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Biomarker assays lacked performance standards until FDA guidance in 2013. The 2015 AAPS Crystal City VI Workshop fostered industry-FDA dialogue on biomarker measurement quality for drug development.

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Area of Science:

  • Biomarker research
  • Pharmaceutical industry
  • Translational research

Background:

  • Biomarker assays, crucial for drug development, historically lacked standardized validation and performance expectations.
  • This led to inconsistent data quality submitted to regulatory agencies like the US Food and Drug Administration (FDA).
  • The absence of clear standards impacted the reliability of biomarker data supporting efficacy and safety claims.

Framework:

  • The US Food and Drug Administration's (FDA) 2013 draft guidance on bioanalytical method validation addressed biomarker assays (LC-MS, LBA).
  • This guidance marked a shift towards establishing performance standards for biomarker measurements.
  • It aimed to standardize the quality of data used in drug development.

Implementation:

  • The 2015 AAPS Crystal City VI (CC VI) Workshop convened industry and FDA representatives.
  • This workshop served as a primary forum for discussing challenges in biomarker measurement, including endogenous levels.
  • It facilitated discussions on the strengths and weaknesses of various assay technologies.

Implications:

  • The CC VI Workshop fostered a shared understanding of biomarker measurement issues within the scientific community.
  • It informed the FDA about the current state of biomarker assay science.
  • The workshop established a foundation for ongoing dialogue and future advancements in biomarker assay validation and application.