There is increasing interest in the application of biomarkers and surrogate endpoints in healthy volunteer studies.

Biomarkers provide pivotal information on efficacy, dose-response and time-effects of drugs. ICON has worked extensively in this area, developing and validating pharmacodynamic models for investigating a range of therapeutic targets, as part of its own research and development efforts and in partnership with Sponsors. These specialist techniques fall broadly into two categories.

PD Models of Disease State

Use of healthy volunteer models has proven to be fast and reliable for determining if a drug has the necessary characteristics to be taken forward into more expensive patient trials. The dedicated Clinical Pharmacodynamics group at ICON has developed and validated a variety of pharmacodynamic models in a broad range of therapeutic areas, including:

  • Pain (acute and chronic)
  • Inflammation
  • Appetite/Obesity
  • Anxiety
  • Cognitive Function
  • Metabolic Function/Diabetes
  • Sexual Dysfunction

Techniques for Specific PD Responses

When a protocol requires the inclusion of a specific technique that is out of the normal scope of a CPU, the PD group is responsible for identifying, validating and testing the equipment. A wide list of techniques is offered by ICON covering tests for sedation, CNS imaging, physiological assessments and mood assessments.