Successfully Implementing NAMs: practical applications in Drug Development and Clinical Practice

December 13th, 2024 | Bern

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

Registration fee: Professionals: CHF 95,00 / Students: Free of charge with no-show fee applicable. Registration closes on December 12th at 23:59.

Register by clicking here.

Accreditation for 1 day of continuing education from the Swiss Association of Cantonal Veterinarians and 4 Credit Points for the ERT (European Registered Toxicologist)


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Confirmed 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

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Check out the full program of the symposium here:

Program_3RCC NAMs implementation symposium_VF
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