About the AuthorMy 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.
My ProfileI 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: December 2009
Well folks, it is the holiday season, and thankfully the end of 2009. I'm not going to do a look-back – frankly I feel 2009 was not worth the time and trouble. But wherever you are, I have a wish … Continue reading
Posted in Uncategorized Comments Off on Holiday Hiatus
Looking Back at 2009 GAO Reports – Map to Future Changes at FDA?
I always think that one of the harbingers of future direction for the FDA is looking to see what the GAO has been saying about the agency. I always say during speaking engagements that you can tell the new shape … Continue reading
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Weekly Roundup – 12/18/09
We are looking out at the horizon for a huge paralyzing snowstorm that is headed to Washington tonight, little realizing that we are already paralyzed – at least in Congress, a body that cannot seem to move and cannot seem … Continue reading
Posted in Uncategorized Comments Off on Weekly Roundup – 12/18/09
Pharma and YouTube – Where are the Eyeballs Going?
Earlier this week, I examined who seemed to be developing the most clout on Twitter, and the winner was clearly Novartis. Today, I want to examine YouTube successes and failures. Most pharma companies came to YouTube in 2008, though some, … Continue reading
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Google and Pharmacovigilance
Can search save the FDA? It is safe to say that the FDA has not been exactly an innovative thinker when it comes to the Internet. The agency has done some nice work with widgets (peanut recall, e.g.,) and has … Continue reading
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