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.
Category Archives: Current Affairs
Virtual Reality – FDA and AdComms
Vaccination has been robust. Cities are opening up. Plans are underway for back-to-school. Travel is robust. Offices are cautiously re-opening. There are multiple hallmarks that, whatever the consequences, we are going back to normal. The age of COVID-19 will likely … Continue reading
Posted in Advisory Committee Prepapartion, COVID19, Current Affairs
Tagged #AdCom, #AdComm, COVID19
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Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19
This week New York became the first state to make available a means for mobile digital confirmation that an individual has been vaccinated for COVID-19. Popularly known as “immunity passports” they are in fact more than that. The New York … Continue reading
Posted in COVID19, Current Affairs
Tagged #COVID-19 #coronavirus #pharma
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“Can You Hear Me?” – The (Hopefully) Coming Transition from Virtual Meetings
Today, FDA published notice in the Federal Register of an upcoming meeting of the Arthritis Drugs Advisory Committee that will be held May 6. The meeting will be held virtually. Last year when the pandemic reality started setting in, like … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs
Tagged #AdCom, #AdComm, COVID19
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What They Said – Overview of FDA Press Releases for 2020
Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously. COVID certainly made a big impact – a … Continue reading
Posted in Current Affairs, FDA Image, FDA Policy
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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
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