21st Century Innovation - Pharmaceutical Technology

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21st Century Innovation
Academic–industry partnerships are increasingly important in biopharmaceutical innovation.


Pharmaceutical Technology
Volume 35, Issue 6, pp. 32

Government support

During the past decade, the US and European Union governments have developed programs to foster translational science. For example, in 2001, the US National Institutes of Health (NIH) released its NIH Roadmap, which was intended to invest in new pathways in drug discovery, support research teams of the future, and re-engineer the clinical research enterprise. In 2006, the Clinical and Translational Science Award (CTSA) program, which was intended to facilitate the transfer of knowledge between basic research and clinical medicine, was launched. With more than 50 CTSAs awarded to date and 60 planned by 2012, NIH has clearly signaled its support for academic institutions as active partners in bioinnovation.

In a similar vein, in 2004, FDA introduced the Critical Path Initiative (CPI) to improve the translation of basic research findings into safe and effective medicines. Mirroring the goals of the EU Innovative Medicines Initiative, a public–private partnership formed in 2007 between the European Federation of Pharmaceutical Industries and Associations and the European Community, CPI fosters precompetitive research by bringing together the respective capabilities of academia, industry, and government to identify new biomarkers and other tools to improve the selection of drug candidates and increase the likelihood of pipeline success.

Obstacles

Despite a shared commitment by both sectors and unequivocal government support, significant obstacles stand in the way of successful partnerships. These obstacles include language barriers (academics speak the language of science while industry speaks the language of business), misaligned reward systems (academics are rewarded by publication, promotion, and grants while industry is rewarded by pipeline success and regulatory filings), intellectual-property issues (academics try to retain ownership as much as possible while industry requires sufficient rights to make downstream investment worthwhile), and a heightened sensitivity to conflicts of interest in academics and a reluctance to align too closely with the private sector.

Despite these obstacles, there are many reasons for academic–industry partnerships. There is a financial imperative for both sectors as NIH grants have diminished and industry lowers its R&D spending. Industry gains access to cutting-edge science, and academics gain access to drug-development expertise. And both parties realize the benefits of translational science. Academic–industry partnerships may not be the perfect marriage, but they are definitely worth fighting for.

Kenneth I. Kaitin, PhD, is director and research professor of the Tufts Center for the Study for Drug Development at Tufts University.


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