CSRC Think Tank: Update on Regulatory Status of Hypertension, Biomarkers and Arrhythmia monitoring in Clinical Trials 

June 7th, 2023 

 7:00-8:00 Registration and Light Continental Breakfast 

8:00-8:10 Welcome – Jonathan Seltzer, CSRC Executive Director View Slides 

8:10-8:20 15 years of CSRC Sustained Public-Private Partnerships Mitchell Krucoff (CSRC Leadership, DCRI) 

8:20-10:00 Session 1: Proarrhythmia 

Moderator(s): Boaz Mendzelevski (Cardiac Safety Consultants) 

8:20-8:25 Introduction to Proarrhythmia Boaz Mendzelevski (Cardiac Safety Consultants) 

8:25-8:35 Whats in the New ICH E14/S7B Q&A Guideline? David Strauss (FDA) 

8:35-8:45 The double-negative conundrum, a practical guide for the perplexed Derek Leishman (Eli Lilly) View Slides

8:45-8:55 Alternative methods for assay sensitivity assessment in routine Phase 1 QT Studies Jorg Taubel (Richmond Pharmacology) View Slides

8:55-9:05 COVID-19 and QT Prolongation – should we be worried? Boaz Mendzelevski
(Cardiac Safety Consultants) View Slides

9:05-10:00 Discussion Panelists: Boaz Mendelevski (Cardiac Safety Consultants), David Strauss (FDA), Derek Leishman (Eli Lilly), Jorg Taubel (Richmond Pharmacology), Lars Johannesen (FDA) 

10:00-10:10 Break 

10:10-11:30 Session 2: Biomarkers 

Moderator(s): TBD 

10:10-10:15 Introduction to Biomarkers Session: TBD 

10:15-10:25 Utility of continuous high-density data using wearable digital sensors in clinical research Charles Benson (Eli Lily) 

10:25-10:35 Is myocardial injury without any other findings an actionable situation? Mandar Aras (UCSF) View Slides

10:35-10:45 Should the form of cancer treatment dictate the means by which biomarkers are utilized? Dan Zlotoff
(Mass General) View Slides

10:45-10:35 What about imaging biomarkers? What role might they play? Kelley Branch
(University of Washington) View Slides

10:35-11:30 Discussion Panelists: Mandar Aras (UCSF), Dan Zlotoff (Mass General), Kelley Branch (University of Washington), Charles Benson (Eli Lily) 

11:30-12:30 Lunch Break 

12:30-14:05 Session 3: Hypertension 

Moderator(s): Philip Sager (Stanford University) and William B White (University of Connecticut) 

12:30-12:35 Introduction to Hypertension Session: Philip Sager (Stanford University) 

12:35-12:45 Small increases in blood pressure and CV risk Raymond Townsend (University of Pennsylvania) 

12:45-12:55 Is there evidence that off-target pressor effects of drugs leads to untoward outcomes? Luke Laffin (Cleveland Clinic) View Slides

12:55-13:05 Intermittent vs chronic use drugs and the targeted population William B White
(University of Connecticut) View Slides

13:05-13:15 How to set up a clinical study to evaluate the off-target pressor effects of non-cardiac drugs Robert Kleiman (Clario) View Slides

13:15-14:05 Discussion Panelists: Philip Sager (Stanford), William B White (University of Connecticut), Christine Garnett (FDA), Robert Kleiman (Clario), Raymond Townsend (Institution), Luke Laffin (Cleveland Clinic) 

14:05-14:15 Break 

14:15-15:45 Hot Topics Roundtable Discussion: 2023 Cardiac Safety Barriers 

14:15-15:00 Hot Topic 1 – Cardio-Oncology 

• 14:15-14:25 Presentation Marc Bonaca 

• 14:25-15:00 Discussion & Topic Polling 

15:00-15:45 Hot Topic 2 – Wearables View Slides

• 15:00-15:10 Presentation Rajesh Ghosh & John Rootenberg View Slides

• 15:10-15:45 Discussion & Topic Polling 

15:45-16:00 Wrap Up & Next Steps