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What Keeps Cancer Drug Developers Awake at Night

This article was originally published in Start Up

Executive Summary

The range of comments, as well as the general tone, of a recent clinical cancer meeting prompted us to ask developers of cancer drugs what they saw as the major issues and hurdles in designing and testing new compounds. Their comments suggest that empirical methodologies, albeit informed by understanding of the biology around a target, will dominate clinical thinking in the near term. Clinical setbacks over the past several years, a lack of validated biomarkers, and an awareness that preclinical models are of limited utility in establishing dose and identifying likely responders, have reinforced that perception. Developers' principal concerns therefore often focus on things that are within their control; in particular, how to resource and manage a program for the long haul.

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