The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

In this free webinar, understand the key benefits of master protocols. Attendees will identify the key challenges of master protocols and strategies to address them. The featured speakers will discuss ...

Five biopharma companies will soon be testing their lung cancer compounds in a very different type of clinical trial. The Lung Cancer Master Protocol will test multiple novel drugs simultaneously ...

As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of ...

The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent ...

Business as usual has not been the mantra for companies developing Covid-19 vaccines and drugs. Instead, biopharma companies and their partners pursued various transformational approaches to get ...

Bortezomib, lenalidomide, and dexamethasone (VRd) ± daratumumab (DARA) in patients (pts) with newly diagnosed multiple myeloma (NDMM) for whom transplant is not planned as initial therapy: A ...

Timing of Adjuvant Chemotherapy After Gastrectomy in Patients With Stage II to III Gastric Cancer: A Target Trial Emulation Study Master protocols represent transformations, enabling multiple ...

Pilot project will bring drug companies together to test targeted lung-cancer therapies. You have full access to this article via your institution. In the push to match medical therapies to the ...