Pharmaceutical Researchers Feel Pressure To Sharpen Their Focus

As the United States moves toward managed health care, scientists at the nation's pharmaceutical firms are under increasing pressure to narrow the parameters of their work. More than ever before, they are being challenged to sharpen their focus on efficient, results-oriented research. "Novelty has a very high premium [now]," according to James Powell, director of the department of pharmacology in the Lawrenceville, N.J.-based laboratories of Bristol-Myers Squibb Co., headquartered in New York City. "For a [new] drug to be truly successful and be accepted for health coverage, it needs to fulfill an imminent medical need, or provide a new approach to improve an existing therapy." Powell, who has been in the industry for 15 years, contends that pharmaceutical companies can no longer afford to spend either time or funds on refining and upgrading versions of existing drugs, as they used to in the past. "The days of the `me too'-type drugs are gone," he says. This push for innovation carries with it imperatives in terms of both time and objectives, pharmaceutical researchers say. "There is a tendency to focus on more immediate goals," observes Ann Berger, associate director of cell biology and inflammatory research at Upjohn Co. in Kalamazoo, Mich. Much of the current streamlining, scientists agree, stems from the budgetary constraints imposed by the movement of the health-care system toward managed care. According to the Pharmaceutical Research and Manufacturers of America (PRMA)- -a Washington, D.C., trade association of research-based pharmaceutical firms--this past fiscal year has seen the slowest rate of pharmaceutical research and development expenditures in almost 20 years. And, say scientists, the pinch is felt right down to individual laboratories. "All of sudden we have had to become budget-conscious," notes Steve Jordan, head of the crystallography section of Glaxo Inc. in Research Triangle Park, N.C. "Money was fairly open until this year. Before this we never really spent all that was given to us. Now we have to plan [for experiments and equipment] a little more." Companies are imposing more cost-containment measures now, agrees Francis Huger, research group manager in biochemistry and pharmacology at Somerville, N.J.-based Hoechst-Roussel Pharmaceuticals Inc. And if the rate of R&D growth seems slow, PRMA--whose membership includes about 100 of the leading U.S. pharmaceutical firms--points out that it is still three times the rate of increase in drug prices, which is also currently at its lowest rate in 17 years owing to price agreements with health insurance companies. This generates a kind of Catch-22 situation, whereby the controlled drug prices place an additional burden on research funding rather than generate revenue for it. "There were about 30,000 jobs cut in industry over the past two years, of which we estimate roughly 10 percent to have been in research," says Steve Berchem, spokesman for PRMA. Despite the seemingly large figure, Berchem maintains that "overall, employment in industry is still relatively stable." Moreover, PRMA estimates that its member companies have collectively spent about $14 billion on R&D in 1994, which, it points out, is considerably more than the annual budget of the National Institutes of Health. "NIH has less than $10 billion allocated for all biomedical research, of which less than $1 billion is in drug research," says Berchem. As a further measure of productivity, he observes that "industry holds more than 90 percent of the patents on new drugs." Scientists say that this productivity--the ability to see tangible results of their research--is one of the main features that attracted them to industry in the first place, and continues to hold them there to this day. "To see a drug you helped develop being used in humans, and feel that it might actually help someone, is one of the most exciting rewards of this job," says Laura Mendelsohn, senior researcher in the cancer division of Eli Lilly and Co. in Indianapolis. During her 15 years at the company, Mendelsohn has had occasion to feel rewarded, having worked on a variety of projects at different levels. She was involved in research on two products that the company is now testing in clinical trials: an insulin-like growth factor (IGF-2) for diabetic patients resistant to insulin therapy; and an oncolytic drug--with the generic name Lometrexol--against solid tumors, as in colon and breast cancers. Beginning in 1979 as a senior biochemist (an entry-level position at Lilly for a Ph.D. scientist), Mendelsohn--who obtained her doctorate from the University of Illinois, Urbana-Champaign, in 1974--worked her way up the ranks of the company, receiving two promotions in 10 years, as well as lateral transfers between departments and projects. On the research front, her interests evolved from biochemistry of the central nervous system during psychosis and analgesia to biochemical events in cellular development in such neurodegenerative disorders as Alzheimer's disease. As she moved further into studying the mechanisms of development, Mendelsohn says, "the research began to fit more with cancer-related studies." Today, she spends about half of her time as a bench scientist, heading her own research group of two master's-level associate scientists. Another aspect of a scientist's work at Lilly is involvement with drug-discovery teams, which are groups of scientists from different departments and disciplines working on a common project. Mendelsohn is the chairwoman of one such discovery team, directing strategic planning for the project--details of which she declines to discuss--as well as coordinating meetings and discussing progress with about 35 people on the team, eight of whom are Ph.D. scientists. In addition, she participates in meetings of other teams. "These teams are fertile ground for cross-disciplinary collaborations," Mendelsohn remarks. For instance, the same team will have "chemists who make the drugs and in vivo pharmacologists who test the drugs in animals"--people, she says, who would not otherwise get the chance to exchange information on their work. "This is a special opportunity which I think would be difficult to generate in an academic setting." Scientists in other firms also agree that industrial research is more interactive than at universities and private research institutions--"because of the nature of making drugs," says Gordon Moore, director of the molecular immunology department at Philadelphia-based SmithKline Beecham. "We emphasize teamwork," notes Berger at Upjohn. "Though the day-to-day work is not all that different, in industry we spend more time with a much larger group than we would in an academic lab." "It's very nice--one can get different ideas from people with different backgrounds," she adds. Another advantage of this collaborative situation, according to Moore, is "the easy access to technology outside your own area." Moore, who has served on the faculty of the University of Michigan, Ann Arbor, for four years (1980 to 1984), and thus been on both sides of the fence, says, "In academia you always have to give something, while in industry there often supporting facilities to provide things like monoclonal antibodies, peptides, or DNA sequences that one may need." For Moore, whose research is concerned with cloning and engineering antibodies for use in such conditions as respiratory syncitial virus (RSV) infections and rheumatoid arthritis, these services are immense time-savers. Researchers stress that, in addition to the advantages offered by service facilities, laboratory equipment in their firms is excellent and experiments are seldom held up because of malfunctioning machines. "Equipment is state-of-the-art," Mendelsohn says. "It is a good feeling to be able to do the science and use [my] intellectual capabilities to solve [science] problems rather than fixing mechanical ones." "There is a lot more access to equipment here," agrees Glaxo's Jordan. "We pretty much have one computer per person here--at a university, even at a higher level, one still needs to sign up to use a graphics machine, for example." But, as many point out, the high degree of collaboration at these large companies carry certain drawbacks, as well--for instance, the "assembly line" nature of research: the inability to see projects through, and the necessity of handing them off to another group for further development. "The downside to industry is that one cannot build up a little empire like in academia," Moore comments. "Almost nothing is your own--you have to be psychologically prepared to share credit. Or blame." Even more frustrating than handing off projects is seeing them discontinued by the companies, these scientists say. "In general, we are more goal-oriented," Berger explains, "and meeting our real goal--to take a therapeutic successfully from concept through design, delivery, and safety studies to the final drug--is a tough thing to do." "Research never goes in a straight line; there are always alternate lines of investigation. Academia offers more opportunities to pursue these lines and succeed." "In academia very few ask why you are doing something," Moore concurs. "In industry you always have to justify your work on the basis of ultimate applicability--`It's interesting' is not an acceptable answer." The difference between academic and industrial laboratories arises from a fundamental dichotomy in the motives driving the two, according to Moore: "In academia the main reason you do something is to learn, whereas in industry you are there to make money. But in order to make money, you have to learn." "There is a lot of excellent science going on in industry," says Berger, who feels that the differences between the two environments are continuing to narrow. "While there is less ability to follow wild ideas, this is probably paralleled in academic institutions, also." Huger at Hoechst agrees: "Universities are more like industries now--there are vigorous efforts under way to come out with patentable discoveries. And companies are becoming more aware of the importance of publication." The most obvious differences between the two settings, say scientists, is not so much in the way research is conducted as in other facets of the job. While most academic scientists are actually in the laboratory throughout their careers, many in industry find themselves spending less time at the bench. Bristol-Myers Squibb's Powell spends about half his time involved in scientific issues but no longer participates in hands-on research. "It's almost embarrassing," he says. "I do miss it--there is a great deal of satisfaction in conducting a series of experiments successfully." These days, much of his input is intellectual. For example, he communicates science to both upper management and subordinate employees in the company, assesses research programs, and reviews progress of individual projects. As management responsibilities increase, some firms encourage their scientist employees to learn administrative and interpersonal skills. Hoechst-Roussel, for example, has a tuition-reimbursement program, which Huger took advantage of to get an MBA from Fairleigh Dickinson University in Madison, N.J., nearly 20 years after his doctoral work. (He earned his Ph.D. from the Medical College of Virginia, Richmond, in 1974.) Industrial researchers have little or no teaching responsibilities, a facet of work that Powell, who taught at Emory University in Atlanta, says he misses. "We do have a lot of impromptu, informal discussions here, but I miss the daily interaction with graduate and medical students," he laments. As more companies open their doors to postdoctoral fellows and undergraduate summer interns, the chance to interact with students is increasing slightly, observes Eli Lilly's Mendelsohn, who employed an intern this past summer and is expecting a postdoc to join her laboratory in January. Indeed, industrial scientists advise, taking on a postdoctoral fellowship at one of the firms is an excellent method for new Ph.D.'s to get a flavor for industrial research. "It's a good way to get your feet wet and learn first-hand what it's all about without a permanent commitment," says Mendelsohn. "I had very strange perceptions of what industry was about before I joined." Huger suggests that would-be industrial scientists "scan journals to gauge what kind of work they are doing and if you are interested in it. Look at the existing and emerging technologies, and see how they would be applicable to pharmaceutical research and development." Powell recommends that students at professional meetings make a special effort to attend talks given by researchers from the industry. "Take the opportunity to explore and learn--don't stereotype--keep an open mind," he says. Above all, these researchers concur, flexibility is important if one is to succeed. "If you have a burning question and answering it is your agenda for life, then going to academics is better," Mendelsohn cautions. Adaptability is also the key to coping with the rapidly shifting scenes in industry, says Moore. "There is a perception that small companies are less secure and large ones more so," he notes. "But there is no security-- nowadays, very few researchers stay with a single company through their entire career."

Pharmaceutical Researchers Feel Pressure To Sharpen Their Focus

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