I'm pleased to introduce Jill Notte, Director of Global Marketing, APCER Life Sciences, who authored this week's post.


Apcer Life Sciences 


As a marketing communications professional in the pharmaceutical industry, I try to choose my words carefully in everything I write. The field of drug safety, where I have spent the past 15 years of my career, is particularly choosy about its terms. Words have precise definitions, and so we say, for example, that an event is “suspected” when we haven’t yet confirmed whether it is “unexpected” or “serious.”

That’s why I was struck by the European Medicines Agency’s Senior Medical Officer Dr. Hans-Georg Eichler’s keynote address at the DIA Pharmacovigilance and Risk Management Strategies conference in Washington DC at the end of January. For 15 years, I have been using the words “efficacy” and “effectiveness” interchangeably, assuming that the former was a clinical term and the latter a lay term – similar to “adverse event” versus “side effect.” Not only did I learn from Dr. Eichler that “efficacy” denotes how a drug performs in clinical trials while “effectiveness” refers to how it works in the real world – a huge difference, potentially, as we all know; but he also gave me this perspective: The purpose of pharmacovigilance is to define the difference between efficacy and effectiveness and do it as rapidly as possible to save patients from harm.

How did I miss this basic yet powerful mission statement for the field of pharmacovigilance?

After listening to the rest of Dr. Eichler’s keynote and other thought leaders throughout the day, I wrote down the one word that summed up the conference to that point: Evidence. Safety data sets are now large enough to be a source of real-world evidence and contribute to everything from comparative effectiveness research to pay-for-performance models.

Providing pharmacovigilance professionals with the ability to turn safety data into evidence is the reason that APCER Life Sciences formed a partnership with Advera Health Analytics and announced it in conjunction with this DIA PV meeting. Advera’s evidence aggregation platform – Evidex™ - was built to do exactly what Dr. Eichler described. It analyzes clinical safety data side-by-side with post-marketing safety data so that companies can define the difference between efficacy and effectiveness. And it does so more rapidly than other solutions. You can read how Evidex™ was able to predict FDA action up to 5 years in advance in the manuscript A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports, published in the journal Drug Safety.

At APCER Life Sciences, we believe that the practice of pharmacovigilance – PV – has been expanded to encompass Patient Voice and Product Value, and this perspective permeates throughout the organization. Our Integrated Response Center isn’t simply performing case intake; we are capturing the Patient Voice. We are not processing a case simply to fulfill a regulatory obligation; we are contributing to valuable global data resources to which more and more stakeholders will have access. Now with Advera in our arsenal of technology tools, we are extending our service capabilities beyond signaling and into quantifying the Product Value that a safer therapy delivers to patients, payers, and pharma.

How is your organization determining the difference between efficacy and effectiveness when products reach the real world?

How is your organization expanding PV to focus on the Patient Voice and Product Value?

If APCER Life Sciences and Advera can help answer these questions, then please email me or share your comments below.

Written by Jill Notte, Director of Global Marketing, APCER Life Sciences 



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.