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Session 10A: Designing early-phase trials with the end in mind

Tracks
Track 1
Friday, October 23, 2026
12:20 PM - 1:05 PM
Plenary / Clinical Innovation & Patient Impact Breakout Room

Overview

Sponsored by: CERULEA CLINICAL TRIALS


Details

Early‑phase trials set the trajectory of an asset’s entire development path. Decisions made at Phase I around design, endpoints, operations, and regulatory strategy can either unlock momentum or create downstream friction. This panel brings together perspectives from organisations with hands‑on experience delivering complex first‑in‑human and early phase clinical trials in Australia to examine the design choices that matter most. Through practical examples, speakers will discuss how early alignment across science, operations, and regulatory expectations can enable smoother progression into later‑phase and global development. The session will also explore why Australia is increasingly seen as a clinical trials partner, not just a location, offering the expertise, collaboration, and execution quality needed to translate cutting‑edge science into robust, globally credible programs. Sponsored by:


Speaker

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Dr. Michelle Bradney
CEO
Cerulea Pty Ltd

Chair

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Dr. Mark Buzza
Head of Research, Innovation and Advocacy
Pancare Foundation

Panellist

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Ms Samantha Guthrie
Vice President, Clinical Operations
Endo Axiom

Panellist

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Mr Patrick Lim
Statistician
Resolutum Global

Panellist

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Mr Greg Plunkett
CEO
Accelagen Pty Ltd

Panellist

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