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: Clinical Trials
Clinical Trials and Social Media – Part 1 in an Intermittent Series
Last week Brian Reid wrote an excellent piece on the Common Sense blog entitled “The 5 Consequences of the Lack of FDA Social Media Guidance“. He got off to a great start, but I actually think there are many more … Continue reading
Posted in Clinical Trials, Social Media
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Adolor Corp. Gets Approvable Letter
Today Adolor Corp. announced receipt of an approvable letter from the FDA requesting 12-month safety data that includes an analysis of any cardiovascular related adverse events. The application was for Entereg, indicated for the management of postoperative ileus.
Posted in Clinical Trials
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Adaptive Clinical Trials Workshop – An Opportunity Gone South
Back in July when Dr. Scott Gottlieb made a speech before the American Medical Association and made a lengthy reference to a November workshop in which FDA would participate regarding adaptive clinical trials, there was a great deal of anticipation … Continue reading
Posted in Clinical Trials
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Antibiotics and Clinical Trials
What happens when the FDA decides on new policies during the course of a clinical trial? Last week, Replidyne and Forest Laboratories reported that the FDA issued a non-approvable letter for Faropenem, an antibiotic. The FDA wanted further clinical studies … Continue reading
Posted in Clinical Trials
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Is the Adaptive Clinical Trials Workshop a Private Affair?
One might ask oneself why, if an important conference in which there is a high level of interest is just a few weeks away, have details not been announced. The answer may be that most of us assumed that the … Continue reading
Posted in Clinical Trials
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