ElMaestro
★★★

Denmark,
2017-01-01 23:47
(2643 d 07:12 ago)

Posting: # 16921
Views: 2,181
 

 The Rubbish Gambit [Design Issues]

Dear all,

Happy New Year.

One thing that really sucked for me in 2016 (well, it actually sucked more for my clients) was a phenomenon which I refer to as the Rubbish Gambit and which is now promoted by several CROs.
It is an approach that apparently may allow early detection of optimal formulation candidates and promotional bull to the same effect.
The Rubbish Gambit targets decision-makers at companies that are caught in IVIVC trouble with high-profile formulations, and that includes inhalation product developers and biosimilar developers. There are some extreme blockbusters going off patent these years, and for some of these products the ability of any in vitro technique (like impactors and other PSD measuring tools for inhalation products) to predict in vivo BE outcome is just abysmally bad. We are talking apocalyptic performance here, and there is zero literature that really covers it well. Many have tried itm, most have failed, the failers don't generally publish their fiascos. Some companies have invested huge sums in these products and they are desperate to find something that works. Really works.

Cheap. Fast. And yesterday.

And this is where companies develop a range of candidate formulations. There is no way around it, they need in vivo testing of the formulations. And that's when the Rubbish Gambit is offered:
[image]

It is spreading like a whirlwind from CRO to CRO, I think, quite possibly all fueled by desperation among Sponsors. Some CROs approached me and offered it without relation to a specific client.

I have talked to a few Sponsors interested in the decision tree, and I have asked them if they have looked into how efficient this approach is at picking a good formulation. They don't know. I have asked them if they have looked into how likely this approach is at making someone take a bad decision. They don't know. But they just like the selling point - Early detection of good candidate formulations blah blah. They guys in Armani suits roaming the executive floor at the Sponsor companies have dollar signs in their eyes just like Uncle Scrooge. And so have the business developers at CROs.

As I see it, it is extremely simple: When there is a very high degree of uncertainty on a point estimate, then it can be a pretty bad idea to base any decisions on it. Fortunately, there is still a safe choice: Avoidance of the Rubbish Gambit. It specifically avoids the risk associated with the Rubbish Gambit. :cool:;-):-):-):-D

Thank you for reading. And all the best for 2017 to all of you.

Pass or fail!
ElMaestro
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