C1A - Quantitative Systems Pharmacology in Late Stage Oncology Drug Development– New Horizons to Dose Optimization

Chair(s)

• 

  Piet van der Graaf, PharmD, PhD

  Senior Vice President
  Certara
  Canterbury, England, United Kingdom

Chair and Speaker(s)

• 

  Amitava Mitra, PhD

  Executive DIrector
  Clinical Pharmacology
  Boston, Massachusetts, United States

  PDF Slides

Speaker(s)

• TL

  Tommy Li, PhD

  Director
  Genmab
  Edison, New Jersey, United States

  PDF Slides
• AR

  Atiqur Rahman, PhD

  Division Director
  FDA, United States

  PDF Slides

Presentations:

• 11:00 AM – 11:30 AM MST

  Dose guidance for a novel combination therapy to treat head and neck squamous cell carcinoma (HNSCC) for patients with HRAS/PIK3CA variants using QSP model
  

  Speaker: Amitava Mitra, PhD – Clinical Pharmacology
• 11:30 AM – 12:00 PM MST

  Model-based Dose Selection for Epcoritamab, a subcutaneous CD3xCD20 bispecific antibody
  

  Speaker: Tommy Li, PhD – Genmab
• 12:00 PM – 12:30 PM MST

  QSP Modeling and Dose Optimization: A Regulatory Perspective
  

  Speaker: Atiqur Rahman, PhD – FDA