Thursday, September 22nd
4:30pm-6:00pm EDT


Topical Workshop


Assessment, Diagnosis & Measurement of Pain


715 B

Integration of Pain Biomarkers into the Therapeutic Development Process and into Clinical Practice

Development of novel pain therapeutics continues to present significant challenges, demonstrated by data showing only a 2% probability of drug approval for Phase I candidate pain therapeutics compared to an overall 10% probability in other disease areas.  One reason for the low probability of clinical success is the lack of biomarkers that can facilitate dose selection and clinical trial design.  It has been shown that patient selection biomarkers can improve clinical success by as much as 17.5%.  This presentation provides an overview of the different uses for biomarkers and how each type of biomarker is utilized in the therapeutic development process.  Evidentiary criteria for biomarker validation will also be discussed, followed by a brief overview of how biomarker development has been integrated into the therapeutic development programs supported by the HEAL initiative. The NIH HEAL Initiative supports the development of biomarkers for pain with funding opportunities that encourage a rigorous, milestone-driven approach aligned with FDA standards. Further, HEAL offers separate opportunities to develop biomarkers in conjunction with therapeutic development and clinical testing as part of its Early Phase Pain Investigation Clinical Network (EPPIC-Net) and the HEAL Therapeutic Development Program.


Dr. Mary Ann Pelleymounter

Program Director