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P200: Driving Continuous Improvement in Structured Benefit-Risk Assessment (SBRA): Insights from Early Rollout

Poster Presenter

Feisal Othman

Benefit Risk Assessment Lead
Bristol Myers Squibb
United States

Objectives

The objective of this abstract is to share our experience and lessons learned from the internal company roll-out of our SBRA process and framework, to enhance knowledge sharing and advance the science of structured benefit risk assessment for the benefit of patients, regulators and industry.

Method

Following a 2-year project to develop a SBRA framework, an SBRA Function was established to drive implementation of SBRA. The framework was applied to select development assets and stakeholder feedback was sought along with monthly lessons learned sessions to ensure continuous quality improvement.

Results

As a result of our post-launch continuous quality improvement initiative, important areas of focus were identified, particularly around aligning source documents early in the process and coordinating stakeholder input. We began by defining our objectives for process improvement which included quality, cross-functional collaboration, timeliness of deliverables, regulatory compliance, stakeholder satisfaction among others. Next, we identified high priority items for enhancement, spanning process design, templates, training, and cross-functional collaboration. We then developed an improvement and implementation plan. Major takeaways: • Cross-functional alignment is critical—early identification and confirmation of BRPT membership and inclusion of clinical scientists ensures comprehensive input and avoids late-stage gaps. • Integrating CSBRA with regulatory strategy documents such as regulatory storyboards, briefing books, assessment aid and Clinical Overview enhances coherence and supports consistent messaging across submissions • Value trees and effects tables help teams prioritize and communicate key benefit-risk drivers. • Iteratively refining processes as new data and feedback emerged. • Clarifying roles and expectations-especially around benefit risk assessment document (BRAD) SME section ownership, regulatory milestones, and BRAD inclusion in relevant documents, reduces confusion and streamlines document development • Embedding flexibility in SBRA SOPs and project plans allows for tailored workflows, senior reviews, and staggered discussions of key benefits and risks across the product portfolio, accommodating assetspecific needs. • Continuous improvement through metric evaluation, stakeholder feedback surveys, strengthens the CSBRA framework and supports regulatory success. Identified areas of focus were prioritized and change management processes initiated to address key areas of improvement.

Conclusion

Continuous improvement is critical to the successful implementation of SBRA. Our continuous quality improvement which began with early rollout of the SBRA framework, provided actionable insights that enhanced process robustness and stakeholder engagement and satisfaction. These findings support the expansion of SBRA across assets and offer practical guidance for other organizations seeking to institutionalize structured benefit-risk assessment.