title: Building a roadmap to biomarker qualification: challenges and opportunities.
abstract: The traditional route for regulatory acceptance of biomarkers in drug development is through submission of biomarker data in drug approval submissions in the context of a single drug development program. The US FDA's Critical Path Initiative called for establishment of a biomarker qualification process to enable progress in the drug development paradigm. In response to this, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to qualify a biomarker for a specific context of use (COU). The qualified biomarker can then be used in multiple drug development programs for this COU without re-review. Here, we describe some of the features of the BQP and two new initiatives that have the potential to aid biomarker development through early interactions with the FDA. Finally, we discuss some of the feedback the FDA has received from submitters and the BQP's actions to strengthen the program.
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: Shashi G
authors.initials: SG
authors.lastname: Amur
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: Sarmistha
authors.initials: S
authors.lastname: Sanyal
authors.affiliation: Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, MD 20993-0002, USA.
authors.forename: Aloka G
authors.initials: AG
authors.lastname: Chakravarty
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: Marianne H
authors.initials: MH
authors.lastname: Noone
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: James
authors.initials: J
authors.lastname: Kaiser
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: McCune
authors.affiliation: Office of Translational Sciences, Center for Drug Evaluation & Research, US Food & Drug Administration, Silver Spring, Maryland, MD 20993-0002, USA.
authors.forename: ShaAvhree Y
authors.initials: SY
authors.lastname: Buckman-Garner
mesh_terms: D015415:Biomarkers / Q000032:analysis*; D002648:Child; D002986:Clinical Trials as Topic; D055808:Drug Discovery; D006801:Humans; D038622:Internationality; D011634:Public Health; D012306:Risk; D012926:Social Control, Formal; D013223:Statistics as Topic
chemical_list: D015415:Biomarkers
keywords: biomarker; context of use; critical path innovation meeting; evidentiary considerations; international harmonization; letter of support; qualification; regulatory science; statistical considerations; submitter