Here I’ll point out a commentary from the SENS Research Foundation on one of the many changes that is needed in medical regulation in order to smooth the path ahead towards clinical availability of the first rejuvenation therapies. It is not a cynical viewpoint, and is focused on working within the system to make incremental beneficial alterations to one of the many regulatory positions that currently hold back progress. Accordingly, I’ll follow it with my much more cynical view of the state of regulation, the harm it does, and the prospects for change – that I think must come from outside the system, not within.
Substantial regulatory reform is needed to create a pathway for investors and pharma to put the necessary time and money into researching and developing rejuvenation biotechnologies such that licensable therapies can come out the other end. The most important regulatory reform would entail acceptance of novel biomarkers of the removal, repair, replacement, or rendering harmless of specific forms of cellular and molecular aging damage as sufficient basis to grant rejuvenation biotechnologies preliminary licensure. This would then be followed up by further monitoring