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: February 2014
Weekly Roundup 2.28.14
Last weekend was so warm I got to take my first bike ride and went around the Mall. It was delightful with temps in the 60’s. Early in the week, I was excited to find a blooming crocus where just … Continue reading
Posted in Weekly Roundup Comments Off on Weekly Roundup 2.28.14
FDA Press Releases – What They Say
Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way. I only started … Continue reading
Posted in FDA Image, FDA Policy Comments Off on FDA Press Releases – What They Say
Weekly Roundup – 2.21.14
The snow has melted and the ground is soggy. Looking at the ground there are daffodil tops poking out of the dirt and this morning on my dog walk, I spotted my first two crocus blooming purple. The volume of … Continue reading
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Building a Case, FDA AdComm Prep – Part 3 (final)
In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting. You have developed your narrative … Continue reading
Posted in Advisory Committee Prepapartion Comments Off on Building a Case, FDA AdComm Prep – Part 3 (final)
Weekly Roundup 2.14.14
Well, I am really tardy with this posting – the Weekly Roundup is not only late, it is real late. Sorry, it was not Valentine’s Day festivities, nor was it a result of the snow storms – some of which … Continue reading
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