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Name and title: James Davis, executive vice president, general counsel and secretary The company: Rockville, Md.-based Human Genome Sciences Inc. is a biopharmaceutical 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, proteins themselves are used to treat disease. In other cases, the company makes 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. The goal is to take knowledge of the human genome and turn it into pharmaceutical products. From scientist to lawyer: Davis was interested in science from an early age, “and was involved early on with fairly exciting organic and theoretical chemistry.” However, upon receiving his doctorate, he promptly went to law school. “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.” It’s been a long time since Davis worked in a laboratory. However, he frequently goes to clinical research meetings and is involved in looking at the science issues of the company. “I am actively involved in . . . dealing with science issues on a management level,” Davis said. Legal team and outside counsel: In addition to a traditional legal department, the firm has an intellectual property department. The former consists of Davis and another lawyer, while the latter 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. Davis also runs some other departments: environmental health and safety, and corporate security and information technology, which is a fairly large department. “At the moment, I’m also running business development,” Davis added. For outside work, Davis turns to DLA Piper Rudnick Gray Cary on corporate issues and securities, employment and environmental matters. Davis goes to McKenna Long & Aldridge on issues pertaining to government contracts. “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,” Davis said. The company uses a variety of IP firms, although most of the routine patent work is done in-house. “Right now, we are working quite a bit with Sterne, Kessler, Goldstein & Fox” of Washington, he said. Davis reports to Tom Watkins, the company’s chief executive officer. He is a member of the management committee, which consists of six people, including the CEO. 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,” Davis explained. “It’s an exciting and scary ride,” he said. “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.” None of the company’s products is on the market yet, but, Davis added, “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.” Ups and downs: “It’s the nature of biotech companies to have ups and downs,” Davis said. Last year was a difficult year, as the company had to undertake a thorough restructuring. However, “now we have a very focused, dedicated team and we are continuing to grow. 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.” Highlights of the job: Good clinical data, Davis said without hesitation. “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.” The company will have more data coming out this year, something Davis looks forward to with enthusiasm. To get drugs on the market: It is a long process to get drugs on the market. First, the company has to run what is called a Phase 1 clinical trial. It is relatively small, its purpose to make sure the product is safe. Then there has to be a larger Phase 2 clinical trial to determine whether the product is not only safe but also active. Finally, there is an even larger trial, the Phase 3 trial, to establish that the drug is both safe and effective. “This whole process can easily take five to six years or even longer,” Davis explained. “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.” Personal: When Davis is not in his office, he can usually be found on the tennis court. “If I’m not on the court, I love to go fly fishing,” Davis added. Currently, Davis is taking French lessons. It is a dream of his, he explained, to spend at least a part of every year in the south of France after he retires. Last book: At present Davis is reading Hotel Pastis: A Novel of Provence, by Peter Mayle. He recently read Dream of Scipio by Iain Pears and The Archer’s Tale by Bernard Cornwell.

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