Pharmaceutical Executive-10-01-2005

Pharmaceutical Executive

From the Editor: No Substitutes

October 01, 2005

From the Editor

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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.";

Bad Rep? A Q&A with Jamie Reidy

October 01, 2005

Features

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TO HEAR JAMIE REIDY TELL IT, HE'S ALWAYS BEEN THE SORT of slacker who succeeds. He did enough work to get decent grades in high school and at Notre Dame University, which he attended on an ROTC scholarship.

From the Editor: Incorporating Compliance

October 01, 2005

From the Editor

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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.

Under the Influence

October 01, 2005

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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.

Thought Leader: Room for Improvement

October 01, 2005

Thought Leader

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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.

Changing Diabetes

October 01, 2005

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Martin Soeters (pronounced soo't rs) has dedicated a quarter century-almost half his life-to the company at which he's now president of US operations. Novo Nordisk, where Soeters has worked since 1980-in various executive roles and locations, from The Netherlands (his homeland) to Belgium to France-is a leader in diabetes treatment, with the largest portfolio in the industry.

Global Report: Animal Attacks

October 01, 2005

Global Report

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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.

Whose Afraid of Authorized Generics

October 01, 2005

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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.

Ad Agencies to the Rescue

October 01, 2005

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The client-agency relationship is a product of its environment. Chock-full of regulatory requirements, scandals, and heightened FDA scrutiny, the current environment leaves much to be desired. But this is hardly news for the pharma industry.

Formulary Additions: The Big Picture

October 01, 2005

Global Report

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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.

Leadership: Feed the Heart

October 01, 2005

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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.

Sampling: Crimes in the Closet

October 01, 2005

Thought Leader

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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.