Remember, your high-dose animals are about to teach you something. Listen carefully. Go break some eggs.
Your Weekly Briefing:
👀 Insights
Your DRF: The Unsung Hero
Most failed GLP studies don't fail at GLP. They fail at the DRF — wrong doses, wrong tissues, sparse TK, no exposure margin. By the time you see mortality at GLP mid-dose, the problem you can't fix started weeks earlier. In this video, I walk through how to design a DRF that actually de-risks your pivotal study.
Some may argue that your GLP is your hero study, but I disagree. The DRF will break your program and then trip you on the way out if it’s not designed right.
💭 Myths v. Realities
Myth: The DRF informs the GLP study.
Reality: The DRF decides the GLP study. Dose levels, top dose justification, target organ histopath, recovery design, sex differences — every major GLP decision gets made off DRF data. If you can't draft your IND safety narrative from the DRF, your GLP study won't fix it.
🔧 Tools
The pre-GLP gut check that decides what your IND looks like.
DRF Study Design Checklist
A practical companion to this week's video. Pre-DRF inputs, dose selection, target organs and histopath, TK profile, and the GLP go-decision — what to lock before the protocol's finalized and what to walk away with before pivotal design starts. The DRF is where the story gets built. The GLP is where it gets confirmed.
😁 In case you missed it
You can have nonclinical on lock by September.
Summer School is now open:
$75 off any tier with code SUMMERSCHOOL — through June 12. Every enrollment includes a signed copy of Data Is Not Strategy, and the first 5 to enroll get a 30-minute 1:1 with me.