Mark Fielding
Director - Chemistry, Manufacturing, Controls, Regulatory Affairs & Radiopharmaceuticals AstraZeneca
I have a PhD in organic chemistry and joined AstraZeneca as a drug substance process development lead for synthetic pharmaceuticals. Following this, I moved into regulatory CMC and have since had oncology project lead roles covering the entire project lifecycle. More recently I have played a lead role in the regulatory CMC development of radiopharmaceuticals within AstraZeneca and am active in external trade associations, to help shape external guidance in this field.
Seminars
Wednesday 2nd December 2026
Panel Discussion: The Industry Perspective on Navigating the Evolving Global Regulatory CMC Landscape for Targeted Radiopharmaceuticals
8:20 am
- Understanding how evolving global regulatory expectations across manufacturing, comparability, isotope supply and control strategy are reshaping the development and commercialisation pathway for targeted radiopharmaceuticals
- Exploring where regulatory fragmentation continues to create challenges across multinational TRP programs and determining how industry leaders are building more globally aligned CMC strategies to reduce downstream delays
- Examining how leading developers are proactively approaching scalability, manufacturing readiness, and supply resilience earlier in development to strengthen long-term regulatory and commercial success
