FP7 logo euThe ESNATS project has received funding from the European Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement n° HEALTH-F5-2008-201619

Embryonic Stem cell-based Novel Alternative Testing Strategies

Partners: H. Lundbeck A/S (Lundbeck)

H. Lundbeck A/SH. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders. The department of Molecular Toxicology is part of the Non-Clinical Research organisation at Lundbeck which is responsible for the safety assessment of new drug candidates.

The Department has expertise within the field of molecular toxicology and runs a laboratory which conducts genotoxicity, cytotoxicity, neurotoxicity testing and toxicogenomics. The Departments has recently introduced several alternative in vitro toxicity tests in the early screening of Lundbecks drug candidates. Currently the Department is involved in the evaluation/validation of alternative test methods for DNA damage response in human cells, embryonic toxicity in Zebra fish and the application of in vitro toxicogenomics for early prediction of toxicity.

The head of Molecular Toxicology will be part of the Steering Committee of the ESNATS project. The main tasks are to provide advice and requirements on industry needs for assay development and to specify reference compounds to be tested.

Key staff involved in the project

Nina OstenfeldtNina Ostenfeldt, Dr., Head of Molecular Toxicology, H Lundbeck A/S, holds a MSc in Biology and a PhD in molecular toxicology, both from University of Copenhagen. She has worked for 15 years in the pharmaceutical industry and has more than 20 years work experience with in vitro toxicology methods; genotoxicity, cytotoxicity, neurotoxicity testing, and mechanism of toxicity investigations by means of molecular biology methods, including genomics. Nina has been involved in internal and collaborative evaluations/validations of several alternative in vitro and in vivo toxicology methods, most recently cytotoxicity assays to predict local toxicity in animals, the GreenScreen assay for DNA damage, the in vitro and in vivo micronucleus test by means of flowcytometry, a Zebra fish assay for embryotoxicity, and prediction of toxicity using Iconix' toxicogenomics database. She has previously been heading Department of Reproductive Toxicology and has general experience with regulatory reprotox studies.

Dr. Nina Ostenfeldt will as Steering Committee member provide input to design of assays and testing strategies and address the specific needs of the pharmaceutical industry.

Further information: www.lundbeck.com

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