Hardware Podcasts

101 - Micro-Array Patches, Combination Products in Australia, Differences between TGA and RoW, Novel Delivery Systems, and Clinical Trials with Megan Polidano

Let's Combinate · 6 Sept 2023 · 29m

What this episode covers

Megan Polidano, Head of Clinical and Regulatory Affairs at Vaxxas, explains the regulatory and technical challenges of developing micro-array patches, specifically Vaxxas' solid micro-needle technology for needle-free intradermal vaccine delivery. She details how the lack of specific guidelines for this novel combination product requires relying on EPARs and AusPARs, while highlighting Australia's CTN clinical trial scheme and Core A/B pathways as distinct from FDA or EMA processes. Polidano emphasizes that even using registered vaccines, formulation and administration changes necessitate full clinical development, including human factors testing and safety studies, to prove efficacy and usability.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vaxxas, CSL, Pfizer, Bill and Melinda Gates Foundation
Also
FDA, EMA, TGA

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