Events

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.

See our draft agenda here