Author Archives: Mark Senak

Meetings, Clinical Trials and Supply Chain Disruption from a Virus We Never Heard of Until New Year’s Eve…

The world changes quickly. A few weeks ago, I published an article on LinkedIn “Communications Challenges for Medical Manufacturers as COVID-19 Epidemic Emerges”. It was meant to outline some thinking for the potential for the disruption of medical meetings, of … Continue reading

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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

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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

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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

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Sorting it Out – FDA AdComm Review for 2019

Has FDA been holding enough AdComms? There have been a large number of drugs approved in the past year, but there has not been a corresponding increase in the number of advisory committees staged by FDA. Late in 2019, I … Continue reading

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