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Record W4400968083 · doi:10.1093/cid/ciae386

US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institutes of Health Co-Sponsored Public Workshop Summary—Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea

2024· article· en· W4400968083 on OpenAlexfundno aff
Hiwot Hiruy, Shukal Bala, James M. Byrne, Kerian Grande Roche, Seong H. Jang, Peter Kim, Sumathi Nambiar, Dan Rubin, Yuliya Yasinskaya, Laura H. Bachmann, Kyle Bernstein, Radu Botgros, Sue Cammarata, Ricardo L. Chaves, Carolyn Deal, George L. Drusano, Erin M Duffy, Ann E. Eakin, Steve Gelone, Thomas J. Hiltke, Edward W. Hook, Ann E. Jerse, Candice J. McNeil, Lori M. Newman, Seamus O’Brien, Caroline Perry, Hilary Reno, Raul A. Romaguera, Junko Sato, Magnus Unemo, Teodora Wi, Kimberly Workowski, Graeme A. O’May, Sunita J. Shukla, John Farley

Bibliographic record

VenueClinical Infectious Diseases · 2024
Typearticle
Languageen
FieldImmunology and Microbiology
TopicReproductive tract infections research
Canadian institutionsnot available
FundersCenter for Drug Evaluation and ResearchNational Institute of Allergy and Infectious DiseasesUniformed Services University of the Health SciencesNabriva TherapeuticsBiomedical Advanced Research and Development AuthorityCenters for Disease Control and PreventionPublic Health AgencyNovo NordiskPublic Health Agency of CanadaBundesministerium für Bildung und ForschungWellcome TrustAmerican Sexually Transmitted Diseases AssociationCombating Antibiotic-Resistant Bacteria Biopharmaceutical AcceleratorGilead SciencesGlaxoSmithKlineU.S. Food and Drug AdministrationModernaHenry M. Jackson FoundationDepartment of Health and Social CareNational Institutes of HealthAdministration for Strategic Preparedness and ResponseU.S. Department of Health and Human ServicesBundesministerium für Bildung und FrauenLouisiana State UniversityBill and Melinda Gates Foundation
KeywordsMedicineFood and drug administrationDisease controlGonorrheaDrugPublic healthAntimicrobialDrug developmentFamily medicineIntensive care medicineEnvironmental healthPharmacologyNursingHuman immunodeficiency virus (HIV)Microbiology

Abstract

fetched live from OpenAlex

There is an unmet need for developing drugs for the treatment of gonorrhea due to rapidly evolving resistance of Neisseria gonorrhoeae against antimicrobial drugs used for empiric therapy, an increase in globally reported multidrug-resistant cases, and the limited available therapeutic options. Furthermore, few drugs are under development. Development of antimicrobials is hampered by challenges in clinical trial design, limitations of available diagnostics, changes in and varying standards of care, lack of robust animal models, and clinically relevant pharmacodynamic targets. On 23 April 2021, the US Food and Drug Administration, Centers for Disease Control and Prevention, and National Institute of Allergy and Infectious Diseases of the National Institutes of Health co-sponsored a workshop with stakeholders from academia, industry, and regulatory agencies to discuss the challenges and strategies, including potential collaborations and incentives, to facilitate the development of drugs for the treatment of gonorrhea. This article provides a summary of that workshop.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.018
metaresearch head score (Gemma)0.010
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Other · Consensus signal: none
Teacher disagreement score0.037
Threshold uncertainty score0.123

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0180.010
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0010.001
Science and technology studies0.0020.001
Scholarly communication0.0050.002
Open science0.0030.004
Research integrity0.0130.011
Insufficient payload (model declined to judge)0.0370.009

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.063
GPT teacher head0.396
Teacher spread0.333 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreOther

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations6
Published2024
Admission routes1
Has abstractyes

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