Oncology
For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
Expedite payer coverage with surrogate endpoints
The idea of surrogate endpoints isn’t new, but they have matured with the increased adoption of accelerated pathways for regulatory approval. FDA will grant limited approval, but require confirmatory studies and as a result, sponsors need to prepare data and develop strategies earlier – for both regulators and payers.