Global PBRER Strategy for Oncology Product
How we developed a comprehensive PBRER for a novel oncology therapy that effectively addressed emerging safety signals while maintaining a positive benefit-risk profile.
Client
Global Pharmaceutical Company
Therapeutic Area
Oncology (Targeted Therapy)
Document Type
Periodic Benefit-Risk Evaluation Report (PBRER)
Regulatory Authorities
EMA, FDA, PMDA, Health Canada
The Challenge
Our client had received a conditional marketing authorization for their novel targeted oncology therapy based on promising Phase 2 data. As post-marketing data accumulated and their clinical development program expanded, several challenges emerged:
- Multiple emerging safety signals identified through spontaneous reporting required careful evaluation and contextualization
- Ongoing clinical trials were generating substantial new efficacy and safety data that needed integration into the benefit-risk assessment
- Regulatory agencies in different regions had varied requirements and concerns regarding the product's safety profile
- The competitive landscape was rapidly evolving, affecting the contextual benefit-risk evaluation
The client needed a comprehensive PBRER that would not only meet regulatory requirements across multiple jurisdictions but also effectively communicate the evolving benefit-risk profile of their product.
Key Challenges
Complex Safety Profile
Multiple potential adverse events of special interest requiring detailed analysis
Global Regulatory Requirements
Needed to satisfy different expectations from EMA, FDA, PMDA and Health Canada
Evolving Data Landscape
Continuous influx of new data from ongoing clinical trials and post-marketing surveillance
Tight Timeline
8-week timeline to prepare a comprehensive PBRER for multiple regulatory submissions
Our Approach
EloquiMed assembled a specialized team with expertise in oncology, pharmacovigilance writing, and global regulatory requirements. Our comprehensive approach included:
1. Data Integration and Analysis
We performed a thorough review of all available safety and efficacy data, including clinical trials, spontaneous reports, literature, and epidemiological studies. Our medical writers with oncology expertise worked closely with the client's safety physicians to identify meaningful patterns.
2. Signal Management Strategy
For each identified safety signal, we developed a structured evaluation framework that included causality assessment, incidence analysis, comparison with background rates, risk factors identification, and potential impact on specific patient populations.
3. Benefit-Risk Integration
We created a comprehensive benefit-risk framework that integrated the latest efficacy data with the evolving safety profile, contextualized within the current treatment landscape for the specific oncology indication.
4. Harmonized Global Strategy
Rather than producing multiple regional reports, we developed a core PBRER that addressed all global requirements while creating region-specific appendices to address unique regulatory concerns in different markets.
The Results
Our strategic approach to PBRER development delivered significant benefits for the client's oncology program.
Regulatory Acceptance
All regulatory authorities accepted the PBRER with minimal queries, avoiding delays in review processes or additional data requests.
Maintained Benefit-Risk Profile
The structured presentation of safety data successfully contextualized emerging signals without impacting the overall positive benefit-risk assessment.
Global Alignment
Achieved harmonized safety assessment across regions while addressing specific regional requirements, leading to consistent labeling updates.
The PBRER development framework we established has been adopted as the company's global standard for safety reporting across their oncology portfolio, ensuring consistent, high-quality submissions for future reporting periods.