Pharmaceutical Executive-06-01-2005

Eyes in the Back of Your Head

Pharma trial sponsors and their CROs should enlist the support of high-level executives to make sure designated decision makers are fully confident in their ability to act.

A leader can reframe a situation. By recognizing that her own perspective may be incomplete, the leader can expand her frame to include more options for action than simply repeating herself.

State clinical trials requirements are in place to protect people from being exploited, or unsafely exposed to compounds. Forty years later, it's easy to say, "How did this happen?"

Pharma companies are committed to using electronic data capture in clinical trials. Technology adoption will continue to grow, as FDA and consumers want faster safety data.

Electronic patient-reported outcomes tools let trial sponsors enforce recording deadlines and compliance. They help keep subjects honest.

All too often, abuse liability and dependence potential are afterthoughts in the drug development process.

If a physician wants to use protected healthcare information (PHI) for research purposes, particularly if the PHI is going to be published as part of research results, an authorization or waiver will be required.

A prolonged QT interval creates an electro-physiological environment that is favorable for the development of cardiac arrhythmias.

CMS envisions studies to show which drugs keep patients out of hospitals or how certain treatments can reduce side effects. Such analysis would support decisions on best practices in using medications.

R&D leaders face the unenviable choice of either dividing their time between science and operations, or focusing on one to the detriment of the other.

Even though data can single out physicians with high marketing upsides, most pharma companies are doing without such high-value data.

Pharma companies want to promote their own, rather than hiring senior people away from competitors or other industries. But given the narrow backgrounds of the coming generation, fewer and fewer managers have the coordination and foresight needed to succeed in a general management job.

Part of the value of a drug comes from the supply chain that protects its integrity. There's a similar supply chain that preserves the value of drug information. And it needs help.

When Jim Dougherty joined Mcgraw-Hill almost 30 years ago, medical journal publishing was just plain different than it is today. The days of the "three-martini lunch" were slowly coming to an end. Yet many companies still determined their ad schedules based on relationships. There was also less competition: without DTC or the Internet, journals garnered larger percentages of pharma's marketing mix. Today, Dougherty is group vice president of McGraw-Hill Healthcare Information and president of the Association of Medical Publications (AMP), an organization of publishing firms in the medical field. Like many of his peers, Dougherty has witnessed-and continues to witness-the transformation of the field. The future is bright, he says, but most certainly uncertain.

A small company with an ambitious goal-to prevent infections instead of treating them after the fact-is about to start a revolution.

Pharma execs and industry analysts say pharma's reputation has improved during the past year. The general public sees things differently. Research says a few select companies are to blame.