Channel: Genentech clear
| # | Channel | Title | Views | Likes | Cmts | Score | Sentiment | Duration | Transcript | Link |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Genentech | Building a Body of Evidence: Translational Medicine | 22387 | 22 | 51.5 | 3:09 | Early clinical development is a time that we learn an incredible amount about the drug for the first time in humans. And we have to be very flexible and nimble in changing our strategy as we learn new information. Clinical trial design is really an art. You want to get the right patient population, you want to make sure you're measuring the right endpoints, you want to do the right size of trial, you don't want it to take too long, you don't want to expose more patients to a drug that maybe doesn't work than you need to determine that. And so how you conduct clinical trials is extremely important in being able to develop drug successfully. In our early clinical trials, at each one of the phases, whether it be preclinical, whether it be phase one or it be phase two, what we're ultimately trying to do is build a body of evidence. And that body of evidence is safety and tolerability first and foremost for the patient. The second is efficacy. Are we hitting the target that we thought we were going to be hitting with our molecule? Those are things that we're thinking about in phase one. Then we take those into phase two where we're testing multiple doses, but we're actually looking at proof of concept. And proof of concept means we're actually having a clinical response. One of the most important parts about science is to be objective. To look at the hypothesis that you've formed, understand how you are going to test that. And in clinical trials, that's a little more complicated, you can't control all the variables. But if you can get the right questions in there, then you can really start to put together a coherent story. And it'll either tell you that you're able to help people or it might tell you this didn't do it. But we have a good idea about what's trying next. We have, among our early clinical development group, many of us continue to see patients on a regular basis. And I think that allows us to do our job better. It helps us to understand what clinicians are really looking for in terms of new therapeutics in all of the disease areas that we work. It helps us understand what patients want and expect from a new drug. From a patient perspective, we try to really understand how it feels to have the disease. And think about disease modification, not just in treating the patient's symptoms from the disease, but also affecting their whole quality of life. This is the largest biomarker intervention I've studied at me. If we can understand the science which we have been trying to do very carefully, and we can apply that to medicines that work in these patients, it will be life changing for these patients and their families. And for me, that's what gets me out of bed in the morning, the potential of really having an impact. | ↗ |