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Problems With Biomarkers: A Tale of Three Drugs

Executive Summary

Enthusiasm for biomarkers to guide drug development and clinical decision making is high, but given how little we know about them, biomarkers are a risky investment, as shown by experiences with EGFR inhibitors.

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Companion Diagnostics Move Toward Mainstream Drug Development

With FDA planning to release guidelines on companion diagnostics by year's end, private sector activity around biomarkers appears ready to accelerate. Pharma companies are taking different strategies to incorporate companion diagnostics into their drug development programs, and experimenting with different applications for co-developed products. The relationship between Pharma and diagnostics companies is evolving, with Pharma leading the way. The pace of dealmaking is picking up, but in negotiating partnerships, both sides are still struggling with how to reconcile their different business models, cost structures, and appetites for risk.

Companion Diagnostics Move Toward Mainstream Drug Development

With FDA planning to release guidelines on companion diagnostics by year's end, private sector activity around biomarkers appears ready to accelerate. Pharma companies are taking different strategies to incorporate companion diagnostics into their drug development programs, and experimenting with different applications for co-developed products. The relationship between Pharma and diagnostics companies is evolving, with Pharma leading the way. The pace of dealmaking is picking up, but in negotiating partnerships, both sides are still struggling with how to reconcile their different business models, cost structures, and appetites for risk.

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