The Nonclinical Podcast

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 isn't a science problem. It's a translation problem. In this episode, we break down the five places nonclinical scientists lose investors...

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 the bloodstream. In this episode, we break down toxicokinetics — what it is, why it underpins every dose justification you'll ever make, and wh...

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 IND, how the 5-module eCTD structure works, and the SEND dataset rules that silently kill submissions before they ever reach a reviewer. Key takeaways: The...

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 actually? In this episode, we cut through the hype and take an honest look at where NAMs stand in nonclinical toxicology today, why the hardest part of the...

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. If your team is running another study because the last one didn't give you the answer you needed, this episode is for you. Key takeaways: Data ho...

"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 exposed, what teams consistently get wrong when they see no major findings, and why the absence of a finding is never the end of interpretation — it&a...

"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 oversight, why GLP compliance and regulatory strategy are two completely different things, and what happens when nobody is doing the sponsor&...

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-executed tox program actually looks like, and why seeing toxicity in animals is not a red flag — it's exactly what you want. If you've ever sat in a me...

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 final report delivery. We break down the legacy dual-track CRO workflow that's been quietly adding 8-10 weeks to timelines, and explore the single-trac...

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 underestimated — decisions in IND-enabling development, and walk through the three sequencing mistakes that quietly accumulate risk while looking like efficiency. K...