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TOPIC: Lifescienceleader article on developments in Japan

Lifescienceleader article on developments in Japan 27 Apr 2015 11:54 #4364

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Pretty good article written by Gail Dutton..

a small excerpt :

TWO NEW REGENERATIVE MEDICINE LAWS
Japan’s new regenerative medicine legislation is actually two separate laws. Law No. 84/2013 amends the Pharmaceutical Affairs Act, renamed the Pharmaceutical and Medical Device (PMD) Act, and pertains to the commercial development of regenerative therapeutics. Law 85/2013, the Safety of Regenerative Medicine Act, deals with clinical and physician-led research.

The PMD Act defines regenerative medicine as cultured or processed human or animal cells, or transgenic cells, used to reconstruct, repair, or form structures or functions in the human body, or to treat or prevent human diseases.

Gene therapies also are covered by that act, providing they are at least equivalent to cellular and tissue-based products and meet either the FDA definition of gene therapy or the EU definition of advanced-therapy medicinal products.

This law speeds therapeutics to market by allowing conditional marketing authorization. For example, Hall says, “A 20-person trial that shows safety and is predictive of efficacy is sufficient to get conditional approval for seven years, without needing placebo trials. Efficacy will be determined by the market. The new regulations dramatically change the pathway toward revenue.”

During the seven-year conditional approval period, companies are expected to continue filing data. By the end of that period, they must either apply for final marketing approval (the equivalent of a BLA [Biologic License Application]) or withdraw the product.

The companion law, the Safety of Regenerative Medicine Act, governs clinical and physician-sponsored research. It allows cells to be processed outside hospitals for safer and faster manufacturing. Oversight is provided through tier-based, risk-dependent analysis, and through accreditation of cell-processing centers.


Link to the full article: Japan´s take on regen medicine
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Lifescienceleader article on developments in Japan 27 Apr 2015 14:49 #4365

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Without the new Celution device the cost of Cytori products is a difficult barrier to overcome. This company needs to find a way to produce the new equipment before other therapies are embraced by the medical community.
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Lifescienceleader article on developments in Japan 28 Apr 2015 05:53 #4366

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Hum.. the link that I posted had a "time limit" - funny, never heard of that before. Anyway- the article mainly concerns the activities of regen Companies in Japan, who are all looking for partners. That is not surprising- if there is one country on this globe where ANY conglomerate (be they Shell, Nestle or Pfizer, has little chance of gaining track INDEPENDENTLY in that country, it is Japan. Local partners are needed, also for Cytori of course despite their Tokyo KK.

Without the new Celution device the cost of Cytori products is a difficult barrier to overcome. This company needs to find a way to produce the new equipment before other therapies are embraced by the medical community.


The new Celution device is important- no doubt- but the therapies certainly even more- their development that is. :yep:

The new regenerative laws, governing conditional approval, require safety and a reasonable level of evidence of efficacy, on top of the fact that the procedure has been "tested in Japanese patients". Thats plenty vague for Japanese legislators to fend off companies they really do not like to have on their market for quite some time. That is the way the Japanese are, I know numerous examples from the past- the Japanese benefit first, the rest later... :grin: :grin:

I bet there is no Company in the world that both have convincing efficacy for an application AND have treated Japanese patients. Besides Cytori that is.

Anyway- just a trip through history again. Most long term observers of Cytori will tell you- back in 2005 when Cytori choose Olympus as its partner- there was another suitor- Astellas. For obvious reasons, Cytori selected device Company- Olympus as its partner, but as DOV recently got confirmed by Cytori management- in the somatic cell technology R&D by Astellas, only fat cells are investigated still- that is about 10 years later.

Its not only those 10 years- also BEFORE 2005, several Japanese multinationals including Olympus, Terumo, Takeda, Kirin Breweries and others had a gigantic complex in Kobe where they did a lot of research- in those days by cultivating BM cells in gigantic "growing machines" :joy: Those things looked funny if you compare them with modern Terumo devices. :cool:

Anyway- all this stuff as guidance that Japanese do not jump in without preparation and leg work. And that things take their time.

At least the players are different now- having known and met CC and Saad- these gentlemen were the perfect examples of over-self confident individuals and lacked a lot of basic assertiveness, which are certainly NOT "the way of the kami" or basics of Shinto attitudes and behaviour. Those red flags to the Japanese mentality do not hinder any longer- to me everything is still possible in Japan, including Daiichi and others. But key remains Astellas, who as urology leader of the globe must have an interest in SUI too.... :yawn:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Lifescienceleader article on developments in Japan 28 Apr 2015 09:33 #4368

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Fas,

Thanks for the history and the information. I agree that the issues of safety and efficacy are primary. I also agree that the Japanese culture is hard for westerners to understand.

:bye:

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Lifescienceleader article on developments in Japan 28 Apr 2015 12:14 #4371

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I'm so tired of this circle jerk. It's all the same bs over and over again. Clearly we can all be classified as insane or just plain stupid for hearing the same BS over and over again expecting a different result. It's all too draining and quite frankly makes me sick to my stomach.

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