Timmerman, Philip, Barfield, Matthew, Bartlet, Jon G., Blattmann, Peter, Boehm, Nils, Christodoulou, Louis, Kjelgaard, Cecilie Freja Dalby, Iles, Tracy, Iltzsche, Fabian, Klinge, Marco, Henderson, Leslie, Monk, Lee, Nelson, Robert and Liu, Yang-19 (2025) Navigating IVDR challenges for pharmacokinetic, anti-drug antibodies, andbiomarker assays in early clinical research: a recommendation from the EuropeanBioanalysis Forum. Bioanalysis, 17 (14). pp. 889-892. ISSN 1757-6180

Abstract

The European Bioanalysis Forum has observed increasing misclassification of pharmacokinetic, anti-drug antibody, and biomarker research assays not used for patient management under the EuropeanUnion’s In Vitro Diagnostic Regulation, despite their non-diagnostic intent in early clinical development.This misinterpretation, fueled by ambiguous protocol language, limited cross-functional awareness, andinconsistent national implementation, is leading to unnecessary delays in clinical trials and increasedand non-added value regulatory burden. Through a structured evaluation involving a focus workshopand regional roadshows, the European Bioanalysis Forum identified some manageable origins of theissue and its operational consequences. This recommendation paper outlines these observations andwants to propose a pragmatic path forward. This includes clearer regulatory guidance to exemptnoncommercial, non-diagnostic assays from In Vitro Diagnostic Regulation when not developed orintended as registered diagnostics. We also highlight the importance of stakeholder education andcoordinated regulatory dialogue. These steps aim to preserve the regulator’s intent of patient protec-tion while enabling timely and efficient clinical research.

Item Type:	Article
Keywords:	IVDR challenge, bioanalytical assay
Date Deposited:	06 Sep 2025 00:46
Last Modified:	06 Sep 2025 00:46
URI:	https://oak.novartis.com/id/eprint/58309