About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in Washington D.C. 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.
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 BlogEye on FDA is published by Mark Senak of FleishmanHillard's Washington, D.C. 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 2018
In the last installment we looked at the first part of the Strategic Roadmap – Addiction which specifically focused on opioids and nicotine. However, the next part of the FDA Strategic Policy Roadmap is less specific and instead is focused … Continue reading
Two announcements last week were in startling contrast. One was a scientific development that moves the needle forward, the other a policy announcement that tries to pull it back. The first development came from Google AI researchers and a published … Continue reading
At least here in the mid-Atlantic region, the ground hog appears to have got it wrong, with a week that had quite moderate temperatures. In the herb garden, the chives have popped up, always a harbinger of Spring. I tried … Continue reading
This week we had 70 degree temperatures and predictions of snow. It seems we are living in roller coaster times – at least for this month. For all the lovers out there, hope the Valentine’s Day was second to none. … Continue reading
With deaths rising each year, there is no question of the urgency that something needs to be done to address the opioid misuse epidemic in the United States. And in addition to mortality there are the lives touched by these … Continue reading