2026 ASA Biopharmaceutical Section Distance Learning Series
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Committee Chair 2026
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Ji Young Kim
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Takeda
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Member (2026)
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Aida Yazdanparast
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AbbVie
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Member (2026)
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Arinjita Bhattacharyya
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Merck
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April: From Data to Cure: Strategize Rare Disease & Precision Care Future Outlook of Real World Data Ecosystem in China Healthcare
Presenters: Dr. Luyan Dai, G-Plume Consulting
Date: April 24, 7:00 pm ET (Note this is an evening webinar as our speaker will join from China)
Registration: ASA BIOP Distance Learning Webinar Series - April
Abstract:
This seminar talk focuses on the development of China's real-world data (RWD) ecosystem for rare diseases and precision care. Strong government-led policies and the National Medical Products Administration (NMPA)'s targeted efforts form the core driving force for industrial development. The Chinese government has initiated a unique data sovereignty model centered on government-authorized carriers and a Trusted Data Space (TDS) and built a multi-tier RWD platform system with privacy computing, multi-modal data governance and end-to-end clinical application capabilities. It also leverages diversified funding channels including government carrier funds and charitable funds to support the construction of research infrastructure, promote multi-center natural history studies, and build a decentralized ecological closed loop and national "1+N" collaboration network, realizing the transformation of RWD from passive collection to asset operation.
A series of supportive measures for rare disease and precision medicine innovation have been rolled out: it optimizes the regulatory review system for clinical research and innovative products, standardizes RWD application and clinical evidence generation, and endorses the integration of AI and Bayesian methodology applications. The construction of compliant cross-institutional data sharing mechanisms and trusted data infrastructure are supported to accelerate the translational application of precision medicine technologies such as gene diagnosis and targeted therapy, and guides the building of an industry win-win ecosystem linking hospitals, biotechs and research institutions, effectively reducing R&D risks and improving the efficiency of clinical trial development for rare diseases.
Driven by government policies and NMPA's regulatory support, China's healthcare ecosystem has achieved notable efficiency gains, including shortening clinical trial recruitment cycles, and achieving a significant reduction in R&D costs. The precision medicine methodologies developed for rare diseases are replicable to complex diseases such as tumors and neurological disorders, evolving from single-disease optimization to disease spectrum-based precision medical capabilities. With government-led institutional guarantees, a standardized RWD ecosystem and industrial collaboration, China is positioned as a global strategic accelerator, unlocking the potential of RWD and precision medicine to address unmet medical needs for global therapeutic innovation.
March: Challenges and opportunities in Neuroscience - Updates from the ASA BIOP SWG of Neuroscience
Presenters: Mandy Jin (AbbVie), Jianchang Lin (Takeda), and Co-leads of the SWG of NS
Date: March 27, 2026 11am-12pm ET
Link to materials: Slides
Abstract:
This ASA webinar will present updates from the ASA BIOP Scientific Working Group for Neuroscience, emphasizing both the unique challenges and promising opportunities in modern neuroscience research. Attendees will gain insight into the group's efforts to address the complexity of neuroscience, including the development of advanced statistical and data science methodologies for clinical research. The session will highlight innovative study methods and designs that improve research efficiency, and discuss how artificial intelligence and machine learning (AI/ML) can transform the clinical trial design and analysis as well as interpretation of large-scale neuroscience datasets. An interactive Q&A segment will foster collaborative dialogue, encouraging practical discussions on overcoming current obstacles and leveraging emerging technologies to advance the field. This session will include an introduction to the ASA BIOP SWG for Neuroscience by Mandy Jin, an update on statistical methods in Neuroscience subteam by Jia Jia (AbbVie) and Hui Yang (Astellas), an update on Innovative study designs in Neuroscience subteam by Bo Lu (OSU) and Inna Perevozskaya (BMS), an update on AI/ML in Neuroscience subteam by Xiaodong Luo (Sanofi) and Yixin Fang (AbbVie). And the session will conclude with a Q&A led by Jianchang Lin.
February: A Bayesian Approach to Kinetic Modeling of Accelerated Stability Studies and Shelf Life Determination for Packaged Drug Products
Authors: Joris Chau, Hans Coppenolle, Yimer Kifle, Stan Altan
Link to materials:
Abstract:
Kinetic modeling of accelerated stability data serves an important purpose in the development of small molecule solid dose pharmaceutical products, providing support for shelf life claims and expediting the development path to clinical investigations. In this context, a Bayesian kinetic modeling framework is considered, accommodating different types of nonlinear kinetics with temperature and humidity dependent rates of degradation and accounting for the humidity conditions of the micro-environment within the packaging to predict the shelf life. In comparison to kinetic modeling based on nonlinear least-squares regression, the Bayesian approach allows for interpretable posterior inference, heteroscedastic error modeling, and the opportunity to include prior information based on historical data or expert knowledge. While both frameworks perform comparably for high-quality data from well-designed studies, the Bayesian approach provides additional robustness when the data are sparse or less well behaved. This is illustrated through several case studies of both real and simulated data.
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