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:

New surrogate endpoints need resolution of ‘reasonably likely’
⁠Regulatory clarity, consistency, key to taking accelerated approval outside of cancer

Turning biomarkers into surrogates, starting with the familiar
⁠Mining decades of clinical practice, three fields are making surrogate endpoints out of common prognostic markers

How omics will drive the next generation of surrogate endpoints
⁠Next-gen tools offer more complete views of disease, drug response, but constraining their outputs is key

Standards of evidence for accelerated approval: a BioCentury Back to School podcast
The complexities of creating an approvable data package for accelerated approval