Discovery of Biomarkers of Response in Early Drug Development.

Ulcerative colitis and Crohn's disease have traditionally been managed by incrementally stepping up within a hierarchy of therapeutic classes consequent to failing a given therapeutic─necessitated by the notion that any type of therapeutic will only induce clinical response and remission in a fraction of, but not all, patients. Hence, the selection of therapies approximates stage of disease rather than patient-specific characteristics that would allow selection of a specific mechanism of action for therapeutic intervention. Development of prognostic biomarkers [to identify patients with more aggressive disease and a worse prognosis], as well as predictive biomarkers [to predict response or non-response to a particular therapy], has been identified as a key requirement for attainment of better overall response rates or to improve the response of the most severely ill patient subgroup. Since the state of biomarker development is early and the process in inflammatory bowel disease appears more complex than in other therapeutic areas such as oncology, profiling of potential biomarkers across broad populations of undifferentiated patients will be important in refining current hypotheses and progressing their study and validation.