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.
Posts by Date
Monthly Archives: February 2006
I have sat through an extraordinary number of FDA Advisory Committee meetings on a wide range of topics. During RX to OTC switch meetings, there is a great deal of fuss about the label and what it is going to … Continue reading
Common Sense Confirmed – Study Reveals Talking to the FDA is Good! – From the department of Dog Bites Man, the FDA issued a press release on February 9 revealing that pharmaceutical and biotech companies that communicate more frequently and earlier … Continue reading
The Value of Drugs and the Standing of Industry – It is Friday, so this is going to be one of those occasions where I am going to claim artistic license and not focus specifically on a matter related FDA … Continue reading
February 15, 2006 – This is a time for a lot of soul searching on the part of industry as well as the FDA. Events of the past two years are shaping an entirely new landscape in drug development and … Continue reading
Who am I? My name is Mark Senak. I’m a lawyer and I work at the international communications firm Fleishman-Hillard in Washington D.C. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged … Continue reading