Eli Lilly SVP on Research Hurdles and Drug Development

Marrecca Fiore; Bart Peterson, JD

| Disclosures | October 24, 2013

A Better Relationship Between Industry and the FDA

Medscape: You spoke very favorably about the FDA today. Can you talk about that, about how the FDA has become a little more cooperative, maybe a little faster in accommodating the drug review process?

Mr. Peterson: I am always hesitant to use the world "cooperative" as it relates to any kind of a regulatory process. I do believe that the FDA has a role and industry has a role, and sometimes there is going to be a natural tension there. And there should be. If you find that the regulated entity in any kind of a system is completely comfortable with their regulator, then I think you have a problem. It means the regulator is probably not working hard enough.

What we have seen, though, is a level of responsiveness from the FDA to some of the very legitimate problems that we brought forth to them over the past several years, such as the consistency of the review process; the amount of communication that occurs during the review process; the number of surprises and reducing the number of surprises, which is sort of the flip side of the communication issue; and also a recognition that there are special cases that need to be treated as such. We've also seen improvements to the risk-benefit analysis, which has now been formalized as a result of the legislation from 2012. All of these things are steps in the right direction, and I think overlaying all of that is a spirit -- not of cooperation, because I don't think that would necessarily be the right way to look at it, but a spirit of recognizing that each one, each side of this equation, the regulated and the regulator, is going to do its job very, very well. And if we both do, then the beneficiaries are going to be patients.

The Blockbuster Drug vs Personalized Medicine

Medscape: Do you agree with those who believe that the era of the blockbuster drug is over, and that personalized and genomic medicine are the future of medical practice? And if so, how will the pharmaceutical industry make personalized medicine profitable when the development of new drugs is so expensive?

Mr. Peterson: Well, it is clearly the right thing to do. We have more information about the individuality of each person through genomic sequencing, as well as other methods that we have of being able to determine what medicine is right for what individual. It is absolutely the right thing to do to try to drill down on that and make sure that a person gets a medicine that is likely to help them, and if it is not likely to help them, then they don't get the medicine. We are moving in the right direction. The industry can't respond immediately to changes, to regulatory changes, to changes in science. So it will be behind, and then it will speed up and be ahead, and then the science will catch up and move ahead. Although we all want this notion of personalized medicine that was on the front page of news magazines 10-12 years ago as being what was happening in medicine any day now, the reality is that it is going to be a while before this is broadly applicable in some areas, like oncology.

The biomarkers are there and the research is very focused on personalizing the medicine based on information we now have that we did not have in the past. That area is sort of ahead, and there are other areas where there don't seem to be a lot of biomarkers, or at least ones that have been discovered yet. So we will continue to have medicines that we know work in 50% of people; we just don't know which 50% percent.

This discussion about the era of the blockbuster being over -- that talk has been around for a long time, but I don't think the blockbuster era will just end one day. I think there will continue to be blockbusters in the future, drugs that are broadly applicable to broad populations. But we are going to increasingly see drugs that are more focused on the individual composition of each of our bodies. I think that is a good thing, and everyone in our industry feels exactly the same. We are all devoting significant resources to try to hasten this.

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Authors and Disclosures


Marrecca Fiore

Editorial Director, Medscape


Bart Peterson, JD

Senior Vice President, Corporate Affairs and Communications, Eli Lilly and Company, Indianapolis, Indiana

Disclosure: Bart Peterson, JD, has disclosed no relevant financial relationships.

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