Uncovering the Impact of Real-World Evidence (RWE) in Clinical & Commercial Development 

The importance of establishing product value in clinical and commercial development is undisputed. But more than ever, there is increasing pressure to provide evidence of clinical, economic, and humanistic value in real-world settings to accommodate patient populations that differ from the homogeneous populations of controlled clinical trials. With the influence of advanced technology and higher quality data sources, regulatory authorities are recognizing the clear impact real-world data has on expediting the traditional drug approval and expanded labeling processes.

How can pharma and biotech companies embrace the shift to real-world evidence (RWE) and balance varying strategic, operational, and organizational implications? 

WHAT TO EXPECT

Join industry peers for an interactive panel discussion centered on uncovering opportunities and challenges of RWE across the clinical and commercial development spectrum. Topics include:

• • Strategic Opportunities
    How can external stakeholder needs be embraced in developing a RWE program?

• • Regulatory Change
    What does the FDA’s recent endorsement of the use of RWD in the drug approval and labelling processes really mean?

• • Organizational Challenges
    What internal organizational obstacles can you expect and how can you overcome them? Where should RWE “reside” for optimal effect?

• • Operational Challenges
    How should RWE initiatives be designed and implemented to achieve operational efficiency without compromising quality?