Discussion about this post

User's avatar
Alison Conley's avatar

The FDA must agree with you because they are looking for new ways to bring drugs to market faster.

Dr Martin Makary, the new FDA commissioner, is talking about using AI and cell line computational models to replace animal toxicology studies for testing biologics for safety and efficacy.

While this sounds good on the surface, it is uncertain how this might impact drug safety. In preclinical testing typically a compound has to be safety tested for 14 or 28 days in 2 species prior to being approved for Phase I. As the compound progresses it has to go through a series of longer duration toxicology studies before it is FDA approved for Phase 2 and 3.

How do you think moving from animal safety testing to AI and computational type models will impact cGMP and safety? It seems like AI and organ on a chip systems are primarily designed to stimulate investment in biotech and ensure speed to market. I might be wrong about this as I am not an expert but this looks similar to the Covid strategy, loosen up pipelines, stimulate investment to get products to market quickly. Profit over patient safety.

It would be interesting to get your thought on this topic and how it will impact cGMP. Again the FDA must not think this is about depopulation but speed to market. If your plan is to kill people why waste time coming up with new ways to accelerate drugs to market???

Expand full comment
Crixcyon's avatar

Over the decades, 10's of millions have sacrificed their lives in order to provide Pig Pharma with a buck or two...tens of billions of them. No one has any desire to stop the deadly carnage.

Expand full comment
5 more comments...

No posts