Dear CiPA Community,
News
CSRC forms partnership with ACCP
In July 2018, the American College of Clinical Pharmacology (ACCP) and Cardiac Safety Research Consortim announced the signing of a collaborative Memorandum of Understanding (MOA). CSRC and ACCP will work together to develop, plan and conduct various educational events and programs. The partnership will also develop and produce research and policy statements/position papers relevant to the fields of clinical pharmacology and the cardiac and vascular safety of medical products.
CSRC Committee Chair to Moderate at CEC Summit
On September 26-27, 2018 the Duke Clinical Research Institute and the Stanford Center for Clinical Research will cohost a CEC Summit, an exciting new educational event at the Chicago Hilton O'Hare. Thought leaders from academia, industry, and government will be in attendance including CSRC Executive Committee member and Scientific Programs Committee Chair Jonathan Seltzer, MD, MBA, MA, who will serve as a moderator.
CiPA Update
Dear CiPA Community,
Announcement of Interest in the Domain of Drug Cardiovascular Safety
On May 31, 2018 the US Food and Drug Administration (FDA) released a draft Guidance for Industry entitled “Assessment of Pressor Effects of Drugs.” The purpose of the guidance is to advise sponsors with regard to their premarketing assessment of a drug’s off-target effect on blood pressure. Given that elevated blood pressure is known to increase the risk of stroke, heart attack, and death, a drug’s effect on blood pressure can be an important consideration in benefit-risk assessment. The guidance therefore recommends systematic characterization of a drug candidate’s effect on blood pressure during drug development.
CSRC, HESI, and FDA to Host CiPA Meeting
The CSRC, Health and Environmental Sciences Institute (HESI), and the FDA will host a two-day meeting titled, “New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrythmia Assay (CiPA),” on May 21-22, 2018 in Washington, D.C.
CSRC Committees Gain New Members
Join us in welcoming Boaz Mendzelevski, MD; Anupam Agarwal, MD, MPH; and Mary Beth Sabol, MD, BSN to CSRC committees. Drs. Mendzelevski and Agarwal joined the Scientific Oversight Committee and Dr. Sabol is now serving as the co-chair of the Membership Committee. Learn more about these members and their expertise by reading their biographies below.
CSRC Heart Failure Think Tank Planning Committee Opportunities Available
The CSRC is currently recruiting planning committee members to help organize and prepare for the upcoming think tank, "Evaluation of Heart Failure as an Off-target Event in Development of Diabetes and other Non-cardiac Drugs."
CSRC Meeting & CSRC Think Tank: Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development
Find slides from our "Detection, Assessment and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development" think tank below.