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The Active Ingredient features expert insights and commentary from leaders of ZS Associates' global pharmaceuticals practice.

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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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Topics: Pharma, FDA, real-world data, patient centricity, RWE, real-world evidence, pharma companies, RWD, data driven decisions, pharma decision-making

How the Right RWE Platform Serves Up the Ingredients for Innovation

Posted by ZS Editors on Tue, Sep 04, 2018

Many pharmaceutical companies have realized the benefits of moving from standalone real-world data (RWD) projects to full-fledged, cross-functional real-world evidence (RWE) capabilities to drive everything from their R&D programs to their commercial teams’ efforts to demonstrate value—and technology is central to their success. “Real-world evidence is essentially extracting intelligence out of real-world data, and now that we have the right technology, scalable cloud storage and tremendous processing power, we’re actually able to sift through big data to find those insights,” says Abhay Jha, a principal at ZS and the business technology lead in the firm’s R&D excellence practice.  

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Topics: Innovation, R&D, technology innovation, RWE, data and analytics, RWD

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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Topics: Pharma, Pharma Industry, healthcare, Europe, EU, patient centricity, RWE, real-world evidence, patient centricity in R&D, ZS European Summit

Why Pharma Manufacturers Should Partner With Rare Disease Communities

Posted by ZS Editors on Thu, Jul 06, 2017

Patient communities are a valuable asset within the life sciences industry. In the rare disease space, these groups are a vital resource for families battling disease, and serve as much-needed patient representatives to help spur funding, research and scientific advancement. ZS’s Rachael Pius weighs in on why pharmaceutical companies should view these patient communities as partners in clinical development. 

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Topics: Pharma, rare diseases, clinical trials, patient communities, rachael pius, RWE

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