Plenary Session 1: The Intersection of Statistics, Data Science, and AI in Drug Development
Jianchang Lin (Takeda), Zhiheng Xu (FDA), 2024 RISW Program Co-Chairs
As the 2024 Regulatory Industry Statistics Workshop (RISW) kicked off, the opening plenary session set the tone by tackling one of the most critical and timely topics in drug development today: the intersection of statistics, data science, and artificial intelligence (AI). This session, designed to explore the potential of these fields to revolutionize healthcare, aligned perfectly with the workshop’s overarching theme—"Harnessing the Power of Statistics, Data Science, and Digital Technology to Drive Patient-Focused Innovation Together."
The first plenary session, moderated by Dr. Simon Davies from Takeda, began with an engaging fireside chat featuring Dr. Patrizia Cavazzoni, the Director of the FDA's Center for Drug Evaluation and Research (CDER). The discussion centered on the intersection of statistics, data science, and artificial intelligence (AI) in drug development. Dr. Cavazzoni emphasized the importance of leveraging these tools to foster innovation and improve patient access to safe and effective treatments. The conversation also underscored a visionary shift in the role of statisticians, who are increasingly integral to the evolving landscape of modern drug development.
Following the fireside chat, a dynamic panel discussion further explored the intersection of statistics, data science, and AI in drug development. The panel featured distinguished experts: Rajanikanth Madabushi (FDA); Paul Schuette (FDA); Kannan Natarajan (Pfizer); Nevine Zariffa (NMD Group); Kelci Miclaus (Dataiku). The panelists shared their insights and experiences regarding AI's impact on various aspects of drug development, including drug discovery, manufacturing, clinical development, operational and safety monitoring. Their discussion provided a comprehensive view of how AI is transforming the industry and the challenges and opportunities that come with it.
The session also included interactive elements, where the audience was surveyed on two key questions: (1) How different is your job currently due to AI? (2) How different do you think your job will be in 10 years due to AI? These questions aimed to gauge the current and future impact of AI on professionals in the field, fostering a deeper understanding of the ongoing and anticipated changes driven by technological advancements. For instance, 58% of respondents believe that there is not much difference in their current job due to AI. However, 51% agreed that there will be a significant change in their job within the next 10 years due to AI. Further details regarding the live survey results are outlined below:
The session underscored the growing importance of AI in the future of drug development, but it also highlighted the need for continued collaboration between statisticians, data scientists, and other key stakeholders. As AI continues to reshape the industry, the opportunities to innovate and improve patient care are boundless, but they will require a collective effort to fully realize. This session provided an optimistic outlook for the future, reinforcing that the fusion of statistics, data science, and AI will be instrumental in shaping the next era of healthcare.
Photos from the plenary session 1:
