| The FDA approves new modalities that do things “in their own way” all of the time! Yescarta, Kymriah, the mRNA vaccines, the approved VHH, scVF and “mimetics” in the article. Here’s a whole page of cell/gene therapies, many of these were produced “in their own way” or in ways that didn’t exist at all 10 years ago. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-t... Warp speed did accelerate review of COVID vaccines, but it didn’t change trial design nor manufacturing requirements - I’m not sure that supports your argument. I have seen the FDA be quite receptive to innovative trial design - baysean protocols, conditional endpoints, genetic diagnostics in inclusion criteria, etc If you think there is a whole wave of innovation being held back by the FDA - can you point to examples of drugs it rejected or innovations happening in any other country that should be happening here? Lots of stem cell “medicine” is happening in Korea where the requirements on cellular medicine are more lax… none of that is translating to effective medicine here afaik. As you say, biology is hard and messy! And it is the job of the FDA to prevent five 20 year olds in a garage from injecting desperate cancer patients with some hacked together MVP. We’re agreed on that. But I just don’t see any evidence of a giant pool of untapped innovation at the preclinical level that the FDA is blocking. |