Case Studies

Designing and running regulatory strategy

Client:

Medium-sized Biotechnology company.

Client Challenge:

Our client was developing a first-in-class, Phase 3 ready anti-FGFR2b antibody for the treatment of gastric cancer (GC) including cancer of the gastroesophageal junction (GEJ).

They required regulatory expertise to guide the strategy and preparation for a Type B EOP2 multidisciplinary FDA Meeting covering regulatory, CMC, clinical, and biomarker design elements of the planned Phase 3 study.

G&L Solution:

Here, we assembled a G&L multidisciplinary team, including Regulatory, Companion Diagnostics, and Clinical experts.

We worked with the client’s development team to author and submit the Type B EOP2 Meeting Request and Briefing Book.

We also guided discussions and provided strategic input into critical regulatory strategy and Phase 3 study design elements. Key design elements included stratification of enriched patient population overexpressing FGFR2b versus a broader FGFR2b-positive population, pre-screening biomarker strategy, safety monitoring plans and risk mitigation strategies.

Outcome:

As a result of G&L’s guidance and collaboration, the client developed a robust and commercially viable Phase 3 development and regulatory strategy, and they were well-prepared for the FDA Type B Meeting. FDA granted Breakthrough Therapy Designation, and the asset was acquired by a leading global biopharmaceutical company.