CORESTA Meeting, Smoke Science/Product Technology, 2017, Kitzbühel, ST 41

Biomarker assay validation: the gold, silver, bronze approach

Celerion Inc., Lincoln, NE, U.S.A.

Biomarkers are an important tool for helping the tobacco industry understand their products and to help register new products. Biomarker data are the most common tool used to support “scientific evidence of substantial overall reductions in exposure to the harmful substance(s)” in the FDA guidance for an modified risk tobacco product (MRTP) application. The pharmaceutical industry has held many workshops on biomarker validation and the tobacco industry can learn from those workshops. The information obtained from most biomarkers can be classified as “nice-to-have” versus “need-to-have.” Obviously, the amount of validation effort will be much different between “nice-to-have” versus “need-to-have” biomarkers. Problems arise however when it is desired to include data validated at a “nice-to-have” level in a regulatory submission. Therefore, it is important to understand the life cycle of biomarker assays. This presentation will define the uses and the fit-for-purpose validation for the following phases of a biomarkers life:

  • Regulatory need → “Gold”
  • Key-decision making → “Silver”
  • Exploratory → “Bronze”

This presentation will offer a strategy for all stakeholders of a project (medical directors, clinical pharmacologists, statisticians and the bioanalytical group) to have a common simple terminology for the life cycle of biomarkers.