Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
428
Date:
Thursday, June 27, 2013
Time:
10:45 AM to 12:15 PM
EST
Location:
154
CHAIR
:
Jeffrey Heilbraun, MS (SCHNON), Director Strategic Development, BioClinica Inc., United States
Jeff holds a Bachelor of Science degree in Biology with a focus on physiology from Tufts University in Boston, Massachusetts and a Masters of Science in Health Promotion and Disease Management from The American University in Washington D.C.. Jeff is supporting the development CSRC BP white paper.
SPEAKER
(S):
Mary Jane Geiger, (SPKNON), Pharmaceutical Consultant, United States
Dr. Geiger is VP, Clinical Development at Relypsa, Inc. Prior to joining Relypsa, she was employed at Eli Lilly and Company for over 10 years. Most of her time was spent in the diabetes business unit. Before that, she worked at Merck Research Laboratories.
Alison Schecter, MD, FACC, Novartis Institutes of Biomedical Research
Description
There has been an increased focus on changes in blood pressure (BP) related to cardiac safety from a regulatory perspective. This session will provide insight into the "off-target" BP response of drugs outside of cardiovascular drugs from a development and regulatory perspective.