Pharmacogenomics In Drug Development Overview of Strategy for Pgx in Biopharma RD

Application of Pgx in drug development may support three main activities. First, to support identification of new drug targets, biomarker analysis of phe-notypically distinct patient groups may be incorporated into the program. Identification of Pgx associations may reveal novel mechanisms of molecular pathology and trigger design of new drug candidates. A second application is to monitor effects of drug candidates at different stages in the program. Early signs of PD effects (before clinical efficacy can be observed) may inform decision-making, elucidate or confirm drug mechanism, and identify target populations for design of later clinical trials. Third, Pgx may support stratification of the patient population to identify responsive patient subsets and to avoid adverse events may be applied in late development. Adoption of a Pgx-based therapeutic strategy may allow a market advantage, patent protection, or a more rapid move to frontline therapy for patients in the responsive subset. This last strategy could also provide a salvage strategy in the case of failed phase II/III trials if a sensitive or responsive patient subset can be identified.

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