Digital Pharma Conf. Thurs. Morning 9

Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Mark Gaydos, Senior Director US Regulatory Affairs Marketed Products, Sanofi-Aventis: Mobilizing your Company for more complete Web 2.0

– Establish a Dedicated Team – need to have representation from all stakeholders (Commercial/Mkting, PR, Reg, Legal, etc.). It’s good for Reg key players to look ahead, and anticipate, and have strategies in place.

– Non-marketers need to think like Marketers – Just Don’t Say “No”! Imagine possibilities. Partner, not oppose.

– Identify Initiatives to be Pursued – advertise on soc med website. Host moderated community. Host moderated KOL blog. Conversation monitoring. Start small and develop a roadmap for moving forward. btw, FDA’s not waiting; they’re using soc med (have own YouTube channel).

– Gain Sr. Mgmt. Approval – know your risks, and have credible/defensible interpretations and policies in place.

– Move forward in Stages “try it on,” learn, evolve, adjust.

– Progress…with Caution

Example of FDA warning letter to Shire for Ty Pennington on YouTube video – but soc med not the problem, it was bread and butter violations of fair balance, etc.