Agnes Shanley

New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?

Advances in development, data management, and automation, and closer collaboration with contract development and manufacturing partners, are pushing more therapies closer to commercialization.

A former Team Biologics' whistleblower’s complaint raises questions about FDA inspector training and support, as well as GMP noncompliance patterns at biologics facilities.

Single-use equipment, analytics, and automation may add complexity, but they are reducing scale-up costs and timelines.