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

Rapid Fire Moderator(s)

• 

  Amitava Mitra, PhD

  Clinical Pharmacology
  Kura Oncology

Presentations:

• 3:00 PM – 3:15 PM ET

  Assessing Food Impact on Bioequivalence Using Physiologically-Based Pharmacokinetic Modeling
  

  Rapid Fire Speaker: Fang Wu, PhD – U.S. Food & Drug Administration
• 3:15 PM – 3:30 PM ET

  First-in-Patient Dose Prediction for Adeno-Associated Virus-Mediated Hemophilia Gene Therapy
  

  Rapid Fire Speaker: Peng Zou, PhD – Daiichi Sankyo Inc.
• 3:30 PM – 3:45 PM ET

  Streamlined Pathways to Clinical Success through Integrated Modelling
  

  Rapid Fire Speaker: Jake Dickinson, BSc (Hons) – SEDA Pharmaceutical Development Services
• 3:45 PM – 4:00 PM ET

  PK/PD and First-In Human Dosing Considerations for Cellular Therapies
  

  Rapid Fire Speaker: Hardik Mody, PhD – Johnson and Johnson