| Time | Events |
|---|---|
| 7:30 AM Registration | Short Course |
| 9:00 AM – 4:30 PM Short Course Full Day |
(SC 1) Information Extraction and Document
Preparation in Clinical Trial Development using RAG-based
LLMs Instructors: Zhaohua Lu; Daichi Sanko; Arina Shen, Biomedical Data Science Masters Student at Stanford University School of Medicine (SC 4) CGM-AI: Causal Generalist Medical AI Instructors: Hongtu Zhu, UNC; Qiao Liu, Yale |
| 9:00 AM – 12:00 PM Short Course Morning Session |
(SC 2) Trust by Design: Applied AI
Governance for Pharma with Hands-On Application
Exercises Instructors: Rebecca D. Jones-Taha, AIGxPLabs (SC 5) Python for Clinical Development with AI Applications Instructors: Yilong Zhang, Meta; Pingye (Eric) Zhang, Eikon Therapeutics; Yuting Xu, Merck |
| 1:30 PM – 4:30 PM Short Course Afternoon Session |
(SC 3) Personally Identifiable Information
Redaction Agent: LLM as Judge, REGEX Instructors: Andrew Semmes, Moderna |
| Time & Session | Presentations |
|---|---|
|
7:30 AM – 8:45 AM Registration & Breakfast |
All Conference Attendees |
|
8:45 AM – 9:05 AM Opening Remarks |
New England Statistical Society Leadership |
|
9:05 AM – 9:45 AM Keynote Speech |
Pending |
|
9:45 AM - 10:15 AM Keynote Panel Discussion |
Prof. Hou, Peking University Somnath Sarkar, PhD, Sanofi Pending |
| 10:15 AM - 10:30 AM: Break | |
|
Session 1: 10:30 AM - 12:00 PM AI in Pharma: Regulatory Perspectives & Safety Applications |
• AI Applications in Drug Development and Regulatory Review:
China Landscape (Peking University & Merck) • Agentic MedDRA Coding: Automated AE Term Standardization (Moderna) • Quantitative Safety Evaluation: AI Agents and Causal Inference in PV (Merck) |
|
12:00 PM – 1:30 PM Lunch and Poster Presentation |
|
|
Session 2: 1:30 PM – 3:00 PM Predictive Modeling & Patient Stratification |
• Improving Interim Decision Making: Predictive Modeling of
Censored Survival Outcomes with Machine Learning
(Servier) • TorchSurv: Deep survival analysis made easy (Novartis) • Identifying High-Risk Asthma Patient Subgroups Using Predictive + Unsupervised Learning (IQVIA) |
|
3:00 PM – 4:45 PM Session 3: Transforming R&D Infrastructure with GenAI |
• Beyond Macros and Mappings: LLMs as the New Co-Programmer
in Clinical Data Standards (BeOne) • Reinventing R&D: Building an AI-Powered Biopharma Future (Sanofi) • Shaping an AI-Native Biometrics Group (Meta) |
| 4:45 PM – 5:00 PM: Break | |
|
5:00 PM – 6:00 PM Mixer & Poster Session |
All Conference Attendees |
|
6:30 PM – 7:45 PM Banquet Keynote Session Ticket required |
Junshui Ma, Our Journey in Building an AI-Ready Workforce, Merck Research Laboratories |
| Time & Session | Presentations |
|---|---|
|
7:30 AM – 8:45 AM Registration & Breakfast |
All Conference Attendees |
|
8:45 AM - 10:15 AM Session 3: Digital Twins & Synthetic Evidence Generation |
• Digital Twins in Clinical Trials: Concepts, Applications,
and Future Directions (BMS) • FedECA: Federated External Control Arms for Causal Inference with Time-to-Event Data (Sanofi) • Assumption-Lean Synthetic Individual Patient Data Generation (HopeAI) |
| 10:15 AM – 10:30 AM: Break | |
|
10:30 AM – 12:00 PM Session 4: Clinical Operations & Execution Excellence |
• AI in Clinical Operations: Risk-Based Management Systems
(ZS) • Accelerating Protocol Development: Standardization, Digital Reuse, and AI Copilots (BeOne) • AI-assisted Literature Review Tool to Boost Evidence Generation for ctDNA (Sanofi) |
| 12:00 PM - 1:30 PM: Lunch | |
|
Session 6: 1:30 PM – 3:00 PM Networking & Roundtable Discussions |
|
|
3:00 PM – 3:30 PM Break & Awards |
|
| Closing Remarks |
*Session timeslots subject to change