Successfully implementing New Approach Methodologies (NAMs): Practical applications in drug development and clinical practice Verified listing

This symposium aims to clarify the ways to achieve regulatory acceptance of New Approach Methodologies (NAMs) by addressing the major obstacles to their implementation.

The event seeks to bridge the gap between in vitro and in silico model developers, end-users, and regulatory bodies, fostering a collaborative environment to streamline the adoption of these advanced methodologies that provide alternatives to animal-based research.

It will highlight practical case studies showcasing the successful integration of NAMs in clinical practice and drug development, featuring insights from biotech companies, clinics, and the pharmaceutical industry. Participants will learn key success factors for turning innovation into impactful applications and achieving NAMs validation.

Program

• Introduction - can we measure replacement? Jenny Sandström, Swiss 3RCC
• What is the regulatory status on NAMs? Tatjana Pecaric Petkovic, Swissmedic

Session 1: Implementing NAMs in clinics: diagnostics and personalized medicine applications

• State-of-the-art on NAMs technology and innovations applied in the clinic. Olivier Guenat, University of Bern.
• Case study I: Personalized drug combinations for cancer treatment in human organoids: clinically relevant approach. Patrycja Nowak-Sliwinska, University of Geneva, & Jeremy Meyer, HUG.
• Case study II: Machine Learning-Driven, Label-Free Image Analysis Enhances Functional Assays for Predicting Treatment Responses for Cystic Fibrosis Patients using Patient-derived Organoids. Sylke Höhnel-Ka, Doppl, & Georgia Mitropoulou, CHUV.

Session 2: Implementing NAMs in drug discovery and development

• State-of-the-art on NAMs technology and innovations applied to drug discovery, with a focus on ADME-Tox. Laura Suter-Dick, School of Life Sciences, FHNW.
• Regulatory acceptance during drug development – status. Elisabeth Klenke, Swissmedic.
• Case study III: Switch from in vivo to in vitro potency assays for market batch release: analytical and regulatory challenges. Francesco Nevelli & Morgane Rochemont, Merck.
• Case study IV: In vitro methods for tumorigenicity and teratogenicity evaluation of cell therapy products Silvana Libertini, Novartis, & Joana Ferreira, AstraZeneca
• Case study V: The successful use of a 3D blood-brain barrier-glioblastoma model to optimize the starting dose for the first-in-human trial of a T-cell bispecific Elisabeth Husar & Alina Gavrilov, Roche