Investigating Sotorasib-related Renal Toxicity in the Rat Using Spatial Bioanalysis

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When Amgen’s sotorasib (Lumakras) received accelerated approval it was hailed as a major milestone for the industry and patients.  To support the development and regulatory approval, Amgen created an accelerated timeline and partnered with ImaBiotech to better understand the renal toxicity and any associated risks to patients.   

In this webinar, scientists at Amgen and ImaBiotech will explain how spatial bioanalysis, specifically matrix-assisted laser desorption/ionization - mass spectrometry imaging (MALDI-MSI), was used to generate data that support a hypothesis for the rat-specific renal toxicity and the global market authorizations. 

This example demonstrates how spatial bioanalysis adds value to the drug development process by giving pharmaceutical companies robust data to assess risk/benefit profiles and drive strategic decisions regarding their pipelines.


Sign up today to discover how Amgen and ImaBiotech collaborated to:

     Investigate renal toxicity in the rat

     Generate a hypothesis based on the weight of evidence
     Support the accelerated timelines for market authorization of sotorasib


Speaker:

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Jonathan Werner

Pathology Director
Amgen


Jonathan Werner received a BS in Biochemistry from Bates College (1994), a DVM degree from Tufts University (1999), and a PhD in Comparative Pathology from UC Davis (2006). Prior to receiving his PhD, he completed a residency in veterinary anatomic pathology at UC Davis and was board-certified in 2002. Jon joined Amgen in 2006 and has served as a project pathologist and project team representative in the non-clinical safety department within the Research and Development organization. He has >15 years of drug development experience with a variety of disease indications, therapeutic targets, and drug modalities. Jon is an active member of the Society of Toxicologic Pathology.

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Mathieu Gaudin

Director

ImaBiotech Laboratories


Mathieu Gaudin received a chemical engineering degree from Ecole Nationale Supérieure de Chimie de Rennes, France (2008) and a PhD in analytical chemistry from University Paris Descartes, France (2011). He then joined Imperial College London as a research associate to develop and implement large scale lipidomic approaches. Mathieu then joined Servier and led the MALDI Mass Spectrometry Imaging facility within the DMPK department for 4 years. Since 2017, he is working as Laboratories Director at ImaBiotech, coordinating the team of scientists providing SpatialBioanalysis and SpatialBiomarker services and bringing its scientific expertise to his customers.


Hosted by

Maire Gerrard

Manager Editor, Custom Content

Pharma Intelligence

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