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.
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.
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.
Topics: Real World 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.