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
2023
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Shock | February 25, 2023 | MDEpiNet & CSRC Think Tanks: Back to Back with CRT2023 PASSION CV Prospective Registry-Supported Trials V and Cardiac Safety Research Consortium Cardiogenic Shock VII | Slides, Recordings and Agenda |
| Shock | June 7th, 2023 | CSRC Think Tank: Update on Regulatory Status of Hypertension, Biomarkers and Arrhythmia monitoring in Clinical Trials | Slides and Agenda |
2022
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Shock | March 18, 2022 | Cardiac Safety Research Consortium: Shock VI Virtual Thinktank Shock Evidence Collection: Needs & Solutions Going Forward | Slides and Agenda View sessions here |
2021
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Shock | January 29, 2021 | Session One: Informed Consent; Session Two: Networks and First Clinical Question | Session One Agenda Session Two Agenda View sessions here |
| Shock | October 29, 2021 | CSRC Think Tank: Shock Academic Research Consortium (SHARC) | Slides and Agenda View sessions here |
| Cardio-Oncology | December 1, 2021 | CSRC Think Tank: CV Safety in Oncology Clinical Trials: Providing Clarity for a New Era of Cancer Therapeutics | Slides and Agenda View sessions here |
2020
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Cardiac Biomarkers | January 22, 2020 | Driving Efficiencies in Clinical Trials through the use of Cardiac Biomarkers | Agenda |
| Cardiogenic Shock | February 22, 2020 | Shock III: Advancing Pragmatic Priorities & Pathways in Shock Research | Agenda |
| Cardiogenic Shock | October 29, 2020 | CSRC At SCAI-Shock IV Virtual Think Tank — 2020 and Beyond | Agenda |
2019
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| NOACs; Pediatrics | April 4, 2019 | NOAC Use in the Pediatric Population: Defining the Path Forward | Slides and Agenda |
| Cardiogenic Shock | July 24, 2019 | Shock II: Practical Approaches to Generating Clinical Evidence for the Treatment of Cardiogenic Shock | Slides and Agenda |
2018
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Cardiogenic Shock | September 7, 2018 | Defining the Clinical and Regulatory Landscape for Cardiogenic Shock | Slides and Agenda |
| Arrhythmia, Proarrhythmia, CiPA | May 21-22, 2018 | New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrhythmia Assay (CiPA) | Slides and Agenda |
2017
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Sudden Cardiac Death | February 10, 2017 | CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study | Slides & Agenda |
| Cardiovascular Regenerative Medicine | September 15 -16, 2017 | Co-sponsored Symposium with the Texas Heart Institute on Cardiovascular Regenerative Medicine | Event Information |
| Oncology Drug Development | October 24-25, 2017 | CSRC Meeting and Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development Think Tanks | Slides & Agenda |
2016
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Sudden Cardiac Death | February 18, 2016 | The 2nd Annual Think Tank on Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care Resource | Slides & Agenda |
| Endpoint Adjudication | March 11, 2016 | CSRC and MDEpiNet Thinktank Meeting: “The Role of Endpoint Adjudication in Medical Device Clinical Trials” | Slides & Agenda |
| Proarrhythmia | April 6, 2016 | CSRC/FDA Workshop: The Proarrhythmic Assessment of New Chemical Entities | Slides & Agenda |
| Social Listening | June 3, 2016 | CSRC/DIA Think Tank: Enabling Social Listening for Cardiac Safety | Slides & Agenda |
| Annual Meeting | October 18, 2016 | CSRC 10th Annual Meeting | Slides & Agenda |
| Efficiencies in Phase 3 Development | October 19, 2016 | CSRC 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 CiPA | December 6, 2016 | Critical Discussion- Future of the Assessment of Drug-Induced Arrhythmias and the Comprehensive in Vitro Proarrhythmia Assay (CiPA) | Slides & Agenda |
| QTc ER Modeling and VT/VF | December 7, 2016 | Part A: QTc Exposure-Response Modeling Workshop: What is Required?Part B: Endpoints When Treating VT/VF in Patients with ICDs | Slides & Agenda |
2015
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Novel Anticoagulants | February 3, 2015 | NOAC Reversal Agent Think Tank Follow-up: Post-Approval Safety and Effectiveness | Slides & Agenda |
| Annual Meeting | February 19, 2015 | 2015 Annual Meeting | Slides & Agenda |
| Sudden Cardiac Death | February 20, 2015 | Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care Resource | Slides & Agenda |
| Cell Therapies for CV Indications | October 23, 2015 | CSRC Roundtable Discussion: Cardiovascular Safety for Cell Therapies in Development for Cardiovascular Indications | Slides & Agenda |
| Social Listening | November 4, 2015 | CSRC/DIA: Social Listening and Safety Surveillance— Enabling Opportunities for Cardiac Safety | Slides |
| Long-Term Electrocardiographic Monitoring | December 2, 2015 | Long Term Electrocardiographic Monitoring: Its Role in Clinical Drug Development and Population Screening | Slides & Agenda |
| Novel Anticoagulants | December 3, 2015 | Is There a Role For Pharmacokinetic/Pharmacodynamics Guided Dosing For Novel Anticoagulants? | Slides & Agenda |
2014
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| CiPA Update Workshop | December 11, 2014 | CiPA Update Workshop CSRC-HESI-SPS-FDA Meeting | Slides & Agenda Rechanneling the Cardiac Proarrhythmia Safety Paradigm- An Update_18 FEB 2015 (Think Tank Synopsis) |
| QT Assessment | December 12, 2014 | Can QT Assessment in Early Clinical Development be used to replace the TQT Study – Presenting Results from the Prospective IQ-CSRC Clinical Study | Slides & Agenda |
| Novel Anticoagulants | April 2014 | CSRC NOAC Reversal Think Tank | Slides & Agenda |
| COPD | March 2014 | COPD Think Tank Meeting | Slides & Agenda Think Tank Synopsis |
| CV Safety Outcome Studies | February 2014 | CSRC FDA ACC Outcome Think Tank | Slides & Agenda Think Tank Synopsis |
2013
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting | December 12-13, 2013 | 2013 Cardiac Safety Research ConsortiumICOS Annual Conference Meeting | Slides & Agenda Day 1 Slides & Agenda Day 2 |
| Clinical Trial Improvements | November 6, 2013 | CSRC CEC Adjudication Think Tank | Slides & Agenda Think Tank Synopsis |
| Arrhythmia Risk Assessment | July 29, 2013 | CSRC/HESI Think Tank: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study & CSRC TREAT IV Meeting | Slides & Agenda Think Tank Synopsis White paper: Rechanneling the cardiac proarrhythmia safety paradigm |
| TREAT IV | July 23, 2013 | Transradial Education and Therapeutics TREAT (IV) 4th Think Tank on Novel Research Infrastructure to Study Access Site and Bleeding Safety of Anti-Thrombotic Drug | Slides & Agenda Logistics Document |
2012
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting | December 9-11, 2012 | CSRC Annual Meeting 2012 & CRF Open Forum | Dates, 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 2012 | Session Program & Speakers |
| CV/Death Case Report Forms | September 6, 2012 | Cancelled: Review and Finalization of CV/Death Case Report Forms for Non-Cardiovascular Studies | Cancelled: Review and Finalization of CV/Death Case Report Forms for Non-Cardiovascular Studies |
| Blood Pressure | July 18, 2012 | Blood Pressure Think Tank | Slides & Agenda |
| TREAT III | June 4, 2012 | TransRadial Education and Therapy (TREAT) III Think Tank | Slides & Agenda |
| DIA | June 27, 2012 | CSRC Session at the DIA Annual Meeting | Overview & 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 Japan | Presenter Information & Meeting Program |
| DIA | April 17-18, 2012 | DIA’s Cardiovascular Safety and State-of-the-art Assessments | Features & Final Program |
| QT Assessment | February 2, 2012 | QT Assessment in Early Clinical Development Think Tank and White Paper Open Forum | Think 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 Summit | Discussion Topics & Event Details |
2011
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting | October 5-6, 2011 | 2011 CSRC Annual Meeting in collaboration with the International CardiOncology Society | Slides & Agenda Logistics Document |
| Diabetes | April 13, 2011 | CSRC Diabetes Think Tank | Slides & 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 Tank | Slides & Agenda Registration Information |
| CBI Risk Assessment | January 26-27, 2011 | CBI’s 5th Annual Cardiovascular Risk Assessment Summit | Event Details |
2010
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting and Pediatric CV | December 9-10, 2010 | 2010 CSRC Annual Meeting; Pediatric CV Safety Think Tank | Annual Meeting Slides & Agenda Think Tank Slides & Agenda |
| T2DM Drugs and Assessment | October 5-6, 2010 | Development of T2DM Drugs & Cardiovascular Safety Assessments | Topics & Speakers |
| DIA | September 23-24, 2010 | Development of T2DM Drugs & Cardiovascular Safety Assessments | Featured Topics |
| TREAT | June 23, 2010 | TransRadial Education Training and Therapy (TREAT) Initiative Think Tank | Slides & Agenda |
| CSRC Document Review | June 28, 2010 | Review of CSRC Document “Use of Cardiac Troponin in Clinical Drug Development” | Agenda |
| Drug Development Safety | April 11-13, 2010 | DIA/FDA/Heart Rhythm Society’s CV Safety in Drug Development | Featured Topics |
| CBI Annual Summit 2010 | January 12-13, 2010 | The 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 Summit | Summit Goals & Featured Topics |
| Drug Evaluation Approaches | January 2010 | Safety Evaluation of Atrial Fibrillation Ablation Using a Collaborative Pan-Stakeholder Critical Path Registry Model: CSRC Think Tank | Slides & Agenda |
2009
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting | October 29-30, 2009 | 2009 CSRC Annual Meeting | Slides & Agenda |
| Atrial Fibrillation Ablation | April 27-28, 2009 | National Registry on Safety & Atrial Fibrillation Ablation: An Incubator Think Tank | Slides & Agenda |
2008
| Topic | Date | Title | Slides and Agendas |
|---|---|---|---|
| Annual Meeting | October 6-7, 2008 | 2008 CSRC/HESI Annual Meeting | Slides & Agenda |