Podcast: Frustration with outdated FDA-regulatory process and Solutions

[Desmond84]

Really nice podcast on how to reduce pressure on innovative companies coming up with state of the art novel therapeutics and the cost FDA imposes on them that sees most of them shelved or delayed by 1-2 decades.

"Richard Barker is Executive Director of the Centre for the Advancement of Sustainable Medical Innovation (CASMI) CASMI is a partnership between Oxford University and UCL, created to develop new structures for medical innovation. CASMI aims to address the issues that have led to current failures in the translation of basic bioscience into affordable and widely adopted new treatments. In this podcast we discuss Richard Barker’s current book 2030 - The Future of Medicine Avoiding a Medical Meltdown and how his vision in this book translates to CASMI. Sit back and learn how you can help expedite cures from the regulator to the patient. Learn about fascinating new tools for diagnosis and treatment. Get involved, this is the future, your future!"

http://biotroveinvestments.com/biotr...richard-barker

[Desmond84]

If these guys got enough publicity, Histogens HSC would be out in less than 6 months!

[hellouser]

Why not just give USA the finger and run trials elsewhere and release the treatment in an ACCEPTABLE timeframe?

[It's2014ComeOnAlready]

What about the 21st Century Cures Act? I wonder, if it gets passed, will it benefit the trial speed of hair loss drugs in the pipeline? It's been designed to speed up the FDA process, and has gotten a lot of support from both Democrats and Republicans. Perhaps we're starting to learn from countries like Japan?

[It's2014ComeOnAlready]

https://www.youtube.com/watch?v=nv_wyTlfUDo

This one's for you, Hellouser. It's going to a vote in Congress very soon, and like I said, it has a lot of bipartisan support.

[nameless]

As far as getting Histogen's HSC in 6 months goes, you can already get a purportedly reasonable facsimile of Histogen's HSC right NOW. It's called AAPE and it can be acquired.

[burtandernie]

Hopefully they do something. Speeding this stuff up and lowering costs would help a ton. I think it could certainly be done in a safe way. I mean look at CB you mean to tell me another AA like that has lots of possible dangers with it? Almost everything about AAs like that is known already. If your classified types of drugs you could tailor the steps and proof to each one. Drugs for things like cancer are a different league than say CB for acne or hair.

[It's2014ComeOnAlready]

I think of a drug like Setipiprant. It has a TON of safety data with many patients. There's no reason why its development should take so long. The FDA's process isn't perfect by any means, and if the United States wants to be at the forefront of innovation, then the bureaucracies involved shouldn't stifle the discoveries of scientists and doctors.

[Illusion]

If your classified types of drugs you could tailor the steps and proof to each one. Drugs for things like cancer are a different league than say CB for acne or hair.

That's actually not a very good comparison in this context because experimental drugs for cancer are usually administered in a way earlier stage of their development than drugs for other things. The reason for this is that people with cancer usually are in a bad condition health wise and will die soon if nothing is done, so possible side effects or long term risks of the usage of certain drugs are suddenly less important than the results it gives.

But I get what you mean. There are, for example, indeed plenty of AA's out there and it sucks that CB still has to undergo all these trials and stuff, whereas if it would be a completely unknown drug it would be logical to trial it thoroughly. At least, from a bro-science perspective this thought process seems reasonable to me.