Tuesday, October 3, 2023

Random Thought

๐‘๐š๐ง๐๐จ๐ฆ ๐ญ๐ก๐จ๐ฎ๐ ๐ก๐ญ: Want to sell pharmaceuticals in the U.S.? The government should require that ๐š๐ฅ๐ฅ such entities develop a ‘๐ฆ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ข๐ง๐  ๐š๐ง๐ ๐ฌ๐ฎ๐ฉ๐ฉ๐ฅ๐ฒ ๐œ๐ก๐š๐ข๐ง ๐๐ข๐ ๐ข๐ญ๐š๐ฅ ๐ญ๐ฐ๐ข๐ง’ for their operations. A standard model to be developed (in cooperation with pharmaceutical manufacturers, etc.) by NIST who will define the data elements, etc., definitions, metrology/measurement, information collection, reporting, technology used, etc., etc. 

Data from the various manufacturers’ digital twins would regularly (e.g. daily) ‘feed’ a government-controlled ‘๐ฉ๐ก๐š๐ซ๐ฆ๐š ๐ข๐ง๐๐ฎ๐ฌ๐ญ๐ซ๐ฒ ๐ฆ๐š๐ง๐ฎ๐Ÿ๐š๐œ๐ญ๐ฎ๐ซ๐ข๐ง๐  ๐š๐ง๐ ๐ฌ๐ฎ๐ฉ๐ฉ๐ฅ๐ฒ ๐œ๐ก๐š๐ข๐ง ๐๐ข๐ ๐ข๐ญ๐š๐ฅ ๐ญ๐ฐ๐ข๐ง.’ 

This will require enabling legislation e.g. to overcome manufacturer claims of proprietary information, trade secrets, etc. that they historically have used to not provide information. A wide variety of “carrots” and "sticks" will need to be used to gain industry cooperation, for example the government underwriting the costs of development, deployment, and implementation, with the benefits of having such a system accruing to the manufacturers. 

Once the FDA’s QMMP is deployed to manufacturers its data can then also be folded into the digital twin. With the resulting complete transparency and end-to-end visibility across the entire industry now available to the government (manufacturing information, quality information, supply chain information, etc.), the use of AI, ML, and other such tools should support the ability to forecast and anticipate problems, issues, disruptions, etc. so that the appropriate efforts at prevention, mitigation, etc. can be carried out successfully.

6-part article of which the above is a sub-part

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