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Monday, June 25 • 11:00am - 12:00pm
#105: Cardiac Safety in Drug Development and the Critical Role of Public-Private Partnerships: The Cardiac Safety Research Consortium Model

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-18-518-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss how the Cardiac Safety Research Consortium’s collaborative, precompetitive approach has significantly advanced the field of cardiac safety in medical product development. Industry, academia, and regulatory perspectives will be provided.

Learning Objectives

Discuss the concept and implementation of Public-Private Partnerships; Recognize the importance of cardiac safety considerations throughout new drug development; Describe new approaches to regulatory science in cardiac safety.

Chair

Rick Turner

Speaker

The Cardiac Safety Research Consortium: Current Accomplishments and Future Goals
Mitchell W. Krucoff, MD

New Approaches to Regulatory Science in Cardiac Safety
Norman Stockbridge

The Comprehensive In-Vitro Proarrhythmia Assay (CiPA)
Philip T. Sager, MD


Speakers
avatar for Mitchell Krucoff

Mitchell Krucoff

Professor of Medicine/Cardiology, Duke University
Dr. Mitchell W. Krucoff is Professor of Medicine/Cardiology at Duke University. He serves as Director of the Cardiovascular Devices Unit and the eECG Core Laboratory at the Duke Clinical Research Institute (DCRI) and is a special government employee of the United States FDA, from... Read More →
PS

Philip Sager

Adjunct Professor, Stanford University
Philip T. Sager, M.D, FACC, FAHA, FHRS is an Adjunct Professor at the Stanford University, the previous chair of the FDA Cardio-Renal Advisory Committee and an Executive Comm. member of the Cardiac Safety Research Consortium. He is a member of the ICH E14 QT Group and is on the Steering... Read More →
NS

Norman Stockbridge

Director, Division of Cardiovascular and Renal Products, OND, CDER, FDA
Norman Stockbridge received his MD and PhD (Physiology) from Duke University. He has been a part of the FDA/CDER Division of Cardiovascular and Renal Products since 1991, serving as Division Director since 2004.
avatar for Rick Turner

Rick Turner

President, Turner Consulting and Communications LLC
J. Rick Turner, PhD, DSc, is an experimental research scientist, and currently President, Turner Consulting & Communications LLC. He is a member of the Cardiac Safety Research Consortium’s Executive Committee, and an active participant in many aspects of the Science of Cardiac Safety... Read More →
avatar for Rick Turner

Rick Turner

Expert Consultant, DRT Strategies, Inc.
J. Rick Turner, PhD, DSc, is an experimental research scientist, and currently President, Turner Consulting & Communications LLC. He is a member of the Cardiac Safety Research Consortium’s Executive Committee, and an active participant in many aspects of the Science of Cardiac Safety... Read More →

Monday June 25, 2018 11:00am - 12:00pm
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session