Susan Desmond-Hellmann
speaker
362 appearances
1 recordings
1 series
first heard Apr 2025
last heard Apr 2025
Susan Desmond-Hellmann’s voice in public audio — every appearance, attributed to the second.
Trend
recordings per month · last 12 monthsNo recordings in the last 12 months.Older appearances are listed below; set an alert to hear about the next one.
Appearances
we were too inexperienced to realize we should have.
Yeah, for sure. It was a mistake.
Oh, gosh, it could be years. It could be two, three years because you're doing animal models.
So the investigational new drug is asking the Food and Drug Administration permission to ship an unapproved drug across state lines. If you and I wanted to do something in Austin, we could actually do it, which is sort of weird when you think about it. But most people don't really want to do that.
You got to have the IND. So the investigational new drug is the request. And what happens is that you take all this information I've been talking about, that you know you have a molecule. You trust the way you're producing the molecule. You understand the biology enough. You have a safety plan and you have a phase one protocol. So phase one has one purpose. We're all greedy. I've been there.
It is only for safety. Phase one is, is it safe to give humans this molecule? Is it safe to give it once? Is it safe to give it multiple times?
It's absolutely true. And it's not uncommon. And you see people all the time backing up on the dose thinking, oh, that was more than we needed or more than we wanted. But phase one with a good preclinical package, a good IND, phase one should be uneventful. And because we are greedy in oncology, we always look to see if anybody responds just because that's what we do.
But phase one often, to be fair, has some really tough patients who are trying something and have tried a lot of other things. So the patient population can be tough to find any efficacy in. So phase one, I always think of phase one as it might be a year that you're in phase one if you're doing a really good job.
Oh, gosh. In the tens of millions?
Yeah, tens of millions. And then you get into the 20s and 30s and 40s of millions with the phase two, depending on how big your phase two is. And phase two, I think that's where people can use their intellect. I think in many ways, phase two, you start to look at what's the right dose and schedule. Very, very important to get the right dose and schedule.
Who do you want to treat? And really what phase two is supposed to do, with one exception, phase two is supposed to get you ready for phase three. You've got a dose, you've got a schedule, you've got a patient selection criteria, and you've got a hypothesis of where this is going to be a drug. The exception in oncology is sometimes you want to get an approval off phase two.
When we tested anti-VEGF in breast cancer in phase two, we wanted to use that as an approvable study. Because we would go in and say, look, it can be a contingent approval, but these patients have nothing else to do. And so I think that can happen, especially targeted therapy, where you've got the perfect target and FDA's feeling good about it too. That can be a phase two study.
But most of the time you're getting ready for phase three.
We did colon, but not the kind of study that I just mentioned for approval. We did a traditional phase two in colon. So what happened is the breast cancer study failed. And I was so disappointed. I was so hoping that that would work. I still remember that day. For me, it was like, oh, we need more better drugs for breast cancer.
Because I often heard from people when they're the three out of four patients, suherceptin wasn't for them. If you looked at your stock that day, it also looked really bad. Because all the hype about Avastin was there. But in colon cancer, we had a phase two, got ready on the dose and schedule. And then we went to a phase three study in colon cancer, much more traditional, just plus minus Avastin.
Five of you and the usual suspects, plus minus Avastin. And that succeeded.
Only stage four.
That was a median survival study. Actually, I don't remember all the details of that one.
Probably right. It was the first new thing in colon cancer for a while, too. So people were pretty excited.
You can get it out of pocket, but not through the National Health Service.
Showing 201–220 of 362 · page 11 of 19
← Previous
Next →