Biotech group defines future business hurdles - C&EN Global

The increasing likelihood that regulation and public perception will play major roles in the commercialization of biotechnology formed the core of dis...
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American Cyanamid's earnings increased 25% to $51.2 million on a sales gain of 6% to $942 million. This raised Cyanamid's profit margin to 5.4% from 4.6% in the same period last year. Olin's earnings also rose 25%, to $16.3 million, and sales rose 2% to $498 million, raising its profit margin to 3.3% from 2.7%. And Rohm & Haas' earnings increased 21% to $38.8 million on a sales gain of 6% to $485 million. This increased the company's profit margin to 8.0% from 7.0%. Three firms—Monsanto, Pennwalt, and Union Carbide—had smaller earnings than in last year's third quarter. Monsanto's earnings declined 10% to $78 million on a 3% sales increase to almost $1.6 billion, giving the company a third-quarter profit margin of 4.9%, down from

5.6% in third-quarter 1983. Pennwalt's earnings were down 9% to $12.5 million on a 2% sales gain to $258 million. This brought the firm's profit margin down to 4.8% in the third quarter from 5.6% a year earlier. And Union Carbide's earnings decreased 4% to $77 million on a sales gain of 3% to $2.34 billion. That pushed its profit margins down slightly to 3.3% from 3.5% a year earlier. For the first nine months of this year, combined earnings for the 16 companies were $2.42 billion, up 51% from earnings posted by the same 16 companies during the first nine months of 1983. Combined sales were $45.6 billion, a 9% gain. As a result, the average profit margin rose to 5.3% from 3.8% in last year's first nine months. D

Monsanto opens life sciences lab Monsanto last week formally opened a $150 million life sciences research center, the cornerstone of its effort to develop new products for the agriculture, nutrition chemicals, and human health care markets. The life sciences program, which is based on both traditional chemical research and biotechnology, is part of the company's strategy to reduce its dependence on commodity chemicals. The four brick structures in suburban St. Louis contain 250 laboratories, 26 rooftop greenhouses, 123 plant growth chambers capable of duplicating most climate and soil conditions, and state-of-the-art computer facilities. Some 600 research and support personnel will occupy the center by the spring of 1985, and staffing will double by the end of 1987. Monsanto chief executive officer Richard J. Mahoney says the company could double both the size of and the investment in the facility in several years if need be. The trigger for expansion, according to research chief Howard A. Schneiderman, would be the appearance of new products. The first products to come out of research at the new center probably will be methionyl bovine somatotropin, a recombinant-DNA-derived

lactation enhancer for cows—targeted for commercialization later this decade—and improved strains of wheat and soybeans. Monsanto expects to begin marketing a turfgrowth regulator later this year or early in 1985 for use on nonresidential turf. Ongoing research is aiming at health care products in blood pressure regulation, senility, and other areas.

Schneiderman: new products

Mahoney notes that life sciences products currently represent about 20% of Monsanto's sales. In the 1990s, he says, he expects them to account for a third of sales. The rest would be split among chemicals and engineered products and other businesses. G

Biotech group defines future business hurdles The increasing likelihood that regulation and public perception will play major roles in the commercialization of biotechnology formed the core of discussions at the Industrial Biotechnology Association's third annual meeting in San Francisco earlier this month. The emphasis on these aspects reinforced the sense among biotechnology-based companies that achievement in the laboratory will no longer suffice to ensure business success, and that the industry is passing from an era of scientific management to one of professional management. Introducing a program of papers on patent, regulatory, and public acceptance issues, Harvey S. Price, IBA's executive director, warned the more than 100 conference attendees that maintaining a positive "climate" for biotechnology commercialization would require substantial effort and expense. "It was narrowly thought by some that the climate question would be a little blip. Most now realize that won't be true," he said. Rene D. Tegtmeyer, assistant commissioner for patents in the U.S. Patent & Trademark Office, described organizational changes the Patent Office has made to provide speedier protection for biotechnology products. Besides consolidating all biotech-related areas into one examining group and hiring more examiners, the office also has instituted a "special status" process that gives priority to patent applications that satisfy certain requirements. He pointed out, on the other hand, that the office is receiving a rapidly escalating number of applications—350 to 400 per year—and is working on a backlog of 2600 biotechnology product patent filings. He also October 29, 1984 C&EN 5

Mews of the Week warned that many issues probably will have to be litigated. Outlining regulatory prospects, Harold P. Green of George Washington University told members of the trade group that increased oversight by the Environmental Protection Agency is probably preferrable to alternatives such as new legislation, which he said would be unpredictable, or review under the National Environmental Protection Act, which he said would "give the public the right to litigate anything industry does." He also noted the fear some small firms have that regulation would give large firms an advantage over them, but asserted that small companies must accept the premise that regulation is inevitable if they want to "play with the big kids." In a description of the Recombinant DNA Advisory Committee's reaction to the May 16 decision by Judge John J. Sirica to halt some field tests of genetically modified microorganisms (C&EN, May 21, page 23), RAC chairman Robert E. Mitchell noted that RAC's working committee on human gene therapy had held its first meeting, highlighting the importance of that issue for public acceptance of biotechnology. Other discussions at the meeting focused on the imprudence of announcing research advances before peer review and on problems of public understanding. D

Organic farming to be studied by academy Organic farming has long been smirched by its critics as the "muck and mystery" approach to agriculture. The American Farm Bureau, the agribusiness lobby, opposes it; the Fertilizer Institute says merely that manure has some use as a nutrient supplement; and the Department of Agriculture turns its nose up at it as not worth encouraging. But now organic farming finally is getting what its proponents have most sought during its frustrating climb to legitimacy: a cool scientific assessment from the scientific establishment. The National Research Council's new Board on Agriculture 6

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has decided to study organic farming's promises and limits in a project slated to begin in January. The study's proposal says farmers and agricultural scientists are taking increasing interest in organic agriculture because of the rising costs of fertilizer and farm chemicals, declining farm profit margins, soil erosion, pollution, and future shortages of energy. One question the study will ask is precisely why organic methods reduce and sometimes eliminate the need for pesticides and herbicides. The board's chairman, William L. Brown, chairman of Pioneer Hi-Bred International, has had an interest in organic farming's potential over the years and urged the study. The project director is Elinor C. Cruze. "There is a pressing need at this time," says the board's proposal, "to appraise organic farming systems from a holistic, national perspective in light of other farm policy objectives, most notably reducing costs of production, fostering resource conservation, and improving environmental quality. "Scientists and farmers," the proposal continues, "are concerned as well with economic sustainability of soil and water resources . . . and these concerns are forcing a reevaluation of cropping patterns and management systems, particularly in regions characterized by highly erodible cropland combined with heavy demand from other sectors for water supplies." The study is expected to last two years. Its report "will draw upon current scientific knowledge to help clarify some misperceptions that prevail about both organic farming and conventional agriculture." Garth Youngberg, director of the Institute for Alternative Agriculture of Greenbelt, Md., says he doesn't think the study will break any new perceptual ground for those who already are sold on organic farming's successes. The importance of the study, he says, is that "finally the right people" are seriously considering the economic and ecological advantages of the organic approach. The board, under its executive director Charles N. Benbrook, has a full menu of activities developed over the few months of its existence.

Studies include several biotechnology assessments, problems in the control of pesticide-resistant organisms, protection of groundwater, and several livestock studies. It will soon be issuing a "white paper" tentatively described as U.S. agricultural research needs in a changing world. D

Women and foreigners earning more PhJXs Women and non-U.S. citizens have been the driving force behind a recent continuing increase in earned doctorates in science and engineering in the U.S., according to the latest annual survey conducted by the National Research Council for the National Science Foundation. The nearly 2% increase in 1983 over 1982 is particularly significant, NSF says. It indicates a clear reversal in the pattern of declines in the numbers of doctorates in science and engineering awarded between 1972 and 1978. Still, the 1983 level was about 6% lower than 10 years earlier. NSF notes that since 1960 there have been three phases in science and engineering doctorate production. Throughout the 1960s, there was dramatic growth, with increases for both men and women, U.S. citizens and non-U.S. citizens, and in each major field. After peaking at 19,000 in 1972, the level declined during the 1970s, reaching a low of 17,050 in 1978. Since then, it has increased slowly to 17,050 in 1983. Non-U.S. citizens accounted for 24% of new science and engineering doctorates in 1983, compared to 21% 10 years earlier. But, NSF notes, the number of recipients with permanent visas declined, and the number of those with temporary visas increased enough to account for most of the overall increase in science and engineering doctorates. NSF points to the increasing participation of women as one of the major developments in higher education and research over the past 20 years. Women earned 2000 more science and engineering doctorates in 1983 than in 1973. During the same period the number earned by men declined more than 3000. G