WELCOME
3rd Workshop on Non-Clinical Safety Assessment of Biopharmaceuticals
“Next generation therapies”
This meeting is sponsored by
Gold
Bronze
SPONSORS BELTOX
Gold
Silver
Bronze
Morning Session: Introductory lectures
8:50 WelcomeJM. 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 break11:05 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