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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-09-06
- Length: 29m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/101---Micro-Array-Patches--Combination-Products-in-Australia--Differences-between-TGA-and-RoW--Novel-Delivery-Systems--and-Clinical-Trials-with-Megan-Polidano-e28u61n

## Summary

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.

## Chapters

- [0:01](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=1) Introduction: Subi Saadeh and Megan Polidano at Vaxxas
- [1:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=97) Megan Polidano's Career Path: From CSL to Vaxxas
- [3:58](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=238) Regulatory Challenges of Novel Micro-Array Patches
- [7:03](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=423) Using EPARs and AusPARs to Guide Development
- [10:40](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=640) Vaxxas Technology: Solid vs. Dissolving Micro-Needles
- [13:04](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=784) Clinical Trials: Why Registered Vaccines Still Need Full Development
- [18:22](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=1102) Device Performance and Human Factors Testing
- [20:02](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=1202) Australia's CTN Scheme and Clinical Trial Advantages
- [23:47](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=1427) TGA vs. FDA/EMA: Core A, Core B, and Access Consortium Pathways
- [28:17](https://hardwarepodcasts.com/podcast/lets-combinate/2023-09-06-101-micro-array-patches-combination-products-in-australia-differences-between-tg#t=1697) Future Outlook: Clinical Studies and Global Access

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Crowdfunding & preorders](https://hardwarepodcasts.com/topic/crowdfunding)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Vaxxas (company)
- CSL (company)
- Pfizer (company)
- FDA (other)
- EMA (other)
- TGA (other)
- Bill and Melinda Gates Foundation (company)

## Related episodes from other shows

- [The Best of Jon & Mike Through the Years](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-12-29-the-best-of-jon-mike-through-the-years) (Global Medical Device Podcast)
- [How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-21-how-radx-tech-ii-program-is-fast-tracking-covid-19-technologies-to-market-in-202) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [S7E22 Amelia Howe | Developing Medical Device Injectrodes for Pain Reduction, & Project Management Best Practices](https://hardwarepodcasts.com/podcast/being-an-engineer/2026-05-22-s7e22-amelia-howe-developing-medical-device-injectrodes-for-pain-reduction-proje) (Being an Engineer)
- [Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-08-emergency-use-authorization-eua-101-what-medical-device-companies-need-to-know) (Global Medical Device Podcast)

## Citing this page

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