Regulatory Strategy 12 min read Building a Regulatory Strategy Before You Need One: Pre-IND Meeting Prep Why regulatory strategy must be built months before the meeting request — and how to prepare in a way that de-risks your IND and builds a productive FDA relationship from day one.
Trial Design 6 min read Difference Between Phase 1b and 2a Phase 1b confirms safety in patients. Phase 2a asks if the drug works. A practical breakdown of the distinction that matters for planning, investor expectations, and what FDA will actually accept.
Oncology 14 min read Project Optimus and What It Means for Small Biotechs How FDA's permanent shift away from MTD-first dose selection changes oncology development — and an 8-point checklist for planning, budgeting, and executing an Optimus-ready program with a small team.
Operations 11 min read The Hidden Operational Cost of Master Protocols Basket, umbrella, and platform trials promise portfolio-level efficiency. The real cost shows up in amendments, biomarker logistics, governance overhead, and CRO capability gaps. Where to look before you lock the design.