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Overview and Comments on the FDA Draft Guidance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
Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.
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.
Reblozyl Misses Primary Endpoint in Phase III Myelofibrosis Trial but Shows Clinical Promise
July 21st 2025The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl (luspatercept-aamt).
Managing Side Effects and Dosing in Off-Label GLP-1 Use with Help from Real-World Evidence
July 18th 2025Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.