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Drug Safety Progressives – The Rise of the Pharmacovigilante

Posted by Jim Davis on Feb 2, 2017 11:00:00 AM
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tshirt.pngThe United States is a polarized place right now. Democrats vs. Republicans. Liberals vs. Conservatives. President Trump vs. the world. The divide runs deep and battle lines have been drawn. And while there is no escaping this highly publicized political chasm, there is another fight being played out in the shadows… The Drug Safety Progressives vs. the Drug Safety Conservatives.

I was at the DIA Pharmacovigilance and Risk Management conference last week, fittingly taking place in Washington D.C right after the inauguration and the women’s march.  The division was obvious.

For all the very engaging talks on ways to advance drug safety science using new datasets and the use of artificial intelligence to help automate case processing, there was still a contingent of  the “old school” who  view their job as only fulfilling regulatory requirements and operating by a “don’t ask, don’t tell” mentality. Now don’t get me wrong, I understand the pharmacovigilance function is highly regulated, and ensuring those needs are met remain first and foremost for any Safety leader. However, it is the growing number of Drug Safety Progressives that will drive our field forward both with small incremental improvements in process and monumental shifts that will take drug safety to the next level.

Let’s call these Progressives, Pharmacovigilantes.

If the Pharmacovigilantes’ voice becomes the majority, 2017 will be the year of drug safety, as my colleague Brian suggested in this blog, earlier in the year. And after attending the conference, I’ve identified three main themes surrounding the use of data and technology that Drug Safety Progressives are using to make Brian’s predictions a reality.  

#1. Pharmacovigilantes are combining different datasets and databases to obtain insight that until recently wasn’t’ possible. There was a very engaging luncheon roundtable discussion on the use of informatics for drug safety. The round table was led by Dr. Keith Burkhart, a Medical Officer in the Informatics division of FDA, surrounding the work that he has done pairing FAERS data with molecular targets. He presented on this work back at the same conference in 2015, and is due to publish a full article on his findings in a major journal this year. It’s fantastic (and a little suprising!) to see this type of innovation at the government level. Technology and data science make this innovation possible and Pharmacovigilantes are embracing the insight it can derive. If any readers are interested in learning more about what we can do to replicate Dr. Burkhart’s work in our Evidex platform, please get in touch

#2. Safety organizations in pharma that have Pharmacovigilantes in their ranks are an asset rather than just a necessity, and everyone knows it. Fulfilling regulatory requirements is a necessity. Properly supporting go/no-go decisions, generating evidence for payer reimbursement decisions, and proactively finding new ways to create safer drugs is an asset. In a session presented by Dr. Doug Tzuzung, who is the Director of Epidemiology from Bristol-Myers Squibb, use cases for real world safety evidence  were presented across the safety spectrum from R&D through drug maturity. Dr. Tzuzung discussed the use of RWE for signal detection, refinement, and evaluation. What really struck me in this session is the openness for using non-traditional data across the spectrum. Ad-hoc analyses of clinical trial data, spontaneous reporting, and Sentinel-like analysis on claims data are being used in combination to identify, refine, and further evaluate a hypothesis that is generated. Much like the work that Dr. Burkhart is doing at FDA, this level of sophistication is technology driven. With the right tools, getting these data to a usable state is no longer complicated. Our clients, both big and small are using Evidex to achieve this type of analysis today.

#3. Pharmacovigilantes are putting legacy Drug Safety vendors on notice, and embracing new, dynamic partners. A surprising number of conversations I had at the conference revolved around what Drug Safety Progressives do not want. And, overwhelmingly, they do not want the status quo. What they say they DO want, is the ability to have a flexible, scalable platform that accomplishes the basics, such as disproportionality analysis, but also can take on virtually any data set, both internal and external. They are looking for clinical trial analyses for competitors. They are looking to incorporate their own database. They are looking to match all of that with a standardized way of looking at other RWE such as multi-payer claims data. And to boot, they want this done in a standardized, easy-to-implement package. A tall order, but this type of software is available, and Pharmacoviglantes are not settling for old standards.

In 2013, as a small company with big aspirations, our entire management team went to this same DIA PV conference and came away with the feeling that the PV and safety market was not yet ready for what we had planned. As we launched our product and started to see success in markets such as managed care and HEOR, we kept safety and PV departments at arm’s length, waiting for signs that drug safety could accept new ways of looking at old problems. We knew they’d get there, but the question was when.

Leading up to and through this year’s conference, we strongly believe that a shift is taking place. We are having more meaningful conversations and establishing relationships with PV/Safety groups and see that they are thinking about drug safety issue progressively.

So, welcome  fellow Pharmacovigilantes. We’re glad you’re finally here.

Topics: Drug Safety, DIA

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