The 21st Century Cures Act, and its effect on next hair treatments

[Pelopeleon]

I read about it the other day in this forum, and I would like to know what kind of effect it could have on the development and release to market of things like replicel, OC, SM, Setipiprant, CB, Bimatoprost... Could it speed up the things for us? Have the companies published something about the date of release considering this? There are products like Cb that are going to take a lot of time(I think until 2019 or so) to be released, so maybe now it is not going to be the same...

Any information? Thanks

[bigentries]

I don't understand why people bitch so much about FDA timelines

The reason we don't have a treatment right now is because no research has ever worked, not because of bureaucracy

Yes, it could speed things up... if something really works.

[Desmond84]

This could effect everything. Can someone more familiar with the act post a summary here so we can expand on it a bit better You guys are champions

[Hair Bear]

I don't think this would affect replicel in the short term but in the long term once it comes to market in japan the testing/approval in the US could be vastly streamlined. Great for the US an should have some sort of knock on affect for other particularly for the western countries.

In regards to the what bigenteries, the FDA is a pain for a great many reason and one such issue is the huge costs and these costs are compounded over a number of years, some researchers simply do not have the money to even get a foot in the door yet they may have some solid science and research available to share with the world.
Timelines/red tape have a huge impact on all sorts of things, we aren't talking months we are talking decades, experienced researchers could die of old age in the time it takes
complete an fda approval.

Just imagine if people such as Tesla had such restrictions...

There is already enough nonsense in the world which has/is already stifling us we don't need outdated systems such as the FDA's to make matters worse.
Its funny how laws are passed every day for copyright infringement and breaches of privacy yet governments and civilization is still dragging their knuckles when it comes to actual important stuff such this new law.

This law should have been conceived and passed long ago, medical science is for the better of mankind at large.

EDIT:
Also a valid argument to make is that we can learn a lot from failure. The quicker things succeed or fail the better, sometimes particular compounds are awaiting approval which could assist researchers take a particular path or not thus saving significant time, effort and hours of research.
These compounds may be part of a larger research effort and could be the reason why such research groups are stuck in that infinite 5-10 year cycle.

[bigentries]

But really, let's analyze the last failures and treatments that have taken forever

Intercytex, Aderans, Histogen, OC, Follica, CB, ASC, Replicel, Bim

Let's say the 21st Century act or the Japanese law hellouser loves to brag about existed 20 years ago.

What difference could they've made? From what I understand, it only means that Phase III testing is more lax, and it allows limited commercialisation. The problem with that reasoning is that, no treatment has ever produced consistent results in Phase II.

Comparing Nikola Tesla is absurd since he didn't work in the medical field, and his contemporaries in the medical field are the reason the FDA and medical trials exists in the first place. Quackery was rampant back then. Hell quackery and unethical testing still exists in the developing world and it hasn't provided a cure yet

[It's2014ComeOnAlready]

But really, let's analyze the last failures and treatments that have taken forever

Intercytex, Aderans, Histogen, OC, Follica, CB, ASC, Replicel, Bim

Let's say the 21st Century act or the Japanese law hellouser loves to brag about existed 20 years ago.

What difference could they've made? From what I understand, it only means that Phase III testing is more lax, and it allows limited commercialisation. The problem with that reasoning is that, no treatment has ever produced consistent results in Phase II.

Comparing Nikola Tesla is absurd since he didn't work in the medical field, and his contemporaries in the medical field are the reason the FDA and medical trials exists in the first place. Quackery was rampant back then. Hell quackery and unethical testing still exists in the developing world and it hasn't provided a cure yet

lol nvm, was gonna post a response, but lumping together all of those treatments is just laughable. There is an obvious negative bias, so I don't know what this person is even doing on the forum.

I'm sure this guy will eventually attack my post-count (like it really matters), optimism, or attempts at trying to help people by providing news and updates.

[It's2014ComeOnAlready]

I don't understand why people bitch so much about FDA timelines

The reason we don't have a treatment right now is because no research has ever worked, not because of bureaucracy

Yes, it could speed things up... if something really works.

Uhh because it takes 15 years to develop a drug.

Also, if were cheaper and less time consuming to develop drugs, more researchers would step up to the plate. Bureaucracy has been the biggest impediment.

There are a number of treatments in the pipeline which would seriously benefit from this law. Setipiprant and bimatoprost, mostly. Bim, because it's already on the market, there is a provision in the law that would benefit repurposed drug development, and it would be entering phase 3. Setipiprant because it has already completed 8 trials, including a phase 3, has safety data on thousands on patients, would only need to prove efficacy.

Thankfully, both these drugs are under Allergan's roof, and it looks very much that they have every intention of dominating the aesthetics market.

[Sogeking]

But really, let's analyze the last failures and treatments that have taken forever

Intercytex, Aderans, Histogen, OC, Follica, CB, ASC, Replicel, Bim

...

Funny that you mentioned Histogen. The first reason why they are moving so slowly is simply money. If this law allows them to avoid gathering money for Phase 3 that would greatly speed up their entry to market. I mean they could finance Phase 3 trials by offering HSC early straight after finishing Phase 2 trials.

Also you mentioned CB. I don't understand what so hard to understand there. It takes 10-15 years to get a treatment from lab to market through FDA. And this is the same timeline CB is following. Their expected release date is in 2021. Probably because they have to follow safety over a long period of time knowing that Finasteride has been proven to be contentious on that front. So they have to gather money and take extra time on Phase 2 DR and Phase 3 trials.

This law could reduce this 10-15 years. Even if all of this treatments don't work although I highly doubt that this could speed up upcoming treatments which
Dr.Gardner and Dr.Christiano are working on.

[hellouser]

But really, let's analyze the last failures and treatments that have taken forever

Intercytex, Aderans, Histogen, OC, Follica, CB, ASC, Replicel, Bim

Let's say the 21st Century act or the Japanese law hellouser loves to brag about existed 20 years ago.

What difference could they've made? From what I understand, it only means that Phase III testing is more lax, and it allows limited commercialisation. The problem with that reasoning is that, no treatment has ever produced consistent results in Phase II.

Comparing Nikola Tesla is absurd since he didn't work in the medical field, and his contemporaries in the medical field are the reason the FDA and medical trials exists in the first place. Quackery was rampant back then. Hell quackery and unethical testing still exists in the developing world and it hasn't provided a cure yet

Histogen, OC, Follica, CB and Replicel are all failures despite not having complete trials nor even having the chance to fold?

Yeah... no bias here.

[bigentries]

Funny that you mentioned Histogen. The first reason why they are moving so slowly is simply money. If this law allows them to avoid gathering money for Phase 3 that would greatly speed up their entry to market. I mean they could finance Phase 3 trials by offering HSC early straight after finishing Phase 2 trials.

Also you mentioned CB. I don't understand what so hard to understand there. It takes 10-15 years to get a treatment from lab to market through FDA. And this is the same timeline CB is following. Their expected release date is in 2021. Probably because they have to follow safety over a long period of time knowing that Finasteride has been proven to be contentious on that front. So they have to gather money and take extra time on Phase 2 DR and Phase 3 trials.

This law could reduce this 10-15 years. Even if all of this treatments don't work although I highly doubt that this could speed up upcoming treatments which
Dr.Gardner and Dr.Christiano are working on.

But again, the law could reduce the timeline for release of a successful treatment.

We've never had a successful treatment. New laws are not going to change anything

Histogen wouldn't be able to release anything with a new law, because their treatment plainly sucks. They can't get money because the results apparently aren't really impressive. They are still on that awkward before admitting defeat. I wonder why people are so defensive about them, as far as I know, Aderans hasn't officially folded either

My main point still stands, Phase III has never been an issue for any hair loss treatment, we've never been able to reach that stage

[Trouse5858]

But again, the law could reduce the timeline for release of a successful treatment.

We've never had a successful treatment. New laws are not going to change anything

I understand what you're saying but you're missing the larger point. It's true that the Science has to be there for the passing of this bill to have a real effect, but the current FDA timelines are a legitimate barrier to potential entrants who could possibly come up with the science down the line for a new treatment. The incredibly long timeframes also necessitate a huge window for private companies to be able to raise and re-raise capital for clinical trials that are largely excessive. So long as companies have a stamp of approval from a safety standpoint, I would be thrilled to test the efficacy of their product myself when it's on the open market. The chances are that something will be produced in the near future that outperforms fin with a much better safety profile.

[bigentries]

I understand what you're saying but you're missing the larger point. It's true that the Science has to be there for the passing of this bill to have a real effect, but the current FDA timelines are a legitimate barrier to potential entrants who could possibly come up with the science down the line for a new treatment. The incredibly long timeframes also necessitate a huge window for private companies to be able to raise and re-raise capital for clinical trials that are largely excessive. So long as companies have a stamp of approval from a safety standpoint, I would be thrilled to test the efficacy of their product myself when it's on the open market. The chances are that something will be produced in the near future that outperforms fin with a much better safety profile.

Again, I don't buy it. Otherwise we would have seen something coming out of Cuba in the last 30 years.

I understand people being upset at FDA corruption, which I guess is why people tend to have so emotional responses against them. But I've never seen any evidence that bureaucracy is stoping or slowing any advancements when it comes to hair loss research. And quite frankly some over here end up advocating ruthless unethical clinical trials from time to time.

We just don't have the knowledge to deliver a treatment at this point, simple as that. Once someone finds a reliable, consistent treatment in the research phase, money or timelines will not be a problem, there are people eager to sell a baldness cure ASAP

[It's2014ComeOnAlready]

Here's an article that explains the effect the 21st Century Cures will have on clinical trials and drug development. It's long, but explains everything quite well.

http://www.raps.org/Regulatory-Focus/News/2015/04/30/21192/Regulatory-Explainer-The-Updated-21st-Century-Cures-Act/

[burtandernie]

There is never a point arguing with pessimists because the glass is always half empty no matter how many times or ways you try explaining something. There are numerous like 4 or 5 treatments pretty far into trials already so I mean its hard to argue there not some things that are working to some degree right now. I would argue patents are almost equally important. All this new stuff popped up like a few years after propecia patent expired seems pretty coincidental.
I would agree though curing most problems like MPB is not at all an easy thing to do and that has always been the biggest show stopper on anything new.

[burtandernie]

When do we know or do we ever how the timelines on any of this changes if the bill did speed it up? Is this something that was passed but takes 5 years to actually implement and enforce? I dont really believe its going to make a difference until companies start announcing real concrete timeline changes. Until then its just government bureaucracy at its finest in my eyes. Can we see Seti in 1 year?