The RxView Blog

Real world data, analytics, and insights for healthcare decision makers

Advera Health Analytics, Inc.

Jim Davis

As Executive Vice President, Jim manages the company’s global sales and business development efforts. Jim brings over 15 years of experience in commercial strategy, global sales management and execution, business development, and product development. He has over 12 years of specific domain expertise in biopharma market research, intelligence, and data.
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Recent Posts

How Pharmacovigilance Departments Can Work Smarter, Act Bigger

Posted by Jim Davis on September 15, 2017

Most pharmacovigilance departments are resource constrained. Whether its human capital, budget, or both, the drug safety specialists within pharmaceutical companies are being asked to do a whole lot with very little.

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Topics: Pharmacovigiance 2.0

Case Studies: Signal Detection Utilizing FDA Adverse Event Reporting System (FAERS) Data

Posted by Jim Davis on August 25, 2017

One of the key benefits of a drug safety evidence aggregation platform is the data source flexibility it provides. Historically, smaller organizations have put off automating aggregate signal detection on FDA Adverse Event Reporting System (FAERS) data to avoid the cost and time commitment needed to implement traditional signal detection software. And those organizations that do have traditional software installed, have typically limited use to specific functional areas within drug safety and “expert” users, making FAERS data and analytics hard to access. An evidence aggregation platform makes these data and the related analytics easy and provides for a robust source of insight.

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Topics: evidence aggregation platform, Pharmacovigiance 2.0

FDA Releases Q1 2017 Drug Safety Watch List: It’s Boring and That’s Good

Posted by Jim Davis on July 21, 2017

Earlier this month FDA quietly published a quarterly update to their publicly available “watch list” of ongoing drug safety concerns. The updates are based on Q1 2017 FDA Adverse Event Reporting System (FAERS) data. You can download a copy of our recent Evidex Alert, covering the new additions, clarifications, and “all clears” so I won’t get into the details in this post. However, it is worth noting that there were fourteen unique drugs, or in some cases entire classes of drugs, that were included in the update. Many of the drugs have been on market for quite a long time and otherwise would be considered to have a well established safety profile. For 8 of the 11 alerts that could be signaled for (3 of the alerts were AEs that were already labeled for), Advera Health’s RxSignal early warning system did its job and picked up on the signal. The remaining alerts either weren't on a RxSignal eligible adverse event, meaning it wasn't a serious event that the FDA typical takes action on, but there was noticable elevated reporting as defined by reporting odds ratios (ROR). 

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Topics: FDA, RxSignal, Pharmacovigiance 2.0

Happy (Drug Safety Data) Independence Day

Posted by Jim Davis on June 30, 2017

First, our sincere apologies about the lack of regular posts recenlty. It's been busy times here at Advera and rather than put out posts just to put them out, we have made the decision to scale back our publishing schedule to make sure we can deliver the quality insight that our readers deserve.

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Topics: Pharmacovigiance 2.0

How is Evidex Different from Traditional Signal Detection Software?

Posted by Jim Davis on May 26, 2017

When first talking with drug safety departments, we often get asked how our platform is different than systems that they already have in place. The key difference between traditional signal detection software and a drug safety evidence aggregation platform comes down to the types of data they each support, the flexibility in which those data are supported, and the much broader use cases available through an evidence aggregation platform.

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Topics: Drug Safety, Pharmacovigiance 2.0

Post-Marketing Drug Safety and Pharmacovigilance Is Now More Important Than Ever

Posted by Jim Davis on May 12, 2017

If you read this blog, you probably follow the world of drug safety closely. So I’m sure you saw the JAMA article, and the resulting coverage by the main stream media, that was authored by Downing, et al., Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010.

If you haven’t had a chance to read the study yet, the results demonstrated that a third of every drug approved from 2001-2010 was subject to post-marketing action by FDA.  Even more alarming was the finding that drugs with accelerated approval by FDA during this period were twice as likely to be subject to label changes or warnings after approval. 

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Topics: Post Approval Data, Pharmacovigiance 2.0

Pharmacovigilance 2.0 – Let Freedom Ring in Philadelphia!

Posted by Jim Davis on April 28, 2017

Next week, May 3rd and 4th, will mark a big moment for Advera Health. Our Chief Product Officer Bob Kyle and I will be attending the World Drug Safety Congress in Philadelphia. The moment will be big, not because we are exhibiting for the first time (we are), or because we are demonstrating significant advances in drug safety data (we are), or even because I’m a huge fan of the Philadelphia Eagles (I am) and Bob has always dreamed of imitating Rocky and running the 72 stone steps before the entrance of the Philadelphia Museum of Art (he hasn’t).

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Topics: Pharmacovigilance, Pharmacovigilantes, Pharmacovigiance 2.0, World Drug Safety Congress

Efficacy vs. Effectiveness - The Role of Pharmacovigilance

Posted by Jim Davis on March 17, 2017

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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Topics: Pharmacovigilance, Pharmacovigilantes, Pharmacovigiance 2.0

ICER Underestimates Adverse Event Rates and Costs for Multiple Sclerosis Medications

Posted by Jim Davis on March 10, 2017

 

On March 6th ICER released their final Evidence Report on Multiple Sclerosis medications. The conclusion was that every MS medication, except for Lemtrada, do not provide enough value to justify their prices. As with every ICER report that is released, the pharmaceutical manufacturers refute the findings and tout their R&D expenses and the very real burden of bringing life saving drugs to markets.

I’m not looking to start a debate on the merits of either ICER’s or the manufacturers’ arguments in this post. Taking my position on the fence, I can say that I believe ICER provides a valuable, independent view into value, but at the same time pharmaceutical companies should expect to be able to be reasonably compensated for their efforts.

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Topics: Multiple Sclerosis

Increasing Pressure for Increased Pharmacovgilance Capabilities

Posted by Jim Davis on February 17, 2017

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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Topics: Pharmacovigilance, Pharmacovigilantes, Pharmacovigiance 2.0

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