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
June 2023 M T W T F S S 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Legislative Tracking Tools
Category Archives: Biologics
Immunogenicity and Follow-on-Biologics
This week, the FDA issued a non-approvable letter to Momenta Pharmaceuticals as outlined in a press release from the company. The approvable letter was issued to Momenta and its partner, Sandoz, Inc, which is a generics manufacturing division of Novartis. … Continue reading
Posted in Biologics 4 Comments
U.S. Stem Cell Policy – Ceding the Competitive Edge
By a margin of 63-34, the Senate passed the Stem Cell Research Enhancement Act – just 3 votes shy of a veto-proof bill. A veto is promised. We are back where we started. Opponents claim a moral high ground that … Continue reading
Posted in Biologics, Current Affairs, Legislation Comments Off on U.S. Stem Cell Policy – Ceding the Competitive Edge
The Bio Conference and the FDA Survey
The BIO conference was held last week in the wonderful city of Chicago. A lot of people have been writing about it. So I decided to join in. The blog On Pharma has some very nice daily updates. Former President … Continue reading
Posted in Biologics, FDA Policy Comments Off on The Bio Conference and the FDA Survey