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: Miscellaney
The Fourth Quarter Will Have Little Oxygen – Implications for Healthcare Milestones
Given the state of things in 2020, a lot of us are already thinking about when it will end. Moreover when it does end, it will be good riddance. That said, this difficult year will not go quietly into the … Continue reading
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My Moment with Jay Thomas
A departure from the usual FDA fare. The blog is meant to cover FDA issues, but also various aspects of communications. This is a story about media training, sort of. Jay Thomas died yesterday. He was 69 years old. He … Continue reading
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Serious Communications Planning Needed Now for Zika
Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad. As the … Continue reading
Posted in Crisis Communications, Current Affairs, Miscellaney Comments Off on Serious Communications Planning Needed Now for Zika
Communications + Medicine = Public Health – The WHO HIV Guidelines and the Role of Comms
Last August I wrote a posting about the important role of communications during the initial stages of an emerging contagious or communicable disease. But communications not only serves a vital purpose at the beginning of an epidemic, it also does … Continue reading
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Preparing Ahead – When Events Overtake Communications
Sometimes events present us with a seismic shift in the environment. And often when that happens, we have to have new language to describe the altered terrain. Inevitably there are gaps in our understanding. Familiar frames of reference become obsolete. … Continue reading
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