A recent New York Times article, F.D.A. Faulted for Problems With Drug Tracking, points out the flaws in the FDA’s post-approval monitoring process for therapeutics. As genetic testing becomes more commonplace and treatments are able to be targeted more specifically to individuals because of our increased understanding of how therapeutics interact with individual genomes, regulation will need to be expedited to reflect this fundamental shift in medicine. Expedited approvals will require effectively monitoring therapeutic results which the FDA currently cannot.
The entire process of drug discovery must be reexamined as treatments are developed more rapidly and are more specifically targeted. Specifically, a process suited to approving a few blockbuster drugs a year needs to shift to a system where hundreds of individually targeted ones are approved annually. The only way to address this is to shift from extensive pre-approval testing to better post-treatment monitoring. Fortunately for the FDA, digital health platforms are ideally suited to providing this, especially as sensors and bio-assays get more accurate and the software data and notification platforms get more sophisticated and robust.
The future of medicine will increasingly be focused on the specifics of the individual patient. Current drug discovery and medical technique is focused on the the average patient, and drugs are considered efficacious even if they only are beneficial to a minority of the population. As the mechanism by which most drugs impact a patient is unknown, effectiveness can only be determined by trial and error – give the patient the treatment and see if it works.
As we increasingly understand the human genome, and experimentation shifts from broad trial and error studies to understanding the mechanisms by which treatments are impacted by specific individual genotypes, the patient’s micro-biome, their environment and health history, etc., extremely personalized therapies will provide much greater treatment outcomes. But developing those therapies will be costly, and next to impossible in the absence of a radical restructuring of the FDA approval process.
The first step in enabling such a restructuring is in ramping up post-treatment monitoring. This provides confidence in both efficacy and safety. As an initial step it is crucial, because the development of the software and data infrastructure to safely and confidentially support such monitoring underlies all the promise of digital health. Better mechanical and biological sensors will enable a physician to monitor crucial parameters of individual health, better analytical software will assist them in making correct decisions, and sophisticated monitoring will enable real-time notification of potentially dangerous conditions.
HTL Life accelerator is suited to develop, alongside treatments, software and hardware platforms that enable the real time monitoring necessary to complement the expedited processes required for individually targeted treatments. One of the many advantages to our model, in our working inside the La Jolla Institute for Allergy and Immunology and having access to their validated IP and lab and mentoring support, is that we can offer to our portfolio companies access to this platform, shortening development times and improving the chances of FDA approval.