MPS WORLD SUMMIT VIRTUAL PRE-CONFERENCE 1: Towards Regulatory Acceptance

Welcome 
Thomas Hartung, CAAT, Johns Hopkins University, United States 


Keynote Address: Advancing Alternative Methods at FDA 
Suzanne Fitzpatrick, Food and Drug Administration (FDA), United States 


Short talks: Standardization, scaling-up, and quality control of platforms and cell sources

  • Multi-organ microphysiological system coupled with mechanistic mathematical modelling for studying cardio-metabolic disorders
    Peter Gennemark, AstraZeneca, Sweden
  • A robotized 1546 compound screen in a perfused 3D microfluidic angiogenesis assays
    Camilla Soragni, MIMETAS, the Netherlands
  • PSIS workshop: the many roles of standards for organ-on-chip
    Monica Piergiovanni, European Commission, Joint Research Center (JRC), Belgium, Italy
  • Supporting the adoption of microphysiological systems for COVID research
    Anthony Holmes, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), United Kingdom 


Short talks: Obstacles to accomplishing regulatory acceptance 

  • MPS initiatives for industrial implementation and regulatory acceptance in Japan
    Seiichi Ishida, National Institute of Health Sciences, Sojo University, Japan 
  • A roadmap to overcoming obstacles to MPS regulatory acceptance: perspectives from technology providers
    Megan LaFollette, North American 3Rs Collaborative, United States 
  • Applicability of organ-on-chip systems in toxicology and pharmacology
    Rob Vanderbriel, National Institute for Public Health and the Environment (RIVM), The Netherlands


Panel Discussion: Perspectives on Regulatory Acceptance 

Moderator – Danilo Tagle, National Center for Advancing Translational Sciences (NCATS), United States 

  • Anne Gourmelon, Organization for Economic Co-operation and Development (OECD) Test Guidelines Programme, France 
  • Sonja Beken, European Medicines Agency (EMA), Belgium 
  • Seiichi Ishida, National Institute of Health Sciences (NIHS), Japan 
  • Jean Lou Dorne, European Food Safety Authority (EFSA), Italy 
  • Donna Mendrick, Food and Drug Administration (FDA), United States 
  • Elizabeth Mendez, Environmental Protection Agency (EPA), United States 


Q&A Session with Panelists