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How 2020 Can Be the Year of Transhumanist Politics in America: USTP Chairman Gennady Stolyarov II Interviewed by Steele Archer on the Debt Nation Show

How 2020 Can Be the Year of Transhumanist Politics in America: USTP Chairman Gennady Stolyarov II Interviewed by Steele Archer on the Debt Nation Show

Gennady Stolyarov II
Steele Archer


On November 24, 2019, U.S. Transhumanist Party / Transhuman Party Chairman Gennady Stolyarov II spoke extensively with Steele Archer on the Debt Nation show regarding recent transhumanist political developments and possibilities to come in 2020, including how 2020 can shape up to become the year of transhumanism in American politics, across the conventional spectrum, with Zoltan Istvan running as a Republican, Andrew Yang running as a Democrat, several Libertarian candidates sympathetic to a highly technological future – with their supporters having the potential to be drawn to the Transhumanist Presidential campaign of Johannon Ben Zion, who will remain in the race all the way to the general election, long after all the other parties’ primaries have concluded.

Watch this conversation here.

Also discussed were subjects such as how transhumanism can give a new sense of purpose and rekindle the belief in progress among Americans, how transhumanism can inaugurate a more rational politics, which seeks creative solutions to replace wedge issues with win-win outcomes, and the key points from the USTP Chairman’s Third Anniversary Message and how they will be implemented so as to further enhance and grow the USTP.

Join the U.S. Transhumanist Party / Transhuman Party for free, no matter where you reside. Click here to apply in less than a minute.

 

Brent Nally Interviews U.S. Transhumanist Party Chairman Gennady Stolyarov II at Sierra Sciences

Brent Nally Interviews U.S. Transhumanist Party Chairman Gennady Stolyarov II at Sierra Sciences

Gennady Stolyarov II
Brent Nally


On October 12, 2019, U.S. Transhumanist Party Chairman Gennady Stolyarov II spoke with Brent Nally at the venerable Sierra Sciences headquarters in Reno, Nevada. They discussed developments in the U.S. Transhumanist Party, fitness, health, and longevity – among other subjects.

Watch the interview here.

Become a member of the U.S. Transhumanist Party / Transhuman Party here for free, no matter where you reside.

Show Notes by Brent Nally

3:15 Brent Nally’s RAADfest 2019 YouTube playlist: https://www.youtube.com/playlist?list=PLGjySL94COVSO3hcnpZq-jCcgnUQIaALQ

4:24 Go to RAADfest primarily to network: https://www.raadfest.com/

6:28 People Unlimited website: https://peopleunlimitedinc.com/

6:30 The Coalition for Radical Life Extension website: https://www.rlecoalition.com/

7:20 We need to increase your healthspan to increase your lifespan.

9:01 Watch Bill Andrews and Gennady discussing transhumanism and radical life extension: https://www.youtube.com/watch?v=U7GJrVBp8FQ

13:35 Gennady just ran the Lakeside Marathon at Lake Tahoe the day before, October 11, 2019.

19:30 Do whatever type of exercise that you enjoy. Don’t push yourself to the point of exhaustion where you’re throwing up or getting injured or not having fun because that’s bad for your telomeres.

24:10 Audit your own thoughts daily as a meditation to recognize your limiting beliefs.

26:15 How Gennady became Chairman of the U.S. Transhumanist Party

29:35 How the 9 USTP presidential candidates competed using a “ranked preference” approach

32:07 43 articles are currently in the 3rd version of the Transhumanist Bill of Rights: https://transhumanist-party.org/tbr-3/

34:27 https://transhumanist-party.org/

35:40 We should be more concerned with ideas rather than people. We’re in an “ideas” economy.

36:28 Politicians are more followers than leaders.

40:27 3 core ideals of USTP: https://transhumanist-party.org/values/

41:40 Gennady shares more details about how his role as chairman may evolve.

44:28 Positives and negatives of centralization and decentralization

49:15 Sophia the AI robot: https://www.hansonrobotics.com/sophia/

51:30 Truth is sometimes stranger than fiction. Try to educate others about transhumanism.

55:30 Ray Kurzweil points out that technology growth and stock market growth are separate. Here’s Brent talking to Ray in February 2011: https://www.youtube.com/watch?v=3TuVn…

57:37 Join the USTP: https://transhumanist-party.org/membership/

58:40 USTP Twitter: https://twitter.com/USTranshumanist; USTP LinkedIn: https://www.linkedin.com/company/19118856/; Gennady’s online magazine – The Rational Argumentator: http://www.rationalargumentator.com/index/

1:01:14 Gennady, Bill Andrews, and Brent ran about 8.4 miles the next morning above Carson City, NV on the Upper Clear Creek Trail.

1:02:15 Don’t forget to subscribe, like, comment on this video, and share on your social media accounts!

Gennady Stolyarov II and Johannon Ben Zion Discuss a Transhumanist Vision for U.S. Policy

Gennady Stolyarov II and Johannon Ben Zion Discuss a Transhumanist Vision for U.S. Policy

Gennady Stolyarov II
Johannon Ben Zion


Johannon Ben Zion of the Futurist New Deal Podcast interviews U.S. Transhumanist Party Chairman Gennady Stolyarov II regarding the U.S. Transhumanist Party’s recent efforts, visions for the future of American politics, technological progress and technological Singularities, the importance of life-extension advocacy, open-source approaches to innovation, and overcoming challenges such as information overload and overly slow and cumbersome approval processes for innovative medical treatments. Mr. Stolyarov and Mr. Ben Zion also discussed in general terms the upcoming USTP Presidential Primary Election, for which voting will open on September 22, 2019.

This interview was filmed in Burbank, California, on August 24, 2019, following the Wellness and Longevity Seminar that was hosted there to mark the publication of The Transhumanism Handbook.

References

– “Progress in the Politics of Abundance” – Presentation by Gennady Stolyarov II
U.S. Transhumanist Party Discussion Panel – Burbank, California – August 24, 2019
The Transhumanism Handbook
– “The United States Transhumanist Party and the Politics of Abundance” – Mr. Stolyarov’s chapter in “The Transhumanism Handbook” – available for free download
Free Transhumanist Symbols
Futurist New Deal Podcast videos
Johannon Ben Zion – Candidate in the 2019 U.S. Transhumanist Party / Transhuman Party Presidential Primary

Join the U.S. Transhumanist Party for free, no matter where you reside. Those who join by September 22, 2019, will be eligible to vote in the Presidential Primary.

U.S. Transhumanist Party Discussion Panel – Burbank, California – August 24, 2019

U.S. Transhumanist Party Discussion Panel – Burbank, California – August 24, 2019

Johannon Ben Zion
Gennady Stolyarov II
Arin Vahanian
Charles Holsopple


On August 24, 2019, many leading transhumanists gathered in Burbank, California, to commemorate the publication of The Transhumanism Handbook. Subsequent to the seminar and book-signing event marking that occasion, the U.S. Transhumanist Party / Transhuman Party (USTP) held a discussion panel hosted by Chairman Gennady Stolyarov II and featuring Director of Marketing Arin Vahanian and USTP Presidential Primary candidates Johannon Ben Zion and Charles Holsopple. Subjects of conversation included assessments of the public’s receptiveness to transhumanist ideas, approaches toward spreading transhumanism, common misconceptions and challenges to overcome, as well as the upcoming Presidential primary election, for which voting will begin on September 22, 2019.

Find out more about The Transhumanism Handbook.

Join the U.S. Transhumanist Party for free, no matter where you reside. Those who join by September 22, 2019, will be eligible to vote in the upcoming USTP Presidential Primary.

See the USTP Platform here.

Read Mr. Stolyarov’s chapter in The Transhumanism Handbook – entitled “The United States Transhumanist Party and the Politics of Abundance” – for free here.

Progress in the Politics of Abundance – Presentation by Gennady Stolyarov II

Progress in the Politics of Abundance – Presentation by Gennady Stolyarov II

Gennady Stolyarov II


Gennady Stolyarov II, Chairman of the United States Transhumanist Party / Transhuman Party (USTP), delivered this presentation, entitled “Progress in the Politics of Abundance“, during the August 24, 2019, Wellness and Longevity Seminar in Burbank, California, to commemorate the publication of The Transhumanism Handbook. Mr. Stolyarov spoke to update the audience on recent USTP activities in 2019 since the writing of his chapter, entitled “The United States Transhumanist Party and the Politics of Abundance” which is available for free download.

Some of the subjects addressed in Mr. Stolyarov’s presentation are the necessity and challenges of overcoming the evolved mindset of scarcity – the zero-sum mentality – in politics, the USTP’s #IAmTranshuman campaign, its successful effort to amend Nevada Assembly Bill 226 to remove the prohibition against voluntary microchip implantation, and its Transhumanist Symbols project, of which the products are freely available here.

The presentation slides are not fully visible in the video but can be accessed and downloaded here.

Find out more about The Transhumanism Handbook.

Join the U.S. Transhumanist Party for free, no matter where you reside. Those who join by September 22, 2019, will be eligible to vote in the upcoming USTP Presidential Primary.

Gennady Stolyarov II Interviews James Strole Regarding RAAD Fest 2019 and Life-Extension Advocacy

Gennady Stolyarov II Interviews James Strole Regarding RAAD Fest 2019 and Life-Extension Advocacy

James Strole
Gennady Stolyarov II
Johannon Ben Zion


On Tuesday, July 16, 2019, U.S. Transhumanist Party Chairman Gennady Stolyarov II invited James Strole of the Coalition for Radical Life Extension and People Unlimited to discuss the upcoming RAAD Fest 2019 in Las Vegas on October 3-6, 2019 – the fourth RAAD Fest in history – https://www.raadfest.com/ – and the first in a new venue. Mr. Stolyarov and Mr. Strole discussed the importance of unity in the transhumanist and life-extensionist movements, as well as what opportunities for education and inspiration RAAD Fest will offer to those who wish to live longer and healthier. They also addressed audience questions and were briefly joined by Johannon Ben Zion, Chairman of the Arizona Transhumanist Party. Watch the interview on YouTube here.

Become a member of the U.S. Transhumanist Party / Transhuman Party for free, no matter where you reside. Apply here in less than a minute.

Watch some of the U.S. Transhumanist Party’s prior appearances at RAAD Fests in 2017 and 2018 below.

RAAD Fest 2017

The U.S. Transhumanist Party – Pursuing a Peaceful Political Revolution for Longevity – August 11, 2017

RAAD Fest 2018

The U.S. Transhumanist Party: Four Years of Advocating for the Future – Gennady Stolyarov II at RAAD Fest 2018 – September 21, 2018

Gennady Stolyarov II Interviews Ray Kurzweil at RAAD Fest 2018 – September 21, 2018

U.S. Transhumanist Party Meeting at RAAD Fest 2018 – September 22, 2018

Andrés Grases Interviews Gennady Stolyarov II on Transhumanism and the Transition to the Next Technological Era – September 23, 2018

Register for RAAD Fest 2019 here

The United States Transhumanist Party and the Politics of Abundance – Essay by Gennady Stolyarov II in “The Transhumanism Handbook”

The United States Transhumanist Party and the Politics of Abundance – Essay by Gennady Stolyarov II in “The Transhumanism Handbook”

Gennady Stolyarov II


U.S. Transhumanist Party / Transhuman Party Chairman Gennady Stolyarov II’s essay “The United States Transhumanist Party and the Politics of Abundance” is available in the newly published master compilation, The Transhumanism Handbook, edited by Newton Lee, the California Transhumanist Party Chairman and U.S. Transhumanist Party Education and Media Advisor, and published by Springer Nature. This book is a milestone publication in transhumanist thought, and the U.S. Transhumanist Party / Transhuman Party encourages everyone to purchase it and read it in full. Fortunately, Mr. Stolyarov is able to share his own chapter – 60 pages within the book – for free download here: https://transhumanist-party.org/wp-content/uploads/2019/07/Stolyarov_USTP_Politics_of_Abundance.pdf.

Read “The United States Transhumanist Party and the Politics of Abundance” for a detailed explanation of the premises behind transhumanist politics and what the U.S. Transhumanist Party stands for. This essay is current through year-end 2018, and various other significant developments have occurred since then. However, this essay should give readers a strong impression of the USTP’s values, operating procedures, areas of focus, and aspirations for the future.

Abstract: “The depredations of contemporary politics and the majority of our era’s societal problems stem from the scarcity of material resources and time. However, numerous emerging technologies on the horizon promise to dramatically lift the present-day constraints of scarcity. The United States Transhumanist Party, in advocating the accelerated development of these technologies and seeking to influence public opinion to embrace them, is forging a new political paradigm rooted in abundance, rather than scarcity. This new approach is simultaneously more ambitious and more civil than the status quo. Here I illustrate the distinguishing features of the Transhumanist Party’s mode of operation, achievements, and plans for the future.”

Purchase the Transhumanism Handbook on Amazon here.

Become a member of the U.S. Transhumanist Party / Transhuman Party for free, no matter where you reside. Click here.

Click on the image of the first page above to read the essay in full. 

Why I Am Future-Positive on My Birthday – Article by Steve Hill

Why I Am Future-Positive on My Birthday – Article by Steve Hill

Steve Hill


Editor’s Note: The U.S. Transhumanist Party features this article by our guest Steve Hill, originally published by the Life Extension Advocacy Foundation (LEAF) on June 7th, 2019. In this article, Mr. Hill discusses how he feels great about being over 40 years old, instead of the depressing feeling that many tend to have on their birthdays, because he is very aware of how close medical science is to curing age-related diseases. He goes on in discuss, in his opinion, two of the most promising research methods being sought by various companies to defeat age-related diseases.

~ Bobby Ridge, Assistant Editor, July 7, 2019


Not so long ago, it was my 44th birthday, and I’ve finally decided to write something that I’ve been reflecting on for a while. To some people, a birthday is a cause for celebration; for others, it is viewed as a bad thing.

Yes, if you take the negative view, you could see it as simply a reminder of being another year older and another year closer to the grave. However, this is not how I see it; in fact, I think quite the opposite. I see it as another year closer to our goal: the defeat of age-related diseases due to the progress of rejuvenation biotechnology that offers longer and healthier lives.

From my point of view, viewing birthdays, or, indeed, the passing of time, as a positive or negative thing is largely a question of knowledge and understanding of the aging research field, which ties in with what I want to address today.

Knowledge is power

During my work as a journalist, people often ask me how things are progressing in the field. This is, of course, a perfectly reasonable and understandable question to ask. While I am always more than happy to talk about the field and answer this question, I also urge people to delve deeper into the field so that they can learn and evaluate for themselves rather than simply taking my word for it.

Our website, including the Rejuvenation Roadmap, is a good resource to start learning and to hear the latest news, as are places such as FightAging and the SENS Research Foundation website. Conferences such as Ending Age-Related Diseases and Undoing Aging are also valuable places to learn more about what is happening in the field.

Sometimes, I encounter people outside, but also fairly frequently within, the community who can be somewhat pessimistic about the field and its progress. It is perfectly natural to be cautious about the unknown, but there comes a point at which caution becomes unwarranted pessimism. The “Science Will Not Defeat Aging in My Lifetime, so Why Bother?” argument is a classic example of this, and much of this is caused by a lack of knowledge and understanding of the field.

The Latin phrase scientia potentia est, meaning “knowledge is power”, is particularly apt here. Knowledge and understanding allow us to better evaluate a situation or a proposal and reach a conclusion. It is hard to reach an accurate conclusion about anything without all the facts in place, yet I often see people doing it. Of course, there are always people who will not put in the time and effort required to learn about a topic properly, so they make predictions without all the facts, but there really isn’t much we can do about these people.

However, as advocates and supporters, we can do our best to learn about such things ourselves, and this will also come in useful when speaking to others about the field, as there is nothing like having a good understanding of the topic to help you convey it to others. That does not mean you need to become a biologist and understand things to such deep levels but even a solid understanding of the basics can be a huge help when it comes to engaging with others on the subject and also for understanding where we are currently progress wise.

Future-positive

This relates to a second question people often tend to ask me, which is if I think that they or we have a chance of living long enough to see these technologies arrive.

Obviously, no one can predict the future, so this question, by its very nature, is a tricky one to answer. I generally avoid being too specific on the timeframe in which we will reach the goal of longer lives through science, but I am optimistic that people in my age group, even perhaps older, have a reasonable chance of making the cut.

The reason that I am generally optimistic about the future is mostly that, as a journalist who speaks to hundreds of researchers, each focused on a part of the puzzle, I get an almost unique picture of the field. I can see the broader landscape and how and where things in the field or related fields connect or may connect in the future. A breakthrough in a related medical field may not have immediately apparent utility in aging research at first glance, but a deeper look could reveal hidden potential.

This fairly unique insight, combined with the knowledge that I have collected over the years working in the field, makes me fairly optimistic about the future and my place in it. As I have said a number of times in the past, the defeat of age-related diseases will not suddenly happen overnight; there is unlikely to be a single moment at which humanity goes from having no choice about aging to having control. It is far more likely that there will be steady progress, with incremental breakthroughs along the road, that will ultimately reach the goal.

Reasons to be cheerful

I would like to touch upon two of the most promising therapies that I am most interested in and believe may have a big impact in the near future (10-20 years) and that may help pave the way for major changes to how society thinks about and treats aging. Both of these therapies directly address one of the nine proposed causes of aging and thus if they work they have the potential to be transformative in healthcare. Of course, there are more therapies in development and at various stages of progress which also address the other causes of aging but these two are what I am most enthusiastic about presently. I urge you to explore the provided links to resources and learn more about each one.

Senolytics

No list of promising technologies would be complete without talking about the senescent cell-clearing drugs and therapies known as senolytics. Senescent cells are aged or damaged cells that should destroy themselves via a process known as apoptosis but, for various reasons, do not do so; instead, they hang around, sending out inflammatory signals that harm nearby healthy cells, block effective tissue repair, and contribute to numerous age-related diseases.

One proposed solution to these problem cells is to remove them by causing them to enter apoptosis, as originally intended, by using senolytic drugs and therapies. Removing these cells in mouse studies has produced some remarkable results, with mice often living healthier and longer lives as well as reversing some aspects of aging.

The race is now on to bring these drugs to people, and a number of companies are developing them right now. So far, UNITY Biotechnology has seen the most progress, and the company is already conducting human trials of its lead candidate drug (UBX0101) for the treatment of osteoarthritis. It has another candidate drug (UBX1967) closely behind; this drug is poised to enter human trials for the treatment of age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and glaucoma. Based on recent comments from UNITY, we are anticipating the initial results of human trials in the next few months; hopefully, the news will be positive.

With the number of companies working on these therapies, it is fair to be optimistic about their potential to address multiple age-related diseases given that senescent cells are a proposed root cause of aging. You can also check out the Rejuvenation Roadmap to see which companies are working on senolytics and how they are progressing.

Partial cellular reprogramming

Cells can be reverted back to an earlier developmental state, known as induced pluripotency, using reprogramming factors, and this process effectively makes aged cells functionally young again in many ways. Ever since its first discovery, there has been a great deal of interest in this area of aging research.

The problem with inducing pluripotency is that the cell loses its identity and forgets what cell type it currently is, as it becomes a new kind of cell capable of being guided into changing into any other cell type, much like our cells during development. This is great for early human development, but as adults, having our cells forget what they are is bad news. Therefore, researchers have wondered if it is possible to reset a cell’s age without resetting its cell memory, and the answer appears to be yes!

Thankfully, during the reprogramming of a cell back to pluripotency, the cell’s age is one of the first things to be reset before the cell memory is wiped, and it appears possible to partially reprogram the cell so that only aging is reset. We have talked about the potential of partial cellular reprogramming and how it is similar to hitting the reset button on aging in a previous article, but, needless to say, if we can find a way to safely partially reprogram our cells, it could have a dramatic impact on how we age and may allow us to remain more youthful and healthy.

In terms of progress, partial reprogramming has already been demonstrated in mice, and now a number of groups, including Turn.Bio, the Salk Institute, Life Biosciences, Youthereum Genetics, and AgeX, are developing therapies based on partial reprogramming, which is essentially the resetting of cells’ epigenetic states (what genes are expressed) from an aged profile to a more youthful one, again directly targeting one of the proposed root causes of aging.

This approach is likely to be quite a few years away, but I think it is plausible that it could be in human trials in the next decade, and it is probably the approach that interests me the most in the field.

In closing

The truth is we cannot predict the future because it is not set in stone, so we cannot be totally certain if or when rejuvenation technologies will arrive. The best we can do is learn as much as we can about the field and try to reach a reasonable conclusion based on the situation as it is now.

The field is advancing steadily, and we should be optimistic but not complacent about progress. We should be mindful of being too negative and, equally, of being too positive without ample justification. Blind optimism is as bad as blind pessimism, and we should always strive for informed optimism.

That said, given the progress being made, I am optimistic about my chances based on the evidence to date. This is why I do not mind birthdays and why I find them positive experiences rather than negative ones. Arm yourself with knowledge, and perhaps you too will agree with me and understand why I am future positive.

Steve Hill serves on the LEAF Board of Directors and is the Editor in Chief, coordinating the daily news articles and social media content of the organization. He is an active journalist in the aging research and biotechnology field and has to date written over 500 articles on the topic as well as attending various medical industry conferences. In 2019 he was listed in the top 100 journalists covering biomedicine and longevity research in the industry report – Top-100 Journalists covering advanced biomedicine and longevity, created by the Aging Analytics Agency. His work has been featured in H+ Magazine, Psychology Today, Singularity Weblog, Standpoint Magazine, Keep Me Prime, and New Economy Magazine. Steve has a background in project management and administration which has helped him to build a united team for effective fundraising and content creation, while his additional knowledge of biology and statistical data analysis allows him to carefully assess and coordinate the scientific groups involved in the project. In 2015 he led the Major Mouse Testing Program (MMTP) for the International Longevity Alliance and in 2016 helped the team of the SENS Research Foundation to reach their goal for the OncoSENS campaign for cancer research.

U.S. Transhumanist Party Chairman Gennady Stolyarov II Speaks with Steele Archer of Debt Nation

U.S. Transhumanist Party Chairman Gennady Stolyarov II Speaks with Steele Archer of Debt Nation

Gennady Stolyarov II
Steele Archer


Watch this wide-ranging discussion between U.S. Transhumanist Party Chairman Gennady Stolyarov II and Steele Archer of the Debt Nation show, addressing a broad array of emerging technologies, the aspirations of transhumanism, and aspects of both broader and more personal economic matters – from the impact of technology on the labor market to how Mr. Stolyarov paid off his mortgage in 6.5 years. This conversation delved into Austrian economics, techno-optimism, cultural obstacles to progress, the work and ideals of the U.S. Transhumanist Party / Transhuman Party, life extension and the “Death is Wrong” children’s book, science fiction, and space colonization – among many other topics.
Not Classing Aging as a Disease is Not a Major Problem – Article by Steve Hill

Not Classing Aging as a Disease is Not a Major Problem – Article by Steve Hill

Steve Hill


Editor’s Note: The U.S. Transhumanist Party features this article by our guest Steve Hill, originally published by at the Life Extension Advocacy Foundation (LEAF) on July 19, 2018. In this article, Mr. Hill does an excellent job explaining why the lack of the definition of aging as a disease under the FDA is not so bad as is sometimes feared. Personally, I do not agree with this. Relying on off-label use is not a good idea because that is much slower of a process than doctors quickly seeing that a drug has FDA approval. Once the FDA considers aging as a disease, pharmaceutical companies will quickly enter this arena and make increasingly better drugs. Mr. Hill makes some excellent points, though, and I highly recommend this article. 

~ Bobby Ridge, Assistant Editor, June 29, 2019

A common concern in the community is that the FDA, the EMA, and other bodies, such as WHO, do not classify aging as a disease and that this poses a problem for developing therapies that target aging. However, this is not really as serious an issue as some people would suggest; today, we will have a look at why that is.

Why this will not stop progress

Aging is a variety of distinct processes, damages, and errors; therefore, simply treating aging in clinical terms is not a viable endpoint. For a clinical trial to be conducted, it requires a verifiable indication, and aging is too general for the FDA and EMA to classify it as a disease.

It also is not a major challenge for damage repair-based approaches, such as those proposed by SENS and the Hallmarks of Aging, as these approaches are not focused on an all-in-one therapy with the indication of “aging”. They are based on a strategy of dividing damages into manageable groups and developing a suite of rejuvenation therapies that addresses each of them.

No single therapy will reverse or halt all of the aging processes when used alone, nor will it prevent all age-related diseases that accompany them. So, to have aging as an indication in any clinical trial would be pointless for any damage repair therapy.

Researchers are free to target aging processes

That said, researchers are very well aware that the processes of aging, which lead to the familiar diseases of aging, are a problem, and this is where the focus lies. There has been considerable effort to classify these processes and precursors of pathology as diseases themselves.

A prime example is the inclusion of sarcopenia (frailty and muscle loss) in the World Health Organization International Classification of Diseases (ICD) a few years ago thanks to lobbying by members of our community. Adding more general codes to the ICD that include these aging processes and precursors is an ideal solution, as it could potentially make it easier to organize trials and develop drugs that target the aging processes.

Back in June 2018, the World Health Organization released the new International Classification of Diseases (ICD-11). The previous version, ICD-10, was published in 1983, and the new ICD-11 will likely be the standard for years to come. The new ICD-11 now includes the extension code “Ageing-Related” (XT9T) for age-related diseases, and this should go a long way towards making focusing on aging easier for future drugs and therapies. Again, this is thanks to work by members of our community, who have spent countless hours researching and pushing for change.

Most aging hallmarks are very clearly linked to specific age-related diseases, such as beta-amyloid protein and malformed tau in Alzheimer’s, lysosomal aggregates in foam cells in atherosclerosis, and alpha-synuclein in Parkinson’s disease. Companies are perfectly welcome to target these aging processes directly, and indeed more and more researchers and big institutions are doing just that in order to treat age-related diseases.

Therefore, not classifying aging itself as a disease poses few barriers to developing therapies that address aging; it’s simply a case of working within the existing framework. UNITY Biotechnology is a prime example; this company is targeting senescent cells and applying its method to multiple age-related diseases; as everyone gets senescent cells, these therapies will be broadly applicable once they become available, and off-label use is likely to expand rapidly.

Also, rejuvenation therapies could, at first, be licensed as treatments for genetic disorders, even though the root cause of the pathology underlying those diseases is not aging. An example of this is the inherited mitochondrial disorders, known as mitochondriopathies, many of which are caused by mutations in the mitochondrial DNA (mtDNA). While these mutations are inherited and are not the result of age-related, deleterious damage to the mtDNA, the same repair-based approach can be applied: the allotopic expression of the protein in the nucleus, as proposed by MitoSENS, could potentially be used to repair the mtDNA allowing normal cellular function to resume.

The majority of damage repair therapies, if not all, could be developed as therapies for diseases with accepted indications and verifiable endpoints, which should satisfy bodies such as the FDA and EMA. Therefore, whether regulatory agencies perceive aging as a disease or not is of no consequence to the development of rejuvenation biotechnologies that address the aging processes.

This does not mean regulatory changes are not needed

Even though classifying aging as a disease is unnecessary, significant reform in the regulatory system is still needed in order to encourage investors and companies to put the time and money into researching and developing rejuvenation therapies.

One area in need of reform is the establishment of aging biomarkers, which indicate the repair or removal of age-related damage, as acceptable endpoints for rejuvenation therapies. Studies that use these biomarkers would also need to include long-term follow-up studies to ascertain the effects of a therapy over a longer period of time.

This would deviate from regulators’ normal requirements that therapies have to prove an effect on hard outcomes to be approved. In an ideal situation, patients should get rejuvenation therapies long before they are in immediate danger and once diseases have manifested, but this makes trials more time consuming and more costly to run.

However, back in February 2018, the FDA published a new guidance document detailing how early-stage Alzheimer’s patients might be identified, which, if accepted, would represent a significant change in policy and a step in the right direction. The document suggests that the results of imaging tests or suitable biomarkers could be enough to consider Stage 1 Alzheimer’s patients as suitable subjects for clinical trials.

This is a positive move as it means that therapies can be tested on people in the very early stages of Alzheimer’s rather than on those who have already suffered considerable if not irreparable damage to the brain, damage that no therapy could hope to address alone. This could mean that these early-stage patients could enroll in a clinical trial and take a therapy that could potentially prevent the disease from ever progressing further or reaching the point where cognitive decline begins.

In the case of repair-based therapies, it would then be a case of demonstrating that the early stages of Alzheimer’s disease were improved via the removal or repair of the underlying age-related damage, and suitable biomarkers would show this.

Moving with the times

Another area where regulatory bodies have struggled is keeping up with the rapid march of technology and medicine. Technologies such as gene therapies have struggled to gain traction due to an antiquated regulatory framework struggling to cope with them. Thankfully, this is also being acknowledged, and the regenerative medicine advanced therapies (RMAT) framework published earlier this year seeks to address this issue and make large-scale changes to how its regenerative medicine policy framework operates as a whole.

According to new FDA regulations, a drug is eligible for designation as an RMAT if:

  • The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
  • The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
  • Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.

While the FDA created these new guidelines, we joined forces with the Niskanen Center to submit comments to the agency so that it would hear the voice of our community.

Conclusion

Aging not being classified as a disease by the FDA, EMA, etc. is not a major issue; the real need is for policy changes that make developing drugs and therapies that target the aging processes easier and more financially viable. It is good that changes are being made to current frameworks and that progress will almost certainly continue in these areas.

Meanwhile, we can continue to support the development of repair-based approaches to aging knowing that such therapies, if they work, will be approved even in the current regulatory landscape.

Steve Hill serves on the LEAF Board of Directors and is the Editor-in-Chief, coordinating the daily news articles and social media content of the organization. He is an active journalist in the aging research and biotechnology field and has to date written over 500 articles on the topic as well as attending various medical industry conferences. In 2019 he was listed in the top 100 journalists covering biomedicine and longevity research in the industry report – Top-100 Journalists covering advanced biomedicine and longevity created by the Aging Analytics Agency. His work has been featured in H+ Magazine, Psychology Today, Singularity Weblog, Standpoint Magazine, and, Keep me Prime, and New Economy Magazine. Steve has a background in project management and administration which has helped him to build a united team for effective fundraising and content creation, while his additional knowledge of biology and statistical data analysis allows him to carefully assess and coordinate the scientific groups involved in the project. In 2015 he led the Major Mouse Testing Program (MMTP) for the International Longevity Alliance and in 2016 helped the team of the SENS Research Foundation to reach their goal for the OncoSENS campaign for cancer research.