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Review
. 2025 Jun;155(6):1753-1766.
doi: 10.1016/j.jaci.2025.03.014. Epub 2025 Mar 26.

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

Ronald L Rabin  1 , Matthew C Altman  2 , S Hasan Arshad  3 , Richard D Beger  4 , Pamela A Frischmeyer-Guerrerio  5 , Elena Goleva  6 , Robert G Hamilton  7 , Gurjit K Khurana Hershey  8 , Mohamed H Shamji  9 , Hugh A Sampson  10 , Alexandra F Santos  11 , Wayne G Shreffler  12 , Alkis Togias  5 , Stefan Vieths  13 , Erik Wambre  14 , Sally E Wenzel  15 , Kathleen Hise  16 , Joohee Lee  16 , Anubha Tripathi  16 , Jay E Slater  16
Affiliations
Review

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

Ronald L Rabin et al. J Allergy Clin Immunol. 2025 Jun.

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.

Keywords: Allergy; US Food and Drug Administration; asthma; atopic dermatitis; basophil activation test; biomarkers; food allergy; lymphocyte subsets; oral food challenge.

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Conflict of interest statement

Disclosure statement Funded with Center for Biologics Evaluation and Research, USFood and Drug Administration internal funds. The opinions expressed herein are an informal communication and represent the best judgment of R.L.R., R.D.B., J.L., K.H., A.T., and J.E.S. They do not bind or obligate the US Food and Drug Administration. Disclosure of potential conflict of interest: M. C. Altman reports personal fees from Sanofi-Regeneron outside the submitted work. G. K. Khurana Hershey reports grants from Adare outside the submitted work. E. Goleva reports grant funding from Sanofi/Genzyme outside of submitted work. H. A. Sampson receives funding to his institution for grants from National Institutes of Health (NIH)/National Institute of Allergy and Infectious Diseases (NIAID); has received consulting fees from DBV Technologies, N-Fold Therapeutics, Alpina Biotechnology, and Siolta; and has received stock options from DBV Technologies and N-Fold Therapeutics. A. F. Santos reports grants from Medical Research Council (MR/M008517/1, MC/PC/18052, MR/T032081/1), Food Allergy Research and Education (FARE), the Immune Tolerance Network, NIAID, NIH, Asthma UK (AUK-BC-2015-01), the Biotechnology and Biological Sciences Research Council, Rosetrees Trust, and the National Institute for Health Research through the Biomedical Research Centre award to Guy’s and St Thomas’ NHS Foundation Trust; consultancy fees from Thermo Fisher Scientific, Novartis, Stallergenes, Allergy Therapeutics, Nestle, and IgGenix; and research support from IgGenix and Thermo Fisher Scientific through collaboration agreements with King’s College London. M. H. Shamji reports grants from Regeneron, Merck, ANGANY, Allergy Therapeutics, and Immune Tolerance Network; personal fees from Allergopharma; and grants and personal fees from ALK, Allergy Therapeutics, ANGANY, and Sanofi. W. G. Shreffler has received clinical trial funding from Aimmune Therapeutics, ALK, Celgene, DBV Technologies, Genentech, Novartis, Regeneron Pharmaceuticals, and Vedanta; served on scientific advisory boards for Aimmune Therapeutics and FARE; received personal consulting fees from Aimmune Therapeutics/Nestlé, Harmony, Merck, and Novartis; received royalties from UpToDate; and received grants from the NIH, the Demarest Lloyd Foundation, the Thornhill Foundation, and the Food Allergy Science Initiative. E. Wambre receives grant support from the NIAID, the National Cancer Institute, FARE, and the Immune Tolerance Network; and research sponsorship from Regeneron Pharmaceuticals, Astellas Pharma, COUR Pharma, and Aimmune Therapeutics. S. E. Wenzel receives grant funding from Regeneron; serves as a scientific advisor for Aer Therapeutics. The rest of the authors declare that they have no relevant conflicts of interest.

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