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.
Episodes
11 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 ...
Data Hormesis: When More Data Makes Things Worse
More data should mean less risk. In nonclinical development, that's not always true. In this episode, we explore the concept of data hormesis — the inflection point where accumulating more data stops reducing uncertainty and starts creating it....
"No Major Findings" — The Most Dangerous Phrase in Nonclinical
"No major findings." Three words that instantly lower the blood pressure of every executive in the room — and sometimes, quietly derail a program. In this episode, we unpack why a clean toxicology study can still leave your IND dangerously expo...
Your CRO Has QA. That's Not Enough.
"Our CRO has QA — we're covered." It's one of the most common phrases in biotech, and one of the most dangerous assumptions in nonclinical development. In this episode, we break down the critical difference between CRO QA and sponsor-side overs...
The Study You Skip Today Is the Clinical Hold You Face Tomorrow
Most nonclinical teams spend a lot of time thinking about which studies to run. Almost none spend enough time thinking about when. In this episode, we unpack why study sequencing is one of the most consequential — and most consistently underest...
Your Study Is Done — So Why Are You Still Waiting for the Report?
The science is finished. The data is locked. So why is your IND still weeks away? In this episode, we pull back the curtain on one of the most consistent — and avoidable — sources of delay in nonclinical programs: the gap between data lock and ...
Hunting for Toxicity to Secure Your IND
Before your drug ever reaches a human, it has to earn its way there — and toxicology is what makes or breaks that journey. In this episode, we break down why the toxicology program is the most critical piece of an IND package, what a well-execu...