Avid Bioservices Inc (CDMO)

[biopharm]

North, now the ex FDA commissioner speaks the truth and we are witnessing the great paradigm shift of our times in Big Pharma....

...The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

The comment came at the end of Woodcock's talk in which she also noted that use of master protocols (ie. protocols for trials that look at multiple therapies in a single disease or a single treatment in multiple diseases) and the development of new clinical trial networks "need to be the future."

Interesting times we live in where so much new scientific information is literally surfacing weekly

Flipped PS has always been there and always will....until targeted and BPs have decisions to make soon. Fight the new system and scientific data or keep looking for loopholes, some legal and many others not quite.

You know it's bad when we have the FDA coming out saying the system is broken