Biomarkers and Targeted Therapies Usage

A 2010 survey conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that sponsor companies are allocating resources, modifying organizational structures, and increasing investment in the development of personalized medicines (i.e., tailoring of medical treatment and healthcare delivery based on individual patient characteristics including genetic, molecular, and imaging).

The average percentage of company pipelines relying on biomarker data.

Responses from 25 companies show that all sponsors are using biomarkers and/or targeted therapies to evaluate compounds in discovery. The use of biomarkers and/or targeted therapies in clinical are less common at this time, with the highest incidence in early stages of development. Nearly 60 percent and 50 percent—on average—of sponsor company preclinical and Phase I/IIA clinical pipelines respectively rely on biomarker data. Only a third of late stage Phase IIb/IV clinical pipelines—on average—rely on biomarker data. The Tufts CSDD found that oncology is the therapeutic area the farthest along in integrating biomarkers and diagnostics. Development programs in cardiovascular, CNS, and immunologics are less advanced than oncology but they are making headway in integrating personalized medicine practices.— Tufts Center for the Study of Drug Development, http://csdd.tufts.edu