2024 RISW Special Issue

Harness the Power of Statistics, Data Science, and Digital Technology to Drive Patient-Focused Innovations Together

Dec 20, 2024

Note from the 2024 RISW Program Chairs:

Dear Colleagues and Friends,

Welcome to this special issue of the BIOP Report, dedicated to the 2024 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop (RISW).

This year’s workshop featured two outstanding plenary sessions. The first session was a fireside chat with Dr. Patrizia Cavazzoni, Director of the FDA CDER, followed by a panel discussion on the intersection of statistics, data science, and AI in drug development. The discussion delved into how AI may influence our work and the limitations it faces in drug development. The second plenary session, titled Ask the Regulators, brought together six regulators from the FDA and EMA to interact with industry representatives on a range of key topics, including Bayesian methods, oncology, real-world data, and labeling. Many attendees commented afterward on the insightful and informative nature of both sessions.

RISW is known for its grassroots approach to planning, and this year we received a record number of session proposals. Following a comprehensive review and voting process, 56 parallel sessions and 10 short courses were selected for the 2024 workshop. By incorporating both FDA and industry speakers in each session, the workshop continues to uphold its core mission of fostering collaboration. A special highlight was the collaboration with EFSPI (European Federation of Statisticians in the Pharmaceutical Industry), which enriched the experience even more. The value was further enhanced by the involvement of academic speakers and representatives from other regulatory agencies. This commitment to relevance has made RISW one of the most important conferences for statistical practitioners in the biopharmaceutical field, evidenced by the nearly sold-out attendance of over 1,250 participants.

This year’s workshop also included a tribute session for Dionne Price, a mixer, poster sessions, and roundtable discussions. The 2024 RISW theme, Harness the Power of Statistics, Data Science, and Digital Technology to Drive Patient-Focused Innovations Together, was reflected in many sessions throughout the event.

The success of RISW 2024 is a result of the tremendous efforts of the ASA BIOP Section, the FDA Statistical Association (FDASA), the RISW Steering Committee, and many volunteers who contributed over the past year. Their dedication has been instrumental in shaping the scientific program and expanding the workshop’s offerings.

Thank you all, and we look forward to seeing you in 2025!

2024 ASA BIOP RISW Co-Chairs:

Jianchang Lin (Takeda)

Zhiheng Xu (FDA)

2024 ASA BIOP Report Editorial Board:

Meijing Wu (Sanofi, Editor), Di Zhang(Teva, Associate Editor), Christie Watters (Novartis, Associate Editor), Maria Kudela(Pfizer, Associate Editor), Charlotte Baidoo (BMS, Associate Editor)

ASA BIOP Section Chairs:

Brian Millen (2023), Ted Lystig(2024), Erik Bloomquist (2025)