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