RWE in an Evolving Regulatory Landscape: Using Real-World Evidence to Support Novel Product Development Pathways
Leanne Larson, Corporate Vice President and WW Head, Real-World Evidence, Parexel
Amy McKee, M.D., Vice President, Regulatory Consulting Services, Parexel
The growing interest in RWE from both regulators and payors, along with innovative data models and technologies, has the potential to transform clinical research as we know it. Particularly for rare diseases, the opportunity to utilize existing data and to link patients across multiple datasets, in concert with proven prospective research models within non-traditional infrastructure settings, offers important opportunities both to streamline the research process and also to bring the needed real-world perspective and data to the table. Real-world data also can provide important information in the post-marketing setting, especially from a safety perspective, to answer regulatory questions. In this session, we will discuss:
- The changing global regulatory perspective on RWE
- Utilizing RWE in synthetic control arms to support regulatory submissions
- Innovative approaches to accessing and integrating RWE today
About the Sponsors
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.
Headquartered near Boston, Massachusetts and in Durham, North Carolina, and supporting clients in more than 100 countries, our almost 20,000 employees are united by one simple fact. We care. We’re not just the people with brains, we’re the people with heart.For more information please visit www.parexel.com.