Ramping Up Real-World Evidence: Assessing the FDA’s New RWE Framework

Posted by Qin Ye on Thu, Jan 24, 2019

Ishita Srivastava and Divya Babbar co-authored this blog post with Qin Ye.

The FDA considers the use of real-world data and real-world evidence a top strategic priority, and on Dec. 6, it unveiled its much-anticipated RWE framework to support the development of drugs and biologics. The framework is aimed at evaluating the potential use of RWE for assessing a product’s effectiveness and focuses on increased stakeholder engagement to effectively leverage RWD and RWE for public health purposes.


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The CVS/Aetna Merger Got the Greenlight, but Pharma Is Stuck at an Imaginary Red

Posted by Paul Darling on Mon, Oct 15, 2018

CVS Health and Aetna. Cigna and Express Scripts. Amazon, Berkshire Hathaway and JPMorgan Chase. Each one of these deals is evidence that corporate America will continue to march into the medical arena, uniting once-distinct healthcare enterprises under one roof. While the long-held divisions between U.S. healthcare stakeholders may be getting hazy, the aim is clear: to deliver convenient, high-quality care to consumers at a lower cost.


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Highlights From ZS’s 2017 European Summit: What Industry Leaders Really Think About Patient Centricity in Pharma

Posted by Giorgio Lentini on Tue, Oct 31, 2017

Robert Selman and Ausrine Vaisvilaite co-wrote this blog post with Giorgio Lentini. 

Are we already patient-centric simply by talking about patients? Do patients define themselves by their medical conditions or by their roles in life as parents, family members or colleagues?

These were just some of the many questions discussed amongst participants at ZS’s European Summit, which took place in Basel, Switzerland, on Oct. 12.


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