Pharmaceutical Executive-04-01-2005

Institutions bring value to industry not only through shared coursework or customized training programs, but also through leveraging the intellectual property of institutional personnel for corporate problem solving.

Conventional wisdom says that generics businesses are a drain on valuable resources. But these units are much less prone to the disastrous drug safety panics that Big Pharma has recently endured.

Every quarter, pharmaceutical manufacturers confront a dizzying array of price reporting obligations. Participation in the Medicare, Medicaid, Veterans Administration (VA), and Public Health Service (PHS) programs requires manufacturers to collect, organize, distill and manipulate vast quantities of information, and to generate from that data reportable figures that can have an enormous impact on the company's bottom line. It is critical that these figures be correct, not only to help ensure the integrity of these public programs, but because submission of false data to a federal agency is a prosecutable criminal offense, and the civil penalties and exposure can be staggering.

Recently developed technologies produce clinical quality cells in as few as12 days. Culturing cells in petri dishes can take a month or more.

Cover Story

In a bright airy office above fifth avenue in New York, Lynn O'Connor Vos is talking about topics dear to her heart: trust-and how pharma can regain it-the need to put physicians back in the center of pharmaceutical marketing, and reinvention, a theme in her own life and the core to her approach to business.

Contrary to myth, Paragraph IV certifications are not reserved only for blockbusters or high-volume primary care products. Three products under recent Paragraph IV challenges had sales of less than $50 million.

Could it be that someone's finally going to wipe the grin off Smiling Bob's face? As we were putting this issue to bed, the Cincinnati newspapers reported that federal agents had raided the offices of Berkeley Premium Nutraceuticals, a company best known for its "natural male enhancement" pill, Enzyte, and for its repulsive television commercials starring Bob. The US Postal Service led the operation, which also included the FBI, IRS, and FDA. They froze bank accounts, sent employees home, and combed records, attempting to determine whether Berkeley, which has accumulated more than 5,000 complaints with the Cincinnati Better Business Bureau and the Ohio attorney general's office since 2001, had committed mail fraud.

The majority of headlines opposed the industry: 57.1 percent were negative, 18.1 percent were positive, and 24.8 percent were neutral. But the headlines were less negative than the stories themselves.

Johnson & Johnson's pharmaceutical group builds team and relationship skills into performance evaluations. J&J's Robert Wills says, "Such skills are a built-in expectation. It's how people are supposed to do their job. Everyone who participates in an alliance is compensated for behaviors that contribute to mutual success."

You can have a biotech company with a great technology base, but if it doesn't have a product in Phase II development, Wall Street won't reward the company by increasing the value of its stock price. When products are valued over technology, there is a higher premium for commercially-focused business leaders.

MVPs go beyond numbers to create extraordinary value for companies and their stockholders. They are the top two to five percent of employees. In other words, if you were to lose 100 people, which two to five would you protect at all costs?

OVERVIEW

Reformers want to give FDA more clout, but agency officials say internal changes will help fix drug safety problems.