A Perspective on the Coming Regulatory Shift to Approval of Drugs to Treat Aging

At some point, regulatory bodies that oversee the development of new medicine will accept that therapies can target causative mechanisms of aging in order to slow or reverse the progression of aging, and that there are viable ways to assess new treatments that treat aging. There is growing pressure from the academic community and longevity-focused biotech industry for the ability to run clinical trials to treat aging, rather than to treat one specific age-related disease. While inevitable, this change will take some years to come to pass, and likely require greater consensus in the research community on reasonable approaches to measure biological age. The scientific community is making good progress towards the adoption of improved epigenetic clocks as as a consensus means of measuring biological age in a natural environment, but it becomes challenging to stand by any of these clocks when any one causative mechanism of aging is slowed or reversed via therapy. The clock may over-represent or under-represent the contributions of that mechanism to degenerative aging, and there is no real way to find out without calibrating the clock against that specific therapy in lengthy animal studies. In the meanwhile, companies developing therapies that target the mechanisms of aging choose one specific age-related condition for clinical trials and regulatory approval. They move ahead assuming that widespread off-label use will likely follow approval for any one age-related di...
Source: Fight Aging! - Category: Research Authors: Tags: Healthy Life Extension Community Source Type: blogs