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A Grant Framework as a Push Incentive to Stimulate Research and Development of New Antibiotics

Published online by Cambridge University Press:  01 January 2021

Miloje Savic  and
Christine Årdal
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Extract

Antibiotic research and development (R&D) has failed to produce innovative antibiotics in the past two decades, which is due to both scientific and economic factors. We reviewed national and international funding agencies and critically assessed current grant funding mechanisms. Finally, we propose four complementary grant-funding incentives aimed to help developers along the R&D pipeline. Equally important objective of these incentives is to address some of the known R&D risks and bottlenecks.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 46 , Issue S1: Incentives to Stimulate Research and Development of New Antibiotics: Detailed Assessments of Select Incentives and Models , Spring 2018 , pp. 9 - 24
Copyright
Copyright © American Society of Law, Medicine and Ethics 2018

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References

Carlet, J. et al., “Society's Failure to Protect a Precious Resource: Antibiotics,” The Lancet 378, no. 9788 (2011): 369–371.Google Scholar
The Review on Antimicrobial Resistance, Tackling Drug-Resistant Infections Globally: Final Report and Recommendations, available at <https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
The Boston Consulting Group, Breaking through the Wall, available at <http://www.bundesgesundheitsministerium.de/service/publikationen/gesundheit/details.html?bmg%5bpubid%5d=3006> (last visited February 7, 2018); Declaration by the Pharmaceutical, Biotechnology and Diagnostics Industries on Combating Antimicrobial Resistance, available at <https://amr-review.org/sites/default/files/Declaration_of_Support_for_Combating_AMR_Jan_2016.pdf> (last visited February 7, 2018); ECDC Directory of Strategies and Action Plans on Antimicrobial Resistance, available at <http://ecdc.europa.eu/en/health-topics/Healthcare-associated_infections/guidance-infection-prevention-control/Pages/antimicrobial-resistance-strategies-action-plans.aspx?preview=yes&pdf=yes> (last visited February 7, 2018); National Action Plan for Combating Antibiotic-Resistant Bacteria, available at <https://obamawhite-house.archives.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf> (last visited February 7, 2018).+(last+visited+February+7,+2018);+Declaration+by+the+Pharmaceutical,+Biotechnology+and+Diagnostics+Industries+on+Combating+Antimicrobial+Resistance,+available+at++(last+visited+February+7,+2018);+ECDC+Directory+of+Strategies+and+Action+Plans+on+Antimicrobial+Resistance,+available+at++(last+visited+February+7,+2018);+National+Action+Plan+for+Combating+Antibiotic-Resistant+Bacteria,+available+at++(last+visited+February+7,+2018).>Google Scholar
Adegoke, A. A. et al., “Antibiotic Resistant Superbugs: Assessment of the Interrelationship of Occurrence in Clinical Settings and Environmental Niches,” Molecules 22, no. 1 (2016); Frieri, M. et al., “Antibiotic Resistance,” Journal of Infection and Public Health 10, no. 4 (2016): 369-378; Lammie, S. L. and Hughes, J. M., “Antimicrobial Resistance, Food Safety, and One Health: The Need for Convergence,” Annual Review of Food Science and Technology 7, no. 7 (2016): 287-312.Google Scholar
Mossialos, E., Morel, C. M., Edwards, S., Berensen, J., Gemmill-Toyama, M., and Brogen, D., Policies and incentives for promoting innovation in antibiotic research (2010), available at <http://www.euro.who.int/__data/assets/pdf_file/0011/120143/E94241.pdf> (last visited February 7, 2018); S. J. Projan, “Why Is Big Pharma Getting Out of Antibacterial Drug Discovery?” Current Opinion in Microbiology 6, no. 5 (2003): 427-430.+(last+visited+February+7,+2018);+S.+J.+Projan,+“Why+Is+Big+Pharma+Getting+Out+of+Antibacterial+Drug+Discovery?”+Current+Opinion+in+Microbiology+6,+no.+5+(2003):+427-430.>Google Scholar
Rex, J. H. et al., “A Comprehensive Regulatory Framework to Address the Unmet Need for New Antibacterial Treatments,” The Lancet Infectious Diseases 13, no. 3 (2013): 269–275; Silver, L. L., “Challenges of Antibacterial Discovery,” Clinical Microbiology Reviews 24, no. 1 (2011): 71-109; A. D. So et al., “Towards New Business Models for R&D for Novel Antibiotics,” Drug Resistance Updates 14, no. 2 (2011): 88-94; Spellberg, B. et al., “Trends in Antimicrobial Drug Development: Implications for the Future,” Clinical Infectious Diseases 38, no. 9 (2004): 1279-1286; Zorzet, A., “Overcoming Scientific and Structural Bottlenecks in Antibacterial Discovery and Development,” Upsala Journal of Medical Sciences 119, no. 2 (2014): 170-175.Google Scholar
Micallef, C. et al., “Patient and Public Understanding and Knowledge of Antimicrobial Resistance and Stewardship in a UK Hospital: Should Public Campaigns Change Focus?” Journal of Antimicrobial Chemotherapy 72, no. 1 (2017): 311–314.CrossRefGoogle Scholar
Castro-Sanchez, E. et al., “What Are the Factors Driving Antimicrobial Resistance? Perspectives from a Public Event in London, England,” BMC Infectious Diseases 16, no. 8 (2016): 465; Holmes, A. H. et al., “Understanding the Mechanisms and Drivers of Antimicrobial Resistance,” The Lancet 387, no. 10014 (2016): 176–187.Google Scholar
Bush, K. and Page, M. G., “What We May Expect from Novel Antibacterial Agents in the Pipeline with Respect to Resistance and Pharmacodynamic Principles,” Journal of Pharmacokinetics and Pharmacodynamics 44, no. 2 (2017): 113–132; Chen, L. et al., “Notes from the Field: Pan-Resistant New Delhi Metallo-Beta-Lactamase-Producing Klebsiella Pneumoniae-Washoe County, Nevada, 2016,” MMWR: Morbidity and Mortality Weekly Report 66, no. 1 (2017): 33.Google Scholar
Power, E., “Impact of Antibiotic Restrictions: The Pharmaceutical Perspective,” Clinical Microbiology and Infection 12, Suppl. 5 (2006): 25–34.Google Scholar
Tillotson, G. S., “GAIN Act Legislation: Is It Enough?” The Lancet Infectious Diseases 12, no. 11 (2012): 823–824.Google Scholar
The 21st Century Cures Act, available at <https://www.congress.gov/bill/114th-congress/house-bill/6/text> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Avorn, J. and Kesselheim, A. S., “The 21st Century Cures Act: Will It Take Us Back in Time?” New England Journal of Medicine 372, no. 26 (2015): 2473–2475; Outterson, K., “All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act,” available at <http://emerald.tufts.edu/med/apua/news/news-newsletter-vol-30-no-1-4.shtml> (last visited February 7, 2018); S. A. Weissman Robert, Generating Antibiotic Incentives Now: GAIN — Or Just Greed, available at <http://www.huffingtonpost.com/anthony-so/antibiotic-resistance-_b_1572284.html> (last visited February 7, 2018).Google Scholar
Kostyanev, T. et al., “The Innovative Medicines Initiative's New Drugs for Bad Bugs Programme: European Public-Private Partnerships for the Development of New Strategies to Tackle Antibiotic Resistance,” Journal of Antimicrobial Chemotherapy 71, no. 2 (2016): 290–295.Google Scholar
DRIVE-AB: Driving Reinvestment in Research and Development for Antibiotics and Advocating Their Responsible Use, available at <http://drive-ab.eu/> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Morel, C. M. and Mossialos, E., “Stoking the Antibiotic Pipeline,” BMJ 340 (2010): 1115–1118.CrossRefGoogle Scholar
Renwick, M. J. et al., “A Systematic Review and Critical Assessment of Incentive Strategies for Discovery and Development of Novel Antibiotics,” Journal of Antibiotics 69, no. 2 (2016): 73–88.Google Scholar
DRIVE-AB Final Report, Revitalizing the Antibiotic Pipeline: Stimulating Innovation While Driving Sustainable Use and Global Access, available at <http://www.imi.europa.eu/projects-results/project-factsheets/drive-ab> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
WHO, Global Priority List of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics, available at <http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
JPIAMR, available at <http://www.jpiamr.eu/activities/evaluation-framework/mapping-exercise/> (last visited February 9, 2018).+(last+visited+February+9,+2018).>Google Scholar
Centers for Disease Control and Prevention, Antibiotic Resistance Threats in the United States, 2013, available at <https://www.cdc.gov/drugresistance/biggest_threats.html> and <https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf> (last visited February 7, 2018).+and++(last+visited+February+7,+2018).>Google Scholar
Jimena, A. T., Ferraro, S., and Mestre-Ferrandiz, J., “Incentives for New Drugs to Tackle Anti-Microbial Resistance,” available at <https://www.ohe.org/publications/incentives-new-drugs-tackle-anti-microbial-resistance> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Innovative Medicines Initiative, available at <https://www.imi.europa.eu/> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Action Plan against the Rising Threats from Antimicrobial Resistance, available at <https://ec.europa.eu/health/amr/action_eu_en> (last visited May 5, 2018).+(last+visited+May+5,+2018).>Google Scholar
ND4BB, available at <https://www.imi.europa.eu/projects-results/project-factsheets/nd4bb> (last visited May 5, 2018).+(last+visited+May+5,+2018).>Google Scholar
Deak, D. et al., “Progress in the Fight against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015,” Annals of Internal Medicine 165, no. 5 (2016): 363–372.Google Scholar
BEAM Alliance Position Paper, available at <https://beam-alliance.eu/assets/2015-Position-Paper.pdf> (last visited May 5, 2018).+(last+visited+May+5,+2018).>Google Scholar
EIB, InnovFin Infectious Diseases Finance Facility, available at <http://www.eib.org/products/blending/innovfin/products/infectious-diseases.htm> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar
Freire-Moran, L., Aronsson, B., Manz, C., Gyssens, I. C., So, A. D., Monnet, D. L., and Cars, O., ECDC-EMA Working Group, “Critical Shortage of New Antibiotics in Development against Multidrug-Resistant Bacteria-Time to React Is Now,” Drug Resistance Update 14, no. 2 (2011): 118–124; Theuretzbacher, U., “Accelerating Resistance, Inadequate Antibacterial Drug Pipelines and International Responses,” International Journal of Antimicrobial Agents 39, no. 4 (2012): 295-299.Google Scholar
Baraldi, E., Lindahl, O., Savic, M., Findlay, D., and Årdal, C., “Antibiotic Pipeline Coordinators,” Journal of Law, Medicine & Ethics 46, no. 2, Suppl. (2018): 25–31.CrossRefGoogle Scholar
UN, Transforming Our World: The 2030 Agenda for Sustainable Development, available at <https://sustainabledevelopment.un.org/post2015/transformingourworld> (last visited February 7, 2018); WHO, Health in 2015: from MDGs to SDGs, available at <http://www.who.int/gho/publications/mdgs-sdgs/en/> (February 7, 2018).+(last+visited+February+7,+2018);+WHO,+Health+in+2015:+from+MDGs+to+SDGs,+available+at++(February+7,+2018).>Google Scholar
Theuretzbacher, U. et al., “Market Watch: Innovation in the Preclinical Antibiotic Pipeline,” Nature Reviews: Drug Discovery 16, no. 11 (2017): 744–745.Google Scholar
BARDA, Technology Readiness Levels (TRLs), available at <https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx> (last visited February 7, 2018).+(last+visited+February+7,+2018).>Google Scholar