TITLE: Real World Evidence Landscape and Evolution in Drug Development
SPEAKER: Jenny Fang and Melvin Olson, Novartis
MODERATOR: Naitee Ting
Real world evidence (RWE) is the evidence obtained from real world data (RWD) through real world clinical practice outside of randomized clinical trials (RCTs). It is playing an increasing role in drug development and health care decision making. It has been used to monitor postmarket safety and to make regulatory decisions by health authorities; to support coverage decisions by payers; to support clinical practice and update clinical guidance by health care community; and to support clinical trial designs and evidence generation by biotechnology and pharmaceutical manufacturers. Classical methods (e.g. propensity score matching, causal inferential analyses etc.) have been widely used in RWE generation. Health authority started to assess the RWE with FDA published the first draft guidance of Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics in May, 2019.
Criticisms of RWD/RWE of lack of causal inference, inability to control confounding exist. The efforts of increasing the transparency, reproducibility and repeatability of RWE are currently ongoing. Advanced analytics approach such as machine learning & artificial intelligence also started to be applied to RWD. This session will cover landscape and evolution of RWE in drug development.
Jenny Fang, MD, MS, is a Senior Real-World Evidence (RWE) Scientist at Novartis Pharmaceuticals Corporation. During her 20+ year professional career, she spent over 3 years as a practice physician with the specialty in neuroscience and 17 years in pharmaceutical industry.
Jenny held various industry positions with expanded and increased responsibilities in clinical statistics, medical affairs and real-world evidence. Her experiences cross drug development to post-approval and lifecycle management. In her current role at Novartis, she has been supporting evidence generation leveraging real-world data. Jenny holds a degree in Medicine from Xian JiaoTong University, China and completed her studies in biostatistics from University of Illinois at Chicago and Health Economics and Outcomes Research (HEOR) from University of Washington. She has over 20 peer-reviewed publications.
Melvin Olson is the Global Head of Real-World Data Strategy and Innovation at Novartis (Basel, Switzerland). In Olson’s current role, he is responsible for promoting best practice in research methodology and applications of real- world data across all therapeutic areas to drive better decision making. Olson has a background in health economics and outcomes research; he previously led the use of real-world evidence to transform the generation of patient insights and value for money assessments. Olson has a Doctor of Philosophy degree in Biostatistics and has worked in the pharmaceutical industry for over 25 years as a clinical statistician, health economics and outcomes research director, and real-world evidence expert.