The Nonclinical Podcast
Getting a drug to the clinic is hard. Understanding the nonclinical science behind it doesn't have to be. The Nonclinical Podcast breaks down toxicology strategy, IND preparation, and nonclinical development for biotech founders, scientists, and anyone who's ever sat in a meeting and wished they understood tox better. Hosted by Dessi McEntee, MS, DABT — a board-certified toxicologist who's been bringing new medicines to the clinic for over 15 years.
The Nonclinical Podcast
Latest Episodes
Your CRO Called It Adverse. Now What?
The word "adverse" appears in your study report and the room goes quiet. Most founders treat it like a verdict. It isn't. It's a scientific conclusion — and it's one you need to own, understand, and be ready to defend when FDA asks about it. In...
How To Translate Your Nonclinical Strategy Into a Language for Investors
You walked an investor through your toxicology data. Species rationale, dose-response, NOAEL, safety margins — technically airtight. They nodded. Then they turned to your CEO and asked: "So can the drug actually be given to people?" That gap is...
TK Profiles: The Good, The Bad, and The Ugly
Every animal survived. Body weights stable. No major clinical signs. You're practically popping champagne — and you're about to get an FDA hold. Because buried in the appendices is a TK table that proves your drug never actually made it into th...
Anatomy of a Bulletproof IND — The Nonclinical Sections Explained
Your IND is rejected before a single human being ever reads it. Not because the science is wrong — because a 10-year-old legacy file was missing a digital tag. In this episode, we break down exactly what goes into the nonclinical sections of an...
NAMs: The Promise, the Gap, and the Cold Hard Truth
Everyone in drug development is talking about New Approach Methodologies — AI, organ-on-a-chip, virtual control animals, in silico modeling. The vision is compelling: fewer animals, faster timelines, better translational data. But where are we ...