Varying Regulatory Philosophies and AD Approval Priorities, AD/PD™ Session Spotlight

In this episode of AD/PD™ Session Spotlight, we delve into Forum Discussion 1, "Varying Regulatory Philosophies and AD Approval Priorities – USA, EU, Asia, and Other Parts of the World," a dynamic exchange exploring how regional regulatory approaches impact the development, approval, and accessibility of Alzheimer’s disease therapies.

Co-moderated by Agneta Nordberg (Sweden) and David Holtzman (USA), this discussion brings together insights from international regulatory and clinical experts: Naohiro Egawa (Japan), Tamara Shiner (Israel), Henrik Zetterberg (Sweden), and Pavel Balabanov (The Netherlands).

Key highlights include:

• The complex landscape of disease-modifying drug approvals, exemplified by the case of kinumab

• Contrasts in regulatory frameworks between the EMA, FDA, and Japan’s PMDA

• The evolving role of biomarkers in diagnosis and treatment selection

• Ongoing challenges in balancing risk, clinical utility, and access across diverse healthcare systems

This episode is a must-listen for global stakeholders in Alzheimer’s research, regulation, and clinical care, looking to navigate the nuances of regional policy and foster cross-border collaboration in advancing neurodegenerative disease treatments.

This podcast was created using AI to provide a quick and insightful summary of an AD/PD™ 2025 session. While every effort has been made to ensure accuracy, listeners are encouraged to refer to original conference materials and recordings for detailed information.

The AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, took place on April 1-5, 2025, in Vienna Austria.

https://adpd.kenes.com/