FDA Opens Pathway For Testing Rejuvenation Biotechnologies For The Prevention of Alzheimer’s Disease
It’s often assumed that the fact that regulators like the FDA don’t recognize aging as a “disease” is a major challenge to the development of medical therapies targeting degenerative aging processes. In fact, as we’ve discussed before (scroll down to “Question of the Month”), this is not a major hurdle for rejuvenation biotechnologies, because of the specifics of the “damage repair” approach to rejuvenation biotechnology that we’re pursuing at SRF. That said, 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 of patients to ensure that the therapy actually does bend the curve on diseases of aging over the longer term. This standard would mark a break with regulators’ usual insistence (which
Article originally posted at
Sens Research Blog