A roadmap assembled from scattered literature.
A translational strategy advisor used Urchin to develop a regulatory and clinical roadmap for a first-in-class therapeutic program.
I knew there were clues to the right strategy scattered across the literature, but there was simply too much to get through, and I was worried I wasn't going to find them or make the right connections on my own. Urchin synthesized that information into a framework I could share directly with the board and with KOLs. What impressed me most was seeing several of the same nuanced recommendations emerge independently from both Urchin and the KOLs we were speaking with throughout the project. I'll absolutely be recommending it to other companies I work with.
Dr. Jonathan Thon, Strategic Advisor
3AnalysesIterative, synthesized into one translational strategy.
Phase 1-3Clinical designConnected to potency assay strategy and mechanism.
Source: engagement recordJonathan Thon, Strategic Advisor
Project overview
Context
A pharmaceutical company was developing a product that physicians were independently using off-label, with encouraging early clinical results. They wanted to pursue regulatory approval for the new indication, but first had a series of foundational questions to answer. The mechanism of action was unknown. There was no validated potency assay to support manufacturing and quality control. And an indication with limited precedent still needed a credible clinical development strategy.
The challenge
The indication space is particularly difficult because outcomes are hard to measure objectively. Clinical trials often rely on subjective endpoints, while there are few established in vitro assays that correlate with clinical outcomes. Without a robust potency assay, manufacturers are forced to rely on expensive and time-consuming in vivo testing to qualify each batch before release. The evidence needed was scattered across decades of research, regenerative medicine, and regulatory precedent.
What Urchin did
- Mapped regulatory precedent to identify how similar therapies had progressed through clinical development and what evidence regulators were likely to require.
- Designed a potency assay strategy linking disease biology, mechanism of action, manufacturing release testing, and clinical outcomes.
- Developed a clinical roadmap connecting preclinical studies, assay development, and Phase 1-3 trial design into a coherent development plan.
Three iterative analyses, synthesized across the biological, regulatory, and clinical landscape into a single translational strategy.
Impact
Rather than treating these as independent questions, Urchin connected them into a single evidence-based framework that could guide decision-making across the program, one the advisor could share directly with the board and with KOLs.