CoRE Seminar Series: Real-World Evidence to Support Decision-Making for Medical Products – Updates from the U.S.

Start Date & Time: 
Wednesday, 28 February, 2018 - 09:30
End Date & Time: 
Wednesday, 28 February, 2018 - 13:00
Venue: 

Amphitheatre, Duke-NUS Medical School

Speaker Details: 

Prof Gregory Daniel
Deputy Director
Duke-Margolis Center for Health Policy 

Clinical Professor
Duke University Fuqua School of Business

Speaker: 
Synopsis: 

Data sources such as electronic health records and patient registries enable the development of real-world evidence (RWE), which can inform decisions across the medical product lifecycle, including treatment decisions and those that impact care quality as well as payment and delivery. While the U.S. FDA has relied on RWE to support decision-making in specific contexts, there are additional opportunities for RWE to further enhance the regulatory framework, especially regarding efficacy and benefit.

CoRE invites you to join us for Professor Gregory Daniel’s seminar, which will:

1) provide an update on the current U.S. policy landscape with respect to RWE;
2) describe current efforts to support the enhanced development and use of RWE across a range of activities; and
3) stimulate discussion on how lessons from the U.S. context might support existing efforts in Singapore.

 

Biography: 

Dr. Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. Dr. Daniel directs the DC-based office of the Center and leads the Center's pharmaceutical and medical device policy portfolio, which includes developing policy and data strategies for improving development and access to innovative pharmaceutical and medical device technologies. This includes post-market evidence development to support increased value, improving regulatory science and drug development tools, optimizing biomedical innovation, and supporting drug and device value-based payment reform. Dr. Daniel is also Adjunct Associate Professor in the Division of Pharmaceutical Outcomes and Policy at the UNC Eshelman School of Pharmacy. Previously, he was Managing Director for Evidence Development & Biomedical Innovation in the Center for Health Policy and Fellow in Economic Studies at the Brookings Institution and Vice President, Government and Academic Research at HealthCore (an Anthem, Inc. company).  In addition to health and pharmaceutical policy, Dr. Daniel’s research expertise includes real world evidence (RWE) development utilizing electronic health data in the areas of health outcomes and pharmacoeconomics, comparative effectiveness, and drug safety and pharmacoepidemiology. Dr. Daniel received a PhD in pharmaceutical economics, policy and outcomes from the University of Arizona, as well as an MPH, MS, and BS in Pharmacy all from The Ohio State University.

 

Host: 

Prof John Lim
Executive Director, CoRE
Duke-NUS Medical School &
Senior Adviser
Ministry of Health, Singapore 

Contact Person: 

Sherna Wadia. Sherna.wadia@duke-nus.edu.sg