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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August 9, 2016

How Information on Health Care’s Value is Currently Shared

On August 1, 2016, Dan Leonard, the President of the National Pharmaceutical Council published an opinion piece for Morning Consult, laying out his reasons for FDA to provide guidance on how biopharmaceutical companies can utilize and share real-world evidence with healthcare decision makers. He argues that due to shortcomings and ambiguities in existing laws, the exchange of information is limited, and stakeholders are making decisions without access to all of the pertinent information.  His solution is more regulation and guidance from FDA.

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March 18, 2016

How Will You Review All 60 drugs up for Approval in 2016?

It was a big week for us here at Advera Health. On Tuesday we released Evidex™, the next generation of our drug informatics platform that combines annotated data from curated clinical trial results together with structured real world evidence. We are extremely excited about Evidex, as it provides the first end-to-end solution that greatly increases the speed and efficiency of drug reviews by our clients.

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February 19, 2016

5 Steps to Forming a Consensus to Mitigate Adverse Events

If you are a regular reader of the RxView blog, you are a drug safety advocate. Most likely though, not everyone else in your organization is as safety focused as you, understands the magnitude of safety issues, or understands how to address those issues.

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February 12, 2016

A Quest for Evidence

This week marks the sixth anniversary of the date that Bob Kyle, Henry Duong, and I incorporated Advera Health Analytics.  We started this journey with a mission to improve patient outcomes by making drug safety data more accessible and actionable.  We spent the early years developing our technologies, building our data delivery platform, and subjecting our early methodologies to peer review.  Two years ago we began to commercialize our enterprise data product and since then we’ve grown exponentially.

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