Symposium: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (BM)

Moderator(s)

• 

  Rodrigo Cristofoletti, PhD

  Assistant Professor
  University of Florida

Presentations:

• 9:00 AM – 9:30 AM ET

  WAPPS-Hemo Modelling on a Global Scale to Dose Optimize Clotting Factor (Biomolecule) Prophylaxis in Hemophilia Patients
  

  Speaker: Andrea Edginton, PhD – University of Waterloo, School of Pharmacy
• 9:30 AM – 10:00 AM ET

  MIDD Using PK/PD Modeling with Discrete Outcomes in Dose Selection for Biomolecules - General Considerations
  

  Speaker: Serge Guzy, PhD – UF
• 10:00 AM – 10:30 AM ET

  Modeling Informed Pre-Clinical to Clinical PK/PD Translation for siRNA Therapeutics
  

  Speaker: Vivaswath S. Ayyar, PhD – Janssen Research & Development, LLC
• 10:30 AM – 11:00 AM ET

  Modeling and Simulation to Fill the Knowledge Gap in Pregnancy and Lactation
  

  Speaker: Nupur Chaphekar, MS – University of Pittsburgh