P207: Implementing a Structured Benefit-Risk Assessment (SBRA) Framework: A Case Study
Poster Presenter
Feisal Othman
Benefit Risk Assessment Lead
Bristol Myers Squibb United States
Objectives
The objective of this abstract is to present our approach to implementing a structured benefit-risk (B-R) assessment framework to improve consistency, transparency and support informed decision-making and regulatory submissions.
Method
The team established a 3-pronged strategy: people, planning & development, consisting of organizational socialization, extensive research into regulatory authority guidance/ industry best practices, & cross-functional integration to ensure all perspectives were considered. The project spanned two years.
Results
An SBRA project team was established and worked over a 2-year period to develop a SBRA Framework for assessing the B-R balance of medicines in development. The project began with a small team within Global Risk Management (GRM) and evolved into a large cross-functional project team consisting of 25+ colleagues in 15 functions. The project was sponsored by GRM Sr. Leadership. The team prioritized communication to foster strategic alignment across functions, including socializing the SBRA project with a continuous feedback loop for process improvement. Extensive research was conducted to evaluate major regulatory and other relevant guidance on SBRA, including but not limited to Food & Drug Administration’s B-R assessment guidance, European Medicines Agency guidance, International Council for Harmonisation M4E (R2) & E2C (R2) guidelines, Innovative Medicines Initiative project, ProACT-URL, and Council for International Organizations of Medical Sciences working group report, as well as a literature search and deep dive into 50+ regulatory submissions, to identify quantitative SBRA methodologies that contributed to the product’s B-R assessment and/or communication. This resulted in the establishment of a systematic & standardized approach to B-R assessment aligned with regulatory frameworks and industry best practices.
A case study was conducted to test the framework end to end in a simulated submission setting. The case study identified gaps and areas of improvement in the process.
The project resulted in the adoption of a semi-quantitative, SBRA framework to foster a consistent and transparent approach to B-R assessment. Processes & procedures, supporting documentation, tools & a robust training program were developed to facilitate the SBRA process. The team conducted more than 10 formal cross-functional presentations to ensure transparency and alignment with different functions, including both communities and leadership, as well as several Q&A sessions.
Conclusion
Establishing a structured approach to B-R assessment of medicines will enhance consistency and transparency across products and therapeutic areas and will streamline decision making. This will result in timely, high-quality assessments which clearly communicate the company’s position on the B-R balance of medicines and the rationale and evidence to support regulatory approval.
Strong leadership support, clear communication and robust change management are crucial for implementing new processes in a large global organization. Alignment and coordination among impacted departments such as Research and Development, Regulatory, Clinical, Epidemiology and others is essential to ensure that all perspectives are represented and accounted for. Additionally, performance metrics and continuous improvement practices help in assessing progress and refining processes.
SBRA represents a significant advancement in regulatory and pharmacovigilance practices, offering a robust and transparent framework for B-R assessment tailored to both industry and regulatory needs. Its successful implementation will enable more efficient and informed decision making, leading to improved patient safety and enhanced regulatory compliance.
