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James Davis is executive vice president, general counsel, and secretary of Human Genome Sciences Inc., a biotechnology company based in Rockville, Md.
Tell us a little bit about the company and its mission. Human Genome Sciences is a bio-pharmaceutical company with a mission to discover, develop, manufacture, and market innovative drugs for patients with unmet medical needs. The company was founded in the early 1990s with the goal of discovering and understanding genes and proteins, figuring out which of those proteins are related to diseases, and using that knowledge to create protein and antibody drugs. In some cases we can use the proteins themselves to treat disease. In other cases, we make an antibody that either blocks a protein that may be causing a disease or activates a protein that the body can use to fight a disease. Our goal is to take knowledge of the human genome and turn it into pharmaceutical products. How did you go from being a scientist to being a lawyer? That’s what my parents kept asking. By training, I’m a scientist. I have always been fascinated by science and was involved early on with fairly exciting organic and theoretical chemistry. While I found the type of science I was doing fascinating, I felt I was working in an ivory tower, divorced from the real world. I found I had a desire to use my background in a more practical way. I had always enjoyed arguing scientific theories; and the legal profession gave me the opportunity to combine these intellectual skills with a science background and apply it in a practical way. So for the last 25 years or so I have been practicing science law. I got my Ph.D. and promptly went to law school. While I had a lot of post-doc offers, I decided it was time to do something else. Do you ever do any lab work at HGS? No way. It’s been a long time since I’ve been in the lab. However, I frequently go to clinical research meetings and I’m involved in looking at the science issues of the company. I am actively involved in looking at those issues and dealing with science issues on a management level. What is the makeup of your legal department? The legal department has two different components. We have an intellectual property department, which consists of 17 people, including four lawyers, six patent agents, and two technical specialists. All of them have Ph.D.s or at a minimum significant scientific experience. It’s a very science-oriented group. Our two leading patent lawyers have Ph.D.s. The second component is a more traditional legal department. That’s fairly small, just another lawyer and myself. Both of us by coincidence are also patent lawyers. I also run a couple of other departments: environmental health and safety, corporate security (including the building’s security and guards), and information technology, which is a fairly large department. At the moment, I’m also running business development. To whom do you report? I report to Tom Watkins, the company’s chief executive officer, and I’m a member of the management committee, which currently consists of six people, including the CEO. What’s it like to work at a pharmaceutical company where the results are never certain? It’s an exciting and scary ride. We are dependent on the results of our ongoing clinical trials, and we can’t predict ahead of time how successful we are going to be. There are significant rewards and significant risks. But a major reason to get involved with a company like this is that the work we are doing can make a major difference in people’s lives. In the clinic right now, we have potential products that could treat a wide variety of diseases � cancer, lupus, rheumatoid arthritis, hepatitis C, and AIDS. So, not to be too sappy, you’re in the business of saving lives. That’s the goal, but we’re not there yet. None of our products are on the market yet, but we are on the road, we hope, to commercialization. It would be fantastic to be able to point to products we have on the market that are making a difference in people’s lives. Your company has had some ups and downs. It’s the nature of biotech companies to have ups and downs. Last year we went through a restructuring that was difficult, but now we have a very focused, dedicated team and we are continuing to grow. What outside firms do you use? The major firm we use is DLA Piper, for corporate work, securities, employment work, environmental work, and a variety of other matters. For government contracts, we also use McKenna Long & Aldridge. For instance, we are doing product development on a human antibody to treat anthrax inhalation, and they are helping us seek a government contract for that product. We also use a variety of IP firms, although most of our routine patent work is done in-house. Right now, we are working quite a bit with Sterne, Kessler, Goldstein & Fox. On a personal level, what would you say are the biggest challenges of the job? The biggest challenge is being a member of a management team that needs to determine how best to use limited resources for a wide range of opportunities. We have so many opportunities to develop drugs, but we have to have the fiscal discipline to make the company profitable with significant revenues in the shortest possible time frame. What would you say are the highlights of the job? Good clinical data � when you really see data that make a difference, and can see patients improving. Those are the things that make your day. It’s been a good year. We’ve had good results in our rheumatoid arthritis, hepatitis C, and cancer trials. We’ll have even more data coming out this year, and I look forward to that. But it’s still a long process to get drugs on the market. First you need to run what’s called a Phase 1 clinical trial, which is relatively small, to make sure your product is safe. Then you run a larger Phase 2 clinical trial to determine if your product is not only safe but also active. Finally you run an even larger trial, a Phase 3 trial, to prove that the drug is both safe and effective. This whole process can easily take five to six years or even longer. Thus, even if you have good initial data, you may still have a long way to go to collect all the data you need. Then you still need FDA [Food and Drug Administration] approval, and you need to get it approved around the world. Every company is going to have some failures and setbacks during this long process. Where would we find you when you’re not at the office? On the tennis court. I live in Howard County, which is a big tennis community. If I’m not on the court, I love to go fly fishing. Read any good books lately? Currently I am reading Hotel Pastis, by Peter Mayle. I’m taking French lessons, and it’s my dream, when I retire, to live for at least part of each year in southern France. I’ve also recently read The Dream of Scipio by Iain Pears and The Archer’s Tale by Bernard Cornwell. Both are historical fiction set largely in France.

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