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
Hunting for Toxicity to Secure Your IND
Use Left/Right to seek, Home/End to jump to start or end. Hold shift to jump forward or backward.
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 meeting and wondered where tox fits into the bigger picture, this one's for you.
Key takeaways:
- Drug development has two phases: before and after IND clearance — and tox owns the first one
- A tox program with zero findings can actually be a bad sign — it may mean your compound isn't doing anything at all
- Every tox program is custom-built to the drug — size, type, mechanism, route, and indication all shape it
- NOAEL and MTD aren't just acronyms — they're the data points that directly determine your Phase 1 starting dose
- Once in the clinic, tox shifts from gatekeeper to tactical support role
Links:
- Online Course: www.nonclinical.academy
- Work with Dessi: www.toxistrategy.com
The Nonclinical is hosted by Dessi McEntee, MS, DABT — board-certified toxicologist and Fractional Head of Toxicology. Subscribe to the newsletter on LinkedIn, take the course at nonclinical.academy, or work with Dessi at toxistrategy.com.