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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Monthly Archives: February 2020
Emerging Pathogens, Communications
In June 1981 I graduated from law school. One month after that an article appeared in the New York Times with the headline “Rare Cancer Seen in 41 Homosexuals” on page A20. These two events would end up pretty much … Continue reading
Posted in Current Affairs Comments Off on Emerging Pathogens, Communications
The Side Effects of a Coronavirus Epidemic for Pharma
There are a lot of important facts on the FDA’s Web Page set up to provide information about the novel coronoavirus (2019-nCOV) outbreak, now dubbed COVID-19. But there are three sobering statements that stand out: There are no FDA-approved diagnostics … Continue reading
Posted in Current Affairs Tagged #coronavirus #COVID-19 Comments Off on The Side Effects of a Coronavirus Epidemic for Pharma
FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the market addresses another policy priority – having an impact on the high cost of medicine. The approval … Continue reading
Posted in Biologics, FDA Policy Comments Off on FDA Takes A Number of Actions to Enhance the Market for Biosimilars – A Process Not an Event