News | March 20, 2008

DIA, FDA and Heart Rhythm Society to Explore QT, Arrhythmia

March 21, 2008 — The Drug Information Association (DIA) will host an educational forum in conjunction with the FDA and the Heart Rhythm Society entitled 'QT and Arrhythmia Issues in Drug Development' from April 7-8, in Bethesda, MD, to focus on the new direction in the development of pharmaceutical agents for cardiac repolarization.

Specific areas of concentration will include:

• QT study design and analyses;
• the use of new methodologies including concentration-effect modeling;
• approaches to QT evaluation in Phase 3 when there is a QT signal;
• QT assessment in patient populations when healthy volunteers cannot be studies;
• QT assessment of biologic compounds;
• regulatory implications; and
• a special session on the science and clinical ramifications of QT shortening.

“The FDA is, of course, keenly interested in safety standards, and their involvement with this workshop means participants will gain first-hand knowledge of regulatory expectations such as how new preclinical or clinical biomarkers can gain regulatory acceptance,” said Program Chair Philip T. Sager, M.D., chief medical officer, CardioDX Inc.

Workshop content will be relevant to a variety of disciplines in drug development, including academic scientists, industry management, clinical project physicians, quality assurance directors, preclinical/discovery scientists, ECG safety data managers, ECG lab and equipment vendors, regulatory specialists and safety assessment personnel.

In addition to the two-day conference, a pre-event tutorial: An Introduction to QT Issues in Drug Development will be offered on April 6. The tutorial will provide attendees with the resources and information necessary to understand relevant concepts in the collection, analysis and interpretation of ECG parameters in their own clinical trials and to learn of the most recent developments in clinical interpretation of QT/QTc prolongation.

For more information: www.diahome.org

Related Content

Humanetics Presents Data on Drug to Protect Cardiac Cells From Space-Like Radiation

Photo from NASA

News | Pharmaceuticals | February 01, 2018
February 1, 2018 –Humanetics Corporation (Humanetics) has recently completed two research studies funded by the Natio
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals | October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
News | Pharmaceuticals | October 04, 2017
October 4, 2017 — MyoKardia Inc.
News | Pharmaceuticals | September 12, 2017
September 12, 2017 — Inclisiran lowers low-density lipoprotein (LDL, or “bad”) cholesterol for up to one year in pati
Merck Announces Results of REVEAL Outcomes Study of Anacetrapib
News | Pharmaceuticals | September 11, 2017
Merck and researchers in the Clinical Trial Service Unit at the University of Oxford announced the publication and...
Statins Associated With Improved Heart Structure and Function
News | Pharmaceuticals | May 26, 2017
Statins are associated with improved heart structure and function, according to research presented at EuroCMR 2017, May...
Feature | Pharmaceuticals | May 16, 2017
May 16, 2017 – Results of a groundbreaking clinical trial demonstrate the effectiveness of a novel, fast-acting nasal
Prescribing Patterns Change Following Direct Marketing Restrictions
News | Pharmaceuticals | May 05, 2017
A study of how policies restricting pharmaceutical promotion to physicians affect medication prescribing found...
EBBINGHAUS study, evolocumab, repatha, statin therapy, cognitive issues, ACC.17 study
News | Pharmaceuticals | April 03, 2017
There is no evidence that adding a new cholesterol-lowering drug to treatment with a statin causes memory loss or other...
synthetic HDL-C injection, cholesterol, arterial plaque, heart attack patients, CARAT trial, ACC.17, clinical study
News | Pharmaceuticals | March 29, 2017
Injection of a novel form of synthetic high-density lipoprotein cholesterol (HDL-C), or good cholesterol, into the...
Overlay Init