The Nonclinical Podcast

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-track solution that's finally fixing it.

Key takeaways:

• Data lock is not the finish line — sponsors who treat it that way get blindsided every time
• The legacy dual-track system has two separate teams manually handling the same data, sequentially — and it was built for an era that no longer exists
• Manual transcription doesn't just slow things down, it introduces reconciliation risk that can cascade into regulatory rejection
• PointCross's single-track process runs report generation and SEND dataset preparation in parallel from a single source of truth — eliminating duplication entirely
• For CROs, slow turnaround is no longer just an operational issue — it's a competitive liability

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.

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.