The first session in Perspective PV’s Perspectives Webinar Series focused on one of the most high-impact topics in modern pharmacovigilance: Structured Benefit-Risk (sB-R). For emerging biotech and mid-sized pharma companies, mastering sB-R is not just about meeting regulatory requirements. It is a competitive advantage that supports earlier planning, clearer decisions, and more confident submissions.
Watch the full webinar below or read on for a summary of key takeaways and expert responses to real-world Q&A.
Key Themes: From Framework to Function
Why Structured Benefit-Risk Matters
Traditional, qualitative benefit-risk assessments can lead to missed expectations, delays, inspection findings, and conservative labeling. Regulators increasingly expect structured, data-driven frameworks that clarify uncertainties and support proactive safety planning.
Start Early and Iterate Often
PPV experts emphasized that sB-R should begin as early as preclinical development and continue evolving through each stage. The CIOMS XII guidance and PPV’s methodology support integration across the full development lifecycle, from first-in-human trials to post-marketing activities.
PPV’s Hybrid 5-Step Framework
Adapted from BRAT and ProACT-URL models, PPV’s hybrid approach is designed for organizations needing a proportionate, scalable solution. It includes:
• Structured context and evidence tables
• Data-driven visuals for cross-functional alignment
• Compatibility with RMPs, eCTDs, and EU JCA submissions
• Early incorporation of patient and stakeholder perspectives
Business Value of sB-R
Beyond meeting regulatory expectations, structured benefit-risk strategies reduce development uncertainty, accelerate timelines, and improve interactions with HTA bodies. They also help companies avoid unnecessary post-marketing commitments and resource strain.
Q&A Spotlight: Expert Answers to Real-World Scenarios
How do you approach sB-R for gene therapies with only one dose?
Gene therapy introduces unique uncertainties. PPV’s framework supports early identification of long-term questions, such as durability and reversibility. Structured assumptions and scenario-based tools help define credible trade-offs that matter to patients and regulators.
What if you’re in early-phase oncology without efficacy signals?
In first-in-human oncology studies, the goal is not to fabricate benefit but to transparently show what is known and what is still uncertain. Context tables and structured visuals guide the conversation about risk, even when benefit data is minimal.
Should structured benefit-risk be used throughout the lifecycle?
Yes. Both CIOMS and PPV advocate for lifecycle-based approaches to benefit-risk, starting early and continuing through regulatory approval and post-market use. This consistency supports stronger governance and better decisions at every stage.
Who owns the sB-R process?
Ownership should rest with the safety function, particularly the safety management team. This ensures alignment with both scientific rigor and organizational accountability. While collaboration with regulatory, clinical, commercial, and medical affairs is essential, safety leadership must guide the process.
What’s Next
PPV’s next Perspectives Webinar will continue this series by exploring how organizations can overcome internal barriers and successfully integrate structured benefit-risk into development and regulatory strategy. The next session is scheduled for November.
Contact Us to Learn How We Can Support Your sB-R Implementation!
