1st Annual Workshop on Non-Clinical Safety assessment of

The Belgian Society for Toxicology and Ecotoxicology
3rd Workshop on Non-Clinical Safety Assessment
of Biopharmaceuticals
“Next generation therapies”
Wednesday 12 March 2014
GSK Vaccines, Wavre, Belgium
Preliminary programme
8:20 – 8:50
Coffee
8:50 – 9:00
Welcome
Morning session: Introductory lectures
9:00 – 9:40
General introduction on oligonucleotides and gene therapy – Lee Coney, Huntingdon
Life Sciences, UK
9:40 – 10:20
Safety Evaluation of Gene Therapy Products including Inhaled Products – Charles River
Laboratories, UK [Speaker TBC]
10:20 – 10:45
Regulatory perspective on the safety assessment of oligonucleotides and gene
therapies [Speaker TBC]
10:45 – 11:05
Coffee break
11:05 – 11:35
Development of oligonucleotides for treatment of Orphan diseases and insight in
personalized medicine - C. den Besten, Prosensa, The Netherlands
11:35 – 12:15
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 – 12:45
Toxicologic pathology of antisense oligonucleotides - C. Sobrie, CitoxLab, France
12:45 – 13:45
Lunch and networking
Afternoon session: Case studies analysis
13:45 – 14:00
Introduction to breakout sessions
14:00 – 15:00
Breakout sessions
15:00 – 15:20
Coffee break
15:20 – 16:50
Case study reporting and discussion
16:50 – 17:00
Concluding remarks
Organizing Committee: Judith Baumeister (Ablynx), Micaela Damsten, Frédérique Delannois, Camille Planty and
Lawrence Segal (GSK Vaccines), Miek Desmidt, Ad Knaapen and Ilham Smyej (Johnson & Johnson), Annick
Cauvin and Miranda Cornet (UCB Pharma)
Info and registration : www.beltox.be

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