March 17, 2017

Efficacy vs. Effectiveness - The Role of Pharmacovigilance

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

 

 

 

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.”

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February 24, 2017

A Big Data Stumble in Healthcare

This week marked the annual HIMSS Conference.  HIMSS, Healthcare Information and Management Systems Society, is the big annual gathering of IT firms trying to market their wares into healthcare systems, pharmaceutical companies, and health insurers.

While usually a time for big partnerships, acquisitions, deployments, and new client wins, this year’s HIMSS kicked off in a rather inglorious manner.  On Sunday news broke that world-renowned cancer center MD Anderson had discontinued their partnership with IBM Watson.  After a string of big wins by the Watson team, this appeared to be the first – and certainly the largest – setback.

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February 17, 2017

Increasing Pressure for Increased Pharmacovgilance Capabilities

A 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…

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February 2, 2017

Drug Safety Progressives – The Rise of the Pharmacovigilante

The 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.

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January 5, 2017

Working Toward a Cure: The Foundation for Sarcoidosis Research

In November 2016, I was honored to be asked to join the Board of Directors of the Foundation for Sarcoidosis Research (FSR). The foundation began in 1999 as a grassroots organization, and now has expanded their efforts and impact to become the leader in supporting sarcoidosis research. I'm looking forward to using my experiences both as a sarcoidosis patient and in drug safety to contribute to the mission. Please visit www.stopsarcoidosis.org for more information. 

I originally wrote the post below for the FSR blog. The original can be seen here

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October 20, 2016

Why Does Adverse Event Reporting to FAERS Continue to Accelerate?

faers_growth.pngSeventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform.  Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS. 

Here is a chart of new case reports (including our estimate for full year 2016).  Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).

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July 15, 2016

Guest Post: BBK Talks #BigData with Advera Health Analytics

This post was originally published on the BBK Worldwide Blog.



Big Data was a Big Topic at this year’s DIA Annual Meeting, and continues to be an area of interest and investment across the life sciences and healthcare industries as organizations seek to further integrate new data streams and real-time analysis into clinical R&D. Data collection, management and analysis are at the crux of everything we do here at BBK, and our clients are keenly interested in how to manage and optimize Big Data. We interviewed Brian Overstreet, CEO of Advera Health Analytics, a leading healthcare informatics company, to get their take and to see how access to meaningful data is helping to push healthcare forward. 

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July 8, 2016

Chronic Underreporting of Clinical Trials


Well, now we’re getting somewhere!

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March 11, 2016

A Crystal Ball for FDA Action: How we Validated RxSignal

We are pleased to report that our latest major publication, “A Pharmacovigilance Signaling System Based on FDA Regulatory Action and Post-Marketing Adverse Event Reports” was released this week in the esteemed journal “Drug Safety.”  It was published as an online-first feature and will also appear in the April copy of the print version of Drug Safety.

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March 3, 2016

Watson Health is the Ultimate Data Parasite


One year after its birth, the ultimate data parasite has come of age by latching on to a $3 billion host. It is big, blue, pretty good at Jeopardy, and if you were to believe the data detractors, utterly useless.

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