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On Tuesday, Back to School focuses on the first stage, creating an approvable data package, where the big issue centers on the standards of evidence required for an accelerated or conditional approval. Senior Editor Lauren Martz picks apart the issues surrounding surrogate endpoints, homing in on the standard, defined by law, that requires these to be “reasonably likely” to predict clinical benefit, and the complexities that creates.
Senior Editor Karen Tkach Tuzman picks up the thread with an article on emerging surrogate endpoints nearing approval. In a separate article, she takes the long view, examining how next-generation omics tools are converging to support the stretch vision by creating insights into disease biology that could fuel a radically expanded biomarker toolbox, and a growing roster of surrogate endpoints across many diseases.
To view Tuesday's Back to School content, click on the links below: