Clarify what must be true before the next commitment.
You have biology worth backing and a runway measured in months. The indication you pick, the first study you design and the way you answer a regulator who has not seen your modality before all compound. Getting them right early means your first trial answers the questions your next investors and partners will ask.
The answer shapes your first indication, your partnering posture and what a sophisticated investor will pay for.
Whether it is a pre-IND, INTERACT or scientific advice meeting, the first interaction is the one inexpensive chance to test the assumptions that would otherwise cost a year and a financing to discover.
Endpoint and comparator choices decide that before enrollment starts.
Senior experts organized around the asset often do more, at lower fixed cost, than headcount organized around an org chart.
Whether it is a pre-IND, INTERACT or scientific advice meeting, the first interaction should test the assumptions the plan depends on most: the indication, the nonclinical package, manufacturing and the first-in-human design. I help you choose the questions that settle those early, while changing course is still inexpensive.
The answer shapes your first indication, your partnering posture and what investors and partners will value. I look at what the science supports today, what it would take to show a platform, and which path gives the company its strongest next stage.
Usually before the first major commitment: the lead indication, the first study, the entity structure or the first partnership. A fixed-fee Diagnostic at that point is a small investment next to the decisions it informs.
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