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: March 2006
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
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
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
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
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