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J Med Oncl Ther 2017 | Volume 2 Issue 4
Oncology and Biomarkers Summit
November 27-28, 2017 | Atlanta, USA
Annual Congress on
B
iomarkers have been used in drug development and
clinical practice for many years. Despite this, there has
been confusion about the definitions and inconsistent use
of key terms–including biomarkers and surrogates. Recently,
an FDA-NIH Biomarker Working Group developed a glossary
of terms and definitions to ensure consistency and clarity,
termed BEST (Biomarkers, Endpoints and other Tools), to
advance scientific progress. The “BEST” glossary describes
seven categories of biomarkers: diagnostic, prognostic,
susceptibility/risk, predictive, pharmacodynamic/response,
monitoring and safety biomarkers. Concepts important in
developing biomarkers for use in drug development include:
need for biomarkers in a specific disease; purpose of use;
how the biomarker performs compared to current standards;
development and analytical validation of a reproducible,
sensitive and accurate assay to measure the biomarker of
interest; and clinical validation that establishes the use of the
biomarker for a specific purpose. These biomarkers can be
integrated into drug development through the drug approval
process and through qualification of the biomarkers through
the Biomarker Qualification Program. An additional route
also exists where a biomarker gains regulatory acceptance of
biomarkers that have evolved through scientific community
consensus. CDER, FDA, has developed efforts to encourage
development of biomarkers for use in drug development;
Critical Path Innovation Meeting (CPIM) Program and the
Letter of Support (LOS) initiative. The CPIM can be utilized
to discuss biomarkers in the early phase of development
and not yet ready for the Biomarker Qualification Program
(BQP) with FDA and receive advice. The goal of the LOS is
to enhance the visibility of the biomarker, encourage data
collection and sharing and potentially stimulate additional
scientific studies.
e:
shashi.amur@fda.hhs.govCDER initiatives to encourage biomarker use in drug development
Shashi Amur
FDA, USA