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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Category Archives: Research
In his State of the Union message this year, President Obama announced a new effort in the way research is done when he unveiled the Precision Medicine Initiative (PMI). The stated goal of this initiative is to begin the transition from … Continue reading
A headline that has been both craved and feared appeared yesterday: "Spinal-Fluid Test is Found to Predict Alzheimer's" The New York Times reports that the Archives of Neurology is today publishing a study on a test for Alzheimer's that is … Continue reading
CBS is running a series on the progress in the development of cancer drugs. Here is a clip from yesterday that discusses how the FDA manages the approval of cancer drugs: