Wouldn’t be great if we could find a treatment to improve longevity? Not just a treatment for a specific disease but one that could dramatically improve longevity for a large percentage of human kind. While there is a lot of longevity research going on and much progress has been made. There are some challenges. Milan Cvitkovic writes about these challenges in his blog post “(How) should we pursue human longevity?” One issue is regulatory.
Before it can conquer death, a longevity treatment will have to conquer the U.S. FDA’s clinical trial process. The FDA doesn’t consider aging to be a medical indication (a.k.a. a valid reason for treatment). This means longevity companies have to choose an existing age-related indication (e.g. Alzheimer’s) to demonstrate efficacy of their treatment on. How to do this well is a key consideration for any longevity biotech.
More optimistically, regulatory changes like dual-track clinical trials or eliminating phase 3 trials altogether might entail a massive acceleration in longevity therapeutic development. Outsourcing or decentralizing clinical trials is also an exciting option. Science 37 is one company working on this.
Increased transparency and a ‘fail fast’ mentality would also be helpful.
Between 25% and 50% of clinical trial results remain unpublished even several years after completion. This isn’t surprising: why publish your clinical data when there’s zero gain to you and even a slim chance you can repurpose the asset in the future? But this means a potential downside of moving longevity efforts from research to commercial therapeutic development is that the field will learn less overall.
A related problem is that because liquidity events can happen far before convincing clinical data, biotechs are incentivized to push their risky studies until as late as possible (ideally after the employees get their money) and to gussy them up to look better than they really are. A fail-fast-and-publish-honestly mentality would of course be better for longevity overall.
Nintil also has a very helpful “Longevity FAQ” post that is worth reading as well.