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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.

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.

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A powerful new tool is available to FDA through a first-of-its-kind cooperative research and development agreement (CRADA) between FDA and EduNeering, a developer of computer-based compliance training systems.

Contrary to popular belief, physicians still can't retrieve the full medical history of every patient who walks into their offices. Nor can they zap prescriptions through a clearinghouse that shows whether patients are eligible for coverage and reviews all medications they are taking to forestall drug?drug interactions.

According to many legislators and the media, pharma companies, abetted by Madison Avenue, lead the corporate villain list, just below auditors and errant CEOs.

May 2003 CE.

Just a few years ago, financiers were celebrating the "recession-proof" US economy, betting on the success of dot-coms and ridiculing the cautious few. Today, pharma industry experts tout mergers and acquisitions as a panacea to solve growth problems, reduce costs, increase sales, and renew R&D productivity.

Check out the ranking of the world's largest pharma companies in the fourth annual Pharm Exec 50.

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In the excellent online magazine The Edge (www.edge.org), Gerd Gigerenzer, director of the Center for Adaptive Behavior and Cognition at the Max Planck Institute for Human Development in Berlin, poses a riddle about risk: Imagine that a 40-year-old woman has her first mammogram and it comes back positive. The incidence of the disease in her age group is 1 percent. The test is 90 percent accurate, and it has a false-positive rate of 9 percent. What's the probability that the woman has cancer?

Advanstar Communications Inc. announced that its Pharmaceutical Executive magazine was awarded, for the second year in a row, the coveted Jesse H. Neal National Business Journalism Award for editorial excellence from the American Business Media (ABM).

April 2003 CE.

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The pharmaceutical industry is experiencing unprecedented late-stage setbacks, product recalls, and difficulties in generating high-quality drug candidates. The problems are not specific to any one company or research effort but rather a result of the industry's limited knowledge of biology and chemistry.

When it comes to recruiting and enrolling individuals in clinical trials, the industry's challenge is similar to the one that General Riggs cites in his call to modernize the US Army.

The trick in understanding any contentious public debate is to figure out what's being left out of the discussion. What, for example, is the assumption that's so obvious that no one thinks to bring it up? More often than not, when you've located that assumption, you've found the secret core of the argument -- the part that everyone's really fighting over and no one can bear to mention.

As scientists' knowledge of biochemical pathways increases, so does the number of patents issued for generic treatment claims. Such claims represent methods of treating disease by modulating a particular protein in the body.

The competition for generics' 180-day marketing exclusivity is fierce, and Dr. Reddy's Laboratories filed the first court case calling into question FDA's methods for determining exclusivity on a patent-by-patent basis.

In hindsight, it seems Catherine Angell Sohn, PharmD, was destined to become vice-president, worldwide business development for GlaxoSmithKline Consumer Healthcare (GSKCH). Sohn, a former pharmacist, architect of three Rx blockbuster launches, and engineer of innumerable partnerships and licensing agreements, is a pivotal link between GSK's pharmaceuticals and consumer healthcare.

The ability to compete globally is essential to success in the pharmaceutical industry. The current trend is to establish joint ventures, outsource various stages of the development and production of a single pharma product, and purchase or start an indigenous business in other countries.

No greater challenge faces any writer than the empty page. To sully that beautiful white space with mere words can seem so arrogant, so pretentious, that one's urge is to leave it alone, in perfect blankness. To paraphrase an old writer's adage, just to begin may require lowering your standards-an act salvaged later only by careful editing.

All is quiet at the Drug Information Association's new headquarters, a short ride from the hubbub of Philadelphia. But inside, the association buzzes with change as it harnesses the expertise and energy of its members to improve healthcare around the world. Now approaching its 40th year, DIA is expanding both its educational programs and its global reach.

Consider the following real-world scenario: Feb. 28-Apr. 14, 2000. Third-party auditors warn Schering-Plough (SP) of problems with product quality, including lack of quality control (QC) and high staff turnover. Dec. 20, 2000. SP's stock price reaches a high of $60 per share. Jan. 19, 2001. FDA completes an in-depth inspection of SP production facilities, identifying significant, repeated, and widespread QC violations dating to 1998. Several production lines are shut down and the Clarinex (desloratidine) launch is delayed.

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.

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For the pharma industry, the year 2002 brought unprecedented competition, pricing pressures, public scrutiny, and ever-increasing regulation, all exacerbated by a weak economy. (See "Defining Events," pages 50-56.) Although a few companies forged new partnerships and produced life-saving treatments, many more struggled to meet the industry's challenges. And no road map exists to guide them through today's continuing market pressures or to help them anticipate tomorrow's challenges.

March 2003 CE.

February 2003 CE.