November 10, 2025
Henry Gonzalez Convention Center | San Antonio, TX
SESSION 1
Regulatory-Ready AI: Applying Large Language Models to Bioanalytical Workflows
Stephanie Pasas-Farmer, PhD
November 10 | 10:00 am – 10:30 am CT
This presentation will explore how AI-powered tools like ChatGPT, BioResearcher, and AI Co-Scientist are transforming bioanalytical workflows—from method development and validation to regulatory submissions. Attendees will gain insights into real-world applications of LLMs in literature review, HRMS data summarization, and hybrid assay modeling, all within the context of global regulatory frameworks including ICH M10, FDA, MHRA, and EMEA.
The session will also address critical risks such as hallucinations in AI outputs and propose validation strategies tailored to the dynamic nature of LLMs. With a focus on transparency, compliance, and innovation, this talk offers a forward-looking perspective on integrating AI into regulated bioanalysis.
SESSION 2
Assessing Risk for the IVDR Application
Joleen White, PhD
November 10 | 3:15 pm – 3:30 pm CT
The EU’s In Vitro Diagnostic Regulation (IVDR) now applies to diagnostic methods used in clinical trials, including those guiding patient enrollment. This presentation introduces a practical framework for preparing IVDR-compliant risk assessments, with a focus on bridging traditional bioanalytical validation and the broader clinical performance expectations under IVDR. Attendees will gain actionable insights to support regulatory readiness while maintaining scientific integrity in biomarker-driven trial designs.