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August 16, 2016

Best Practices for Integrating Biomarkers across the Drug Development Continuum

The use of biomarkers throughout all phases of the drug development process plays an increasingly important role in the drug approval process.  Biomarkers used in early discovery stages of drug development enable companies to identify the most promising drug candidates in preparation for preclinical studies.  Preclinical studies enable drug developers to characterize the safety, efficacy and toxicity of the early drug candidates.   The value of a well-designed biomarker strategy then extends to first-in-human studies where the drug’s activity, mechanism of action, safety, and proof of concept are tested.  Once a drug candidate- enters phase II studies, the use of biomarkers shifts to identifying subjects that may have better responses to the drug, safety, decisions on dosing, as well as prognostic purposes.  A well-designed biomarker- strategy is the cornerstone for utilizing precision medicine in a study and determining the right treatment for the right patient.  Biomarkers that demonstrate usefulness in patient selection or patient responsiveness may be utilized in further phase III studies and ultimately may lead to diagnostic markers.   

This presentation covers important concepts of biomarker usage throughout the drug development process and provide case studies that demonstrate the value of biomarkers. 


Patrice Hugo, PhD, Chief Scientific Officer 
Patrick Hurban, PhD, Senior Director and Global Head, Genomic Development/Esoteric Assays 
Linda Robbie, PhD, Senior Director, Biomarkers and Global Translational Science Laboratory 
Radha Krishnan, MD, Chief Pathologist and Senior Medical Director 

Best Practices for Integrating Biomarkers across the Drug Development Continuum

A roadmap for a successful biomarker strategy

Planning and implementing biomarker testing for immuno-oncology trials

Exploring the challenges with the diverse clinical biomarker requirements

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