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SPCs extend a drug's basic patent protection for up to five years, to take into account the time that may have lapsed between the filing of a patent application and the granting of market authorization.

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Manufacturers will have to incorporate Part D–specific messaging into all of their current marketing materials. In addition, they should consider publication plans and CME that specifically address the needs of seniors.

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As a result of the rapid innovations in drug technology, and the increasing complexities surrounding drugs' safety, cost, and efficacy, the demand for extensive formulary reviews is growing. To keep pace, Pharmacy & Therapeutics (P&T) committees have been ardently reviewing medications to determine which ones deserve inclusion and preferred placements in health plans and formularies. While there are many factors that influence the committees' decisions, with some carrying more weight than others, pharmaceutical execs complain that there is no accurate way to predict which drugs will make the cut.

Elegant positioning strategies often fail when doctors learn that a prescribed product isn't on a patient's managed care formulary.

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Garry Barnes says he joined the pharma industry for job security-but don't believe him. During the last 25 years, Barnes has worked for four pharma companies and built five sales forces in therapeutic areas ranging from contraception to organ transplantation.

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Traders say parallel distribution of drugs generates savings for patients. Industry says it creates more profits for traders, leaving pharma with less R&D funding.

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Accept distortions and untruths. Don't try to undo them. The point is not to win an argument; your critics' views are legitimate, irreversible realities. It's time to give the public something new to think about.

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.

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Our goal is competency-based training that has a solid business need, sound instructional design based on adult-learning principles, and metrics that can capture, evaluate, and track what we do. We want a blended-learning approach that can be delivered over the Web, on CD-ROM, or on paper.

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"You're fired!" It's a simple phrase that everyone is using, and it's put Donald Trump back into the spotlight. However, the most important statement you will ever make as a manager is "you're hired." With all the pressures of the job and the limited time you have for interviewing, it is easy to rush through this process to fill a slot. Stop yourself-hiring a good person is one of the most important decisions you will make as a manager.

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It's twelve o'clock-do you know where your reps are? According to research from Health Strategies Group, lunches provide one of the few opportunities in today's short-call environment for sit-down discussions with doctors. The average length of a lunch is 13 minutes, with an average of three physicians per meeting.

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A new TV doctor show features the most loathsome pharmaceutical executive in recent memory. But in another important way, the show is serving pharma's best interests.

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If you work for a company that isn't interested in increasing sales across your portfolio, don't read this article. Otherwise, you'll learn that your district managers (DM) are the keys to doing just that. DMs select and hire new sales reps, guide product knowledge, develop selling skills, provide feedback, and take action to turn around or terminate poor performers. The average industry DM is responsible for generating tens of millions of dollars in sales through his or her teams. But, only 45 percent of industry DMs achieve their sales goals. Companies that succeed in raising the overall effectiveness of their DMs will create sustainable competitive advantage.

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OIG now requires corporate marketing departments and field sales reps to not only document how they promote products, but to also-for the first time-demonstrate the "intent" of marketing activities.

Direct-to-consumer spending increased from $3.2 billion to almost $4.1 billion between 2003 and 2004, the biggest leap since the category began in 1997. While other US industries are just getting their footing back after a prolonged economic slump, DTC advertising, as in previous years, seems unaffected and continues to thrive. Even in the wake of FDA's virtual shutdown of the lucrative COX-2 inhibitor market, both DTC and professional promotional spending have, so far, remained in tact. (See "TV Dominates")

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.

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.

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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.