1. BIOSPECIMENS: The Source of Biomarkers Carolyn Compton, MD, PhD National Biomarkers Development Alliance Public Forum Arizona State University March 25, 2013

2. NBDA BIOSPECIMENS Biospecimen Analysis Biospecimen Collection Biospecimen processing and banking Molecular Data Biomarkers PERSONALIZED/PRECISION MEDICINE Biospecimen Processing, Banking, Data Capture QUALITY HERE DETERMINES QUALITY HERE

3. IMPACT OF POOR QUALTY BIOSPECIMENS ON BIOMARKERS  Irreproducible research results  Variations in gene expression data  Variations in post-translational modification data  Misinterpretation of artifacts as biomarkers  Potential for incorrect diagnosis  Morphological/immunostaining artifact  Skewed clinical chemistry results  Potential for incorrect treatment  Therapy linked to a diagnostic test on a biospecimen (e.g., HER2 in breast cancer)

4. NDBA BIOSPECIMENS AND BIOBANK  Poor quality biospecimens + High quality biorepository  High quality biospecimens + Low quality biorepository  High quality biospecimens +  High quality biorepository  NDBA   The right samples from the right patients at the right time  Evidence-based collection, processing, storage protocols  Quality verification at every step, every time  Rich, diverse data on every sample  Best specimen type for the intended assay “Fit for purpose” Purpose defined by analysis method for the target biomolecule type and the intended use of the analysis data