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
The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic
There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, … Continue reading
Posted in COVID19, Current Affairs, Pharma Industry Image
Tagged #coronavirus, #COVID19, pandemic
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T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches
As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the … Continue reading
Posted in Approval Announcements, COVID19, Current Affairs, Pharma Industry Image
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Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting
Virtually everyone is going virtual. Even in February, which seems like a very long time ago, many organizers began either postponing or canceling major conferences and meetings. This has included major medical meetings and given that large gatherings will be … Continue reading
Posted in Advisory Committee Prepapartion, Current Affairs
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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research
With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading
Posted in Current Affairs, FDA Policy
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Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2
Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading