Think Tank
June 7th
Update on Regulatory Status of Hypertension, Biomarkers and Arrhythmia Monitoring in Clinical Trials.
Join us at FDA to examine proarrhythmia, hypertension and biomarkers.
In Session 1, these leading industry professionals will speak on panels discussing:
- Regulations for ECG/QT
- The double-negative conundrum
- Alternative methods for assay sensitivity assessment in routine Phase 1 QT Studies
- Covid-19 and prolonged QT
In Session 2, we will discuss:
- Small increases in blood pressure and CV risk I
- Intermittent versus chronic use hypertension drugs
In Session 3, the meeting faculty will dive into:
- Biomarkers
In Session 4, the panelists will discuss hot topics in the field such as:
- Biologics/cardiomyopathy and vaccine development
- MACE
- Gene therapies
- Wearables
We will be joined by professionals from FDA Regulatory, Cardiac Safety Consultants, Ltd., Eli Lilly, Richmond Pharmacology, University of Connecticut, Stanford University, University of Pennsylvania, Cleveland Clinic, Clario, Mass General, DSI, Penn Medicine, and UCSF.