TY - JOUR
T1 - New business models for antibiotic innovation
AU - So, Anthony D.
AU - Shah, Tejen A.
N1 - Funding Information:
Anthony So serves as the Director of the Program on Global Health and Technology Access which also serves as the Strategic Policy Unit of ReAct—Action on Antibiotic Resistance. The authors gratefully acknowledge funding from the Robert Wood Johnson Foundation Investigator Award in Health Policy Research and a SIDA-supported grant to ReAct— Action in Antibiotic Resistance.
Funding Information:
Putting the 3Rs together, India’s Council on Scientific and Industrial Research has begun piloting the Open Source Drug Discovery (OSDD) initiative, beginning with TB drugs. Through an online collaboration platform, OSDD shares resources across a network of collaborators. Those joining this online community commit to a clickwrap license not to take from the research commons, nor to privatize the product of their work. With funding from the Indian government and a private foundation, OSDD shares the risks and rewards of these efforts. Many volunteer and receive micro-attribution for their work. It is anticipated that the druggable leads generated will receive support for publicly funded clinical trials, and the resulting inventions would come to market as a generic drug licensed for affordable access and not excess. If this bold experiment succeeds, open-source innovation may offer a new business model, one that could complement and catalyze the faltering, traditional R&D pipeline of bringing novel antibiotics to market.
PY - 2014/5
Y1 - 2014/5
N2 - 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.
AB - 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.
KW - 3Rs strategy
KW - Antibiotic innovation
KW - Antibiotic resistance
KW - Business models
KW - Delinkage
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U2 - 10.3109/03009734.2014.898717
DO - 10.3109/03009734.2014.898717
M3 - Review article
C2 - 24646116
AN - SCOPUS:84900837864
SN - 0300-9734
VL - 119
SP - 176
EP - 180
JO - Upsala Journal of Medical Sciences
JF - Upsala Journal of Medical Sciences
IS - 2
ER -