Remember, your IND timeline is your raise timeline. Run them that way. Go break some eggs.
Your Weekly Briefing:
👀 Insights
A Case Study: From Inherited Plan to IND in 12 Months
A composite case study following a pre-IND biotech from an inherited $2.4M nonclinical plan to a filed IND and a closed Series A. Four quarters, eight decisions, the studies we killed, and the FDA alignment letter that anchored the round.
💭 Myths v. Realities
Myth: Running every study you can afford makes the package stronger.
Reality: Running every study you can afford makes the package longer. FDA reads for defensibility, not completeness.
🔧 Tools
This week’s tool isn’t a checklist. It’s the whole map.
A complete IND-enabling nonclinical development plan — the kind I build for clients — laid out end to end for a fictional oncology small molecule (ONC123, a PI3K inhibitor).
Most teams see nonclinical in fragments. This is an example of the whole picture before you spend the first dollar.
🎰 Poll
Would you join a live 12-week cohort of The Complete Guide to Nonclinical Development?
❓ Not sure what The Complete Guide is? Check out the course here: https://www.nonclinical.academy/
👉 Grab my book Data Is Not Strategy: https://a.co/d/00NqNjW7