Replies to post #203599 on Anavex Life Sciences Corp (AVXL)

[plexrec]

kevli--"computing power to identify clinically meaningful patterns in the data "--this appears to me what Anavex is doing with their PM--am I correct ??? another dot to connect ???

[nidan7500]

Kevli33...great paper here. Possibly explains some of the issues the FDA has faced behind the curtain. One can see definite culture clash possibilities for systems and structure as new learning methods and tools do not fit w/existing FDA practices. Maybe explains a few things.

This is the kind of paper you read and question...NOW WHAT? This helps me to connect some dots in my own mental model and recognize the kind of changes the medical/trials community has to deal with. BTW, the process outcome has a direct impact on AVXL SP.

Another key challenge in the clinical development process is linked to reporting the results of most conventional clinical trials of average treatment effects that may not easily translate into making individualized treatment decisions at the routine point-of-care.4 Promising approaches to overcoming this challenge are more streamlined processes, exploiting new digital clinical endpoints and treatment response biomarkers amenable to close and efficient monitoring (such as circulating tumor DNA), improve safety and efficacy while reducing toxicity and adverse events and greater insights into the patient journey via sensors, and low cost imaging.5,6,7,8 Securing, standardizing, and enhancing routinely collected EHR data as a source of credible medical evidence based on RWD can facilitate the organization of clinical trials at the point-of-care and should serve to improve the clinical development process.

https://www.nature.com/articles/s41746-019-0148-3

Now apply these new thoughts to the conversation about the AVXL-team-Consortium. We can only speculate on what or who initiated the formation of the consortium. Not spontaneous but developed from common needs which will grow exponentially as system dynamics dictate (Senge).To suggest it is a method for Cognision to sell more headsets is very dubious at least. This is how change happens. "the form follows function" organizational structure is a factor. The geographical makeup is different to say the least. This model-collection is dealing with a nationalized regulated healthcare industry w/incomplete but existing links by disease function. Will rules be disease MOA specific or product specific? How will that impact the organizational form, bot regulatory and private? It looks like different countries will allow/share approvals but will data bases and clinical data be open and who owns it? Cannot imagine a company like AVXL just opening its files on trials and results for the world to see.

One thing is getting to be clear at least. The strategic management challenges of such a structure will become almost as important as the scientific accomplishments certain to quickly develop. Who is on first.

BTW-score was another win for the drug clean side yesterday, that makes it 3 wins to 0 for the PED Crew. Ain't science grand.