Insights

Questions worth examining.

Useful thinking for leaders working through choices that do not come with a complete playbook. Every paper is free to read, quote and forward.

The library, by theme.

Evidence and assumptions

Finding what a plan is standing on, before capital is committed to it.

The Load-Bearing QuestionsIs the assumption carrying more weight than the evidence? Finding the assumption a plan cannot survive.Method →Reading a Platform ClaimWhat would change the platform thesis? Read-through, and the risk that travels with it.White paper →The Zero-Dollar VoucherWhat if the voucher is worth nothing? Why the only defensible base case is $0.White paper →

Capital and economics

Keeping the money, the timeline and the science in step.

Planning for the ReadoutWhat if the runway ends before the readout? Cutting before you know the answer.White paper →When the Science Works and the Economics Do NotWhat if the science works and the economics do not? Entity, access and risk financing when the numbers refuse.White paper →

Regulation for new kinds of therapy

Frameworks built for chronic dosing, applied to therapies that are new or given once.

Regulating the CureWhat if the therapy works once and the framework assumes chronic dosing? Classification, evidence and access for a therapy given once.White paper →Before the First PatientWhat should be built before the first patient? No IND date before the material calculation.White paper →

Governance and scale

Who decides, and what has to change as one program becomes several.

Who Actually DecidesWho actually decides? Decision rights are conceded, never installed.White paper →From One Trial to a PortfolioWhen does one program become a portfolio? Portfolio governance is the last layer to build.White paper →

Apply this thinking to a live problem.

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.

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☎+1 317 985 1613✉roberta.duncan@tmdgimpact.com

Roberta Duncan, Founder and Principal

Confidential, and NDA-first if you prefer.
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