Biomarker Solutions

Biomarkers

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Why biomarkers?

Biomarkers are particularly useful when translating pre-clinical to clinical findings (bench-to-bedsite). Biomarkers can be helpful:

  • when difficulties arise in the decision-making process with regard to investigational new drug (IND) applications, i.e, when trying to extrapolate results from preclinical animal studies to the use in humans.
  • for proof-of-principle and proof-of-concept studies. In the field of drug research, a company will often undertake research initially, to prove that the core ideas are workable (proof-of-principle) and feasible, before going further (first-in man studies, first-in-patients studies). The use of “biomarker-enhanced” proof-of-concept studies helps to establish viability, technical issues, and overall direction.
  • For stratification of patients.During phase-I, early phase-II and in the subsequent process during late phase-II and phase-III (or even phase-IV studies), biomarkers can be helpful, i.e., to stratify proband and patient groups („personalized medicine“).

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