Title:
Cardiovascular Safety and Development of Type 2 Diabetes Mellitus Medications: Current State of the Art and Opportunities to Advance the Science
Date(s) And Time(s):
Sep 23 2009 8:00AM - Sep 24 2009 2:05PM
Location:
Omni Shoreham Hotel
2500 Calvert Street NW
Washington, DC 20008
Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research, Medical Communications, Regulatory Affairs, Research & Development, Statistics
Overview:
Join Industry and FDA Leaders to Discuss the Evolving Science of Cardiovascular Safety
(CV) and Diabetic Drug Development
OVERVIEW
Recent data published in major medical journals suggests possible increase in cardiovascular (CV) risk associated with the use of certain drugs for the treatment of type 2 diabetes (T2DM). The Division of Metabolism and Endocrinology Products of the US Food and Drug Administration (FDA) summoned an advisory board meeting on July 1and 2, 2008, which recommended that all new T2DM drugs demonstrate CV safety in appropriately designed and powered outcome studies. The agency adopted these recommendations in a new guidance document issued in December 2008. This new guidance required all new drugs developed to treat T2DM be shown not to increase the risk of cardiovascular events based on formal statistical acceptance criteria for the relative risk ratio. The new standard is in effect and impacts all drugs and biologics currently in development. The approach to medications to treat type 2 diabetes Mellitus is undergoing discussion.
This two-day workshop will examine evolving scientific data surrounding CV safety and diabetic drug development, future methods to make development of these drugs more streamlined while ensuring safety, investigative efforts, and provide background information and a platform for multidisciplinary discussion on the issues at stake. You will also explore possible new solutions in terms of global developpment strategy for T2DM agents, CV safety study design, statistical considerations, outcome parameters, surrogate vs. hard CV endpoints, and more.
FEATURED TOPICS
· Type 2 Diabetes: Clinical implications, CV manifestations, and epidemiology
· Therapies and targets for treatment of Diabetes Mellitus – potential implications on CV safety
· Glycemic control – evidence for positive and negative impacts on CV and renal outcomes in Type 2 DM
· New trial design approaches to assessing CV Safety
· The clinical evidence that T2DM diabetic drugs can increase CV risk and potential mechanisms
· Diabetic drug development and CV safety
· Approaches to Clinical Analysis of CV Risk
· Novel Clinical Trial Approaches
· Future Approaches to Assessing T2DM Drug Development and CV Safety
· QT experience as a model for furthering collaborative approaches/research in CV – Safety
· assessment of T2DM agents
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
· Summarize the basis for assessing the evidence for cardiovascular risk with new and existing T2DM drugs;
· Recognize the current and evolving regulatory initiatives for CV safety of T2DM drugs;
· Discuss how new regulations will impact clinical development of new T2DM drugs; and
· Evaluate scientific data from preclinical and clinical sources, pre-and post-marketing strategies, and other innovative approaches to drive future efforts to develop efficient approaches to the development of T2DM drugs while ensuring CV safety.
Target Audience:
Professionals involved in:
· Pharmaceutical cardiac safety
· Clinical diabetology
· Clinical epidemiology
· Regulatory affairs
· Drug development
· Pharmacovigilance
· Clinical Drug Safety
· Biostatistics
· Data managers
· Endocrinology/Metabolism
· Clinical investigation
Event Code:
09021
Contact Information:
Contact Benjamin Zaitz at the DIA office by telephone +1-215-293-5803,
fax +1-215-442-6199 or email Benjamin.Zaitz@diahome.org.