From prediction to decision: Digital twins and predictive modeling in clinical development

Oncology clinical development leaders face mounting pressure to move faster, often while making critical decisions with limited information. Predictive models and digital twins powered by real-world data (RWD) offer new ways to inform those decisions, helping accelerate timelines and improve probability of success.

This panel brings together perspectives from across the ecosystem to explore how these tools are being applied in go/no-go calls, biomarker strategy and trial design and analysis. Panelists will discuss where they already deliver value today, why data quality and transparency matter as much as the models themselves, and what's still standing in the way of broader adoption, along with strategies to address those barriers.

What you’ll learn:

Where RWD-powered predictive models are already being used in clinical development and how they support decisions across the asset lifecycle
What to look for in a predictive modeling solution, including data quality, methodology, and transparency
Practical strategies for navigating data, regulatory, and adoption challenges

Jacqueline Law

VP, Scientific Engagement and Applied Research

Flatiron Health

Jacqueline Law leads the team responsible for scientific engagement and applied research at Flatiron Health, where they focus on advancing the use of AI and predictive modeling for cancer research. Prior to joining Flatiron Health in 2021, Jacqueline led data sciences and biostatistics teams at pharmaceutical and diagnostic companies. Jacqueline graduated from UCLA with a Ph.D. in Biostatistics.

Nicole Gormley

Founder

Gormley Advisory, LLC

Nicole Gormley is the founder of Gormley Advisory LLC, an independent regulatory consulting practice focused on oncology drug development. She brings nearly two decades of federal service to her advisory work, including most recently serving as Division Director for the Division of Hematologic Malignancies II at the U.S. Food and Drug Administration and as Associate Director for Oncology Endpoint Development in the Oncology Center of Excellence. During her nearly 15 years at the FDA, Dr. Gormley oversaw drug development for multiple myeloma, lymphomas, and chronic lymphocytic leukemia, and provided scientific and policy leadership on early endpoint development in oncology. She was instrumental in advancing novel endpoints including minimal residual disease and championed efforts to improve clinical trial representation. Prior to the FDA, Dr. Gormley completed fellowship training in hematology and critical care at the National Institutes of Health and served as Deputy Clinical Director at the National Heart, Lung and Blood Institute.

Xun Chen

VP, Global Head of Data and Statistical Sciences

AbbVie

Xun Chen is Global Head of Data and Statistical Sciences at AbbVie. The Data and Statistical Sciences department at AbbVie drives the integrated quantitative strategy and its execution across the lifecycle of drug development. Grounded in industry-leading statistical science, her organization has a strong focus on advancing AI-powered predictive modeling and simulation to strengthen evidence generation and decision-making. Xun is particularly passionate about translating emerging technologies into scientifically rigorous, decision enabling and scalable capabilities that unlock the full value of data, improve development decisions, and ultimately help bring innovative medicines to patients faster.

Mark Guinter

Director of Research Sciences

Flatiron Health

Mark Guinter is a Director of Research Sciences at Flatiron Health, where he leads research partnerships and the design of fit-for-purpose real-world evidence solutions. As an epidemiologist researching in oncology for over 10 years, Mark has extensive experience applying advanced methodological approaches to generate rigorous, high-quality evidence to support multiple phases of drug development, from early-stage target product profiling to post-market evaluation. Mark earned his Ph.D. in Epidemiology from the University of South Carolina Arnold School of Public Health and completed a postdoctoral fellowship at the American Cancer Society.

Country

From prediction to decision: Digital twins and predictive modeling in clinical development

Panelists

Moderator

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