About the Author
My 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.Stay Connected
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I 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: Clinical Trials
Waiting for Word on the Adaptive Clinical Trials Workshop
Back in July, FDA’s Dr. Scott Gottlieb gave a speech in which he talked about an upcoming conference on clinical trial design to be held in November. Word has it that the conference is going to be on the 13th … Continue reading
Posted in Clinical Trials
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Adaptive Clinical Trials – Just Do It!
Some time ago, it became apparent that the FDA was going to participate in a conference on adaptive clinical trials. Dr. Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration — gave a speech on … Continue reading
Posted in Clinical Trials
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Prevention Pill Research – An HIV Opportunity for Pharma
From Toronto. Last night, the XVI International AIDS Conference opened in Toronto, Ontario. It is now a biennial conference and it is my sixth, having attended Florence, Amsterdam, Berlin, Vancouver and Geneva previously. For what it is worth, like the … Continue reading
Posted in Clinical Trials, Current Affairs, Pharma Industry Image
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Weighing the Benefits of Adaptive Clinical Trial Designs – An Update
As stated yesterday, there is a great deal of interest in the upcoming workshop on adaptive clinical trial design to be held in November in the Washington area. While plans have not yet been finalized, here are some insights. The … Continue reading
Posted in Clinical Trials
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Public Relations and Clinical Trial Recruitment
Last night ABC World News Tonight carried a piece about clinical trial recruitment and cancer. It was an important piece, not only because of clinical trial recruitment generally, but also as a piece, spoke to the need of great public … Continue reading
Posted in Clinical Trials
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