Dr Carolyn Tucek-Szabo is a senior director and global regulatory sciences lead for Moderna Australia and New Zealand.
Dr Tucek-Szabo was one of the authors of a paper that established the case for adopting a 'platform technology' approach for mRNA products.
"The paper is the product of roundtables Moderna initiated with a broad cross-section of the sector and community. We invited governments, federal and state, regulators, academic institutions, and leading experts," she said.
"We all came together to consider how to take and deploy the scientific learnings from the pandemic. First of all, what do we need to do to be ready for another pandemic? How can we take those learnings and unlock the potential of the science?
"Can we identify any blockers to realising the potential of mRNA science? Is there an opportunity to adapt how we regulate these technologies? From the outset, we approached the roundtables as an opportunity to create a unified voice for practical opportunities to move forward."
Dr Tucek-Szabo said the recently published paper is a product of the roundtables. "We thought there was an opportunity to put forward a clear path on how the regulation of these products could be modified to allow for the platform approach," she said.
"As Moderna with a focus on mRNA, we would not be in the clinic with 45 programs if we had not applied a platform approach to development, under which the technology can be modified for multiple therapeutic areas. This creates opportunities and efficiencies.
"We have years of experience with this. The regulators gained significant experience with mRNA during the pandemic, particularly as the COVID variants emerged, and they have built that expertise and are now looking to generate their own efficiencies."
"With the variants, regulators worldwide started to see the reproducibility, very similar to how the seasonal flu vaccines are updated each year.
"The TGA adapted some of its own guidance for the COVID-19 vaccine variants. We initially required a full set of clinical data. By the last variant, it was more about quality. They learned along the way, as we all did. Now, going forward and thinking about how we might adopt the lessons from that experience, is there an opportunity to truncate what has historically been a 10 to 15-year product development process by relying on the knowledge gained from a platform technology."
Dr Tucek-Szabo said the Australian Government's recently released RNA Blueprint has several pillars, including regulation and guidance development. "So, they already recognise that this is important to unlock the potential of RNA science."
She said the US FDA and Europe's regulators have developed an approach where sponsors can apply for a platform designation.
"If the platform meets all the criteria, then you can get some efficiencies in how much data you need to supply with subsequent products, depending on the areas of expertise. Importantly, that does not alter the rigour of the process."
"The great thing about the paper is that the authors represent the broader sector. They know about regulation, what it is to be in the clinic, and the public health implications. We wanted this because it would have the most impact," added Dr Tucek-Szabo.
