and advancing regulatory science.
Many successful large industries, such as computer-chip manufacturers, the cable television industry, and high-definition television developers,(1) have established successful precompetitive collaborations focusing on standards, applied science, and technology that advance the field for all stakeholders and benefit the public.(2) The pharmaceutical industry, however, has a well-earned reputation for fierce competition and did not demonstrate willingness to share data or knowledge until the US Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 (ref. 3).