Companion Diagnostics: Strategies to Optimize Performance in the Era of Precision Medicine

Informed drug development in an era of “precision medicine” requires a clear understanding of the risks and benefits that accompany the pursuit of companion diagnostics, a difficult objective given the complexity and rapid evolution of the field.

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The Breakthrough Therapy Designation

What are the key advantages and disadvantages for a biopharmaceutical company to consider prior to pursuing the breakthrough therapy pathway?

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