pressure2.jpgA few weeks ago, I published a post in this blog, Drug Safety Progressives - The Rise of the Pharmacovigilante. I was blown away by the positive response and resulting discussions. I even received a few requests for the t-shirt shown in the picture, but I’m sorry to say that our business model is based on software-as-a-service, not retail. But I digress… back to the Pharmacovigilantes…

One theme that came through in those conversations revolved around the fact that it is really hard for most safety professionals to be forward thinking when the majority of their time is spent processing cases. The graph below shows the dramatic rise of cases that have been submitted to FDA from 1997 – 2015.  To that, we’ve added a future projection by using the ~24% average growth rate from the past three years. No wonder PV professionals are feeing  resource constrained!.

pv is more than case processing.png

On top of the ever-increasing case processing, safety teams are now expected to do more to support the entire enterprise. They are being asked to contribute expertise and data to go/no-go decisions for pipeline drugs, help generate evidence to get a new drug accepted by payers and health authorities, and of course meet business and regulatory requirements for post-marketing safety commitments.

With all of these pressures it is easy to see why for some the only solution is to do the bare minimum. That said, true Pharmacovigilantes think differently. They are looking at all of their processes and evaluating novel ways to maximize the resources they have. They are looking beyond long and complicated implementations and focusing on quick wins that can scale over time. They are accomplishing a lot with a little through strong partnerships and technological advances.

Pharma and biotech companies of all sizes are feeling the pressure build. It is exciting to be working with the true Pharmacovigilantes within these organizations to help them deal with all of these emerging challenges.

Interested in hearing some case studies? See our comprehensive guide to using drug safety data. 

Topics: Pharmacovigiance 2.0

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.