Michelle Hoffman

At a time when the industry is struggling with innovation, it might do well to learn a lesson from a few great innovators.

A report commissioned by FDA evaluates the QbD paradigm.

Are biosimilars the next big thing or just the next big bubble?

Which route will we take to arrive at a national stem-cell policy?

Those who doubt there's faith in science, should check out our annual Bioprocessing Survey.

Research and development headed for divorce.

Capable of great works, pharma too often yields to the lesser angels of its nature

So often a leader on the world stage, the US is a laggard when it comes to regulating follow-on biologics.