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.Stay Connected
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I am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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Monthly Archives: April 2007
Weekly Roundup – 4/13/07
For those who are superstitious it is Friday the 13th. Lately, for some, it seems that characterizes every day as it has been an active week on the bad news front for many. Here in the Beltway, Congress is back … Continue reading
Posted in Weekly Roundup
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U.S. Stem Cell Policy – Ceding the Competitive Edge
By a margin of 63-34, the Senate passed the Stem Cell Research Enhancement Act – just 3 votes shy of a veto-proof bill. A veto is promised. We are back where we started. Opponents claim a moral high ground that … Continue reading
Posted in Biologics, Current Affairs, Legislation
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Scenario Planning in the Face of Trouble
It seems that there is a lot of trouble brewing lately. Sometimes it seems events overtake us without our being able to actually strategically consider our options. We are reactive, rather than proactive. There are many reasons for that, not … Continue reading
Posted in Tutorial
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Leaving PDUFA Alone
PDUFA IV, as has been noted here many times, is up for passage in the Congress. For those new to it, PDUFA is the Prescription Drug Users Fee Act which, if authorized, will provide a majority of funding for FDA … Continue reading
Posted in Legislation, PDUFA
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TheStreet.com Speaks – Evaluating Pharma Stock Before Approvals – A Talk with Adam Feuerstein
A few weeks ago, I noticed an excellent article by Adam Feuerstein, Senior Columnist at TheStreet.com called Putting a Value on Provenge describing what went into the evaluation of a single biotech company when analyzing the impact of an approval … Continue reading