Comment from https://utahhealthentrepreneurs.org/
AnonymousSupportIndividual
Summary: Joe argues that current animal testing methods are outdated and economically unsustainable due to high drug failure rates. He advocates for the FDA to rapidly adopt AI and machine learning technologies to modernize the drug commercialization process.
How many proteins are there in a human? Current estimates say a range of several hundred thousand to several million distinct proteoforms (proteins) per human. How many animal studies to make sure the any new drug candidate (api) is not toxic to any of them? Let's see the numbers at $30,000 per animal test times say on 1,000.000 proteins...and there are many more proteins to go. Now do we understand why the failure rate is 96% that we know of? I bet the failure rate is closer to 99% failure rate after the post Phase 4 lawsuits for drug injuries. Are those lawsuits due to not doing enough animal tests or too many? Animal testing is 1939 technology giving us 1939 data. To benefit society the FDA must rapidly adapt 2025 technology and authorized AI/machine learning paths to commercialization ASAP. Furthermore, spending an average of $5,000.000 on each bio startup at an estimated 2700 startups per year is a non-sustainable economic model when an estimated 96% fail due to toxicity factors. All that money is now bad debt to society......which will not advance the role of the FDA.
I guess that is why the FDA modernization act came into being.
FYI
Joe