Accelerating the Development and Uptake of Rapid Diagnostics to Address Antibiotic Resistance Proceedings of a Workshop (2023) / Chapter Skim
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4 Incentives at the Intersection of Drug Development and Complementary Diagnostics
4 Incentives at the Intersection of Drug Development and Complementary Diagnostics
Pages 41-48
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From page 41... ...
Speakers in this session explored incentives and disincentives for the development of rapid diagnostics and new antibiotics and discussed innovative approaches to foster innovation at the intersection 41
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From page 42... ...
Pharmaceutical companies gain an increased probability of clinical trial success, safer drug prescription practices that protect drug efficacy and prevent misuse, and the opportunity to get a premium reimbursement because a higher medical value is being delivered to patients. For diagnostics companies, there is increased recognition of their medical value and opportunities for collaboration on market access, medical education and promotion, and reimbursement.
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From page 43... ...
BPP was used in ATTACK to enable early identification of ABC in respiratory samples from patients being evaluated for enrollment eligibil ity, said Miller. Although the BPP test can detect multiple viral or bacterial pathogens, only positive results for ABC were considered or documented for enrollment purposes in ATTACK.
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From page 44... ...
44 Narrow spectrum/pathogen specific antibiotic Example of an Acinetobacter specific antibiotic Potential subjects Eligible patients with confirmed Hospitalized adults with respiratory Rapid screening assay + infection symptoms Enrollment Positive result = Patients infected by inclusion criteria in the Acinetobacter baumannii Acinetobacter baumannii clinical trial 6 to Clinical Trial Optimization patients patient 10 screened 1 enrolled BIOMÉRIEUX FIGURE 4-1 Clinical trial with diagnostic screening SOURCE: Presented by Valérie Raymond-Schwartzmann, October 13, 2022; BIOMÉRIEUX, the BIOMÉRIEUX logo, PIONEERING DIAGNOSTICS are used, pending and/or registered trademarks belonging to bioMérieux, or one of its subsidiaries.
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From page 45... ...
Frank noted that these examples speak to the need for collaboration between antibiotic and diagnostic developers to share the risks associated with anti biotic development and increase the chances of success, as seen in the BPP/ ATTACK example discussed above. There are incentives available to sup port antibiotic development, said Frank, but it is unknown how effectively these incentives link support for antibiotic development with support for complementary susceptibility testing.
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From page 46... ...
. BARDA's 2022-2026 strategic plan contains a prominent commitment to combat antimicrobial resistance through approaches including reinvigorating the antibiotic pipeline and catalyzing innovation across the medical countermeasure pipeline.3 Sciaretta said that BARDA is more than a funding agency and is available to provide wraparound support and expertise in any stage of the product development cycle, including regulatory approval.
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From page 47... ...
He emphasized that it may be difficult to adjust existing funding programs, but this would still be easier than establishing a new incentive program solely dedicated to co-development. In terms of market incentives, Frank suggested that one approach could be a temporary add-on reimbursement for a new susceptibility test that, if crafted properly, could support more rapid uptake of susceptibility testing and help de-risk the process of bringing these diagnostic products to market.
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From page 48... ...
Frank added that the cost of enrolling patients in an antibiotic trial may be close to one million dollars, which is not a sustainable price for small or large companies. The more collaboration encouraged between diagnostics and pharmaceutical companies to de-risk the process and make trials more efficient, the better.
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