Think Tanks

Sharing Knowledge

“I have learned a good deal about the regulatory side of medicine. Thanks to the CSRC, I have a much better appreciation of the pressures people are under when making decisions about the development and approval of drugs, biologics, and devices.”

Peter K. Kowey, MD, FACC, FAHA, FHRS
Professor of Medicine and Clinical Pharmacology, Jefferson Medical College
William Wikoff Smith Chair in Cardiovascular Research, Lankenau Heart Institute

Explore Think Tanks by Year

2021

TopicDateTitleSlides and Agendas
ShockJanuary 29, 2021Session One: Informed Consent;
Session Two: Networks and First Clinical Question
Session One Agenda
Session Two Agenda
View sessions here

2020

TopicDateTitleSlides and Agendas
Cardiac BiomarkersJanuary 22, 2020Driving Efficiencies in Clinical Trials through the use of Cardiac BiomarkersAgenda
Cardiogenic ShockFebruary 22, 2020Shock III:  Advancing Pragmatic Priorities & Pathways in Shock ResearchAgenda
Cardiogenic ShockOctober 29, 2020CSRC At SCAI-Shock IV Virtual Think Tank — 2020 and BeyondAgenda

2019

TopicDateTitleSlides and Agendas
NOACs; PediatricsApril 4, 2019NOAC Use in the Pediatric Population: Defining the Path ForwardSlides and Agenda
Cardiogenic ShockJuly 24, 2019Shock II: Practical Approaches to Generating Clinical Evidence for the Treatment of Cardiogenic ShockSlides and Agenda

2018

TopicDateTitleSlides and Agendas
Cardiogenic ShockSeptember 7, 2018Defining the Clinical and Regulatory Landscape for Cardiogenic ShockSlides and Agenda
Arrhythmia, Proarrhythmia, CiPAMay 21-22, 2018New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrhythmia Assay (CiPA)Slides and Agenda

2017

TopicDateTitleSlides and Agendas
Sudden Cardiac DeathFebruary 10, 2017CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot StudySlides & Agenda
Cardiovascular Regenerative MedicineSeptember 15 -16, 2017Co-sponsored Symposium with the Texas Heart Institute on Cardiovascular Regenerative MedicineEvent Information
Oncology Drug DevelopmentOctober 24-25, 2017CSRC Meeting and Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development Think TanksSlides & Agenda

2016

TopicDateTitleSlides and Agendas
Sudden Cardiac DeathFebruary 18, 2016The 2nd Annual Think Tank on Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care ResourceSlides & Agenda
Endpoint AdjudicationMarch 11, 2016CSRC and MDEpiNet Thinktank Meeting: “The Role of Endpoint Adjudication in Medical Device Clinical Trials”Slides & Agenda
ProarrhythmiaApril 6, 2016CSRC/FDA Workshop: The Proarrhythmic Assessment of New Chemical EntitiesSlides & Agenda
Social ListeningJune 3, 2016CSRC/DIA Think Tank: Enabling Social Listening for Cardiac SafetySlides & Agenda
Annual MeetingOctober 18, 2016CSRC 10th Annual MeetingSlides & Agenda
Efficiencies in Phase 3 DevelopmentOctober 19, 2016CSRC Think Tank: Real World Data to Assess Cardiovascular Safety- Can We Improve Efficiencies in Phase 3 Development?Slides & Agenda
Think Tank Synopsis
Drug-induced Arrhythmia and CiPADecember 6, 2016Critical Discussion- Future of the Assessment of Drug-Induced Arrhythmias and the Comprehensive in Vitro Proarrhythmia Assay (CiPA) Slides & Agenda
QTc ER Modeling and VT/VFDecember 7, 2016Part A: QTc Exposure-Response Modeling Workshop: What is Required?Part B: Endpoints When Treating VT/VF in Patients with ICDs Slides & Agenda

2015

TopicDateTitleSlides and Agendas
Novel AnticoagulantsFebruary 3, 2015NOAC Reversal Agent Think Tank Follow-up: Post-Approval Safety and EffectivenessSlides & Agenda
Annual MeetingFebruary 19, 20152015 Annual MeetingSlides & Agenda
Sudden Cardiac DeathFebruary 20, 2015Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care ResourceSlides & Agenda
Cell Therapies for CV IndicationsOctober 23, 2015CSRC Roundtable Discussion: Cardiovascular Safety for Cell Therapies in Development for Cardiovascular IndicationsSlides & Agenda
Social ListeningNovember 4, 2015CSRC/DIA: Social Listening and Safety Surveillance— Enabling Opportunities for Cardiac SafetySlides
Long-Term Electrocardiographic MonitoringDecember 2, 2015Long Term Electrocardiographic Monitoring: Its Role in Clinical Drug Development and Population ScreeningSlides & Agenda
Novel AnticoagulantsDecember 3, 2015Is There a Role For Pharmacokinetic/Pharmacodynamics Guided Dosing For Novel Anticoagulants?Slides & Agenda

2014

TopicDateTitleSlides and Agendas
CiPA Update WorkshopDecember 11, 2014CiPA Update Workshop CSRC-HESI-SPS-FDA MeetingSlides & Agenda

Rechanneling the Cardiac Proarrhythmia Safety Paradigm- An Update_18 FEB 2015 (Think Tank Synopsis)
QT AssessmentDecember 12, 2014Can QT Assessment in Early Clinical Development be used to replace the TQT Study – Presenting Results from the Prospective IQ-CSRC Clinical StudySlides & Agenda
Novel AnticoagulantsApril 2014CSRC NOAC Reversal Think TankSlides & Agenda
COPDMarch 2014COPD Think Tank MeetingSlides & Agenda
Think Tank Synopsis
CV Safety Outcome StudiesFebruary 2014CSRC FDA ACC Outcome Think TankSlides & Agenda
Think Tank Synopsis

2013

TopicDateTitleSlides and Agendas
Annual Meeting December 12-13, 2013 2013 Cardiac Safety Research ConsortiumICOS Annual Conference MeetingSlides & Agenda Day 1
Slides & Agenda Day 2
Clinical Trial Improvements November 6, 2013CSRC CEC Adjudication Think TankSlides & Agenda
Think Tank Synopsis
Arrhythmia Risk Assessment July 29, 2013CSRC/HESI Think Tank: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study & CSRC TREAT IV MeetingSlides & Agenda
Think Tank Synopsis
White paper: Rechanneling the cardiac proarrhythmia safety paradigm
TREAT IV July 23, 2013Transradial Education and Therapeutics TREAT (IV) 4th Think Tank on Novel Research Infrastructure to Study Access Site and Bleeding Safety of Anti-Thrombotic DrugSlides & Agenda
Logistics Document

2012

TopicDateTitleSlides and Agendas
Annual Meeting December 9-11, 2012CSRC Annual Meeting 2012 & CRF Open ForumDates, Topics & Prices
Annual Meeting Slides & Agenda
CRF Open Forum Agenda
Cardiac Disease and Safety with Cancer Treatment November 7, 2012 CSRC Session at the AHA Scientific Sessions 2012Session Program & Speakers
CV/Death Case Report Forms September 6, 2012 Cancelled: Review and Finalization of CV/Death Case Report Forms for Non-Cardiovascular StudiesCancelled: Review and Finalization of CV/Death Case Report Forms for Non-Cardiovascular Studies
Blood Pressure July 18, 2012 Blood Pressure Think TankSlides & Agenda
TREAT III June 4, 2012 TransRadial Education and Therapy (TREAT) III Think TankSlides & Agenda
DIA June 27, 2012 CSRC Session at the DIA Annual MeetingOverview & Objectives
ICH S7B Guidelines June 28, 2012 CSRC Co-sponsors: “ICH S7B Guidelines: Then and Now”Registration & Webinar Brochure
DIA May 28-29, 2012 3rd DIA Cardiac Safety Workshop in JapanPresenter Information & Meeting Program
DIA April 17-18,  2012 DIA’s Cardiovascular Safety and State-of-the-art AssessmentsFeatures & Final Program
QT AssessmentFebruary 2, 2012 QT Assessment in Early Clinical Development Think Tank and White Paper Open ForumThink Tank Slides & Agenda
White Paper Open Forum Invitation for Participation
CV Risk Assessment Summit January 30-31, 2012 CBI and Applied Clinical Trials 6th Annual Cardiovascular Risk Assessment SummitDiscussion Topics & Event Details

2011

TopicDateTitleSlides and Agendas
Annual Meeting October 5-6, 2011 2011 CSRC Annual Meeting in collaboration with the International CardiOncology SocietySlides & Agenda
Logistics Document
Diabetes April 13, 2011CSRC Diabetes Think TankSlides & Agenda
Registration Information
DIA April 2011 DIA’s Cardiovascular Safety in Drug Development: State-of-the-art Assessments Dates & Session Topics
TREAT II March 7, 2011 TransRadial Education And Therapy (TREAT) II Think TankSlides & Agenda
Registration Information
CBI Risk Assessment January 26-27, 2011CBI’s 5th Annual Cardiovascular Risk Assessment SummitEvent Details

2010

TopicDateTitleSlides and Agendas
Annual Meeting and Pediatric CVDecember 9-10, 20102010 CSRC Annual Meeting; Pediatric CV Safety Think TankAnnual Meeting Slides & Agenda
Think Tank Slides & Agenda
T2DM Drugs and Assessment October 5-6, 2010 Development of T2DM Drugs & Cardiovascular Safety AssessmentsTopics & Speakers 
DIA September 23-24, 2010Development of T2DM Drugs & Cardiovascular Safety Assessments Featured Topics
TREATJune 23, 2010TransRadial Education Training and Therapy (TREAT) Initiative Think TankSlides & Agenda 
CSRC Document ReviewJune 28, 2010Review of CSRC Document “Use of Cardiac Troponin in Clinical Drug Development”Agenda
Drug Development Safety April 11-13, 2010DIA/FDA/Heart Rhythm Society’s CV Safety in Drug DevelopmentFeatured Topics
CBI Annual Summit 2010 January 12-13, 2010The Latest Approaches in the Evaluation of Drugs that Affect Heart Rate, Blood Pressure, QT Prolongation and Other CV Safety Related Issues; CBI’s 4th Annual Cardiac Safety Assessment SummitSummit Goals & Featured Topics
Drug Evaluation ApproachesJanuary 2010Safety Evaluation of Atrial Fibrillation Ablation Using a Collaborative Pan-Stakeholder Critical Path Registry Model: CSRC Think Tank Slides & Agenda

2009

TopicDateTitleSlides and Agendas
Annual Meeting October 29-30, 2009 2009 CSRC Annual Meeting Slides & Agenda
Atrial Fibrillation Ablation April 27-28, 2009National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Think Tank  Slides & Agenda

2008

TopicDateTitleSlides and Agendas
Annual Meeting October 6-7, 2008 2008 CSRC/HESI Annual Meeting Slides & Agenda