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RAPS 2014 Day Two Recap

September 30, 2014

 

Another great day at RAPS in Austin. Here’s some of the highlights from today as I prepare to head out for a night of networking at the dine around.

European Regulatory Environment

It was a great first session on changes to clinical data requirements in Europe. This would have been a great presentation for folks in the business to attend, because the speakers did a good job painting the complexity of the EU regulator landscape and the tremendous risk and uncertainty this imparts to the product development process. But beyond this, the session also did a good job sorting out what has and hasn’t changed and what that means tactically for regulatory affairs. And David Rutledge from Abbott and SengDao VanMany from Hollister provided real-world examples of how their organizations were adapting to align with the EU regulatory environment for Class III and Class I devices respectively.

The Future is Now

There was a wonderful session on 3D printing that was inspiring and just plain cool. It began with a short history of 3D printing, which has been around since the early 1970s and (until recently) used primarily for prototyping. The big innovation lately (and the thing that has everyone excited about this “new” technology) is the reduced cost of the technology, which has allowed innovation in its use beyond prototyping, i.e., to printing finished products for consumer end use. Beyond that, the speakers talked about the range of current applications for 3D printing in life sciences, from breast and facial reconstruction to print-on-demand surgery templates, individualized patient “models” of internal organs to aid doctors, to printed human tissue samples for use in clinical trials–awesome stuff. There was also a lot of talk about the emerging nature of regulatory guidance for 3D printing, which is a matter of wait and see.

Social Media

I went to the two back to back social media sessions. The first was a panel discussion that began with Stella Stergiopoulos from the Tufts CSDD presenting their recent survey data on social media usage for PV. I’ve seen Stella speak on this topic before, and she’s always excellent–plus the CSDD has such rich data that it’s always worth hearing what they have to say. In addition, there were regulatory practitioners from Lundbeck (Ilze Kurins Antons) and AstraZeneca (Matthew Boyd), as well as a true blue digital marketing person (Sue Niedrich)–a very valuable perspective to have in the conversation.  The second was a situation room where everyone let down their guards and talked openly about challenges with social media. Without betraying the “what happens in the situation room stays in the situation room” pledge, I can say that some common themes were the fine line between product marketing and patient education/disease awareness, the nuts and bolts of running a social media monitoring function, and the complexities of AE reporting.

The Final Word

Ok, so much for day two–off to network and enjoy Austin. Would love to hear what you all out there found valuable on day two!

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