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BIOMARKERS

A biomarker is a molecule/image, changes (qualitative or quantitative) in which are correlated with specific clinical phenotypes or outcomes.


Uses of Biomarkers:

  As a diagnostic to predict patient outcome or response to therapy
  As a surrogate endpoint in a clinical trial leading to smaller, shorter and successful clinical trials


Biomarkers in Oncology Drug Development

Biomarkers and their measurement have particular significance in cancer where most new drugs are targeted therapeutics:

  Confirmation of a drug's pharmacological or biological mechanism of action
  As an aid for clinical trial protocol design
  Patient selection, dose selection and minimization of safety risks
  Extraction of DNA and RNA from snap-frozen tissue and blood
  As an aid to corporate decision making at go/no-go milestones
  Data to justify accelerated provisional regulatory approval of a drug


Triesta's oncology programs have been set up on the basis of global and local disease prevalence.