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New FDA Regenerative Medicine Framework is Win-Win for Gene Therapies – Article by Keith Comito and Elena Milova

New FDA Regenerative Medicine Framework is Win-Win for Gene Therapies – Article by Keith Comito and Elena Milova

Elena Milova
Keith Comito


Editor’s Note: In this article, Keith Comito and Elena Milova positively discuss new a FDA regulatory framework on RMAT (regenerative medicine advanced therapies) and on how it benefits the healthy-life-extension community. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, March 3, 2018

Back in November 2017, the FDA announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. Both draft guidance documents had 90-day comment periods, and we at LEAF joined forces with the Niskanen Center to submit comments to the FDA to ensure that the voice of the community for healthy life extension was heard. These new regulations could have considerable implications for the therapies and technologies being developed as part of the biomedical gerontology field.

The first draft guidance addresses how the FDA intends to optimize its regulatory requirements for devices used in the recovery, isolation, and delivery of RMATs (regenerative medicine advanced therapies), including combination products.

The second document explains what expedited programs may be available to sponsors of regenerative medicine therapies and describes what therapies may be eligible for RMAT designation.

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

We hope that this joint project will support the improvement of US regulations that concern these innovative treatments and will make the overall regulatory landscape more friendly. Below, we cite the most important notes from our resulting paper.

Last week, the Niskanen Center joined with the Life Extension Advocacy Foundation in filing comments to the Food and Drug Administration (FDA), offering our support for the agency’s new regenerative medicine advanced therapy (RMAT) designation draft guidance for industry.

Although there are opportunities for marginal improvements to the guidance, and FDA approval processes more generally, we are happy to see that the agency chose to include gene therapies in its interpretation of what qualifies as a regenerative medicine therapy.

Under section 3033 of the 21st Century Cures Act, the FDA was tasked with developing an accelerated approval process for regenerative advanced therapies. Such therapies would qualify for expedited review and approval so long as the drug (a) met the definition of a regenerative medicine therapy, (b) was “intended to treat, modify, reverse, or cure a serious condition,” and (c) “has the potential to address unmet medical needs” for a serious disease or condition. Unfortunately, the bill’s definition of a regenerative medicine advanced therapy was unclear on whether gene therapies, in particular, would qualify. Luckily, the FDA clarified this point. As the RMAT guidance document notes:

gene therapies, including genetically modified cells, that lead to a durable modification of cells or tissues may meet the definition of a regenerative medicine therapy. Additionally, a combination product (biologic-device, biologic-drug, or biologic-device-drug) can be eligible for RMAT designation when the biological product component provides the greatest contribution to the overall intended therapeutic effects of the combination product.

This is an excellent development and one that portends immense benefits for future gene therapy applications submitted for FDA approval. According to the guidance, the new RMAT designation, unlike other fast-track approval and review processes, “does not require evidence to indicate that the drug may offer a substantial improvement over available therapies.” Liberalizing the threshold standards of evidence for RMAT designation ensures that future gene therapies will encounter fewer unnecessary roadblocks in delivering more effective and innovative treatments for individuals suffering from debilitating diseases.

As we note in our concluding remarks:

Overall, we consider the RMAT guidance to be a stellar improvement over other expedited programs, especially in its qualifying criteria. However, greater clarity is needed in order to capture the benefits of more advanced cell therapies that can help contribute to the healthy aging and well-being of American citizens. As FDA Commissioner Scott Gottlieb recently noted: “The benefits of [gene therapy] science—and the products that become available—are likely to accelerate. How we define the modern framework for safely advancing these opportunities will determine whether we’re able to fully realize the benefits that these new technologies can offer.”

We agree wholeheartedly. Developing a regulatory framework that accommodates safety and innovation will be a key determinant of how quickly the benefits of regenerative medicine, gene therapy, and anti-aging research revolutionize the lives of Americans. This guidance is an important and promising step in the right direction. With the right modifications, it can help usher in a new age of healthcare improvement for individuals from all walks of life.

Read the full comments submitted to the FDA here.

Source: Niskanen Center

About Elena Milova

As a devoted advocate of rejuvenation technologies since 2013, Elena is providing the community with a systemic vision how aging is affecting our society. Her research interests include global and local policies on aging, demographic changes, public perception of the application of rejuvenation technologies to prevent age-related diseases and extend life, and related public concerns. Elena is a co-author of the book “Aging prevention for all” (in Russian, 2015) and the organizer of multiple educational events helping the general public adopt the idea of eventually bringing aging under medical control.

About Keith Comito

Keith Comito is President of LEAF / Lifespan.io and a long-time advocate of longevity research. He is also a computer programmer, mathematician, musician, lover of life and perhaps a man with too many hobbies. He earned a B.S. in Mathematics, B.S. in Computer science, and M.S. in Applied Mathematics at Hofstra University, where his work included analysis of the LMNA protein.

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

World Health Organization Puts the Elderly Back in the Picture – Article by Elena Milova

World Health Organization Puts the Elderly Back in the Picture – Article by Elena Milova

Elena Milova


Editor’s Note: In this article, Miss Elena Milova explains the success the anti-aging community has had in influencing policy makers at the WHO in including several provisions related to aging, in their global strategy and action plans of the next decade. This article was originally published by the Life Extension Advocacy Foundation (LEAF).

                   ~ Kenneth Alum, Director of  Publication, U.S. Transhumanist Party, January 27, 2018

Not long ago, we wrote about some complications involving the WHO 13th programme of work. In the initial version of this document, developed by the WHO working group in November 2017, the problems of the elderly were nearly completely overlooked. The joint effort of our community helped to bring this critical flaw to public attention.

During the meeting of the working group, it was announced that 90% of the comments received by WHO (out of 400) pointed out the need to set healthy aging as one of the priorities of the new programme of work. However, we didn’t know if our demand to focus on the implementation of the global strategy and action plan on aging and health would be fulfilled.

The good news is that the new draft programme published on the WHO site on November 5th includes several provisions related to aging. Our community managed to persuade these global policymakers to implement all activities listed in the global strategy to help society prepare for the Decade of Healthy Aging (2020-2030). Let’s have a closer look at these provisions.

15. The foundation of WHO’s work is SDG 3: ensuring healthy lives and promoting well-being for all at all ages. WHO is an organization focused principally on promoting health rather than merely fighting disease, and especially on improving health among vulnerable populations and reducing inequities. Leaving no-one behind, the Organization aims to give women and men, girls and boys, in all social groups, the opportunity to live not just long but also healthy lives. WHO will explore measuring this foundation of its work using healthy life expectancy, which could serve as one overarching measure aligned with SDG 3, complemented by the triple billion goal, which leads to three more specific priorities, each with overlapping one-billion people goals.

Healthy life expectancy (HALE) is an assessment of the period of time a person can live in full health. HALE is usually lower than total life expectancy, and the difference between HALE and total life expectancy is regarded as years of life lost to disease.

As the goal of our community is to prolong the healthy period of life by addressing the root mechanisms of aging and postponing age-related disease, the introduction of HALE as a way to measure WHO activities is a very good outcome. It is very hard to preserve health in older ages without addressing the underlying mechanisms of aging and implementing an extensive program that involves educating the public about healthy lifestyles. This choice of indicator means that WHO will strengthen its efforts to keep people healthy for as long as possible, which will ease the introduction of rejuvenation interventions once they are available, as it will likely be a cost-effective way to achieve a more favorable HALE.

16. Life expectancy at birth has consistently increased since the 19th century, largely due to socioeconomic developments and public health measures such as vaccination, nutrition and
sanitation. Today, socioeconomic, political, cultural, environmental and economic forces continue to drive changes in the burden of disease. However, efforts are needed to ensure that their impact is positive. Poor health literacy coupled with weak health-promoting policies make it difficult for people to make healthy choices for themselves and their families. Investment in health promotion and disease prevention allows countries to address economic concerns about the rising costs of the health system and enables potential savings if disease can be avoided.

The WHO draft programme of work refers here to the increasing burden of chronic, non-communicable diseases due to the increasing proportion of people age 60 and over. Indeed, it would be really hard to double or even triple healthcare and pension expenditures for many countries, especially taking into account the ongoing economic crisis. However, this is what aging societies will have to do, if HALE does not grow faster.

This is why WHO is only promoting evidence-based interventions that represent the “best buy” scenarios: the most realistic and cost-effective. When it comes to age-related diseases, which can last 20-30 years or longer, prevention could be much cheaper, and it is more humane, as this scenario would reduce unnecessary human suffering. Therefore, we could consider this provision of the new draft programme as supporting our efforts to introduce longevity lifestyles and even “soft” (careful and evidence-based) biohacking.

17. Healthy life expectancy has not increased at the same pace as life expectancy, and increasing age often brings increasing morbidity and reduced functioning, making healthy ageing an important focus. Most disability-adjusted life years in older age are attributable to chronic conditions and the accumulated impact of such conditions can lead to significant loss in function and care dependence in older age. At the same time, there is emerging evidence that healthy ageing depends on early childhood development and is epigenetically determined. Ensuring healthy ageing is an urgent challenge in all countries.

This provision once again underlines how important it is to focus on prevention. I would like to point out that if childhood is perceived as the foundation of healthy lifestyles, longevity advocates receive carte blanche for working with the younger generation. Activists could think of developing corresponding education programs for schools and universities, and this very provision can be a strong argument when offering such a program to educational authorities.

37. Ensuring healthy ageing is central to universal health coverage, just as it is to the other priorities of GPW 13. The number of people over the age of 60 is expected to double by 2050 and this unprecedented demographic transition will require a radical societal response. The Secretariat will support Member States to promote healthy ageing through the actions defined by the Global strategy and action plan on ageing and health (2016), as well as through the Decade of Healthy Ageing that is planned for the period 2020−2030. These actions include aligning health systems to the needs of older populations, with a special focus on enhancing the functioning of older persons and the management of chronic disease; improving access to medicines; developing systems of longterm care including community-based services; promoting palliative care, creating age-friendly environments; and improving measurement, monitoring and understanding of healthy ageing.

This provision is exactly what we were aiming for when calling the members of our community to take part in the Open Consultation or the Draft. As you remember, all mentions of the WHO documents related to aging were absent; this provision clearly shows that we achieved our goal! Even though the global strategy and action plan on aging and health may not be ideal in terms of rejuvenation research promotion, it helps member states navigate the field with more confidence. This global strategy, which we wanted so much to be the foundation of the draft programme provisions related to aging, contains a very important paragraph that every activist should know about:

105. Finally, better clinical research is urgently needed on the etiology of, and treatments for, the key health conditions of older age, including musculoskeletal and sensory impairments, cardiovascular disease and risk factors such as hypertension and diabetes, mental disorders, dementia and cognitive declines, cancer, and geriatric syndromes such as frailty. This must include much better consideration of the specific physiological differences of older men and women and the high likelihood that they will be experiencing mutimorbidities. This could also be extended to include possible interventions to modify the underlying physiological and psychological changes associated with ageing.

Conclusion

Dear friends, this is a victory! Our community managed to influence policymakers of the highest level: the World Health Organization. We managed to ensure that the new programme of work considers aging and age-related diseases to be an important issue, and the resulting global strategy and action plan on aging and health is an effective guide to helping our society adapt to population aging.

In terms of advocacy, this is a complete victory, which shows two important things. First, when we join forces, we can influence global health policy at the highest level. Our community became stronger, and our voice is being heard! Second, this victory shows that dialogue with the UN and its institutions, including decision-makers in these agencies, is possible, and it goes in the directions that we need: more focus on prevention and more focus on public health education related to aging.

I offer special thanks to Dr. Ilia Stambler for initially turning the attention of the community to this issue. I want to thank and congratulate all participants of the Open Consultation with this achievement. Of course, we are still at the beginning of our path to rejuvenation as a public health priority, but outcomes like this one make me believe that there are more victories to come. Let’s keep working, as the main reward is worth it: health, youth, and freedom from age-related diseases for all!

About Elena Milova

As a devoted advocate of rejuvenation technologies since 2013, Elena is providing the community with a systemic vision how aging is affecting our society. Her research interests include global and local policies on aging, demographic changes, public perception of the application of rejuvenation technologies to prevent age-related diseases and extend life, and related public concerns. Elena is a co-author of the book Aging Prevention for All (in Russian, 2015) and the organizer of multiple educational events helping the general public adopt the idea of eventually bringing aging under medical control.

About LIFE EXTENSION ADVOCACY FOUNDATION (LEAF)

In 2014, the Life Extension Advocacy Foundation was established as a 501(c)(3) non-profit organization dedicated to promoting increased healthy human lifespan through fiscally sponsoring longevity research projects and raising awareness regarding the societal benefits of life extension. In 2015 they launched Lifespan.io, the first nonprofit crowdfunding platform focused on the biomedical research of aging.

They believe that this will enable the general public to influence the pace of research directly. To date they have successfully supported four research projects aimed at investigating different processes of aging and developing therapies to treat age-related diseases.

The LEAF team organizes educational events, takes part in different public and scientific conferences, and actively engages with the public on social media in order to help disseminate this crucial information. They initiate public dialogue aimed at regulatory improvement in the fields related to rejuvenation biotechnology.

LEAF Panel: How to Promote Longevity? ft. Drs. Aubrey de Grey, Alexandra Stolzing, Oliver Medvedik

LEAF Panel: How to Promote Longevity? ft. Drs. Aubrey de Grey, Alexandra Stolzing, Oliver Medvedik

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Keith Comito
Oliver Medvedik
Steve Hill
Elena Milova
Aubrey de Grey
Alexandra Stolzing
Alen Akhabaev


The U.S. Transhumanist Party is pleased to feature this extensive discussion, hosted by our allies at LEAF – the Life Extension Advocacy Foundation.

Description by LEAF: Dr. Alexandra Stolzing, Dr. Aubrey de Grey, Dr. Oliver Medvedik and a number of other guests discuss longevity, advocacy and rejuvenation biotechnology in an exclusive panel hosted by the Life Extension Advocacy Foundation (LEAF). This panel, moderated by LEAF president Keith Comito, talks about the latest progress in rejuvenation biotechnology and about how to engage, educate and excite the public regarding cutting-edge medicine.

Panel: Dr. Alexandra Stolzing, Dr. Aubrey de Grey, Dr. Oliver Medvedik , Elena Milova, Keith Comito, Steve Hill and Alen Akhabaev.

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Support LEAF’s work by becoming a “Lifespan Hero”: http://lifespan.io/hero

A “Disease” Approach in Life-Extension Advocacy Can Facilitate Communication with the General Public – Infographic by Elena Milova and Keith Comito

A “Disease” Approach in Life-Extension Advocacy Can Facilitate Communication with the General Public – Infographic by Elena Milova and Keith Comito

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Elena Milova and Keith Comito


The U.S. Transhumanist Party is pleased to share this infographic from our friends at the Life Extension Advocacy Foundation (LEAF), one of the Transhumanist Party’s most active Allied Organizations. Life-extension advocates Elena Milova and Keith Comito have compiled a set of tips for communicating ideas regarding the progress of medical science and technology, for the pursuit of healthy life extension, in such a manner as to enable many in the general public to understand and sympathize with our goals and the science behind them. We encourage you to distribute this infographic to any activists and advocates who you think would benefit from the advice therein.