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.
Posts by Date
Monthly Archives: October 2006
Lately the environment for generic drugs has grown much warmer. Consider, last week the FDA/CDER proposed a speedier process for considering approval of generics. Walmart, one of the biggest retail chains in the country, announced it would sell many generics … Continue reading
PhRMA is staging the Adaptive Clinical Trials Workshop that is being held in November. This week, a call to PhRMA to ask for more information would be forthcoming has gone unanswered. Still, what I have been able to find out … Continue reading
Well, today is Nick and Nora’s first birthday. They are in every way a blessing, though puppy hood is more work than I remembered. Looking back on the week as it comes to a close, it was an active one. … Continue reading
An incident this week makes me want to echo back to a posting a few weeks ago about counterfeit drugs. Every time there is a debate about importation someone has a fit claiming that importation is a vector for terrorism … Continue reading
Back in July, FDA’s Dr. Scott Gottlieb gave a speech in which he talked about an upcoming conference on clinical trial design to be held in November. Word has it that the conference is going to be on the 13th … Continue reading