New business models for antibiotic innovation.
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The increase in antibiotic resistance and the dearth of novel antibiotics have become a growing concern among policy-makers. A combination of financial, scientific, and regulatory challenges poses barriers to antibiotic innovation. However, each of these three challenges provides an opportunity to develop pathways for new business models to bring novel antibiotics to market. Pull-incentives that pay for the outputs of research and development (R&D) and push-incentives that pay for the inputs of R&D can be used to increase innovation for antibiotics. Financial incentives might be structured to promote delinkage of a company's return on investment from revenues of antibiotics. This delinkage strategy might not only increase innovation, but also reinforce rational use of antibiotics. Regulatory approval, however, should not and need not compromise safety and efficacy standards to bring antibiotics with novel mechanisms of action to market. Instead regulatory agencies could encourage development of companion diagnostics, test antibiotic combinations in parallel, and pool and make transparent clinical trial data to lower R&D costs. A tax on non-human use of antibiotics might also create a disincentive for non-therapeutic use of these drugs. Finally, the new business model for antibiotic innovation should apply the 3Rs strategy for encouraging collaborative approaches to R&D in innovating novel antibiotics: sharing resources, risks, and rewards.
Published Version (Please cite this version)10.3109/03009734.2014.898717
Publication InfoShah, TA; & So, Anthony D (2014). New business models for antibiotic innovation. Ups J Med Sci, 119(2). pp. 176-180. 10.3109/03009734.2014.898717. Retrieved from http://hdl.handle.net/10161/8997.
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Visiting Professor of the Practice in the Sanford School of Public Policy
Dr. Anthony So joined Duke University’s Sanford School of Public Policy in 2004 as director of a new Program on Global Health and Technology Access. The program focuses on issues of globalization and health, particularly innovation and access to essential medicines for those in developing countries. The program works as the Strategic Policy Unit for ReAct, a global coalition dedicated to combating antibiotic resistance. Dr. So's research on the ownership of knowledge and how it is best h