Planning for the 2025 ASA Biopharmaceutical Regulatory-Industry Statistics Workshop

Wanjie Sun (FDA) and Yingwen Dong (Sanofi)

The Regulatory-Industry Statistics Workshop (RISW), hosted by the American Statistical Association (ASA) Biopharmaceutical Section, is the premier event for statisticians and professionals engaged in FDA-regulated fields. What began as a meeting for FDA statisticians has grown into a pivotal forum for discussing statistical practices and innovations across all FDA-regulated areas. The 2025 workshop, marking the 44^th annual meeting, will take place at the Bethesda North Marriott Hotel & Conference Center in Rockville, Maryland, from September 24-26, 2025.

The three-day workshop features a rich and diverse program, including short courses, parallel sessions, roundtables, poster presentations, and ample networking opportunities. It is committed to achieving balanced representation from industry, regulatory agencies and academia among its organizers, presenters, and panelists, fostering an inclusive and comprehensive exchange of ideas.

Introduction of 2025 RISW Steering Committee

The success of the workshop will be largely driven by the meticulous planning and the unwavering dedication of the Steering Committee (SC), which oversees the strategic planning and execution of the event. For the 2025 RISW, the SC comprises of two co-chairs (one from the FDA and one from industry), 12 senior advisors, six subcommittees – each led by two co-leads (one from the FDA and one from industry), and two ASA meeting planner/workshop coordinators. Notably, in addition to the traditional subcommittees, a new Communication/Social Event Subcommittee has been established this year. This subcommittee is tasked with promoting RISW across various social media platforms and coordinating social events for the workshop.

Below is a list of the selected Steering Committee members for the 2025 RISW.

Workshop co-chairs:

• Wanjie Sun, FDA/CDER

• Yingwen Dong, Sanofi

Senior advisors:

• Shein-Chung Chow, Duke

• Sylva Collins, FDA/CDER

• Gene Pennello, FDA/CDRH

• John Scott, FDA/CBER

• Zhiheng Xu, FDA/CDER

• Lilly Yue, FDA/CDRH

• Erik Bloomquist, Merck

• Li Chen, Amgen

• Xun Chen, Sanofi

• Jianchang Lin, Takeda

• Ted Lystig, BridgeBio

• Steven Novick, Takeda

Short-course subcommittee:

• Yun Wang, FDA/CDER (Co-lead)

• Qin Li, FDA/CDRH

• Fairouz Makhlouf, FDA/CDER

• Satrijit Roychoudhury, Pfizer (Co-lead)

• Matt Psioda, GSK

• Linda Sun, Merck

Parallel session subcommittee:

• Shanti Gomatam, FDA/CDER (Co-lead)

• Tianyu Bai, FDA/CDRH

• Dalong Huang, FDA/CDER

• Yong Ma, FDA/CDER

• Greg (Guoxing) Soon, FDA/CDER

• Robert Tumasian, FDA/CDER

• Zhenzhen Xu, FDA/CBER

• Shu Yang, NCSU

• Vivian (Wei) Zhuang, FDA/NCTR

• Yabing Mai, AbbVie (Co-lead)

• Qiqi Deng, Moderna

• Man (Mandy) Jin, AbbVie

• Siying (Sylvia) Li, Verily Life Sciences

• Rong Liu, Regeneron

• Gautier Paux, Sanofi

• Charles Tan, Pfizer

• Sabrina Wan, Merck

• Bo Zhang, Harvard

Roundtable subcommittee

• Chia-wen Ko, FDA/CDRH (Co-lead)

• Xin Gao, FDA/CDER

• Abigail (Yuqun) Luo, FDA/CBER

• Hongwei Wang, AbbVie (Co-lead)

• Mouna Akacha, Novartis

• Gaohong Dong, Sarepta 

• Jinglin Zhong, Sumitomo Pharma

Poster subcommittee

• Kun Wang, FDA/CDER (Co-lead)

• Adrijo Chakraborty, FDA/CDRH

• Haiyan Chen, HHS

• Lingjie Zhou, FDA/CDER

• Thomas Zhou, FDA/CBER

• Elena Polverejan, J&J (Co-lead)

• Brent Burger, UroGen

• Li Wang, AbbVie

• Sutan Wu, Daiichi Sankyo

• Wei (Michelle) Zhang, AffaMed Therapeutics

Voting subcommittee

• Xin Fang, FDA/CVM (Co-lead)

• Rachael Liu, Takeda (Co-lead)

Communication/Social Event subcommittee

• Jing Zhai, FDA/CDER (Co-lead)

• Freda Cooner, FDA/CBER

• Susan Mayo, FDA/CDER

• Hiya Banerjee, Eli Lilly (Co-lead)

• Cindy Lu, AstraZeneca

ASA meeting planner/workshop coordinator

• Kathleen Santoro, ASA

• Sabina Schlichtmann, ASA

2025 RISW SC meeting at 2024 RISW

A hybrid meeting of the 2025 RISW SC was held on September 26, 2024, during the 2024 RISW, officially launching the planning process for the upcoming event. The meeting centered on key discussions, including finalizing the parallel session topic categories and developing the conference theme for the 2025 workshop.

Parallel session topic categories

The objective is to encompass a broad spectrum of relevant topics, ensuring that participants can easily align their proposals with the appropriate category, while keeping the total number of categories manageable. The aim is to highlight emerging trends and key issues, while also incorporating under-represented areas from previous workshops, ensuring a comprehensive and diverse program.

Below is the final list of topic categories for the 2025 RISW, determined after thorough discussions by the SC:

• AI/ML (e.g. AI in manufacturing, Benefit risk of AI/ML)

• Bayesian Analysis

• Causal Inference

• Clinical Trial Design (Innovative/complex design, Master protocol, Multiplicity, Multi-regional clinical trial, etc.)

• Clinical Trial Conduct and Analysis Tools (Monitoring, Operations, De-centralized, Visualization, etc.)

• Cross-disciplinary Research (e.g., Data science, Clinical pharmacology, Epidemiology)

• Data Management/Data Quality

• Decision Analysis (e.g. Go/No-Go, Benefit: Risk Determination, Patient-preference)

• Diagnostic (e.g. ctDNA, Biomarker, Precision medicine, Imaging)

• Digital Health (e.g. Digital biomarker)

• Early Phase/Pre-clinical Trials (e.g. PK/PD)

• Estimands

• Medical Device

• Non-inferiority, Biosimilar, Bioequivalence (e.g. Interchangeability)

• Oncology/Hematology

• Patient Focus Drug Development (e.g. PRO, Decentralized clinical trial, Ethics, Diversity)

• RWE (e.g. Historical control, Meta-analysis, Digital twins)

• Safety

• Small Population (Pediatric, Rare disease, Orphan drug, etc.)

• Statistical Leadership and Effective Communication

• Statistical Methods and Analysis in Clinical Trials (Covariate adjustment, Missing data, Survival, Subgroup, etc.)

• Tobacco/Food

• Veterinary Medicine/Non-clinical (CMC)

• Vaccine and Gene/Cell Therapy

• Other

Conference theme

After extensive deliberations, SC carefully evaluated several compelling options for the 2025 workshop theme, ultimately narrowing them down for a final vote. Following thoughtful consideration, the chosen theme for the 2025 RISW is: "Future in Statistics: Collaboration and Innovation in the AI/ML Era."

The theme underscores the evolving role of statisticians in the ongoing transformations of drug development and regulatory approval processes, driven by the integration of AI/ML technologies. These advancements are revolutionizing how data is processed, analyzed, and interpreted.

During the discussions, the ideas of "Collaboration" and "Innovation" emerged as pivotal focal points, reflecting their critical importance in navigating this dynamic landscape. The theme emphasizes the importance of fostering collaboration among experts from diverse disciplines to address the complex challenges in drug development. By integrating complementary expertise, more effective and holistic solutions can be achieved.

Innovation is also a key focus. By adopting innovative approaches, statisticians can harness the full potential of emerging technologies, such as AI/ML, to enhance patient outcomes while upholding the highest standards of scientific rigor.

Call for Participation:

We are delighted to invite statisticians, data scientists, and all relevant professionals to actively participate in the 2025 RISW. This event offers an exceptional opportunity to share your expertise and collaborate with leading professionals from industry, academia, and regulatory agencies.

Key dates for participation are as follows:

• November 20, 2024 – December 18, 2024: Submit your proposals for Parallel Sessions and Short Courses

• January 15, 2025 – March 26, 2025: Submit your proposals for Roundtables

• January 15, 2025 – April 8, 2025: Submit your proposals for Posters

Don’t miss this opportunity to showcase your research, share innovative ideas, and connect with influential leaders in the field. Whether presenting your latest work, leading a discussion, or contributing to a session, your participation will play a pivotal role in shaping the future of statistics in drug development. We look forward to your valuable contributions and to another successful and impactful workshop!