Jim Davis

Jim Davis

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

Recent Posts

June 29, 2018

The Value and Validity of Social Media Monitoring in Pharmacovigilance

In talking with current and prospective clients around Advera Health's partnership with Booz Allen's Epidemico social media monitoring data, we get asked a lot about not only the validity of the process Booz Allen goes through to cut through the "noise", but also about the value social media monitoring has for post-marketing drug safety surveillance and pharmacovigilance. In addition to highlighting the primer we put together, we also refer those interested to the numerous academic publications on the topic. Three core publications that Booz Allen has conducted in collaboration with regulators and industry serve as a starting point, and below is a summary of key points and links to the full publications. 

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June 15, 2018

Depression as a Drug Side-Effect: A Quick FAERS Analysis

A study published Tuesday in the Journal of the American Medical Association found that people who take at least one of the 200 drugs that list depression as a side-effect are, in fact, more likely to be depressed. The study, which included 26,192 adults who participated in the National Health and Nutrition Examination Survey, does not prove a causal effect, but the association is striking. 

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March 27, 2018

Can Modern Analytics be Forced into Traditional Pharmacovigilance Workflow Tools?

Modern pharmacovigilance departments today do more than process and review ICSRs. They are involved in the entire lifecycle of a drug, providing vital data points and analysis that inform everything from clinical trial design to commercial planning to post-market safety surveillance. In order to perform well, pharmacovigilance and safety science teams require access to an array of data and the analytics to make sense of those data. The insights gained from unique combinations of clinical and real world data drive signal detection, epidemiological research, and evidence generation, all of which support organization-wide decisions.

The problem is that drug safety insights are hard to obtain and teams often get caught in a "paralysis by analysis" trap.

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February 28, 2018

Advera Health's Commitment to FAERS Data Quality and Turn Around Time

Wow, it’s the end of February. I’m sure I’m not the only one who feels that the first two months of 2018 have flown by. Advera Health’s engineering, product, and analyst teams have been hard at work. Evidex’s back-end data architecture has been enhanced to keep up with our growing library of datasets and to ensure the analytics layered on all of the data are efficient and fast to meet client demands.

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February 2, 2018

Social Media Monitoring for Pharmacovigilance and Drug Safety

It is now well established that the rapid expansions of the internet and computing power have opened up the use of social media and Internet forums for pharmacovigilance. These sources contain untapped, albeit noisy, safety and benefit information. As noted in Social Media Listening for Routine Post-Marketing Safety Surveillance, published in the journal Drug Safety, methods exist to reduce noise and make the data suitable for post-marketing safety surveillance. However, the use of these data to date have been constrained by limitations in how to best implement novel methods without disrupting traditional signal detection management and evaluation work flow.

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December 29, 2017

Top Free Drug Safety Downloads of 2017

Happy Holidays! In what many describe as the most exciting countdown of the year, here are the top free downloads from Advera Health for 2017!

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December 22, 2017

Most Popular Drug Safety Articles of 2017

Happy Holidays! As another year comes to a close we share with you our most popular blog posts of 2017. Enjoy!

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December 1, 2017

Analysis of a FDA Safety Signal: DPP-4's and Rhabdomyolysis

Recently the FDA published the Q2 2017 version of Potential Signals of Serious Risks / New Safety Information as identified by the FDA Adverse Event Reporting System (FAERS).

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November 10, 2017

An Analysis of Adverse Events Associated with Endothelin Receptor Antagonists (ERAs) using FAERS

Advera Health released a new functionality framework in Evidex this week called Custom Analytics. The goal of Custom Analytics is to provide Evidex users an easy way to perform complex queries across all of the clinical, spontaneous and other real-world data included in the Evidex platform and to return a filtered set of specific information. 

We have launched Custom Analytics with a Custom Drug-Adverse Event Analysis search function. With the Custom Drug-Adverse Event Analysis, users can easily filter case reports by specific drug combinations, demographic, and descriptive information, create customized MedDRA queries with multiple preferred terms, and calculate Reporting Odds Ratios (RORs).

The best part? It's simple to use.

Let's demonstrate the power of Custom Analytics through a case study, analyzing adverse events associated with endothelin receptor antagonists (ERAs) using the FDA Adverse Event Reporting System (FAERS) data. 

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September 29, 2017

Dear FDA, There is No Single Truth Standard

FDA needs to think of itself as an information curator, rather than an arbiter of information, FDA Commissioner Scott Gottlieb told attendees of the National Academy of Sciences’ workshop on the impact of real-world evidence ( RWE) on Tuesday, September 19th. Further stating, where a single truth standard is secured to a fixed orthodoxy”. 
 
If only it were that easy. 
 
A single truth standard sounds great in a world where patients are homogeneous, human biology is fully understood, and motivated trial sponsors don’t design studies to hit specific goals. 
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