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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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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Category Archives: Marketing
IMS, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries released the annual "U.S. Pharmaceutical Market Performance Review" which found that pharmaceutical market growth slowed from 8% in 2006 to 3.8% in 2007. According … Continue reading
If a tree falls in the forest, and almost no one notices, did the tree almost not fall? Pharmaceutical Executive noticed, but I didn’t notice anyone else notice. I’m talking about the long-proposed user fee program for the FDA’s Division … Continue reading
One of the many confounding things about the AIDS epidemic is the radical shift of the HIV disease burden to populations of countries with the least ability to payfor therapy. That creates a number of dilemmas and conundrums. One, those … Continue reading
I was fascinated to read the RPM Report analysis of the new system that will emerge when the new FDA bill is signed into law. A new user fee program for review of DTC ads will exist that allows the … Continue reading