Here’s the one-hundred dollar question: how can we improve the pace of drug development and approval? Why does it take so long to develop new drugs and treatments and get them approved?
Here’s our take on this obstacle towards the ideal future. What do you think?
Novel and innovative therapeutics and treatments will need to be developed and approved in order to slow down the aging process. Such therapies, however, tend to take an extremely long time to be developed and approved, which means progress towards the preferred future state will be extremely slow as well.
Drug development process is composed of multiple steps, each of which requires time, effort, and significant monetary investment. Once a certain developmental candidate has been identified in the lab, almost always after clinical trials in animals, it goes through three phases of clinical trials, as follows -
The specific assessments vary, but the general agreement is that somewhere between 5 to 13.8% of all developmental candidates that enter phase 1 of clinical trials, end up being approved  . As for time, all three first phases combined require 6-7 years, followed by another 0.5 - 2 years for the FDA review and for manufacturing to start. Finally, the fourth phase can take 0.5 - 10 years.
Since the pace of new drug development is so slow and fraught with failure, new medications arrive very slowly to the market. Additionally, the high costs involved in the development of every new drug, as well as the need to compensate for past failures, require pharma companies to charge extraordinarily large sums for the medications that make it to the market. As a result, even if successful anti-aging therapeutic were to be developed, it would probably be accompanied by a hefty price tag that would keep the medication out of the hands of many.
**This obstacle is relevant to all user groups, since future anti-aging medications may be used at any stage in life. However, at the moment this obstacle is especially relevant for people who are 60 years old or older, and who suffer from at least one chronic disease.
While the regulator is often held at fault for slowing the pace of progress, at least in this case it is performing admirably well. The FDA only takes eight months to review any new treatment, which is a reasonable amount of time considering that its scientists must go over the results of several clinical trials and produce a 200 page report. The European Medicines Agency (EMA) similarly requires around six months to assess new submissions.
The main difficulty behind this obstacle is that the science underlying age-related diseases (and diseases in general) is complex and is not yet fully understood. The unfortunate implication is that pharma firms cannot forecast in advance whether or not a certain therapeutic candidate will achieve success or not, and what kind of side effects it may carry.
Additionally, there are currently no good models of human tissues and body to test new drugs on in the lab, which may account for the fact that only 30.7% of all candidate drugs successfully pass the second phase, in which they’re tested for their actual efficacy in human beings.