Qing Li

Company: Moderna

Job title: Director - Pathology, Clinical Development, Oncology

Seminars:

Panel Discussion: Closing the Gaps in Regulatory Guidance to Improve Biopharma Adherence to Ambiguous Guidelines 2:15 pm

Navigating pre-submission & cohort design: meeting fda expectations for AI tools Where do current regulatory frameworks fall short in addressing AI and digital pathology integration? What pre-submission strategies are most effective when engaging regulators on AI-based pathology tools? What guidance is needed to support the clinical use of exploratory tools for biomarker and CDx development?…Read more

day: Conference Day Two

Overcoming Regulatory Hurdles for Black Box Signatures in Digital Pathology for Accelerated Approvals 3:15 pm

How can developers validate algorithms that identify complex, non-interpretable patterns with no clear human comparator? What new approaches are emerging to measure trust, transparency, and performance in these “black-box” models? How can biopharma balance innovation with the need for explainability and clinical accountability?Read more

day: Conference Day Two