Pharmaceutical Executive-06-01-2006

Pharmaceutical Executive

What You Need to Know About Adaptive Trials

July 01, 2006

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Adaptive trials aren't just for propeller-heads anymore. They're one of the issues that need to be top-of-mind for the whole executive suite, as a driver of new processes and timelines, as a hot-spot on the budget, and as a battleground where public policy on drug safety and efficacy will be fought out.

Back Page: The "Help is Here" Express

June 01, 2006

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Patient assistance programs have been around for a quarter of a century. But many patients have failed to reap the benefits because of confusion over eligibility and the mechanics of joining. But all that has become much easier with the Partnership for Prescription Assistance (PPA), a one-stop-shop for industry-sponsored assistance programs.

What Type of Brand Are You?

June 01, 2006

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Despite Rituxan's initial success, the brand team considered the long-term opportunity for future indications. Equity research studies demonstrate that a significant "halo" exists around the brand, which is bolstered by greater optimism and excitement for all B-cell mediated conditions.

Setting the Standard

June 01, 2006

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Home and abroad, the US Pharmacopeia is stepping up to maintain quality control. But it's not so easy. USP's Roger Williams discusses Medicare formularies, drug safety, international drug production, and the organization's changing role.

Washington Report: Promises to Keep

June 01, 2006

Washington Report

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Pharma follow-through? As of September 2005, drug manufacturers had promised to perform 1,200 post-marketing studies. Companies hadn't even started 65 percent of them, and only 200 were completed.

Personalized Medicine Meets the Real World

June 01, 2006

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Personalized medicines often come to market without much safety information. Small populations mean less data. Genzyme, for example, received FDA approval for Cerezyme, to treat Gaucher disease, based on a pivotal trial with only 30 patients.

Leadership: On the Firing Line

June 01, 2006

Leadership

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It's difficult to terminate an associate, be it a new colleague or someone you've worked with for years. But if you can't do it, you risk losing the respect of your top performers. They'll look elsewhere for a level playing field.

Thought Leader: Paul Chang, IBM

June 01, 2006

Thought Leader

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In a product recall, manufacturers would know which retailers and hospitals got bad bottles. Instead of clearing shelves everywhere, they could call specific customers and say, "Hey, we know you have five of these bottles. We want them back."

Global Report: People Problems

June 01, 2006

Global Report

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Staggering doses in clinical trials may prevent large numbers of people from experiencing serious side effects. But it presents practical and ethical dilemmas, such as determining who is going to be first in line for their dose.

From the Editor: Forecast — and Fast

June 01, 2006

From the Editor

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At the rate science is progressing, there may be more new knowledge in the next 25 years than in the past 100. That's great news, but not if you are planning to run your business as you run it today.

Who's Coming to Meetings?

June 01, 2006

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Meeting Spend: Take stock of how much your company can and does spend on promotional meetings. And look carefully at the effects of new compliance regulations on audience recruiting. Among survey respondents, about half work for companies that spent less than $1 million a year on promotional meetings. The other half spent more, sometimes in excess of $5 million a year. About half of the respondents forecast a 15-percent rise in meeting budgets next year. The other half did not expect changes in the budget.