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Statements posted on this blog represent the views of individual authors and do not necessarily represent the views of the Center for Law Science & Innovation (which does not take positions on policy issues) or of the Sandra Day O'Connor College of Law or Arizona State University.

Governance of Emerging Technologies Conference 2015: Anti-aging Treatments

Anti-Aging Treatments: Scientific Progress Needs to Be Accompanied with Regulatory Advances

BY GARY E. MARCHANT (Professor of Law, ASU)

One of the many cutting-edge sessions at the 3rd Annual Governance of Emerging Technologies conference focused on anti-aging technologies. There has been a long history of unproven life-extension claims and bogus anti-aging products. But in recent years, significant progress has been made in developing scientifically- based approaches for extending the quality and length of life. However, there are serious legal and practical obstacles impeding the regulatory pathways for such agents.

Dr. James Kirkland, Director of the Mayo Clinic’s Robert and Arlene Kogod Center on Aging in Rochester, MN, kicked off the session with an overview presentation on “The Basic Biology of Aging: New Interventions and Therapeutic Opportunities.” Dr. Kirkland emphasized that aging biology is at the core of a large number of chronic diseases, including cancer, cardiovascular disease, stroke, sacrcopenia (muscle wasting), diabetes, and neurodegenerative disease. Attacking these chronic diseases one-by-one is not a viable anti-aging strategy, since preventing the onset of just one of these diseases will only extend life a year or two until the next disease on the list sets in. Rather, the strategy needs to target fundamental mechanisms shared by chronological aging and age-related chronic diseases, such as Inflammation, cellular senescence, macromolecular dysfunction, and stem cell or progenitor dysfunction. Fortunately, we now have a growing list of over 35 potential interventions that increase lifespan and/or healthspan in animal studies that are now candidates for human trials. Dr. Kirkland ended his presentation by listing some of the practical challenges in conducting human trials on these exciting new potential anti-aging agents, such as the potentially long duration of such trials and the need for surrogate biomarkers. He suggested some innovative approaches for overcoming these challenges, such as focusing on research subjects with “accelerated aging” conditions.

Next, Dr. Lewis Gruber, CEO of the biotechnology company Siwa, reported on a specific approach to anti-aging therapy that his company is pursuing. Siwa is targeting senescent cells, which accumulate in tissue over time and secrete substances that impede the proliferation of stem cells and other healthy cells. Cell senescence has been associated with all of the chronic diseases associated with aging, including cancer, Alzheimer’s disease, atherosclerosis, chronic obstructive pulmonary disease, hypertension, and sarcopenia. Siwa has developed a momoncolonal antibody therapy called NeaVira™ that targets a cell surface marker found on senescent cells. The potential of this agent has been demonstrated in animal studies targeting sarcopenia in which statistically significant increases in muscle mass were observed in treated aged mice compared to controls, with no adverse effects and no regression after cessation post treatment. This potential anti-aging agent is now being prepared for human trials.

Well-known author Joel Garreau then addressed the social consequences of anti-aging therapies, presenting four possible scenarios for 2030, which he referred to as “small change,” “drooling on their shoes,” ”live long and prosper,” and “immortality.” These four scenarios and their implications were previously described by Garreau in a Slate article.

Finally, I (Gary Marchant) discussed the regulatory impediments to regulatory approval of anti-aging therapies. Our current regulatory system is geared towards single-disease therapeutics, and is not a good fit for oversight of new health-based interventions such as preventive treatments, human enhancements, and anti-aging therapies. With the recent progress in anti-aging treatments, there is an urgent need for new regulatory pathways for anti-aging treatments, which may be part of a transition from a disease-focused model to a health-focused model. A vigorous discussion closed the session, with some people focusing on changes within the existing statutory framework, and others calling or innovative new governance approaches. Many of the audience members agreed to work together to pursue a more viable regulatory pathway for ant-aging therapies. Send me an email at gary.marchant@asu.edu if you would like to be part of this search for a solution.