Let me point to a new multi-stakeholder white paper that was just highlighted by Dun Liang, the director of Global Regulatory Affairs / Diagnostics, at Lilly. The white paper has authors from Lilly, Merck, Sanofi, J&J, consultancy Hanson Wade, and others. It's based on a conference in June 2024.
Liang essay introducing the white paper:
Liang at Linked In:
https://www.linkedin.com/in/dunliang/
Liang writes,
- This first-of-its-kind white paper explores the critical role of diagnostics—particularly Companion Diagnostics (CDx)—in modern pharmaceutical development and precision medicine.
- Co-authored by a cross-industry subject leaders, the paper provides a comprehensive overview of global regulatory frameworks, including those in the U.S., EU, Japan, and China, and offers practical insights for integrating diagnostics into therapeutic product strategies.
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Connect directly to the white paper PDF here:
https://world-cdx.com/about/content-hub/#
Here's how the white paper opens:
- Subject matter experts attended the World CDx Regulatory Affairs & Policy Summit in Boston in June 2024 (organized by Hanson Wade). Following the conference, diagnostic regulatory experts from across the pharmaceutical industry formed a working group to provide an overview and propose recommendations in the format of this white paper.
- This white paper explores the evolving impact of global diagnostics regulation to support therapeutic product development, focusing on their application in clinical trials, navigating regulatory landscapes, and discussing pragmatic considerations. Specific emphasis is placed on the role of the new and specialized function known as Precision Medicine or Diagnostic Regulatory Affairs, highlighting its value in pharmaceutical development to ensure timely patient access to cutting-edge therapies while navigating regulatory landscapes effectively.
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