3rd Workshop on Non-Clinical Safety Assessment of Biopharmaceuticals “Next generation therapies” WELCOME.

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Presentation transcript:

3rd Workshop on Non-Clinical Safety Assessment of Biopharmaceuticals “Next generation therapies” WELCOME

This meeting is sponsored by Gold Bronze

SPONSORS BELTOX Gold Silver Bronze

Morning Session: Introductory lectures 8:50 Welcome JM. Wilkin, GSK Vaccines, Belgium 9:00 Nucleotide therapies: Past failures and future challenges L. Coney, Huntingdon Life Sciences, United Kingdom 9:40 Safety Evaluation of Gene Therapy Products including Inhaled Products M. Mc Elroy, Charles River Laboratories, United Kingdom 10:20 Regulatory perspective on the safety assessment of oligonucleotides and gene therapies C. Beuneu, Federal Agency for Medicines and Health Products, Belgium 10:45 Coffee break 11:05 The personalized medicine approach in orphan disease: development of oligonucleotides for the treatment of Duchenne’s Muscular Dystrophy C. den Besten, Prosensa, The Netherlands 11:35 Non-GLP Pharmacology and the GLP Toxicology Studies to support the use of CpG as adjuvant in anti-nicotine and anti-IgE therapeutic vaccines M. McCluskie, Pfizer, Canada 12:15 Toxicologic pathology of antisense oligonucleotides C. Sobry, CitoxLab, France 12:5 Lunch and networking

Afternoon Session: Case studies analysis 13:45 Introduction to breakout sessions 14:00 Breakout sessions 15:00 Coffee break 15:20 Case study reporting and discussion 16:50 Concluding remarks M. Martens, President Beltox