Date: Thursday 22nd June 2023
Time: 08:00-09:00 PDT | 11:00-12:00 ET | 16:00-17:00 BST | 17:00-18:00 CEST
Speakers: Dr. Heng Li (FDA), Dr. Lilly Yue (FDA) and Dr. Jason (Jixian) Wang (Bristol Myers Squibb).
Chair: Amy Mulick (Veramed).
Who is this event intended for? Anyone interested in learning more about propensity scores.
What are the benefits of attending? People should attend to learn more about the different techniques and applications propensity scores and the advantages and disadvantages of different methods.
Please join us to hear Dr. Heng Li & Dr. Lilly Yue (FDA), and Dr. Jason (Jixian) Wang (Bristol Myers Squibb) present their recent work.
Presenters and Papers:
1. Heng Li, Lilly Q. Yue: Propensity score-based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation
https://onlinelibrary.wiley.com/doi/10.1002/pst.2294
2. Jixian Wang: To use or not to use propensity score matching?
https://onlinelibrary.wiley.com/doi/10.1002/pst.2051
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers will be made available to view prior to the meeting and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
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Speaker |
Biography |
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Dr. Heng Li is a Lead Mathematical Statistician in the Division of Biostatistics, CDRH/FDA. He is instrumental in the establishment and evaluation of policies and procedures to maintain a unified and consistent program for biostatistical aspects of the regulation of medical device. He leads a team of statisticians in technical reviews and research. He has made substantial contributions in advancing regulatory statistics, especially propensity score-based methods, including developing and implementing novel propensity score-based approaches for leveraging real-world evidence to support regulatory decision-making.
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Dr. Lilly Yue is a Deputy Director, Division of Biostatistics in the FDA's Center for Devices and Radiological Health, where she oversees statistical reviews of therapeutic and diagnostic medical devices. She has played a key leadership role in advancing regulatory statistics, including efforts on adapting and advancing propensity score methodology for premarket observational studies and on developing and implementing the novel propensity score-integrated approaches for leveraging real-world evidence to support regulatory decision-making. Dr. Yue is an Editor-in-Chief of Pharmaceutical Statistics and served as an Associate Editor (and a Guest Editor) for Journal of Biopharmaceutical Statistics and Pharmaceutical Statistics. She is a Fellow of the American Statistical Association.
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Jason (Jixian) Wang is a statistician in Statistical Methodology Group in Bristol Myers Squibb based in Switzerland. He has more than 20 years’ experience in the pharmaceutical industry, has worked in several therapeutic areas such as cardiovascular, oncology, hematology, and cell therapies, and in difference phases including clinical development, in which he did multiple regulatory submissions, as well as pre-clinical statistics, clinical pharmacology, and post-marketing drug safety and HTA. He was an academic researcher in biostatistics and epidemiology before joining the industry. He has a wide range of research interests including casual inference, innovative trial designs, dose optimization, machine learning, and PK/PD and health economics modeling and simulation. He published more than 60 papers, one book and two book chapters. He is a member of the RWD SIG in PSI/EFSPI.
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Chair |
Biography |
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Amy is Head of the Evidence and Value Generation group at Veramed, which generates clinical evidence for pharmaceutical products and medical devices using data collected partially or wholly outside the context of randomised controlled trials. Previously she was based at the London School of Hygiene and Tropical Medicine using the Clinical Practice Research Datalink (CPRD) to research disease epidemiology, and developing a novel cause of death estimation method to cope with sparse data inputs. She has expertise in Bayesian methods for evidence synthesis as well as causal and predictive statistical modelling.
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