Why Early Trial Strategy Is the New Biotech Differentiator

By Jenna Levenson, PhD, RN, MS

Biotechnology success used to be measured by the molecule. Now, it is just as much about the model—how a company designs, implements, and de-risks its trials from day one.

Investors are demanding strategic foresight. Regulatory agencies expect a higher standard of trial readiness. And companies that wait until Phase 2 to "figure things out" are often already behind their peers.

 Early-phase planning is no longer a box to check; it is a true competitive advantage. Successful biotech leaders are building adaptive protocols, pre-aligning with regulators, designing diversity strategies early, and establishing digital infrastructure that supports high-quality, efficient execution.

 What does this look like in practice?

• Embedding operational insights into protocol development before IRB submission

• Defining go/no-go criteria and interim analyses ahead of first patient dosing

• Building site and patient access strategies using geographic, demographic, and feasibility modeling

• Engaging cross-functional input from clinical, regulatory, medical affairs, and data teams from the start

This kind of foresight helps de-risk development, impresses investors, and leads to cleaner, more meaningful data. In today’s financing climate, anything that increases efficiency and reduces waste is not just helpful—it is essential.

If your biotech company is approaching an IND or gearing up for a first-in-human trial, the time to build your trial strategy is not during execution. It is right now.

Let’s Talk: What is one area of early trial planning your team wants to strengthen this year?