About the Author
My name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
Monthly Archives: March 2006
A Question on Risk/Benefit Budgeting
It is Friday and I tend to allow myself a little wiggle room on Fridays to wander far and wide, topically. One of the reasons I’m really ready for Friday is that I attended the Pediatric Advisory Committee meeting this … Continue reading
Posted in FDA Policy, PDUFA
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A Voice for FDA
The FDA, as I’ve been noting, has been having an image problem, both with the public and with policy-makers. There is a proverb that an accusation that goes unanswered is an accusation that is admitted. In other words, if the … Continue reading
Posted in FDA Image
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What Are People Saying and How Do You Know?
Forgive me, but I think there was a seismic shift yesterday. (I lived in L.A. for 10 years.) Yesterday, my friend Tarsis in Chicago gave me the head’s up about the fact that the exceptional company Google had launched a … Continue reading
Posted in Pharma Industry Image, Weblogs
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A Presidential Call for Transparency in Healthcare
Recently the President has been calling for more transparency in healthcare pricing. Initially he is talking about how hospitals and healthcare plans operate. But as the realities of Medicare Part D begin showing themselves, that call may broaden to the … Continue reading
Posted in Pharma Industry Image, Pricing and Value
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Tragedy in Britain – Magnifying the Risk in the Risk/Benefit Equation
By now you have probably heard the terrible story out out of the United Kingdom regarding six human volunteers in a Phase I study who became seriously ill almost immediately after taking a study medication. An analysis of the situation … Continue reading
Posted in Safety and Clinical Trials
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