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With new guidelines and rising scrutiny, product managers need to know what to do today to anticipate a better tomorrow.
Oct 1, 2005
By:
Patrick Clinton
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.
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Attention to state-of-the-art methods help companies forge new and long-term partnerships.
Oct 1, 2005
By:
Patrick Clinton
There's more than one way to slice and dice a deal to understand how value is distributed. In doing so, companies may be better able to construct biopartnerships that not only capitalize on the promise offered by a compound today, but minimize them against losses if a drug doesn't succeed through the pipeline.
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Don't use surrogate measures in clinical trials, says a major industry critic. OK, but don't the critics base a lot of their points on surrogate measures, too?
Oct 1, 2005
By:
Patrick Clinton
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.";
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Sep 1, 2005
By:
Patrick Clinton
As pharma moves into a new phase, one can sense an added level of sophistication in how the industry and its suppliers handle the issues surrounding medical education meetings. In this issue, we look at some new threats and new solutions.
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Sep 1, 2005
By:
Patrick Clinton
As pharma moves into a new phase, one can sense an added level of sophistication in how the industry and its suppliers handle the issues surrounding medical education meetings. In this issue, we look at some new threats and new solutions.
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Sep 1, 2005
By:
Patrick Clinton
My doctor and I have two different visions of an avian influenza pandemic. She's picturing regular flu season, but worse. I'm imagining 1918. Does the conflict sound familiar?
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Aug 1, 2005
By:
Patrick Clinton
With patients who suffer from poverty, lack of education, and disease, it is incredibly easy to do damage through a marketing tactic that might be acceptable for another group.
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Jul 1, 2005
By:
Patrick Clinton
If congressmen gathered to work through the nuances of banning ED drugs from reimbursement under Medicare, they'd still back the ban. But the decision would be grounded in lack of faith in prescribing behavior, not disregard for a debilitating condition.
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The regulatory load thrust upon pharma's shoulders in recent years has made compliance solutions a top budget priority for IT executives, and sent technology suppliers on a mission to uncover for pharma companies
Jul 1, 2005
By:
Patrick Clinton
For pharma companies large and small, one of the most pressing challenges of the next few years will be to understand compliance at a much deeper level, to obtain the tools to make it possible.
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