Turn early clinical signals into regulatory acceleration—and strategic value.
The Challenge
Breakthrough Therapy Designation (BTD) is a powerful regulatory tool that can unlock faster development, greater FDA support, and stronger positioning for BD and investor interest. But securing BTD is notoriously difficult. Many companies either apply too early, without compelling clinical data, or miss the window by failing to prepare in time. This is especially challenging for APAC-based innovators unfamiliar with U.S. regulatory expectations.
JRC’s Solution
We help biotech teams begin BTD planning as early as Phase I—well before submission—by shaping clinical design, aligning endpoints with FDA expectations, and structuring the story that supports breakthrough value.
- Pre-BTD assessment based on early clinical data and FDA precedent
- Guidance on trial design, biomarker strategy, and endpoints aligned with BTD criteria
- Strategic preparation of BTD justification narrative and unmet need framing
- Drafting of FDA-ready clinical summary and supporting data analysis
- Advisory on optimal submission timing and communication strategy with FDA
Results We Deliver
- Increased BTD success likelihood through data-driven storytelling
- Integrated regulatory and clinical roadmap aligned with fast-track goals
- Enhanced BD and investor engagement based on breakthrough positioning
Working on a Phase I program with promising early signals?
Let’s explore how BTD could accelerate both your clinical path and commercial value.