Insights
At SSI Strategy, we believe that knowledge is a key driver in building better biotechs. Our Insights provide valuable information and expert perspectives to empower biotech leaders like you.
Insights
02-06-2026
The Regulatory Agency Interaction Plan: A Tool for Biotech Leaders
Meeting preparation and meeting readiness are not the same thing. The strategic work that makes an agency interaction productive happens months before the briefing document is written. The difference shows in the feedback received.
02-06-2026
TPP as a Leadership Tool: Aligning Evidence, Labeling, and Company Strategy
Most biotech programs have a Target Product Profile. Few use it as the strategic instrument it was designed to be. When the TPP is not actively shaping decisions, the evidence package and labeling ambition quietly drift apart.
01-06-2026
Risk-Based Regulatory Strategy: A Framework for Complex Biotech Programs
In complex biotech programs, regulatory risk rarely surfaces where it started. A CMC decision made without regulatory input carries consequences that only become visible later in the clinical timeline, the financing plan, and the board room.
01-06-2026
When is it Time for a Chief Regulatory Officer?
The gap between a regulatory affairs lead and regulatory leadership rarely announces itself. It shows up at a fundraise, a major agency interaction, or a board meeting when the stakes are high enough to expose what was missing.
01-06-2026
Why Regulatory Belongs in the C-Suite
Regulatory decisions shape development timelines, capital efficiency, and what a program can credibly claim at market. When those decisions are made without senior regulatory input, the cost compounds quietly until it cannot be ignored.
04-02-2026
EU HTA Regulation: Early Signals, Open Questions, and Practical Choices for Biotechs
In our fifth and final webinar on the new EU HTA Regulation, Chantal van Gils and Mel Walker will reflect on how the regulation is beginning to play out in practice for small and mid-size biotech teams preparing for EU market access.
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Building Better Biotechs
