Japan to offer fast-track approval path for stem cell therapies

[ANW]

Not sure if this has been posted before, but if approved by the Japanese parliament in July this could have positive ramification for Tsuji Labs in bringing a solution to market quicker. There is the potential for products to come to market in 3 years rather than the 6+ years going through 3 clinical phases.

http://www.nature.com/nm/journal/v19/n5/full/nm0513-510.html?goback=.gde_81555_member_239117599

The proposed amendments to the pharmaceutical law will create a new, separate approval channel for regenerative medicine. Rather than using phased clinical trials, companies will have to demonstrate efficacy in pilot studies of as few as ten patients in one study, if the change is dramatic enough, or a few hundred when improvement is more marginal. According to Toshio Miyata, deputy director of the Evaluation and Licensing Division at the Pharmaceutical and Food Safety Bureau in Tokyo, if efficacy can be “surmised,” the treatment will be approved for marketing. At that stage, the treatment could be approved for commercial use and, crucially for such expensive treatments, for national insurance coverage

[hellouser]

This is HUGE news!! Why hasnt anyone commented on this yet?!

Tsuji is going to have a much easier path with this, honestly a 3 year timeline isnt bad and they've got a full out cure thats better than Dr. Lazy's, I mean Dr. Lauster's.

What also needs to be taken into consideration is this:

How does this new regulation affect Replicel and Aderans?? Both have successfully passed Phase I and Aderans should have finished Phase II by April at the very latest. Would they be ready to deploy a product in Japan within 2 years or maybe NOW for Aderans in Japan?

[Conpecia]

Woah dude calm down. It's a proposal and not yet law:

"Despite these concerns, passage of the pre-vetted law is almost a given. Esaki says there's a 50% chance the Japanese parliament will pass the law during the current session, ending in June. If so, it would go into effect next April. If not, scientists might have to wait until November 2014 or as late as April 2015."

If it hasn't been passed by now we are still kind of ****ed.

[hellouser]

Woah dude calm down. It's a proposal and not yet law:

"Despite these concerns, passage of the pre-vetted law is almost a given. Esaki says there's a 50% chance the Japanese parliament will pass the law during the current session, ending in June. If so, it would go into effect next April. If not, scientists might have to wait until November 2014 or as late as April 2015."

If it hasn't been passed by now we are still kind of ****ed.

It only makes sense to have different regulations for stem cell based therapies considering its a different animal from chemicals/pills. Those regulations are archaic for stem cell research and its definitely in need of an update.

Lets hope the Japanese gives this the green light.... I'm pretty stoked

[Conpecia]

Well we should know by now the article was in May and the parliamentary session ended in June...

[ANW]

well a partial answer. according to David Hall from Replicel in news released yesterday

http://www.replicel.com/replicel-and-shiseido-complete-collaboration-and-technology-transfer-agreement-on-technology-for-treating-pattern-baldness/

David Hall, CEO of RepliCel commented, “This agreement gives RepliCel’s RCH-01 hair regeneration technology important third-party validation from one of the most respected cosmetic companies in the world. In addition, the Japanese government has recently committed to establish a new approval process for regenerative medicine products focused on accelerating approval timelines. This changing regulatory environment enhances the strategic nature of our collaboration with Shiseido. In parallel with RepliCel’s planned Phase II trial in Europe, the Shiseido license represents a second clinical pathway for the development of our RCH-01 technology.”

I need to locate the details of the new laws to see what it actually means and if it is retrospective. i.e. does it apply to previous clinical trials undertaken abroad.

Here is a brief summary

Establishment of well-suited regulation for regenerative medicine
(1) Establishment of specific definition of regenerative medicine.
- Introduction of the separate definition of a regenerative medicine from pharmaceuticals and medical devices in the PAL.
(2) Marketing Authorisation system for early commercialization of regenerative medicine.
- Introduction of “Tentative Marketing Authorisation” with conditions and expiration date.
- Efficacy and safety will be further confirmed after acquiring the Tentative Marketing Authorisation.
(3) Ensuring safety and ethics in post-marketing phase.
- Providing adequate explanation to patients by physicians with prior informed consent.
- Implementing post-marketing safety measures (periodic reports of infectious diseases, record retention and others).

[Westonci]

well a partial answer. according to David Hall from Replicel in news released yesterday

http://www.replicel.com/replicel-and-shiseido-complete-collaboration-and-technology-transfer-agreement-on-technology-for-treating-pattern-baldness/

David Hall, CEO of RepliCel commented, “This agreement gives RepliCel’s RCH-01 hair regeneration technology important third-party validation from one of the most respected cosmetic companies in the world. In addition, the Japanese government has recently committed to establish a new approval process for regenerative medicine products focused on accelerating approval timelines. This changing regulatory environment enhances the strategic nature of our collaboration with Shiseido. In parallel with RepliCel’s planned Phase II trial in Europe, the Shiseido license represents a second clinical pathway for the development of our RCH-01 technology.”

I need to locate the details of the new laws to see what it actually means and if it is retrospective. i.e. does it apply to previous clinical trials undertaken abroad.

Here is a brief summary

Establishment of well-suited regulation for regenerative medicine
(1) Establishment of specific definition of regenerative medicine.
- Introduction of the separate definition of a regenerative medicine from pharmaceuticals and medical devices in the PAL.
(2) Marketing Authorisation system for early commercialization of regenerative medicine.
- Introduction of “Tentative Marketing Authorisation” with conditions and expiration date.
- Efficacy and safety will be further confirmed after acquiring the Tentative Marketing Authorisation.
(3) Ensuring safety and ethics in post-marketing phase.
- Providing adequate explanation to patients by physicians with prior informed consent.
- Implementing post-marketing safety measures (periodic reports of infectious diseases, record retention and others).

Yes, I also received that e-mail from Replicel today. Sounds exciting!

Maybe now we wont have to wait so long for replicel to come to market (in asia that is)

[TravisB]

Wait, so did Japan approve that new law or not?

[sausage]

How long do you think it will be before Replicel is in Asia?

Although it is positive to hear good things about future procedures/cures it is also very frustrating not knowing exactly what is going on, when specific treatments will likely come to market etc...

Questions/thoughts come up for me personally like......

-I need something now or very soon.
-Should I get a hair transplant when something better could be around the corner.
-If I wait for something else will there be more delays, setbacks.
-If I did get a mature looking hair transplant then what if something new comes out that can produce a full head of hair....
-What if I get a HT and then something new comes out that I can't afford cos I just spend thousands on a HT.

So many frustrating dilemmas to consider.

Is there anyone with extensive knowledge of the hair loss cure -research/science/technology industry that has a good idea as to what the current most positive discovery/tangible treatment/cure is that could potentially be on the horizon and how close are we from receiving these treatments.

[TO YOUNG TO RETIRE]

sausage wait bro, we are at the edge....

How long do you think it will be before Replicel is in Asia?

Although it is positive to hear good things about future procedures/cures it is also very frustrating not knowing exactly what is going on, when specific treatments will likely come to market etc...

Questions/thoughts come up for me personally like......

-I need something now or very soon.
-Should I get a hair transplant when something better could be around the corner.
-If I wait for something else will there be more delays, setbacks.
-If I did get a mature looking hair transplant then what if something new comes out that can produce a full head of hair....
-What if I get a HT and then something new comes out that I can't afford cos I just spend thousands on a HT.

So many frustrating dilemmas to consider.

Is there anyone with extensive knowledge of the hair loss cure -research/science/technology industry that has a good idea as to what the current most positive discovery/tangible treatment/cure is that could potentially be on the horizon and how close are we from receiving these treatments.

[sausage]

No offence but ideally I need more than 'we are near the edge' from someone with as much knowledge on the industry as I have.

I need some strong analysis and predictions from someone who has a strong knowledge of where we are at. I don't know who that would be....may be a silly question but would/does Spencer Kobren give his views regularly on his overview of the current-near future of hair loss treatments?

[hellouser]

No offence but ideally I need more than 'we are near the edge' from someone with as much knowledge on the industry as I have.

I need some strong analysis and predictions from someone who has a strong knowledge of where we are at. I don't know who that would be....may be a silly question but would/does Spencer Kobren give his views regularly on his overview of the current-near future of hair loss treatments?

You need to look at the regulation in the sense that it may speed up current cell based research, particularly Replicel and Tsuji Labs but also Aderans considering they're supposed to be past Phase II.

Beyond that, there's nothing to really boast about because we don't know anything. If approved, then we'd need to find out how the laws will affect researchers, current work and future work.

Just keep your fingers crossed for now, hope that the Japanese are forward thinking in this regard.

[KO1]

Do you think this is one of the reasons Shiseido had in mind in investing in Replicel? If Replicel does not need a P3 trial, then only one more trial is enough to bring it onto market. May need to read Shiseido's agreement in more detail.

[joely]

What is replicels method to restoring hair I'm unfamiliar with them

[hellouser]

What is replicels method to restoring hair I'm unfamiliar with them

Watch the video, its pretty straight forward:

http://www.replicel.com/hair-regeneration/how-our-science-works/