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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Tag Archives: #COVID19
Emerging from Emergency – Two COVID-Related Developments This Week
Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced … Continue reading
Posted in FDA Image, FDA Policy Tagged #AdComm, #COVID19, #Face-to-Face FDA Meetings, AdCom, AdComms Comments Off on Emerging from Emergency – Two COVID-Related Developments This Week
The Definition of “Fully Vaccinated” Needs to Change
The COVID-19 pandemic is a rapidly changing landscape. We are long gone from the days of being threatened by a rampant Alpha virus to having several successive variants. It now appears that the very fast-spreading Omicron may become dominant over … Continue reading
Posted in COVID19 Tagged #CDC, #COVID19, coronavirus Comments Off on The Definition of “Fully Vaccinated” Needs to Change
COVID-19 Vaccinations – Where a Commitment to Diversity is Essential
In my last posting on preparedness for a post-vaccination world I touched on some of the questions facing employers in general – policy questions that should be considered now for the eventualities of later. But digging a little deeper, there … Continue reading
Posted in Uncategorized Tagged #COVID19 Comments Off on COVID-19 Vaccinations – Where a Commitment to Diversity is Essential
As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner
Coincident to COVID-19 case levels in Europe and the United States entering new and serious levels comes welcome news on the development of a vaccine. Last week Pfizer and BioNTech announced findings from the first interim analysis of the Phase … Continue reading
Posted in Current Affairs Tagged #COVID19 Comments Off on As the Prospect of a Vaccine Approaches, Business and Communications Challenges Are Just Around the Corner
FDA AdComm Agenda Covers the Bases
First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as research into a vaccine is aggressively underway, we also see serious … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs, FDA Image, FDA Policy Tagged #COVID19 Comments Off on FDA AdComm Agenda Covers the Bases