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Overview and Comments on the FDA Draft Guidance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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.