We recently wrapped up the July 23, 2025, PHUSE Single Day Event in West Windsor (Mercer County) NJ, proudly hosted by Atorus and Posit. It was an inspiring day filled with innovative discussions, cutting-edge technologies, and brilliant minds from across the industry. Reflecting on the last 5 to 10 years, the progress and collaboration showcased here would have been hard to imagine back then.
Highlights From the Event
Tackling Rare Disease Trials With Open-Source and AI
Anbu Damodaran from AstraZeneca kicked things off by delving into how open-source tools, machine learning (ML), and AI technologies are addressing the unique challenges in rare disease trials. He highlighted critical issues such as patient recruitment hurdles, regulatory complexities, high costs, and the implementation of external controls.
Enhancing DMC Reporting With Open-Source Tools
Peng Zhang, of CIMS Global, discussed the integration of modern R packages like {rtables}, {tern}, and {teal} to support Data Monitoring Committees (DMCs). His presentation emphasized the transformative power these tools have in streamlining DMC reporting.
J&J’s Groundbreaking R Submission to the FDA
A standout presentation came from Alicia Humphreys and LinshanYuan, of Johnson & Johnson, who shared insights into their successful R submission to the FDA. They explored how open-source R packages were utilized for statistical analysis and the creation of tables, figures, and listings (TFLs).
Exploring Gen AI in Clinical Research
Sai Yengannagari, of BMS, explored the intersection of Generative AI and clinical research. He showcased web applications designed to interact with the CDISC Library API, illustrating both the development of Gen AI tools and their integration into web applications, particularly from a SAS programmer’s perspective.
Merck’s Innovative Approach to Clinical Trial Reporting
Benjamin Wang, of Merck, provided an in-depth look into Merck’s strategies for clinical trial analysis and reporting. He emphasized metadata-driven programming, advanced R techniques, and the incorporation of interactive elements within static documents to enhance reviewer engagement.
Python’s Role in Clinical Programming
Michael Chow, from Posit, took us into the Python realm, demonstrating how tools like Polars and Great Tables are revolutionizing clinical programming activities. He drew parallels to familiar packages in the pharmaverse, showcasing Python’s growing influence in the industry.
CDISC 360i: Pioneering End-to-End Study Packages
Sam Hume, of CDISC, presented exciting developments within CDISC 360i, focusing on the goal of publishing comprehensive, pre-configured study packages. These packages encompass defined metadata, raw test data, and open-source software for seamless end-to-end study execution.
Embracing Open-Source in Biotech
Nicole Jones, from Denali Therapeutics, highlighted how smaller biotech firms are leveraging R and open-source tools for clinical trials. Notably, Denali submitted its first biologics license application (BLA) to the FDA via the Accelerated Approval pathway in 2025, a testament to their transformative approach and the benefits of open-source adoption.
AI-Native Validation in Clinical Applications
Mel Hullings, of Formation Bio, concluded the presentations by discussing the integration of AI in navigating the Software Development Life Cycle (SDLC) and validating clinical R Shiny applications. She showcased their AI-native validation framework, compliant with GAMP 5 and FDA guidelines.
Final Thoughts
This PHUSE Single Day Event was more than just a series of presentations — it was a vivid snapshot of the rapid advancements shaping our industry. From AI and open-source technologies to innovative clinical trial methodologies, the event provided a comprehensive overview of modern data science applications in clinical research.
We look forward to seeing how these discussions inspire future collaborations and breakthroughs in the field. To dive further into any of these presentations, visit the PHUSE event page.