Bioequivalence and Bioavailability Forum

Hi David,

❝ I can't understand how sponsors risk their business for 40 ou 50k€

yes, that's right but there are many nuances.
People in Gx companies who solicit these trials are often in a terrible bind. They may get fired if they don't meet their annual goals, and that may involve a certain number of trials within a given and unrealistic budget. They do not necessarily have freedom to operate within what we would call reasonable limits. It is easy enough for you and I to say this is the recipe for failure but you try and explain that to a penguin who fiercely guards his spreadsheet and basically doesn't give a sh!t because he isn't a scientist and does not understand what quality is. he understands what money is. Like you say. All about money.

I could name several people who were forced into buying trials from subpar CROs and afterwards were sacked because the CROs were caught cheating. If you see a way to get rid of the Lean concept in the way it is currently being totally used and misused in the industry then there is a way forward. I have no idea myself. It has to involve a buy-in from top management, not from middle managers.

Finally, this isn't actually about just Generics. It is also about innovator meds.