Richard Scheller: Drug Development Process

I'm in charge of discovering medicines that will make a real difference in people's lives. So as you may know, Genentech is now, it's an incorporated company in the United States, but 100% owned by a large Swiss drug company called Roche. But our group is completely independent and our job is to discover medicines to that make a difference. We don't make any generic drugs, we don't make any copies of other drugs. Innovation is our. We're going to live or die based on innovation. We also believe very strongly in the view of personalized medicine, that is making medicines that are tailored to individuals. The Roche group owns two businesses, pharmaceutical business and a diagnostic business. It's a very large, I don't know, maybe fourth, fifth largest pharmaceutical company in the world and the largest diagnostic company in the world. So the idea is to make medicines that really, really deliver benefit, tangible, terrific benefit for people. So if we make a medicine for somebody with cancer, we have to show that they actually live longer when they take the medicine, for example. So I oversee research. So our research group is about 1300 folks. We have about 150 of the people are postdocs. And why would we have a postdoc program? People come through, they come from all over the world. They stay for four or five years. They bring in new techniques and ideas. They're, you know, not cynical yet. You know, they work at night and on the weekends, and it's just that it just energizes the place. Then we have scientists at various levels. And the job of the scientists is to twofold, to make, to do basic science. We like to give each of our scientists somewhere, some what we call discretionary time. You know, maybe it's somewhere between 10 and 30% of their time. Sort of depends on the individuals. Some people, frankly, it's 100%, but that's a different topic. And with their discretionary time, they're supposed to just do interesting things, do whatever you want, make a discovery, publish a paper. We published 20 papers in Science, Nature and Cell last year, hundreds of papers overall from the company. But the other real tangible, deliverable of the scientists is to, is to come up with a medicine and move that medicine into what we call early development. And in early development, the compound goes through various further stages of testing to make sure that it's safe. We do all of the work to file an ind, that's a new drug application with the fda. Then we file the ind, and then we do the clinical studies, phase one and phase two. In phase one, you usually just treat patients, then make sure that the drug is safe. You start at a very, very low dose. I mean, imagine putting something into a human that's never been in a human before. You slowly escalate the dose. It depends on the disease. Sometimes it'll be in patients with the disease, sometimes not. Then usually in phase two, you do. You do a relatively small number of patients, but enough patients so that you have statistical power to see that you're making a difference in the disease. And what we then do would be to, if the phase two trial works, to hand the medicine to then the global development group to do the final clinical testing. And the final clinical testing would then be done in 80 countries around the world. It's a logistical absolute nightmare. It's done in many, many more patients so that the statistical power increases dramatically. And then work with the regulatory authorities to get permission, if you will, so the fda, in the case of the United States, permission to market the drug. So we're. So my job is to deliver molecules that we say have gone through proof of concept. We believe that they work. We have the chemical entity, we know that it can be manufactured. And to hand this to the global group, where there's a lot of science involved, but there's a huge amount of logistics and regulatory involvement, and that's when the commercial people get involved and so on. And frankly, I'm less interested in that. I then go back and try and discover a new medicine and show that it works.