A platform-based approach connects AI across workflows, data and governance, helping life sciences organizations move from isolated wins to real scale.
|Articles|June 18, 2006
- Applied Clinical Trials-06-19-2006
- Volume 0
- Issue 0
Meeting Highlights - June 19, 2006
Welcome, Awards Presentation, Keynote Address and Hot Topics
Advertisement
June 19, 2006
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Overview and Comments on the FDA Draft Guidance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
Articles in this issue
over 20 years ago
BBK Healthcare, Inc. Evolves to Become BBK Worldwideover 20 years ago
Datafarm Announces the Release of Web-Based eCTD ViewerAdvertisement
Related to this article
In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.
The clinical research industry talks about patient-centeredness constantly but embeds it too late, too narrowly, and without clear ownership, and the cost shows up in enrollment failures, protocol deviations, and outcomes that don't reflect what patients actually care about.
Why clinical development’s next AI bottleneck is not the model, but the system around it.
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
FDA Opens Applications for Expedited IND Pilot Designed to Accelerate First-in-Human Trial Timelines
The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.
A Syneos Health-announced study from Tufts Center for the Study of Drug Development finds no single sourcing model consistently outperforms others, pointing instead to vendor coordination, governance, and fit-for-purpose design as the real performance drivers.
Regulatory expectations for patient input in drug development have shifted from aspiration to documented methodology across three major jurisdictions.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Lessons from Hundreds of Clinical Trials: AI’s Successes, Gaps, and Opportunities
2
The Execution Gap: Why Clinical Trial Infrastructure Has to Be Built Before AI Can Deliver
3
Benchmarking Study Finds Clinical Trial Performance Is Shaped by Operating Model Design, Not Sourcing Strategy
4
What "Patient Voice" Actually Requires: Beyond the Buzzword
5