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
OPDP Outlines New Research
FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. The research was new (kind of) but the direction was more of the same … Continue reading
Posted in FDA Policy, Research Tagged #DTC, #OPDP, #pharma Comments Off on OPDP Outlines New Research
Precision Medicine and FDA – Emerging Cloud Platform in Beta
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
Posted in Research Comments Off on Precision Medicine and FDA – Emerging Cloud Platform in Beta
Tap, Tap, Tap … Waiting for an Alzheimer’s Test? A Spinal Tap Test Emerges.
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
Posted in Current Affairs, Research 1 Comment
Progress in Cancer Drugs
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:
Posted in Research 3 Comments
Alzheimer’s = An Insidious Disease State (AIDS)
In the Sunday New York Times Business Section, there was an article about Alzheimer’s research. As I read it, I was struck by the current state of research and the way it mimicked the AIDS epidemic during the late 1980s. … Continue reading
Posted in Research 4 Comments