This webinar addresses preclinical program designs for biological therapeutics. Using case studies, our speakers explore key areas to consider when building these complicated safety assessment packages in accordance with regulatory guidance and the 3Rs. Topics will include:

  • Target engagement
  • Selection of animal models
  • Mechanism of action
  • Species differences in response
  • Immunogenicity
  • Biomarker validation
  • Role of in vitro studies

Presenters

  • Peter Gaskin, PhD, Associate Director, Program Management, Charles River
  • Benoit Ruot, PhD, MSc, Director, Program Management, Charles River
  • Marie-Soleil Piché, PhD, MSc, Scientific Director, Immunology, Charles River