Join the Boston Chapter of the ASA for a webinar with Dr. Zhiheng Xu, as he talks from a regulatory perspective about the potential of AI in drug development and the statistical challenges it presents. Below is the detail about the event.
Time/Date: 12:00 – 1:00pm (ET), Feb 23, Friday, 2024
Location: online (Zoom link will be provided to attendees one day before the event)
Cost: Free
Please note, this webinar is cost-free for all registrants. Please use the registration link to register. On the other hand, if you are not a Boston Chapter member and wish to join our chapter, you can pay the membership fee while enjoying the free event: a $4 membership fee if you are a student and $10 if a non-student.
Registration
Speaker: Dr. Zhiheng Xu, Lead Mathematical Statistician in the hematology division (DBIX) at FDA/CDER Office of Biostatistics, US Food and Drug Administration and the President for the FDA Statistical Association in 2023
Presentation Title: Statistical Thinking in the Age of AI for Drug Development: A Regulatory Perspective
Abstract: Artificial Intelligence (AI) has shown great potentials in advancing drug development, particularly in areas such as drug discovery, disease diagnostics, clinical research, real-world data (RWD) and digital health technologies (DHTs). This development is fueled by the exponential growth in computer power and data accessibility. However, there are concerns related to explainability, reliability, privacy, safety, security, and bias mitigation. For example, the complexity of AI algorithms, the data-driven nature in which they are trained, and the unique characteristics of clinical data create challenges in developing robust evaluation methods for AI algorithm. In this talk, I will delve into the statistical hurdles associated with the use of AI in drug development and explore how vigorous statistical thinking can ensure that data-driven conclusions are not only accurate but also robust and reproducible.
Bio: Zhiheng Xu has over a decade of experience in regulating drugs and medical devices at the FDA. He is the lead mathematical statistician in the hematology division (DBIX) at FDA/CDER Office of Biostatistics. Before that, he was a mathematical statistician with FDA/CDRH since 2012. He was the president for the FDA Statistical Association (FDASA) in 2023 and currently serves as the program co-chair for 2024 American Statistical Association (ASA) Biopharmaceutical Section Regulatory Industry Statistical Workshop (RISW). Zhiheng received his Ph.D. in Biostatistics from Emory University in 2011. His research interests include real-world data, innovative trial design, dose finding, biomarker evaluation and digital health. In his spare time, he like reading, gardening, running, and swimming. He is also a content creator on LinkedIn.
The webinar will be moderated by Wenting Cheng (President of Boston Chapter of the ASA; Biogen) and Kristin Baltrusaitis (Boston Chapter Planning Committee Member and Past Program Chair; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health).
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Jianjun Hua
Program Chair of Boston Chapter of ASA
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