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: COVID19
New Landscape for the Old Pandemic
Tectonic pandemic plates are shifting respecting the COVID-19 pandemic. For weeks now we have been watching caseloads in the United States broadly fall. It feels as if we are indeed shifting gears. There are other moving parts that are in … Continue reading
Posted in COVID19, Current Affairs
Tagged #COVID19; #coronavirus
Comments Off on New Landscape for the Old Pandemic
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
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
Comments Off on Virtual Reality – FDA and AdComms
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
Comments Off on Passport Please – An App to Verify Your Status in a World Re-Shaped by COVID-19
Vaccine Development and Approval in a Time of Pandemic
Sometimes in the midst of events, perspective is elusive. Today the Food and Drug Administration will hold a meeting of the Vaccines and Related Biologics Advisory Committee (VRBAC) to consider the application for an Emergency Use Authorization (EUA) submitted by … Continue reading
Posted in COVID19, FDA, FDA Image
Tagged #COVID-19 #coronavirus #pharma
Comments Off on Vaccine Development and Approval in a Time of Pandemic