Global Development of Biopharmaceutical Products: Past, Present, and Future

• Activity Number: 149
• Type: Invited
• Date/Time: Monday, August 4, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Kevin J. Carroll*+
• Companies: KJC Statistics
• Keywords: multi-regional clinical trial

Abstract

Consistent with the theme of this joint statistics meeting ("global impact"), the growing importance of the emerging markets has led to an increased demand for global drug development. Many biopharmaceutical companies are moving towards simultaneous development and registration of new drugs or vaccines across the world: a single integrated development program, leading to a single set of data (including bridging studies) that would allow simultaneous submission in major markets. Global clinical development strategy utilizing multi-regional clinical trials (MRCTs) plays a crucial role to ensure the success of such approach in developing innovative biopharmaceutical products. Although it comes with great opportunities, there are also challenges in the design, conduct and interpretation of MRCTs. In this session, a recent outcome study, PLATO trial, will be used to illustrate some of the challenges. A panel of experts from academia, biopharmaceutical industry and regulatory agencies will share their thought and new ideas on resolving the issues/challenges encountered in current MRCTs.