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BIOMARKERS/BIOSIGNATURES Standards needed for Translational Research

BIOMARKERS/BIOSIGNATURES Standards needed for Translational Research. Standardized QUESTIONS in Clinical Trials Standardized PRACTICES in advancing pilot studies Standardized VALIDATION/VERIFICATION studies. Michael E. Berens, Ph.D.

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BIOMARKERS/BIOSIGNATURES Standards needed for Translational Research

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  1. BIOMARKERS/BIOSIGNATURESStandards needed for Translational Research • Standardized QUESTIONS in Clinical Trials • Standardized PRACTICES in advancing pilot studies • Standardized VALIDATION/VERIFICATIONstudies Michael E. Berens, Ph.D.

  2. Develop standardized QUESTIONS in ClinicalTrials that position success (“low hanging fruit”) from biomarkers/biosignatures • patient stratification for balancing the trial arms for equivalency (survival biomarkers) • patient eligibility into clinical trial (is the target present?) • tumor response/non-response to therapy (futility marker) to predict failure early • Include the ecosystem of players in the design of biomarkers/biosignatures (academic, industry, advocacy, regulatory, philanthropic, etc)

  3. Adopt standardized PRACTICES in advancing pilot studies using clinically-annotated specimens • Use specimens from no more than 3 sites to ensure minimal deviation from SOPs • Use best-in-class analytical partner matched to the analyte • Work in close collaboration with PK and PD correlative endpoints (best-in-class partner) • Operate in a parallel, blinded, limited competition model for maximal learning • Include the ecosystem of players in the design of PRACTICES  that enable biomarkers/biosignatures (academic, industry, advocacy, regulatory, philanthropic, etc)

  4. Conceive, deploy, test, iterate, and improve standardized VALIDATION/VERIFICATION studies with an eye to business development • Deploy Laboratory Developed Tests under CLIA (versus FDA) • Harmonizetest validation requirements between CMS and FDA • Portability &reproducibility testing by >3 performance sites • Work with regulatory groups on “gold standards” for highly complex or multi-plex analyte tests • Support as a thought-leader, FDA’s requirements to launch companion diagnostics with drug trials • Include the ecosystem of players in the design of VALIDATION/VERIFICATION studies for biomarkers/biosignatures (academic, industry, advocacy, regulatory, philanthropic, venture funding,  etc)

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