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.
Date: December 13th, 2024
Location: Bern, UniS, S003
Register by clicking here.
Accreditation for 1 day of continuing education (pending confirmation)
_________
Confirmed program:
Introduction - can we measure replacement? Jenny Sandström, Swiss 3RCC
What is the regulatory status on NAMs? Tatjana Pecaric Petkovic, Swissmedic
State-of-the-art on NAMs technology and innovations applied in the clinic Olivier Guenat, University of Bern
Case study I: 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
Case study II: Personalized drug combinations for cancer treatment in human organoids: clinically relevant approach Patrycja Nowak-Sliwinska, University of Geneva, & Jeremy Meyer, HUG
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
_________
Check out the full program of the symposium here: