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: Clinical Trials
FDA Guidance on Clinical Trials During COVID-19 Pandemic
Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care … Continue reading
Posted in Clinical Trials, FDA Policy Tagged #COVID-19 #coronavirus #pharma Comments Off on FDA Guidance on Clinical Trials During COVID-19 Pandemic
Taking a Peek at Transparency – An FDA Pilot Program
Yesterday, Commissioner Scott Gottlieb announced a new effort on the part of the agency aimed at increasing transparency around clinical trials, a goal long sought by many patient advocates, particularly outside the U.S. Specifically, FDA is introducing a pilot program … Continue reading
Posted in Clinical Trials, FDA Policy 2 Comments
FDA and Patient Involvement
“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading
Posted in Clinical Trials, FDA Image, FDA Policy Comments Off on FDA and Patient Involvement
NIH Clinical Trials and You
For a long time, I have thought that clinical trial information was too clinical to be of much use for patients who might be considering entering one. The information available was either in the form of searchable data bases, text … Continue reading
Posted in Clinical Trials 1 Comment
Clinical Trials and Search
You are sitting in the doctor’s office on that crinkly paper that pops every time you move. Your physician is leaning against a table and has just uttered some words that were a diagnosis. It is a serious diagnosis. For … Continue reading
Posted in Clinical Trials 2 Comments