Developing a Benefit-Risk Process That Becomes Fully Integrated into Developmental Processes and Decision-Making Within a Biopharmaceutical Organization

• Activity Number: 680
• Type: Topic Contributed
• Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Mondira Bhattacharya* and Rebecca B. Reindel
• Companies: AbbVie and AbbVie
• Keywords: Benefit-risk ; Framework ; Decision-making

Abstract

Regulatory agencies have always assessed new drug approval submissions within the construct of the overall benefit and risks (B-R). While a uniform approach has not been adopted by agencies worldwide,the data informing B-R assessment is now expected to be viewed within a structured framework, potentially with incorporation of quantitative methodologies. AbbVie developed a new, comprehensive internal process to facilitate this assessment. Incremental data review throughout development, systematic and consistent approaches to assessment, multifunctional team approach with varied expertise and timing that dovetailed well with other objectives and deliverables of development teams were addressed in process development. Provision of significant team support and the use of tools designed to assist in decision-making is anticipated and planned. The experience gained by these first teams will serve as a basis for communication within the developmental organization and may lead to future process refinements. An iterative approach is necessary to ensure that period B-R assessments serve as the cornerstone for decision-making and communication without our organization.