Dr. Gary Steinberg
๐ค SpeakerAppearances Over Time
Podcast Appearances
I think greater collaboration with industry and promoting more academic industry kinds of relationships would help because
The government agencies do not provide enough money to do the final stage.
You know, there's called this valley of death where you get initial encouraging data, even clinically, but you can't move the hurdle to get it into FDA approval.
Because of money in some cases.
I've seen, as an example, a number of very good stem cell therapies not make it because the companies went bankrupt.
The board of directors of the company felt the results were good but not good enough and they pulled the funding.
So this is a whole area which I was not well informed of until I got into this, of how you move through the FDA and how you work with industry.
I haven't formed a company yet, but I'm going to have to because for the next trial, this trial, I was fortunate to get a grant from CIRM, California Institute for Regenerative Medicine of $12 million.
So that's taxpayer dollars.
Exactly.
But the next trial and our results are good enough that we probably will only need, if we do a statistical power analysis, 69 patients.
Initially, we thought we'd need 170 patients, but the results keep getting better and better.
So now it seems we would only need about 69 patients.
That will cost at least $45 million.
And as the trials get larger, even more so, yeah, we need to figure out a better way to allocate money to make these advances.
Well, I was being facetious.
When I came to Stanford in 1974, the medical center was more like an NIH of the West and there was not a lot of clinical excellence except for cardiac surgery, Norm Shumway, and radiation oncology, Henry Kaplan, who had developed the first radiation method for treating lymphoma.
And we were great at making basic discoveries, not very good at translating them.
But over the last, what, 50 years, Stanford has gotten much better at translating them into clinical therapies.
And even doing some of that work at Stanford, not farming it out to other places.