Remember, the FDA has seen worse. Probably. Maybe. Go break some eggs.
Your Weekly Briefing:
👀 Insights
3 Studies You Can Run Before You Have a CRO
Three studies. No GLP. No pivotal-study budget.
All three can run in parallel with CRO selection — and all three generate data that changes what you do once the contract is signed. The founders who run them move faster and design better. The ones who wait pay for the lesson twice.
💭 Myths v. Realities
Myth: Real nonclinical data starts at GLP.
Reality: Some of the most program-defining data you'll generate is non-GLP — in vitro studies, MTDs and DRFs, METID/TCRs, etc. None of it requires a GLP CRO. All of it changes what your pivotal studies look like once you get there.
🔧 Tools
All the nonclinical studies you can run before you need a GLP CRO
Pre-CRO Nonclinical Checklist
A practical companion to this week's piece. Every study you can run in parallel with CRO selection — in silico genotox, hERG, MET ID and species selection, plasma protein binding, in vitro ADME, off-target panels. Scope, cost, and timeline for each. Plus the full data package you should be walking into your kickoff meeting with. Stop letting CRO selection dictate when your program moves.
📞 Phone-a-Friend for Your Program
The Complete Guide to Nonclinical Development gives you the framework. The higher tiers give you me — private Slack for the questions that come up between modules, and monthly Office Hours where we work through your actual program decisions live. Coaching, not just curriculum.
Ps. Stay tuned for something big next week. You guys get it first. Be on the lookout for a special edition on Monday 👀