Transition of Biomarkers to Surrogate Endpoints: A Critical Path Initiative….. …..Introduction.
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Clinical Pharmacology Subcommittee of ACPSNovember 4, 2004Lawrence J. Lesko, Ph.D., FCPDirector, Office of Clinical Pharmacology and BiopharmaceuticsCenter for Drug Evaluation and ResearchFood and Drug Administration
Biologisk markor Biomarqueur
Biologische merker Marcatore biologico
Biologischer marker Marcador biologico
Biomarker (Biological Marker): A characteristic that is measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.
Surrogate Endpoint: A biomarker intended to substitute for a clinical endpoint.
"Critical Path" Paper Calls for Academic Researchers, Product Developers, and Patient Groups To Work With FDA To Help Identify Opportunities to Modernize Tools for Speeding Approvable, Innovative Products To Improve Public Health
“Adopting a new biomarker or surrogate endpoint for effectiveness standards can drive clinical development. For example, FDA adoption of CD4 cell counts and, subsequently, measures of viral load as surrogate markers for anti-HIV drug approvals allowed the rapid clinical workup and approval of life-saving antiviral drugs…..”
From “Innovation/Stagnation – Challenge and Opportunity on the Critical Path to New Medical Products” (2004), p. 21.
“Additional biomarkers (quantitative measures of biological effects that provide informative links between mechanism of action and clinical effectiveness) and additional surrogate markers (quantitative measures that can predict effectiveness) are needed to guide product development.”
From “Innovation/Stagnation – Challenge and Opportunity on the Critical Path to New Medical Products” (2004), p. 23.
(1) General, conceptual framework to continuously reduce uncertainty associated with biomarkers over the course of the entire drug development process
(2) Better articulate the standards or specifications to validate and accept biomarkers for intended use including surrogates for registration, and any extensions of their application, e.g., additional drug classes