Precision medicine biomarker planning

The challenge

• A top biopharma client was in early-stage clinical development of an asset that showed efficacy in all-comers with the target disease, but even greater efficacy in those with a predisposing genetic mutation. We were engaged to determine feasibility of a precision medicine/ biomarker strategy for this drug to inform the ongoing clinical development program, scientific narrative building, and whether to pursue a companion diagnostic

Our solution

• We conducted a landscape assessment to understand provider and payer receptivity to a precision medicine/ biomarker approach in the disease and built an exhaustive analog database to study historical uptake of biomarkers in similar indications
• We defined priorities for the brand Medical Affairs team for the following 3+ years (through launch) including building the scientific narrative, medical education, key stakeholder engagement, and evidence generation plan

The results

• Client was reassured of the promise of a novel precision medicine/ biomarker-based approach in this disease and began building a holistic scientific narrative in advance of anticipated Phase 3 success in further demonstrating incremental efficacy in allele-positive patients