Webinar Webinar

From APAC to Global: Designing Data that Travels

July 16, 2026 7:30 AM - 8:30 AM IST


Register

Navigate clinical development strategies across regions with confidence. Discover best practices for integrating ex-US evidence, precision dosing, and innovative approaches into your global operations — from organizations already doing it successfully.

What you'll gain:

  • Strategies to optimize clinical development across multiple regions
  • Insight into precision dosing approaches that enhance global development
  • Best practices for integrating diverse evidence into your data strategy
  • Real-world case studies and implementation strategies

Bernardo Haddock Lobo Goulart, M.D.

Vice President - Technical, Regulatory Strategy

Title: “Ex-U.S. Oncology Trials: FDA Perspective”

Key points: 

  • Growing interest in initiating drug development ex-US (China).
  • Risk-based approach to transition from China to US-based development.
  • FDA expectations for use of ex-US data for approval.
     

Pengfei Song, Ph.D.

Senior Vice President, Regulatory Strategy

Title: Complying with FDA’s Project Optimus

Key points: 

  • What is Project Optimus?
  • Why is it so challenging?
  • How to convince the FDA?

Martin Roessner

Corporate Vice President, Biostatistics

Title: Insights into Smarter Drug Development

Key points: 

  • Efficient study designs for early oncology development
  • Statistical approaches from first-in-human to the optimal dose
  • Regional differences and requirements during early development