Welcome, Awards Presentation, Keynote Address and Hot Topics
08:30 am - 10:00 am
Welcome and Awards Presentation
Teresa K. Musser,
President, DIA,
Senior Director, Project Mgt. & Clinical Operations
Rigel Pharmaceuticals
Opening Remarks
Charles C. Depew, PharmD
2006 DIA Annual Meeting Chairperson,
GlaxoSmithKline
Keynote Address
Sanjay Gupta, MD
Senior Medical Correspondent
Health and Medical Unit at CNN
Faculty, Department of Neurosurgery
Emory University School of Medicine
10:00 am - 6:00 pm — STUDENTS POSTER SESSION
10:30 am - 12:00 pm
Patient-reported Outcome Instruments:
Overview and Comments on the FDA Draft Guidance
Chairperson, Laurie Beth Burke,
Office of New Drugs, CDER, FDA
3:30 pm - 5:00 pm
Electronic Patient-reported Outcomes (ePRO) Technology and the
FDA Draft PRO Guidance: A Town Meeting to Discuss Industry's Response
Chairperson and Moderator: John M. Weiler, MD, President,
CompleWare Corp.
3:30 pm - 5:00 pm
Prescription Drug Labeling: Implementation of FDA's New Regulation for the Content and Format of the USPI and Accompanying Guidance Documents
Chairperson: Steven W. Bass, PhD, Group Director,
Global Labeling and Promotion Compliance,
Bristol-Myers Squibb Co.
5:00 pm - 6:00 pm
MONDAY RECEPTION
Exhibit Hall A, B, & C, 2nd Floor, Convention Center
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.