Too bad they've only partnered with the incapable J Hewitt so far which has done nothing with their tech over the past 3+ years.
Stemson is going to use minipigs in the next stage of their hair cloning research
- Thread starter werefckd
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Gotta kiss Stemson eg*s, if I finally can get the Norwood-1 hairline, I always wanted lol.Great news:
A treatment for a rare genetic disease that causes cancer has become the first drug to benefit from a new fast-track approval process aimed at speeding up patients’ access to breakthrough medicines and boosting the UK’s appeal to life sciences companies post-Brexit.
The approach, which mirrors the way Britain led the world in approving the first coronavirus vaccines in December, is intended to dramatically cut the 10 years it usually takes for a new drug to move from initial concept to receiving a licence. The UK’s Medicines and Healthcare products Regulatory Agency announced on Friday that a treatment called Belzutifan has received an “innovation passport” — putting it on course to receiving a verdict in no more than 150 days after the final submission of trial data.
Cancer drug is first to begin fast-track UK approval process | Financial Times
Approach seeks to cut years off traditional licensing process for treatmentswww.ft.com
If Stemson also falls under this category, then you could also get admission 150 days after your graduation. So with a bit of luck already in 2022/2023/2024
Geoff Hamilton, Chief Executive Officer, Stemson Therapeutics, said: “Stemson is focused on the path towards the first human trial, and to achieve this goal our focus has to be on research and development, good infrastructure, strong regulatory environment, access to scientific talent and, of course, cost.
“The UK is on our short list with its world class scientific talent and infrastructure, and I know Fortunis Capital certainly believe we will find full support for this level of scientific innovation in the UK.
“We are open to where we will eventually look at trialling it. Yes, the USA is the most valuable market – but there are clear positives in terms of research and scientific experience in the UK.
I think there is good hope. They might still have to carry out a phase two study. But I think everything should work out quickly.
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What is the probability that a cosmetic procedure gets approved? Plus, correct me if im wrong, but this would be the first commercialized procedure involving the implantation of a cloned organ onto the human body in all of history. Fast-tracking something so unknown seems a bit of a stretch.UK to fast-track drug trials to boost post-Brexit life sciences | Financial Times
Companies will need to apply separately to register new medicines when Britain leaves EMA
"Drugmakers will be offered fast-tracked approvals for innovative medicines in the UK as ministers seek to build on the country’s world-leading approval of a Covid vaccine and attract life sciences companies to invest post-Brexit".
I hope that goes quickly
Drug trials to be fast-tracked after Brexit as ministers relax rules
New laws will be designed to create a ‘streamlined, internationally competitive’ process to ensure that patients get the latest treatmentswww.independent.co.uk
"Ministers plan to fast-track new drugs after Brexit
New laws will be designed to create a ‘streamlined, internationally competitive’ process to ensure that patients get the latest treatments"
Nevertheless, medical treatments are getting approved faster which is exceptional news.
p.s. sorry hate to be that guy. Someone has to tame our hopes right??
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[https://www.nice.org.uk/news/articl...ocess-for-new-medicines-opened-on-january-1st]
“Now we have left the EU, we have the freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety is at the heart of everything we do.
“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible.”
From:
www.gov.uk
Seems to be a bureaucratic change that allows companies to collaborate with regulatory entities faster. This is implication that the process initially took 10 years due to system inefficiencies rather than due to regulations. So my allusion that fast-tracking would not be possible due to safety regulations does not apply to the same extent. Although, it would be interesting to discuss whether cloned hair requires long-term studies. For a skin deep procedure, is potential harm a concern?
Anyways, YAY! Stemson could very well benefit from this system. Thanks for the news NoMoney.
Guys, lets take a moment to realize the implications of cloning an organ and implanting it. Its absolutely INSANE! would be the mark of a true anti-aging era. In the next few decades, how long will humans be able to live? will organ failure be a thing of the past? But more importantly, will I still have my hair??
EDIT: I misinterpreted the criteria list. Stemson would very unlikely be eligible. Thanks to Yadonkey.
“Now we have left the EU, we have the freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety is at the heart of everything we do.
“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible.”
From:
Innovative Licensing and Access Pathway
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Seems to be a bureaucratic change that allows companies to collaborate with regulatory entities faster. This is implication that the process initially took 10 years due to system inefficiencies rather than due to regulations. So my allusion that fast-tracking would not be possible due to safety regulations does not apply to the same extent. Although, it would be interesting to discuss whether cloned hair requires long-term studies. For a skin deep procedure, is potential harm a concern?
Anyways, YAY! Stemson could very well benefit from this system. Thanks for the news NoMoney.
Guys, lets take a moment to realize the implications of cloning an organ and implanting it. Its absolutely INSANE! would be the mark of a true anti-aging era. In the next few decades, how long will humans be able to live? will organ failure be a thing of the past? But more importantly, will I still have my hair??
EDIT: I misinterpreted the criteria list. Stemson would very unlikely be eligible. Thanks to Yadonkey.
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Fast tracking exists in the USA with the FDA as well, it still takes 5+ years. It just allows companies to initiate phase 1/2 trails and 2/3 trials instead of 1 => 2 => 3 => Review filing => approval, while also testing on fewer people then normally required. In certain (serious) cases like cancers & fatal orphan diseases you can even get the product to people after the phase 1/2 is completed and have a phase 3 review study be pending for up to 5 years.[https://www.nice.org.uk/news/articl...ocess-for-new-medicines-opened-on-january-1st]
“Now we have left the EU, we have the freedom to innovate and cut red tape to speed up the approval process for new treatments and ensure patient safety is at the heart of everything we do.
“The new pathway represents a totally new way of thinking and is a truly collaborative approach between the healthcare system, the pharmaceutical industry and patients with the common goal of getting the best products to the people who need them as safely and quickly as possible.”
From:
Innovative Licensing and Access Pathway
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Seems to be a bureaucratic change that allows companies to collaborate with regulatory entities faster. This is implication that the process initially took 10 years due to system inefficiencies rather than due to regulations. So my allusion that fast-tracking would not be possible due to safety regulations does not apply to the same extent. Although, it would be interesting to discuss whether cloned hair requires long-term studies. For a skin deep procedure, is potential harm a concern?
Anyways, YAY! Stemson could very well benefit from this system. Thanks for the news NoMoney.
Guys, lets take a moment to realize the implications of cloning and implanting an organ. Its absolutely INSANE! would be the mark of a true anti-aging era. In the next few decades, how long will humans be able to live? will organ failure be a thing of the past?
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The consensus here is that the FDA is slow with cosmetic procedures which is completely understandable. ILAP seems to be a fast-track that has an emphasis on innovation relative to the FDA (im assuming, please correct me if I am wrong) like NoMoney says. If haircloning is considered ATMP it could be fast-tracked even if its not a cure to a "life-threatening" disease.
I still think that haircloning will require more than 5 years of trialling before approval even with all the fast-tracking. The reasons for this is because 1) I assume cloning has a ton of unknown mechanisms. So long term safety especially in regards to cancer is significant. 2) Hair takes a while to grow (how do we know how long the cloned grafts will last)?
What do you think trialAcc? I don't have a scientific background on hair cloning, so I'm not in a place to give any valid estimates.
EDIT: I misinterpreted the criteria list. Stemson would very unlikely be eligible. Thanks to Yadonkey.
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I think they specifically got Fotunis Capital involved because of the UK move.
Well first, I don't have a science background either, but to the point, I don't think the process will be any longer/shorter then with any other clinical trials because it's cloning (in fact if it was a localized procedure it'd probably be quicker). The safety aspect would be looking at how the body reacted to the implantation/procedure similar to how the body is monitored after a organ transplant. If the body were to have an acute immune reaction or reject the follicles it would probably happen within the first life-cycle of the follicle. The length of the life of the follicle probably won't be something they look for in the trials. I'm assuming it would just be the functional characteristics and health of it compared to a native one.
Either way, this is all sort of baseless speculation right now because we don't seem to know a lot of about the procedure. If they were implanting cultured follicles into the head like Riken/a hair transplant, the regulatory hurdle will be a lot more minimal than if the follicles were actually being dosed/created within your scalp.
I'm not nearly as informed in this field as you, but I would've thought Stemson took whatever money they could. Also, Fortunis is pretty new and poor for a VC from what I've seen, I don't think they have the resources to spare to get Stemson to the UK.
I don't think it's nearly as expensive or jarring to do registered trials in a different country as you seem to imply. Several millions of dollars in funding would be enough, which Fortunis should certainly be able to inject.
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Great insight. I think you are closer to the truth than I am.
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and Tsuji, if Tsuji succeeds. Or Hairlosstalk in honor of this website.
I think this is easily the safe bet. One is VC funded and has business development plans, the other is asking for donations on Twitter.
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and re-tweeting political posts wtf
At least you won't have to name your son Stemson.
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Oh I must have misinterpreted the criteria. So stemson must fall in all 1, 2, and 3 criteria in order to be approved. Sorry if I confused anyone.
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Ya. Then again, hairloss treatment would be pretty absurd to fast-track. As a matter of fact, any cosmetic treatment. It is much better to prioritize life-threatening/ debilitating conditions even if I do hope stemson gets some bureaucratic support somewhere.
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Buddy, it's about hair=life, f*** soccer lol
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They got their pigs?