Track
:
Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code:
157
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
William Wheeler, Wheeler Biopharm Consulting, LLC, United States
William Wheeler, a board-certified cardiologist providing independent cardiovascular drug development consulting. He has worked in private and academic practice, big pharma, biotech and CRO environments. Dr. Wheeler completed his cardiology fellowship at Cedars Sinai in Los Angeles.
PRESENTER
(S):
William Wheeler, Wheeler Biopharm Consulting, LLC, United States
William Wheeler, a board-certified cardiologist providing independent cardiovascular drug development consulting. He has worked in private and academic practice, big pharma, biotech and CRO environments. Dr. Wheeler completed his cardiology fellowship at Cedars Sinai in Los Angeles.
Royce Morrison, Comprehensive Clinical Development, United States
Royce Morrison MD CPI brought over 20 years' internal medicine practice experience to early phase research in 2002. PI, Dir. of Medical Affairs, then Dir. of Clinical Strategy, he has developed cardiac safety & radiolabeled study capabilities. He is a CP SIAC Core Committee member.
Gary Gintant is a Research Fellow in the Dept. of Integrative Pharmacology, Global Pharmaceutical R&D, Abbott Laboratories and also chairman of the Abbott QT-Proarrhythmia Working Group.
Description
QT "derisking," mandated for all drugs, has become simpler and inexpensive to confidently achieve in early-phase clinical studies. Learn how to acquire continuous ECG data with small N and analyze by methods translated from preclinical to human.
Learning Objectives: Discuss the safety and regulatory imperatives for cardiac safety studies Identify the need for research/analytic methods that translate across preclinical and clinical development Explain how to better choose the available options for when and how to "derisk" a drug in development.