Design a path that works across science, economics and access.
A tractable therapy, a population the conventional commercial model was not built for, and a mandate measured in reach. Good science and committed partners get a program started. The structure that carries it through development, approval, manufacture and delivery is what gets it to a patient.
A grant moves a program through a phase. An entity, a named owner and a plan for each stage carry it the rest of the way.
Each stage carries a different risk. The program moves best when its structure, partners and commitments are designed for every stage from the start.
Ultra-rare, pediatric and global-health programs often need trial designs built for their populations, and the achievable path is shaped with the review division itself.
Funders, sponsors, manufacturers and ministries each hold part of the authority. The plan works when it has an owner and an agreed way to resolve differences.
By designing its structure for every stage from the start: who owns the program, which partners carry which risks, and how each stage is resourced. Shared platforms can lower the cost of each new indication. I help foundations and sponsors build that structure.
Ultra-rare, pediatric and global-health programs often need designs built for their populations, such as natural-history comparisons, real-world evidence or adaptive trials. The achievable path is shaped with the review division itself, and I help plan those conversations.
Funders, sponsors, manufacturers and ministries each hold part of the authority. The plan works when it has an owner and an agreed way to resolve differences. I design that governance and, where useful, convene the working session that sets it.
A finished brief is not needed. I read every message myself and reply with the two questions I would ask first. If I am not the right person, I will tell you who is.
Roberta Duncan, Founder and Principal