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

2. This meeting is sponsored by Gold Bronze

3. SPONSORS BELTOX Gold Silver Bronze

4. Morning Session: Introductory lectures 8:50Welcome JM. Wilkin, GSK Vaccines, Belgium 9:00Nucleotide therapies: Past failures and future challenges L. Coney, Huntingdon Life Sciences, United Kingdom 9:40Safety Evaluation of Gene Therapy Products including Inhaled Products M. Mc Elroy, Charles River Laboratories, United Kingdom 10:20Regulatory perspective on the safety assessment of oligonucleotides and gene therapies C. Beuneu, Federal Agency for Medicines and Health Products, Belgium 10:45Coffee 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 11:35Non-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 12:15Toxicologic pathology of antisense oligonucleotides C. Sobry, CitoxLab, France 12:5Lunch and networking

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