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    Roadmap for developing and validating therapeutically

    Among the lessons learned from the aftermath of Hurricane Katrina was that effective disaster response requires planning followed by the execution of training and exercises to validate those plans.The Federal Emergency Management Agency (FEMA) is responsible for disaster response planning.Although not identified as the primary biomarker in the study protocol, on the basis of preclinical results from 2 independent laboratories, expression levels of the HER3 ligand heregulin (HRG) were prospectively declared the predictive biomarker before data unblinding but after subject enrollment.

    Here we discuss the basis of this shift toward genomic computational integrative approaches that has precedence in scalar theories of biological information and is aptly warranted for exploitation in drug repurposing.“…HERALD (NCT02134015) was a double-blind, phase 2 study in patients with non-small cell lung cancer (NSCLC) randomized to erlotinib with placebo or with high or low doses of patritumab, a monoclonal antibody targeted against human epidermal growth factor receptor 3 (HER3).While the primary objective was to assess safety and progression-free survival (PFS), a secondary objective was to determine a single predictive biomarker hypothesis to identify subjects most likely to benefit from the addition of patritumab.We present a case study of a prospective–retrospective approach for a continuous biomarker identified after patient enrollment but defined prospectively before the unblinding of data.An analysis of the strengths and weaknesses of this approach and the challenges encountered in its practical application are also provided.

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