ASA Connect

Dear Members of the Biometrics Section of ASA,

We would like to remind you to join us for a collaborative virtual session hosted by the AAAS Section on Statistics (Section U) and the AAAS Section on Pharmaceutical Sciences (Section S). This timely program will feature Dr. Daniel L. Gillen, Chancellor's Professor and Chair, Department of Statistics, at UC Irvine.

The webinar will examine the FDA's Accelerated Approval Program and the role of surrogate endpoints in drug development, highlighting both successes and failures through notable case studies.

Register here via Zoom

If the Zoom link is not available in your email software, please use this link:

https://aaas.zoom.us/meeting/register/8v3H_7aZScaei8y-MdhvIw#/registration

Session Details
Title: FDA's Accelerated Approval Program and the Critical Role of Advisory Committees in the Regulatory Process
Date: Tuesday, November 25, 2025
Time: 3:00 to 4:00 p.m. ET
2:00 p.m. to 3:00 p.m. CT
1:00 p.m. to 2:00 p.m. MT
12:00 p.m. to 1:00 p.m. PT
8:00 p.m. to 9:00 p.m. UTC

Speaker: Dr. Daniel L. Gillen, Chancellor's Professor and Chair, Department of Statistics, UC Irvine
Moderator: Dr. Lucio M. Miele, Director, LSU-LCMC Health Cancer Center
Collaborating Sections: AAAS Section U (Statistics) and AAAS Section S (Pharmaceutical Sciences)

In this presentation, Dr. Gillen will discuss how surrogate endpoints support earlier access to treatments for serious conditions and the statistical considerations required to determine true clinical benefits. Drawing on his experience with FDA advisory committees, he will highlight regulatory challenges, methodological innovations, and lessons learned from high-profile case studies in oncology and Alzheimer's disease.

This joint program brings together both the statistical and pharmaceutical sciences communities within AAAS, reflecting the importance of cross-disciplinary dialogue in shaping evidence-based regulatory policy.

We look forward to having you join us for this timely and informative online discussion.

Best regards,

AAAS Section U and S Steering Committee