Bart Peterson, JD, Senior Vice President for Corporate Affairs and Communications at Eli Lilly, recently served as the keynote speaker at Research!America's National Research Health Forum in Washington, DC. He spoke with Medscape about the future of research and drug development, and whether cooperation between industry and the US Food and Drug Administration (FDA) can ever truly exist.
Hurdles Facing New Drug Development
Medscape: You participated in a panel that focused on "clearing the hurdles to a research and healthcare renaissance." What are some of the biggest hurdles in the pharmaceutical industry?
Mr. Peterson: First and foremost is making sure that we discover the potential new medicines and then develop the ones that are going to make a difference in people's lives in the future, that are going to improve the quality of people's lives, that are going to reduce suffering, that are going to save lives. That requires a significant investment in science. We make that at the pharmaceutical company level. Our industry invests tens of billions of dollars a year. Lilly invests over 20% of its gross revenue in research and development. It also means a significant public-sector investment through the National Institutes of Health and other funding sources, including academia. We also need other research opportunities to do early-stage discovery and development of new medicines and of new technologies, and it's the breakthrough science that happens when you make a real commitment to it. That is number one.
Then we need a broader ecosystem. We need sound public policy that supports and encourages the kind of research and investment that we do. If we make these kinds of investments -- the tens of billions of dollars a year out of our industry that I mentioned -- it is very important that that be rewarded down the road with appropriate pricing around our medicines and that we are able to sell them and cover the cost of our research, or else that research simply won't happen. That is the real risk here. And so we have found that right balance. We have found and created in this country a very good ecosystem for discovering and developing new medicines, but it is really at risk, as a lot of the funding sources are at risk right now.
Improving Clinical Trials
Medscape: Your panel also discussed the clinical trial process and how difficult it is in some cases. Many researchers and physicians feel that the randomized, placebo-controlled trial just doesn't work in many cases, that there needs to be a better way to test new molecules and medications. What do you think about the process as it stands?
Mr. Peterson: I think it will evolve. I think we are in a period of evolution around proof of efficacy and of safety of drugs. While I think the randomized clinical trial will continue to be a very important part of drug development, I also think there is going to be an increasing reliance on real-world evidence. In other words, what happens when our medicines are actually taken by people not in a very controlled setting like a clinical trial, but just as part of their normal lives out in the real world? What effect does it have? What effect do the medicines have? I think that will become increasingly important as well.
Of course, you can't get to the point where patients are taking medicines unless you have passed certain safety hurdles. You just can't take those risks. So I think that we will see changes inevitably in the speed of clinical trials, in the number of patients that are required, in the analytical capabilities that will allow us to get more data out of fewer patients or out of a shorter period of time, and more adaptive trials where, if we see something halfway through, we can switch and do something different. All of these evolutions are very positive and are moving us in the right direction. I don't think the clinical trial world will look the same 10 years from now or even anywhere near the same as it does today, but fundamentally there has got to be a systematized, controlled way of testing these medicines both for safety and efficacy, and that is why I don't think the randomized clinical trial will ever completely go away.