Strategy

The clinical trials space these days is an alphabet soup of technologies: CTMS (clinical trial management systems); CDM (clinical data management); CDR (clinical data repositories); eCTD (electronic common technical document); and many more. But the technology with the most promise for transforming the way clinical trials are performed (and for driving everyone mad throughout implementation) is EDC-electronic data capture. It's taken more than a decade, but today most big pharma companies-and a fair number of smaller ones-are using some form of EDC in clinical trials. The early adopters might have experienced some growing pains, but the benefits seem to be outweighing the high cost of implementation. Few companies would consider going back to paper-based trials.

Very few drugs live forever. Barring remarkable scientific advances and radical market dynamics, most drugs hit old age-and sharply declining sales-several years before their patent expires. But some drugs go out with a bang, not a whimper.

Ever since Jeffrey Kindler rocked our world last December with the news that Pfizer was cutting its sales force by 10,000, we've been waiting for all the other behemoths' shoes to drop. While no precise domino effect has occurred, downsizing, particularly on the sales side, is very much pharma's strategy du jour.

For the sixth year in a row, Pharm Exec invites Professor Bill Trombetta of St. Joseph’s University to analyze the pharma industry's financial performance with a battery of business metrics, old and new. The highlights: Genentech pulls ahead of its longtime rival, Amgen. Forest delivers another strong performance, despite dropping revenue. Schering-Plough is building enterprise value. Biogen Idec racks up a stellar profit margin. And Merck? Well, Merck is back, baby. And the winner is…

Many see Vioxx and Avandia as clear signs that the drug safety system has failed. As soon as reports of these drugs' adverse events began to flood the media, consumers-and Congress-demanded to know: "Why didn't we know sooner?"

Is the American Medical Association's (AMA) Prescribing Data Restriction Program (PDRP) the answer to physicians' privacy concerns, or will it just hamper the relationship between rep and doc? Observant LLC recently gauged reactions to the PDRP and doctors' expectancies of how this initiative affects physicians' practices and their relationships with pharmaceutical representatives. The findings suggest that the initiative may have paradoxical negative implications for physicians.

It's certainly not headline news that these are tough days for the pharmaceutical industry. More than $60 billion in revenue from blockbuster drugs will evaporate as these products go generic over the next five years, while the productivity of clinical development has hit a particularly rough patch. Even in the companies with relatively strong pipelines, many of the new treatments are biotech products acquired out of house. The expected authorization of biogenerics will squeeze profits only further.

There is probably not a senior executive on the planet who, at one time or another, hasn't raised an eyebrow or two to express exasperation over "people problems." But just try to run the modern business corporation without them. Forget the Internet chatter about the peopleless workplace. There’s no substitute for the contribution people make to the bottom line.

here's a solid case to be made for choosing A. The market for deals has been robust through the first half of 2007. A Cowen research report counted 10 public deals done by July 2007, compared with 14 for all of 2006. Another data source, Irving Levin Associates, cites 455 public and private healthcare deals in the first six months of 2007, a 12 percent decrease from the same period last year-but an 18 percent rise in deal value.

It's testimony to the high anxiety-and hectic activity-in the industry that the merger of German chemicals-to-pharmaceuticals firm Merck KGaA and Swiss biotech Serono elicited only faint fanfare. Both family-owned drugmakers boast an illustrious heritage, but their union garnered none of the pomp and circumstance befitting a marriage of European royalty.

New marketing agency helps pharma companies clean up their act

A new class of scales that can help capture drug effects-not necessarily disease impacts, as quality-of-life instruments currently do-will likely be needed to identify the meaning of the drug's benefits to patients

Severin Schwan takes over at Roche

In the wake of a high-profile death from counterfeit drugs, the industry reacts

It's bittersweet being one of the leaders of an industry that is not sustainable," a top pharma CEO recently told Carolyn Buck Luce, Ernst & Young's global pharmaceutical sector leader. Bittersweet is a poignant word for a hard-driving exec to issue.

Global market will be twice as big by 2020, but industry needs new vision

While the most sought-after opinion leaders are often older, well-established physicians, companies should also be aware of the rising stars. Younger, up-and-coming specialists who are beginning to publish are often more cutting-edge and open to experimental approaches.

It was like the end of the arms race last November when Pfizer announced it was slashing its national sales force by 20 percent. Coolly downplayed as cost-cutting by new CEO Jeffrey Kindler, the stunning move was met by industry insiders, Wall Street analysts, and the media with one humongous collective sigh of relief. Big Pharma was seen as having grown dangerously addicted to the detailing game over the past decade, with the top firms plowing more and more of their blockbuster profits into trying to keep up with Pfizer's "flood the zone" strategy and with less and less to show for it.

Today's highest science, most fierce competition-and make no mistake, biggest gains-are coming from the oncology arena. In fact, there are more than 380 cancer compounds in development, according to a recent report by IMS Health, with almost 100 of them in Phase III trials.

Drug industry leads in 'world class' competitive intelligence.

And while reporters aren't writing any more about the industry, the topics they cover are a moving target.

Dr. Doug Bierer felt like he was in a courtroom, waiting for the jury to render its verdict. It was June 2002, and executives from Procter & Gamble and its partner AstraZeneca had just finished presenting their bid to FDA's Non-Prescription Drugs Advisory Committee (NDAC) to market the popular heartburn medication, Prilosec (omeprazole), as an over-the-counter (OTC) drug.

Everyone agrees that by streamlining and downsizing, Big Pharma is taking a step in the right direction. What no one yet knows is if it's too little, too late. Or what "too little, too late" might look like. Or what else might work.

Ever wonder how all those biotechs, specialty shops, and generics that make up Not Big Pharma ever manage to stay in business? Pharm Exec asked Bill Trombetta of St. Joseph's University to look at their books, analyzing their financial performance with the same metrics he uses for our annual Industry Audit. His findings may surprise you. In fact, when you check the bottom line, you just might consider changing teams.

Big, bold, and brash, Frank Baldino has built Cephalon into one of the nation's most dynamic biotechs. The company, based in suburban Philadelphia, is 20-years-old this year, and is already marking its birthday with a flurry of honors. In January, Cephalon was inducted into the World Economic Forum's Community of Global Growth Companies-a tribute to a 44 percent increase in annual revenue (to $1.67 billion in 2006) and its new footprints in Europe and Asia.