Open Longevity is Attempting the ICO Route for Fundraising

The Open Longevity group is a Russian non-profit volunteer organization that emerged from the Science for Life Extension Foundation community, and is working to organize responsible, open trials of potential therapies to address aspects of aging. They are a little too focused on tinkering with metabolism rather than repair of the damage that causes aging for my tastes, but each to their own. Based on recent news it seems they are going to try the Initial Coin Offering (ICO) path of fundraising for their ongoing efforts. It will be interesting to see how this goes, as just about anyone who has watched the frenzy over ICOs this past year has probably at some point wondered how to tap this flow of funding. A few months ago I asked whether or not ICOs are a viable approach to pull funding into the field of longevity science. Here I mean in any capacity, whether that is running patient-paid clinical trials, conducting fundamental research, commercializing a senolytic drug candidate, and so forth. You should probably look back at that prior post for a brief overview of what an ICO is, how it relates to blockchain technologies such as Bitcoin and Ethereum, and why ICOs presently look like magical money fountains from some angles. Groups with very little credibility are raising tens of millions of dollars via this mechanism, bypassing traditional venture funding mechanisms. If they can do it, why not credible efforts in the field of rejuvenation research? Following that post, a small group of us set up a mailing list to talk about the prospect (if you are knowledgeable regarding blockchain matters and have an interest in longevity science, let me know if you'd like an invite). We fairly quickly came to the conclusion that, magical money fountain or not, the only viable ICOs are those that promise some sort of network effect that, at least in theory, could increase coin value enormously given enough participation in that network. While it is entirely possible to run a Kickstarter-like project through an ICO, using a blockchain to track obligations, and allowing those obligations to be transferred, any sort of token that is at the end of the day exchanged for a product or service has a upper limit to its value. It is rather like a futures contract in nature. This is not interesting to the people pushing funds through the ICO ecosystem. They are looking for unlimited upside, in the same mindset as startup investors: this is true whether or not the ICOs in question are pump and dump schemes, failures waiting to happen in some other way, or actually legitimate ventures taking advantage of the opportunity to obtain funding without having to give up equity. At this point we found ourselves a little stuck; if the goal is pull in some of the funds flowing through the ICO marketplace, then there must be a suitably attractive coin mechanism, one with network effects and upside. Yet there doesn't seem a good way to attach a suitably attractive coin mechanism to any of the potential near term ventures that our community might undertake. They all look, at best, like Kickstarter projects, or like equity fundraising, and at worst like traditional non-profit fundraising with no return on investment. Without that mechanism, the ICO marketplace will ignore any use of blockchain technologies, and so there is little point in trying to use them. It just complicates the usual process of fundraising, and that is not even to talk about the regulatory issues, which are evolving rapidly now that the SEC has taken an interest. Has Open Longevity found a viable way forward by tying tokens to a voting mechanism in addition to Kickstarter-like forms of redemption? That is an open question, but we'll see how it goes. I'd suggest reading their white paper. Certainly, I wish them the best of luck in exploring this avenue: any group that pioneers a useful means of bringing more funding into our community has performed a useful service. Open Longevity Project: a Scientific Approach to Conquer Aging Open Longevity is organizing research of anti-aging therapies in humans by providing online advisory services. Their ultimate goal is to find and introduce effective methods of radical life extension into clinical practice. Therefore, the tokens are called YEAR. Mikhail Batin, the CEO of Open Longevity, states he is sure that effective ways to delay the onset of aging will be found - it is only a matter of time. He and his colleagues just want to accelerate the research. The project consists of two parts: clinical trials and online service. Part of the funds raised through ICO will be spent on the first three studies: Longevity Diet-1 (a variant of a fasting mimicking diet); Alzheimer's disease therapy (vitamin B12) and atherosclerosis therapy (sartans + statins). One can even find documents for the first trial in progress, though just in Russian yet. As the trial is planned to be submitted to the NIH's Clinical Trials registry, the documents will be translated into English at some point. All the subsequent studies will later be also funded: life extension projects are expected to be submitted for voting on a general basis, voting will be conducted among all the YEAR token holders. All clinical trials will be carried out in strict accordance with existing norms. Thus CROs (contract research organizations), laboratories, and clinical institutions that traditionally carry out similar research, will be involved. But the OL team is already talking about making all paperwork more automated. Another part of the funds will be spent on creating an online platform. By uploading biomedical data, users will be able to monitor their health and aging status in dynamics; receive recommendations from specialists and expert system based on AI; and also become volunteers in trials. The service will be accessible to everyone. But payment with YEAR tokens is promised to be more favorable than paying with fiat currencies due to 50% discount. Open Longevity ICO Open Longevity is a project that initiates, organizes, and guarantees openness of clinical trials of antiaging therapies. Two important components of our project are an online expert system, which interprets users' biomedical information in terms of aging biology, and new infrastructure for antiaging clinical trials. They are closely connected: the data obtained through trials is taken into account in the operations of the expert system, and the funds raised from users are spent on antiaging research. At the first stage, the aim of which is the development of the platform and launching of the first trials, we will raise funds through our ICO. Our task is to build a self-sufficient system that will provide paid services to individuals but at the same time solve important problems for humanity on a noncommercial basis. We do not plan to protect our therapies with patents - our research results will be publicly available. We endeavor to direct patients' energy toward the fight against aging, and in our experience, our policy of openness attracts projects, funding, scientists, and volunteers to us. One of the common concerns in the industry is that, once on the market, antiaging medicine will become available only to the elite. The openness of our project is a possible solution to this potential problem. Moreover, publishing final and intermediate results, as well as research protocols and all related materials, will give us the highest level of expertise. All clinical trials will be carried out in strict accordance with existing norms. We will prepare questionnaires, informed-consent forms, permissions of ethical committees, and brochures describing the design of our experiments. We will involve a CRO (contract research organization), laboratories, and clinical institutions that traditionally carry out similar research. We will include patients in a global movement to seek and test potential antiaging therapies that, once proven effective, will immediately become part of their own lives.

https://www.fightaging.org/archives/2017/09/open-longevity-is-attempting-the-ico-route-for-fundraising/

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Towards the Recognition of Aging as a Treatable Medical Condition

In recent years numerous groups have made a start on the long road of changing the public view of aging, from considering it a normal state to considering it a pathological state. To have it recognized as a harmful medical condition that can in principle be treated - that medical technologies can be developed for this purpose soon enough to matter. This is a process of unofficial advocacy and persuasion on the one hand, to change minds and educate people, but on the other there is also a strong component of formalism, of working with regulatory definitions. Medical research and development is, sadly, heavily regulated. The structure of regulation shapes the ability to raise funding and carry out meaningful work on the creation of means to treat aging. The US FDA, for example, doesn't recognize aging as a condition that can or should be treated, though the first cracks in that position are taking shape in the form of the TAME metformin trial. Yet the current position still means that efforts to treat aging struggle to find the necessary resources to proceed. Since most agencies base their regulation on the World Health Organization's (WHO's) International Statistical Classification of Diseases and Related Health Problems, with ICD-11 being the latest edition in the process of being finalized, some initiatives have focused on placing aging into that document as a formally defined disease. This would be in a definitive way, unlike the one or two present entries that might be interpreted as referring to aging, given the right light, but in practice are disregarded. Whether or not aging is called a disease is a matter of semantics, and in this the powers that be and the fellow in the street both seem quite willing to designate numerous specific aspects of aging as diseases, with fashion rather than logic dictating what is a portion of normal aging and what is a disease. But when it comes to the ICD, these semantics drive policy and regulation. That has material consequences, more is the pity. Things would move forward a lot more rapidly absent the heavy restrictions placed upon medical research and development, I feel. There are already ample laws covering fraud and harm in the conduct of any human action. Why all the rest layered on top? It feels like control for the sake of control, institutions perpetuating themselves simply because they can. Ultimately, rules follow opinions, or at least those opinions prevalent among the rule-making class. They are swayed by the zeitgeist. So a shift of public opinion and awareness about aging - and about the advent of near-future rejuvenation therapies that actually work - is important. In the ideal world, the fellow in the street would think of aging in the same way as he thinks of cancer: that someone should do something about it, because it is a painful, undesirable thing, and it is both good and generous to help the laboratories and clinics and funding institutions to make progress on this front. As things stand, we're a fair way from that goal, unfortunately. It will be very interesting to watch how matters progress in public opinion should the first human trials of senolytics produce good data and proof of effectiveness. Meanwhile, there are people toiling in the maze of regulatory definition, trying to carve out a path, a way to adjust the present stifling system of rules and statements: Recognizing Degenerative Aging as a Treatable Medical Condition: Methodology and Policy Given the rapid aging of the world population and the accompanying rise of aging-related diseases and disabilities, the task of increasing the healthy and productive period of life becomes an urgent global priority. It is becoming increasingly clear that in order to accomplish this purpose, there is an urgent need for effective therapies against degenerative aging processes underlying major aging related diseases, including heart disease, neurodegenerative diseases, type 2 diabetes, cancer, pulmonary obstructive diseases. One facilitating possibility may be to recognize the degenerative aging process itself as a medical problem to be addressed. Such recognition may accelerate research, development and distribution in several aspects: 1) the general public will be encouraged to actively demand and intelligently apply aging-ameliorating, preventive therapies; 2) the pharmaceutical and medical technology industry will be encouraged to develop and bring effective aging-ameliorating therapies and technologies to the market; 3) health insurance, life insurance and healthcare systems will obtain a new area for reimbursement practices, which will encourage them and their subjects to promote healthy longevity; 4) regulators and policy makers will be encouraged to prioritize and increase investments of public funds into aging-related research and development; 5) scientists and students will be encouraged to tackle a scientifically exciting and practically vital problem of aging. Yet, in order for the degenerative aging process to be recognized as a diagnosable and treatable medical condition and therefore an indication for research, development and treatment, a necessary condition appears to be the development of evidence-based diagnostic criteria and definitions for degenerative aging. Such commonly accepted criteria and definitions are currently lacking. Yet without such scientifically grounded and clinically applicable criteria, the discussions about "ameliorating" or even "curing" degenerative aging processes will be mere slogans. Such criteria are explicitly requested by major regulatory frameworks, such as the International Classification of Diseases (ICD), the Global Strategy and Action Plan on Ageing and Health (GSAP), the European Medicines Agency (EMA), the US Food and Drug Administration (FDA). Nonetheless, nobody has yet done the necessary work of devising such criteria. "Senility," tantamount to degenerative aging, is already a part of the current ICD-10 listing. In the draft ICD-11 version (to be finalized by 2018), the code MJ43 refers to "Old age," synonymous with "senescence" and "senile debility." The nearly 40 associated index terms in the ICD-11 draft also include "ageing" itself, "senility," "senile degeneration," "senile decay," "frailty of old age," and others. Still, the current definitions, such as "senility," seem to be rather deficient in terms of their clinical utility. This may be the reason why "senility" has been commonly considered a garbage code, e.g. in the Global Burden of Disease (GBD) studies. The reason "senility" has been considered a garbage code is likely because there have been no reliable, clinically applicable and scientifically grounded criteria for diagnosis of "senility" or of "senile degeneration." Consequently, there could be no official case finding lists. Hence, in order to successfully use this code in practice, it appears to be necessary to be able to develop formal and measurable, biomarkers-based and function-based diagnostic criteria for "senility" or "senile degeneration," as well as measurable agreed means to test the effectiveness of interventions against this condition.

https://www.fightaging.org/archives/2017/10/towards-the-recognition-of-aging-as-a-treatable-medical-condition/

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