Real-world Evidence (RWE) for Label Expansion

Watch this video on the growing acceptance of real-world data (RWD) to generate real-world evidence supporting regulatory submissions.

The evolution of RWE to support regulatory approval for new treatments and label expansions

With RWE gaining traction with regulators, both nonrandomized real-world studies and randomized pragmatic clinical trials are contributing to regulatory assessment and decisions concerning new or expanded treatment labels.

Regulators have gradually demonstrated adoption of RWE alongside clinical trial data, finding it beneficial during the evaluation process of new or expanded product indications in selected situations. Today, when life sciences companies include RWE as a complement to their new or expanded product submissions, they are well positioned to address questions about the safety or effectiveness of treatment, particularly for subgroups and situations of special interest.

Group 53241

Won Chan Lee, Ph.D.

Principal, RWE/HEOR, Axtria

Dr. Lee has more than 17 years of experience in health economics and outcomes research (HEOR), including strategic planning, economic modeling, RWE studies, post-marketing studies, HRQL/PRO assessments, HEOR roadmap, value proposition development, HTA assessment, publication strategies, etc.
Dr. Lee holds a Ph.D. in Health Economics from the City University, New York Graduate Center, and a master’s degree in Economics from the University of Grenoble, France.


Jennifer Ken-Opurum, Ph.D.

Associate Director, RWE/HEOR, Axtria

Dr. Ken-Opurum has been responsible for providing strategic insights and leading teams of research analysts and data scientists on secondary database analysis, primary patient / stakeholder surveys, patient chart revies, prospective cohort studies, etc.
Dr. Ken-Opurum holds a PhD in Nutrition Science and Bachelor of Science in Dietetics from Purdue University, USA.