American College of Toxicology 2026 Annual Meeting

Co-Chairs:

• Kevin P. Snyder, PhD – Director of Nonclinical Innovation and Emerging Technologies, Certara Predictive Technologies, Certara
• Kamel Mansouri, PhD – Computational Chemist, NTP Interagency Center for the Evaluation of Alternative Toxicological Methods, National Institutes of Health

Speakers:

• Seneca Fitch – Managing Scientist, Health Sciences, ToxStrategies
• Srijit Seal, PhD – Principal Scientist, Human Chemical Company
• Ben Birnbaum, PhD – Cofounder and CTO, Inductive Bio

Valuable results from toxicology studies are often locked in unstructured PDF reports and heterogeneous spreadsheets, hindering efficient integration of study results within and across studies. AI can accelerate table detection, entity normalization, and schema mapping, but domain expertise is essential at every step to ensure the quality of output. This presentation outlines a conceptual framework for developing human in the loop approaches that leverage AI based methods to transform non standard data sources into standards conformant datasets, e.g., CDISC SEND. Using AI assisted coding tools, skilled data scientists can build maintainable components for table extraction, controlled terminology enforcement, and mapping into standardized data structures. These components can be deployed through intuitive interfaces that enable subject matter experts to review outputs, resolve exceptions, and supply missing metadata. Once converted, harmonized datasets can be reliably integrated and analyzed together, yielding reproducible, cross study insights.

Co-Chairs:

• Mahnoush Bahjat, PhD – Associate Director, Clinical Pharmacology and Safety Sciences, AstraZeneca
• Birgit Fogal, PhD – Senior Distinguished Scientist, Preclinical Safety, Sanofi

Speakers:

• Zhechu Peng, DABT – Director, Project Toxicologist, AstraZeneca
• Kevin P. Snyder, PhD – Director of Nonclinical Innovation and Emerging Technologies, Certara Predictive Technologies, Certara
• Swetha Rudraiah, DVM, PhD – Toxicologist, Division of Pharmacology and Toxicology for Immunology and Inflammation, US FDA
• Richard FitzGerald, MBChB PhD FRCP – Director, NIHR Liverpool Clinical Research Facility, Clinical Pharmacology, University of Liverpool

T-cell engagers (TCEs) are a promising class of immunotherapies with distinct mechanistic and translational complexities. This presentation as the second talk, will provide a concise overview of TCE modalities and highlight key scientific and strategic questions that arise during their discovery and development. Emphasis will be placed on best practices for applying quantitative systems pharmacology (QSP) to support first-in-human (FIH) dose projections, illustrated through selected case studies. The presentation will introduce the importance of predicting trimers (e.g., CD3:TCE:TAA complexes) for preclinical-to-clinical translation. The talk will present the data package needed for translating from preclinical to FIH and how toxicology and cytokine release data are used in FIH decision-making. Finally, regulatory acceptance of QSP-supported FIH dose projections will be discussed.

Speakers: Melissa Cunningham and Carrie Malinczak

Toxicologists are inundated with structured study data that requires significant time for thorough analysis and interpretation. This session showcases how SEND Explorer is changing that equation with AI-enabled functionality that rapidly surfaces endpoints of interest and automatically drafts narrative summaries describing the toxicologic relevance of study findings. A Certara toxicologist will share real-world case examples — including challenges encountered and how using SEND Explorer can accelerate interpretation and inform faster decision-making.