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RAPS 2014 Day One Recap

September 29, 2014

RAPS logoSo day one at RAPS 2014 exceeded expectations. The sessions were great, networking was superlative, and social media usage was active from not only vendors, but also practitioners and industry thought leaders.

Although we still have lots more RAPS 2014 to go, I wanted to get my first day thoughts and impressions down while they’re still fresh in my mind…

TransCelerate

This was a great session, not only for the information it provided about TransCelerate, an industry consortium focused on improving R&D operations, but for the larger issues it raised about the future sustainability of the drug development process as it currently operates. It was great to see major life sciences orgs teaming up in a non-competitive way to develop common standards, streamline operations, reduce supply chain overhead, and work together to bring transformative therapies to the patients who desperately need them more quickly. I’m excited to see where this initiative takes the industry over the next few years–it seems to hold a tremendous amount of promise.

 Regulatory Intelligence

If you thought Reg Ops was a red headed stepchild, you should spend some time Reg Intelligence folks. They’re tasked with monitoring all the chatter from the FDA and other regulators (as well as pundits who report on them), culling it for relevant, actionable information, and sharing their analysis of the information with the larger organization. What came through loud and clear in the session I attended, however, was that RI, done properly, is a significant strategic differentiator in the organization. Problem is, most business folks have no idea that this is the case, and RI practitioners haven’t done a good job of making the case for relevancy–we’re too focused on getting the research right rather than articulating how our research impacts the larger organization’s value chain.

Regulatory as a Strategic Partner

This was not only the best session of the day, it was one of the best sessions I’ve ever attended, full stop. A common complaint, not only in Life Sciences, but in every heavily-regulated industry, is that regulatory compliance is viewed as administrative overhead rather than as a strategic partner. And most conference sessions on the topic are little more than stitch and bitch sessions: woe is me, we are so misunderstood, the rest of the organization has no appreciation of the important work we do, blah blah blah.

This one was 180 degrees away. The organizer, Kathleen Wessberg, director of Reg Affairs and Reg Ops at Abbott, managed to bring together a wide range of business stakeholders to speak to the strategic partnership between regulatory and “the business”. Three of them showed up in person; the other seven or so recorded video responses to her panel questions–all of them were superlative. As a regulatory practitioner, this was gold…especially if you weren’t fortunate enough to work at an organization as forward thinking as these companies are. I hope that this session is the beginning of a widespread evolution that ends with regulatory being as strategic as R&D, Clin Ops, and Commercial…time will tell.

 The Final Word

So much for day one–I look forward to what the next two days bring. In the meantime, I’d love to hear from you all out there–what were your impressions of day one? Did you have different takes on the sessions I attended? General heckling to offer? Jump in, and let’s get the conversation started!

 

 

 

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