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Risks and Rewards of Using Surrogates to Accelerate Commercialization

Executive Summary

Surrogate endpoints, including biomarkers, are a great idea, a legitimate way to speed drug development and thus lower cost and risk. But their use is also problematic from both scientific and, especially, regulatory points of view. Still, the investment proposition is too compelling to ignore, and companies such as KAI Pharmaceuticals, HaptoGuard, and Perlegen are using them in various ways to find drugs, speed their development, or make their eventual marketing more effective.
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