TITLE: Towards an AI-First Workflow for Clinical Development and its Analysis and Reporting
SPEAKERS: Yilong Zhang, Meta, and Pingye (Eric) Zhang, Eikon Therapeutics
MODERATOR: Bill Wang
Abstract:
As AI adoption accelerates across the biopharmaceutical industry, the challenge for organizations has shifted from “if” to “how.” To remain competitive, leaders must transition from ad-hoc AI usage to AI-First strategies, where AI serves as the default starting point. This requires a rigorous definition of workflows where humans are strategically positioned on-the-loop for oversight and experts are in-the-loop for complex edge cases.
In this short course, we provide publicly available examples and hands-on exercises for implementing selected AI-First processes around deliverables for Biometrics organizations including clinical trial design, analysis and reporting. The short course is structured into three key modules:
- The AI Evolution: Mapping the journey from AI-adoption to AI-first, and ultimately to AI-native organizational structures.
- Strategic Use Cases: Deep-diving into AI-first processes for study design, clinical analysis, and reporting with focus on reducing human review burden.
- Applied AI Agent Skills: Hands-on exercises in developing and evaluating Agent Skills for biometrics use cases using modern, publicly available AI agents and clinical development tools.
Instructors’ Biography:
Yilong Zhang, PhD, is a Health Quantitative Scientist at Meta. He previously worked as a statistician at Merck & Co., Inc. on late-stage clinical trial development. His interests include developing AI workflow, R and Python packages to improve clinical trial analysis, reporting, and regulatory submission. Yilong has published over 25 peer-reviewed articles and holds a PhD in Biostatistics from New York University.
Eric Zhang is the Director of Biostatistics at Eikon Therapeutics, where he supports oncology programs spanning early to late-stage clinical development. He earned his Ph.D. in Biostatistics from the University of Southern California and began his career at Merck, where he served as the lead statistician for late-stage oncology trials and played a pivotal role in the regulatory filing and approval of pembrolizumab (KEYTRUDA) for RCC and HN cancer. Following his time at Merck, Eric worked at BeiGene and Gilead Sciences. In addition to his project work, Eric is also an active participant in scientific discussions across industry and regulatory bodies, and has published extensively in both statistical and medical journals.