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Re:Life After Eroom’s Law by contravariant on Monday December 28, 2020 @12:42PM (#25561208)
The current Covid-19 vaccine seems a crucial example of how important model validity can be. The mod-mRNA vaccines can apparently be created in a matter of hours and validated on animal subjects within days/weeks, yet it has taken us almost a year with extensive testing to be sure it will work and be safe. And even that is considered a record breaking time.

It cannot be overstated how big an advancement in medical science it would be if we could show that all such vaccines are safe and (probably) effective.

Re:Life After Eroom’s Law by refoundable on Monday December 28, 2020 @01:46PM (#25561898)
You're right on the money.

Any breakthrough that could either dramatically shorten the feedback cycle (from years to weeks), or reduce the cost of drug development by 100-1000x would unlock so much value as to completely reshape the structure of the Pharma industry.

The consolidation of the industry in recent decades could be justified by the high fixed costs of drug development that made it necessary to seek greater economies of scale, but in a world where the cost of drug development drops precipitously, the pendulum could swing in the other direction, unleashing a wave of decentralization in the industry.

Absent this kind of breakthrough, I expect only more intense regulatory and pricing pressures for the Pharma industry in coming years.

Re:Life After Eroom’s Law by eganp on Monday December 28, 2020 @04:30PM (#25563442)
It's a tough lift to demonstrate that all such modified-mRNA vaccines are safe and likely effective. This trial is a good validation of off-target safety, and that's a huge achievement. However, you still have on-target safety concerns (e.g. cross reactivity). Then, for each pathogen, the selected antigen expressed needs to 1. generate an antibody response and 2. provide protection from infection.

Antibody titers can de-risk 1 pretty effectively. But, without human challenge trials, you're stuck waiting for nature to test 2. Even using non-human primates as the model to test infection has many pitfalls as the species barrier is often strong with infectious diseases. Human immunology is often idiosyncratic when compared with closely related primates.