DIA/FDA/PVRI Debate on Clinical Trials for Pulmonary Arterial Hypertension

Date(s) And Time(s):
Mar 2 2010 8:00AM - Mar 3 2010 5:00PM

Location:
Marriott Bethesda North Hotel
5701 Marinelli Road
North Bethesda, MD 20852-2785

Interest Area(s):
Clinical Research, Pharmacology, Regulatory Affairs, Research & Development, Statistics

Overview:

Have Your Voice Heard During a Special Debate on Issues Related to Clinical Trials for Pulmonary Arterial
Hypertension.

Currently there have been seven drugs approved for the chronic treatment of pulmonary arterial hypertension (PAH). Yet, because of the use of similar trial design and endpoints, questions remain about the longterm benefits, effects on survival, and mechanism of action of these agents, as well as the appropriate trial design. Join regulatory, industry, and academic leaders as they debate the uncertainties around the approved treatments for PAH, alternative clinical trial designs for future studies that better address the unanswered questions from the existing trials, and limitations in performing clinical trials in patients with PAH.

Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Discuss the results of existing clinical trials for PAH
• Identify the limitations of approved therapies for PAH and approaches to address these questions in future trials
• Explore recommendations for new clinical trial designs for future trials in PAH
• Describe surrogate and alternative endpoints that may be used in PAH in future trials

Target Audience:
Professionals involved in:
• Treatment of pulmonary hypertension
• Global regulatory affairs/Policy/Drug or DeviceApproval/GRP
• Pharmaceuticals
• Academic Health Centers
• Biotechnology
• Clinical Research & Development
• Pharmaceutics
• Pharmacokinetics/Metabolism/Pharmacodynamics
• Statistics/Biostatistics/Modeling

Contact Information:

Ben Zaitz at DIA. Tel +1-215-293-5803 Fax +1-215-442-6199

email benjamin.zaitz@diahome.org