As companies move into development of drugs against novel targets, including a host of genomically derived drugs, they are assuming a new kind of target risk. The heightened risk exists largely because the targets revealed by genomics techniques for the most part have not been validated by linking them empirically to the initiation or maintenance of a disease state, nor through the use of biomarkers during clinical development. Stumbles in the pursuit of drugs against EGFR are symptomatic of this new pharma industry problem. In this context, the cancer drugs Herceptin and Gleevec, widely touted as the first examples of rapidly developed, rationally designed molecular medicines, will prove to be much more the exception than the rule. And importantly, the emerging pattern of EGFR drug development suggests that pursuit of novel targets will do little to ameliorate the industry's R&D productivity problem.
by Mark L. Ratner
When ImClone Systems Inc. finally acknowledged last December that the US Food and Drug Administration had raised substantial issues...
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