US FDA public meeting: identification of concepts and terminology for multicomponent biomarkers

Abena S Agyeman; Abbas Bandukwala; Khaled Bouri; Jessica Hawes; Daniel M Krainak; Samir Lababidi; William B Mattes; Elena V Mishina; Phillip Turfle; Sue-Jane Wang; Theresa Thekkudan

doi:10.2217/bmm-2023-0351

US FDA public meeting: identification of concepts and terminology for multicomponent biomarkers

Biomark Med. 2023 Jun;17(11):523-531. doi: 10.2217/bmm-2023-0351. Epub 2023 Sep 15.

Authors

Affiliations

¹ Division of Pharmacology & Toxicology-Rare Diseases, Pediatrics, Urologic & Reproductive Medicine, Office of New Drugs (OND), Center for Drug Evaluation & Research (CDER), US FDA, Silver Spring, MD 20993, USA.
² Division of Biomedical Informatics, Research, & Biomarker Development, OND, CDER, FDA, Silver Spring, MD 20993, USA.
³ Office of Regulatory Science & Innovation, Office of the Chief Scientist, Office of the Commissioner (OC), FDA, Silver Spring, MD 20993, USA.
⁴ Division of Systems Biology, Office of Research, National Center for Toxicological Research, FDA, Jefferson, AR 72079, USA.
⁵ Division of Radiological Imaging & Radiation Therapy Devices, Office of Radiological Health, Office of Product Evaluation & Quality, Center for Devices & Radiological Health, FDA, Silver Spring, MD 20993, USA.
⁶ Office of Data, Analytics & Research, Office of Digital Transformation, Office of the Commissioner (OC), FDA, Silver Spring, MD 20993, USA.
⁷ Office of the Center Director, Center for Food Safety & Applied Nutrition (CFSAN), FDA, College Park, MD 20740, USA.
⁸ Division of Individual Health Science, Office of Science, Center for Tobacco Products (CTP), FDA, Beltsville, MD 20705, USA.
⁹ Division of Companion Animal Drugs, Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM), FDA, Rockville, MD 20855, USA.
¹⁰ Division of Biometrics I, Office of Biostatistics, Office of Translational Sciences, CDER, Silver Spring, MD 20993, USA.
¹¹ Division of Nonclinical Science, Office of Science, Center for Tobacco Products, FDA, Beltsville, MD 20705, USA.

PMID: 37713233
DOI: 10.2217/bmm-2023-0351

Abstract

The US FDA convened a virtual public workshop with the goals of obtaining feedback on the terminology needed for effective communication of multicomponent biomarkers and discussing the diverse use of biomarkers observed across the FDA and identifying common issues. The workshop included keynote and background presentations addressing the stated goals, followed by a series of case studies highlighting FDA-wide and external experience regarding the use of multicomponent biomarkers, which provided context for panel discussions focused on common themes, challenges and preferred terminology. The final panel discussion integrated the main concepts from the keynote, background presentations and case studies, laying a preliminary foundation to build consensus around the use and terminology of multicomponent biomarkers.

Keywords: concepts; definition; multicomponent biomarkers; terminology.