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Monthly FDA Guidance and Regulatory News Review - April 2026
This April 2026 regulatory update highlights new policies on biomarker validation, expanded access to investigational...
Veristat’s President and Chief Biostatistician, John P. Balser, PhD will moderate the second in a two-part series of panel discussions on Biomarkers at the upcoming MassBio Forum taking place on Tuesday, August 4, 2015 from 8:00-10:00 AM. This second forum will focus on the use of biomarkers in clinical development, with specific discussion on clinical study design, patient selection, statistical analysis, and the regulatory challenges with using biomarkers.
The panel will explore the following:
- How biomarkers may inform a meaningful clinical decision for a specific patient
- How does research help systematize the utility of biomarkers?
- Clinical issues in the use of biomarkers
- Statistical issues in the use of biomarkers - prediction versus prognosis
- Regulatory issues in the use of biomarkers as adjuncts to drug approvals
- Case studies in the use of biomarkers in clinical research, successful or otherwise
Additionally, the discussion will begin with a brief review of the main points covered during the Biomarker Part 1 Forum, titled “Basic Concepts of Biomarkers, Discovery and Identification”.
To learn more about this Biomarker panel discussion or to register, visit the Biomarker Part II Forum.
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Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works
Apr 27, 2026 Veristat Blog
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a scan or it does not. A...