Evidence map›Paper›PMID 40154576›Full record

ArticleThe Journal of allergy and clinical immunology2025

Biomarker-driven drug development for allergic diseases and asthma: An FDA public workshop.

Ronald L Rabin, Matthew C Altman, S Hasan Arshad, Richard D Beger, Pamela A Frischmeyer-Guerrerio, Elena Goleva, Robert G Hamilton, Gurjit K Khurana Hershey, Mohamed H Shamji, Hugh A Sampson and 10 more

Abstract readConference Proceedings
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of allergy and clinical immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Ronald L RabinCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md. Electronic address: ronald.rabin@fda.hhs.gov.
Matthew C AltmanUniversity of Washington, Seattle, Wash.
S Hasan ArshadClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.
Richard D BegerNational Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, Ark.
Pamela A Frischmeyer-GuerrerioNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Elena GolevaDepartment of Pediatrics, National Jewish Health, Denver, Colo.
Robert G HamiltonJohns Hopkins University School of Medicine, Baltimore, Md.
Gurjit K Khurana HersheyDivision of Asthma Research, Cincinnati Children's Hospital, Cincinnati, Ohio.
Mohamed H ShamjiImmunomodulation and Tolerance Group, Allergy and Clinical Immunology, Department of National Heart and Lung Institute, Imperial College London, London, United Kingdom.
Hugh A SampsonDepartment of Pediatrics, Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Alexandra F SantosDepartment of Women and Children's Health (Pediatric Allergy), School of Life Course and Population Sciences & Peter Gorer Department of Immunobiology, School of Immunology and Microbial Sciences, King's College London, and the Children's Allergy Service, Evelina London Children's Hospital, Guy's and St Thomas' Hospital, London, United Kingdom.
Wayne G ShrefflerFood Allergy Center, Division of Pediatric Allergy and Immunology, and the Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital, and the Department of Pediatrics, Harvard Medical School, Boston, Mass.
Alkis TogiasNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Md.
Stefan ViethsMolecular Allergology, Paul-Ehrlich-Institut, Langen, Germany.
Erik WambreJaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
Sally E WenzelDepartment of Environmental and Occupational Health, School of Public Health, University of Pittsburgh, Pittsburgh, Pa.
Kathleen HiseCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.
Joohee LeeCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.
Anubha TripathiCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.
Jay E SlaterCenter for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Md.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, National Institutes of Health staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform FDA of the status of various biomarkers in development. The workshop was divided into 3 sessions: (1) FDA and European Union regulators discussing regulatory perspectives on use of biomarkers in drug development programs, (2) investigators discussing biomarkers for pediatric and adult asthma, and (3) investigators discussing biomarkers for food allergy. In this report, we review the information presented at the workshop and summarize the current status of potential biomarkers for these allergic diseases.

Indexed as

AsthmaBiomarkersDrug DevelopmentFood HypersensitivityHypersensitivityHumansUnited StatesUnited States Food and Drug AdministrationBiomarkersAllergyasthmaatopic dermatitisbasophil activation testbiomarkersfood allergylymphocyte subsetsoral food challengeUS Food and Drug Administration

Identifiers

PMID40154576
PMCPMC12145241

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.