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Biomarkers of disease are assuming an ever increasing role in the discovery and development of drugs. ICON has long recognized their importance in all phases of the development process and has built significant expertise in biomarker development and analysis. Working closely with sponsors, our global laboratory groups (Bioanalytical, Central and Imaging) and our Clinical Pharmacodynamics team lead the industry in biomarker research utilizing the latest scientific innovation and state-of-the-art development platforms.

Identifying markers of clinical response can add pivotal information concerning efficacy, dose response and the time course of drug effects to the standard safety, tolerability and pharmacokinetic (PK) packages traditionally included in Phase I study designs.

In 1993, ICON established its Clinical Pharmacodynamics Department as a dedicated scientific group supporting the development of PD techniques in association with ICON's Clinical Pharmacology Units (CPU). These techniques fall broadly into two categories:

• Pharmacodynamic models of disease state ICON has successfully modeled a number of complex pathologies in a wide range of clinical areas e.g. Neuropathic Pain, Anxiety, Cognitive Degeneration. 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.
• Techniques designed to initiate 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.