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Not long ago the average pharma development organization spent $100 to $200 million a year. It consisted of about 100 people working on only a half dozen compounds. Its leaders typically knew all their employees by name. There was a good deal of visibility within the organization: Managers could see from top to bottom and could make decisions aided by nothing but their own brains.

The next five years will determine whether pharma retains its position as the most profitable major industry. It will do so only if it succeeds in justifying its profit margins and the high prices that US consumers pay for its products. That will be tough. When Adlai Stevenson was running for president, an enthusiastic supporter gushed, "Oh, Mr. Stevenson, you will win the thinking man's vote.

The Outsider

In his new book, former Lilly CEO Randall Tobias explains his ideas about management. Do they work? He'll have a chance to prove it as he takes the reins of America's $15 billion global campaign against AIDS.

The economy may still be suffering from the twin shocks of September 11th and a bursting technology bubble, but pharma spending on promotions continues to grow at a double-digit pace.

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I suppose, when you get right down to it, I've gotten used to the idea that in this country we don't actually debate issues. We holler and call our political enemies names. We play elaborate games of spin control and do our damnedest to ensure that every question of policy, no matter how straightforward and practical, gets linked in the public mind with abortion rights, gun control, and a half dozen other completely intractable hot-button issues.

Affordable healthcare has become a leading political and social hot button in the United States, and managed care organizations (MCOs) have responded by seeking to reduce pharmaceutical expenses to rein in rapidly increasing costs.

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When I was a kid, I remember reading magazine articles that set out to determine the worth of the human body-not its personal value, or its ability to produce valuable labor, but just the market value of the chemicals that composed it. The figure I remember hearing was $1.98. Pocket change for the crown of creation.

Before Botox became a popular beauty treatment, Allergan was just a small ophthalmic business that made prescription eye therapies and contact lens care products.

Innovative products, and the research and development teams that produce them, are pharma's life blood. So it's no surprise that, according to PE's 2003 Top 50 Pharma, the largest 20 pharma companies alone spent $45.5 billion on R&D.

Now that patents on several blockbuster drugs have expired, the industry-feeling the pinch-has focused its attention on intellectual property. Because every additional month of market exclusivity can mean an extra $50 million or more in revenue, pharma companies have gone to great lengths to block the entry of generic competition.

Thanks to managed care's efforts to steer patients into the least intensive treatment settings, primary care practitioners (PCPs) play an increasingly important role in prescribing.

Pharma companies seem to have forgotten one key lesson: Blockbusters are made, not discovered. Few drugs achieve top sales based on their initial formulation and indications.

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Point a finger at a map of the United States and try to find a state that's not competing to attract pharma and biotech business. It's nearly impossible. The story is the same in Europe and Asia. Around the world, countries, regions, and cities are trying to build their economies, and the life sciences are a key element in their plans.

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Even among industry insiders, company reputations are hard-earned and subject to change. Rating Research's (RRC) second annual Reputation Strength Study of the Pharmaceutical Industry surveyed financial analysts and industry senior executives to see how 19 companies stack up against each other and to see how their overall reputations changed from last year.

Patient recruitment for clinical trials is one of the most significant bottlenecks in drug development. As a result, several organizations have called for the establishment of recruitment best practices, beginning in 2000 with the Office of the Inspector General's (OIG) report on recruiting human subjects and most recently in a Clinical Research Roundtable report published in the March 12, 2003 issue of the Journal of the American Medical Association (JAMA).

During the next ten years, big pharma companies will need to launch two products a year to generate 5 percent annual growth, five products a year to hit 10 percent growth, and nine products a year to meet a 15 percent annual growth target. Clearly, the stakes are high.

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My train reading this week has been Protecting America's Health, Philip J. Hilts' enlightening history of the Food and Drug Administration. It's a book with a strong sense of how politics, people, and the uncontrollable flow of events conspire to shape institutions. It's also a good read, thanks to the author's fine eye for anecdote. Over and over, Hilts selects just the right story to capture the essence of an era in the agency's history.