Parallel

PS53: Non-clinical Statistical Methods to Support FDA's Initiative to Reduce Animal Testing

Fri, Sep 18, 2:50 PM - 4:05 PM Room Brookside AB Bethesda North Marriott Hotel & Conference Center

Qianyu DangOrganizerMeiyu ShenCo-OrganizerChao WangChairYu-Ting WengCo-Organizer

About this session

The workshop, hosted by the Food and Drug Administration in collaboration with the National Institutes of Health in July 2025, focused on reducing animal testing. Since then, significant development in statistical methods has made for supporting the Agency's initiative to promote the use of New Approach Methodology (NAMs) in drug development and safety assessments. Statistical issues in regulatory evaluations of NAMs related reviews have been addressed to advance science in the emerging area of statistical assessment in non-animal NAMs. This session presents statistical methodologies supporting this transition.

5 Presentations

From Animal Tests to Human-Relevant Evidence: FDA's Initiative to Advance NAMs in Nonclinical Drug Development

2:50 PM - 4:05 PM

Co-authors: Thomas Hartung (Johns Hopkins University), Thomas Hartung (Johns Hopkins University)

New Approach Methodologies (NAMs)nonclinical safety assessment fit-for-purpose evidence

Cell-based Potency Bioassays

2:50 PM - 4:05 PM

Co-authors: Meiyu Shen (CDER, FDA), Meiyu Shen (FDA)

Model Training and Validation – Lessons Learned from Using Human-induced Pluripotent Stem Cell-derived Cardiomyocytes (hiPSC-CMs) in Preclinical Cardiac Risk Evaluation

2:50 PM - 4:05 PM

Co-authors: Qianyu Dang (FDA Center for Drug Evaluation and Research (CDER)), Qianyu Dang (FDA Center for Drug Evaluation and Research (CDER))

Statistical approaches to classify investigational product using hERG safety assay

2:50 PM - 4:05 PM

Co-authors: Yu-Ting Weng (FDA), Yu-Ting Weng (FDA)

hERG safety assay ICH E14 S7b logistic regression for classification

2:50 PM - 4:05 PM