Agnes Shanley

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

Despite the persistence of the patent thicket, and slow uptake by the medical community, biosimilars are positioned for growth in the US.

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.

Joerg Ahlgrimm has left Lonza and is now leading The Discovery Labs’ mission to establish a powerhouse for cell and gene therapy development and manufacturing in the Philadelphia area.

Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.