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Shares in Danish company Novo Nordisk took a hit after it suspended trials for o­ne of its main pipeline candidates, the dual-acting insulin sensitizer, ragaglitazar. The Type II diabetes treatment was in Phase III trials with 2,500 patients when researchers found that it caused tumors in mice and rats. Early clinical trials showed that ragaglitazar has significant potential as a blood glucose regulator. The company is now carrying out a renewed benefit-risk assessment, which it hopes to complete by the first quarter of 2003. If it determines that the tumors are rodent-specific, it will resume the trials, and filing for approval will likely be delayed by two years.

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Sipping coffee from an ordinary paper cup that looks like it came from the company cafeteria rather than the closest Starbucks, Christine Poon, Johnson & Johnson's worldwide chairman of medicines and nutritionals, starts her day as many women do. But beneath her humble persona is the leader of J&J's $17 billion drug business—which accounts for 60 percent of the company's operating profits and is its most dynamic unit.

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Gary Stibel , Gaurav Kapoor
Pharmaceutical Executive, May 1, 2002

United States-At this time last year, the United States’ supply of tetanus vaccine was easily met by the two companies licensed to produce it there, Aventis Pasteur and Wyeth-Ayerst. But in June 2000, the latter ran into regulatory problems, and FDA seized thousands of substandard doses of acellular pertussis vaccine from the company’s Marietta, Pennsylvania, plant.

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Tremendous changes are underway at FDA headquarters in Rockville, Maryland. Whole sections of biologics review moving from o­ne center to another. Regulatory activities being refocused o­n risk. Restructured roles for agency field inspectors. And a variety of other reforms, many driven by the specter of bioterror. Despite operating for almost two years without a commissioner, FDA is moving full speed ahead with a major reorganization and a new regulatory philosophy.

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This is a tough time for group purchasing organizations (GPOs). The government is challenging their claim that they save hospitals money. A recent series of articles in the New York Times alleges that some GPOs have engaged in questionable business practices. Other critics claim that the business model that GPOs operate under is just plain wrongheaded. Despite the bad publicity, GPOs are holding steadfast to their position that they represent an asset to hospitals. For most health-system pharmacy managers, GPOs are an integral part of doing business. However, some believe that the recent intense scrutiny that GPOs are undergoing could change the nature of how they operate in the future.


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What are the industry's current hiring needs? What functions are most challenging to retain? How do misconceptions about working in pharma affect recruiting? These were some of the questions raised at an exclusive roundtable o­n pharma industry recruiting, co-sponsored by Pharmaceutical Executive and the New York Times Job Market. The discussion was moderated by Mary Cianni of Towers Perrin and included representatives from Wyeth, Johnson & Johnson, Novo Nordisk, Sankyo, and Hoffman–La Roche, as well as the State of New Jersey and Rutgers University. (See "Roundtable Participants.")

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A demographic tidal wave will break over the United States within the next few years: by 2012, an average of 10,000 Americans will turn 65 every day. But the issue of aging in the 21st century is more than a matter of numbers. Because older patients have more complex illnesses than younger adults, they present a unique healthcare challenge. The average 75-year-old suffers from three chronic conditions and regularly uses five prescription drugs, as compared with the average 40-year-old, who has no chronic condition and may use o­ne prescription drug.

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Although the extremely close race for the White House and for control of Congress in November signaled a lack of consensus o­n national health policy, voters have made it clear they are unhappy about the high cost of medical products. That was o­ne of the few issues to emerge from the political haze, and it promises to shape the debate o­n numerous health and medical topics.

As the popularity of o­nline training grows, many pharma companies are likely to implement learning management systems (LMS) that can manage the reams of data generated by training divisions in a regulated environment. Each company has a different reason for moving its training o­nline. It might want to reduce sales staff training time avoid negative 483s-the reports FDA staffers file after inspections-which frequently focus o­n software testing and poor employee training make it part of an overall productivity improvement initiative.

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