Pharmaceutical Executive-10-01-2005

In an opinion piece in the September 8 New England Journal of Medicine, Harvard medical professor and long-time industry critic Jerry Avorn takes a whack at FDA, accusing the agency of practicing a level of science that wouldn’t pass muster anywhere else in research-science that’s only "good enough for government work.";

Growing by Indication, Genentech Has a New Type of Blockbuster

Many still regard FDA's approach as costly and unnecessary. But the prospect of qualifying for purchase by PEPFAR is attracting applicants. The policy has helped bring news AIDS treatments to market.

Think of the role compliance plays in your job. Now imagine that level of concern increased by 25 percent, 50, or even more. That's what pharma has to look forward to in the next few years, as the effects of old regulatory initiatives, such as 21 CFR Part 11 and Sarbanes Oxley, start fully kicking in-and as we experience the as-yet-unknown regulatory fallout of the new concern with drug safety. It's no surprise that a great portion of this volume of Pharm Exec's Successful Product Manager's Handbook series is given over to compliance.

Sales reps should be able to access, in a central location, company-enerated influences that have affected a given physician. This type of closed- loop marketing creates a more customer-centric approach that provides etter influencer-level insight by connecting each resource, providing direction and metrics, and continually re-evaluating key influences and ROI.

Product managers would be less disrupted if compliance activities at pharma companies were more anticipatory than reactionary.

When you have a workable technology, the question becomes ‘To what do you apply this technology?’ and ‘Where do you spend your time?’ We really believed we would be most successful by spending a lot of time figuring out which drugs to work on and then working assiduously on those few products with huge potential.

UK courts are affirming the belief that medical research and drug development have made a huge contribution to people's quality of life, and that a small but vital part of that work involves the use of animals.

As the industry thinks about new sales force models, it should look beyond ROI numbers, toward a new paradigm that not only works for pharma, but also for its customers.

No brand manufacturers plan to market generic versions of their own product, at least not until the patent expires. And why would they? As long as the branded version enjoys patent protection, marketing a cut-rate product would eat away profit margin during the years when a drug makes the most money.

Data suggest that pharma companies engage the same key opinion leaders on assignments in three to seven departments or product groups at once.

To get along with the CFO, drug companies need to express more data in units that a health plan can integrate into its own internal actuarial analysis. The financial decision makers at a health plan want to know how a new drug affects the value of expected claims on the whole.

There comes a point when people have enough stuff in their lives, but they can never have enough meaning. Leaders have to find opportunities for their eams to do more than turn the machine of profit.

Market researchers often fail to realize that whenever they collect competitor information they are in fact collecting competitive intelligence. The same is true in reverse.

The pharmaceutical industry devotes more of its promotional budget to samples than anything else, unless you count the army of sales representatives that delivers them. This year, the average wholesale price of samples passed out to doctors will approach $15 billion-roughly twice the value of samples five years ago. And although few in the industry have come to grips with it, the federal regulations governing this enormous investment have undergone drastic changes.

It's important to empower individuals to understand and accept the responsibility for being stewards of their own health.

Partnerships with geriatric pharmacists will be critical for brand teams that market products specifically to seniors.