This new interview came out 9/21/2022 -
what does “2030 class of FDA new approvals” mean? Does it mean they are hoping the new treatment will be available in 2030?
@Myhair1 I think the pharmaceutical industry is concerned that FDA had not been keeping up with the progress of technologies that aren’t typical drugs, like “biologics” (which include cell therapies) and other non-traditional forms of medical therapy. They’re implying that for these “new modalities” FDA review can be very slow because they’re traditionally used to reviewing drug applications, and for newer types of products or treatments, the review process is less “cookie cutter” and can move slower.
The “2030 class of FDA approvals” is not a specific date but a view of the future of FDA and will it get more flexible and start speeding up the review process for products that don’t fall clearly into the conventional categories like an application for a drug approval.
See the article below and look at the last few lines. The pharmaceutical industry appears to be concerned that FDA is setting the bar too high on “stability performance” of new modalities (like cell therapy), and they’re arguing that review should be on a “benefit-risk” basis.
For instance if you have a cell therapy which is found to be safe, but its stability performance is not perfect - that means results can be a bit irregular or results can diminish with time - then the FDA should weigh the risks against the benefits - for instance in the case of cell therapies or bioengineered follicles for hair loss, the safety of the treatment versus giving the person their hair back. So if the risks are low, and the benefits are high, even if the treatment is not perfect - for instance if results are a bit inconsistent and not perfectly predictable - those things shouldn’t stand in the way of approval. Risk-benefit analysis means weighing the potential benefits against the risks, and not putting too much weight on other things like consistency and permanence, because those things don’t have much effect on risk and have a minor effect on benefit.
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@jarjarbinx it’s a nothing update, nothing that we don’t already know.
OK
But it sounds like they are saying that they were having success with their pig studies.
Sounds like they are ready for human trials
It sounds to me like they’re saying their getting close to starting human studies but they aren’t quite there yet.