CDER speakers to address cardiovascular safety, diabetic drug development

The Drug Information Association (DIA), in collaboration with FDA and the Cardiac Research Safety Consortium, will host Development of Type 2 Diabetes Mellitus Drugs Conference: State-of-the-Art Cardiovascular Safety Assessments, Oct. 5–6 in Washington, D.C.

The 2-day workshop will allow participants to join senior FDA and industry leaders to discuss timely issues related to cardiovascular safety in the development of pharmaceutical therapies for type 2 diabetes mellitus (T2DM). Topics include optimal clinical trial designs; diabetes mellitus regulatory guidance; post-marketing assessments; preclinical testing to evaluate CV risk and mechanistic considerations; and biomarkers, pharmacogenomics, and collaborative efforts.

FDA speakers are expected to include Robert J. Temple, MD, deputy center director for Clinical Science, Center for Drug Evaluation and Research (CDER); Mary Parks, MD, director, Division of Metabolism & Endocrinology Products, Office of Drug Evaluation II, Office of New Drugs, CDER; Norman Stockbridge, MD, PhD, director, Division of Cardiovascular & Renal Products, Office of Drug Evaluation I, Office of New Drugs, CDER; Ilan Irony, MD, clinical team leader, Division of Metabolism & Endocrinology Products, Office of New Drugs, CDER; Hylton V. Joffe, MD, MMSc, lead medical officer, Diabetes Drug Group I, Division of Metabolism & Endocrinology Products, Office of New Drugs, CDER; and J. Todd Sahlroot, PhD, deputy director and team leader, Office of Translational Sciences, Office of Biostatistics, CDER.

“The development of type 2 diabetic medications has been significantly impacted by recent data suggesting possible increases in CV risk associated with the use of aggressive glucose control with insulin or certain oral medications to treat T2DM,” said Philip T. Sager, MD, FACC, FAHA, program chair and chair, Scientific Oversight Committee, Cardiac Safety Research Consortium. “Our expert presenters will discuss how the development of T2DM has been significantly impacted by recent data suggesting possible increases in CV risk associated with the use of aggressive glucose control with insulin or certain oral medications to treat T2DM.”

For more information, contact Benjamin Zaitz, program manager, at (215) 293-5803 or Benjamin.Zaitz@diahome.org.