Sunday, October 11, 2020 9:59:09 AM
https://www.sciencedirect.com/science/article/pii/S235287371830026X
IMO, the problem we have is not(does AVXL science do what we must have in CNS diseases??). The problem we have is the tools and methods used to prove efficacy are primitive and harmful to technical leadership and medical science Biomedical development.
Your comment here makes the point well and is consistent with my own past comments here. This has all been solved before in another industry (electronics) buy a bunch of people from industry and academia. I was there and helped make some of it happen. The big leader then was AT&T affiliation w/Bell Labs (Dr. Connie Zert-Cherry Hill, N.J. and RADC in upstate NY. The key lies in being able to accelerate the rate of failure. This link discusses some of the physics behind the "Bath Tub Curve". (see failures curve shows Infant mortality, useful life, wearout). This process in physics is basically the opposite of the current FDA trials process. (if we have to wait 5-10 years to evaluate results we will never solve anything). This point has been made before here about the massive/expensive waste of resources tied to FDA trials process. A complete failure and yet they insist it must be used.
https://www.hindawi.com/journals/as/2014/304724/
This tech paper explains part of the solution but it gets a little tricky so, simply put we must find a way to accelerate CNS failures and then apply the science to a trials tool suite which quickly shows results (see AI).
Such a simple tool suite linked w/HH thinking on BIOMED PM will quickly provide a set of tools and methods which can be used to produce breakthrough thinking along w/lab results to navigate our way out of the woods. BTW, I think we (AVXL) have IP and patents heading that way now. IMO, this may be evidence of just how far ahead of the herd AVXL already is.
DR.M. has gone back to RSD trials results b/c it effectively accelerates PDD-CNS MOA proof-results (even if great) will still take decades to prove using current methods.
The acceleration of failure rates in semiconductor technology during the 60's is analogous to complexity of medical-biomed technology/science in use today (IMO).
Had AT&T-RADC and others not done this out of the box thinking back then we would all still be using dial system technology today and things like Web based tools would not exist. It is that simple. (BTW in those days the US military controlled the processes in the Hi Rel world)
So, the key point in science here is to develop and apply a method for accelerating the rate at which CNS disease failures may be demonstrated/simulated in the lab, then apply what is learned until results eliminate failures. We will then produce medical solutions which allow a "Bathtub Curve" for pharma research to be applied where solutions with confidence approaching certainty can be demonstrated. It is really a lot easier to do than it sounds. The current trial and error methods will never get us to where we need to be. These new tools will also have an effect to accelerate the evolution of new medical learning-thinking using AI tools for simulation.
I reflect back on the now famous quote from FDA a while back where they said/published , "They were not even sure exactly where AD starts". If we rely on FDA-WHO-NIH-other's, we deserve exactly what we get.
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