Creating a genetic medicine manufacturing ecosystem: part 3

Close to a year ago, when I wrote in the first article of this series, we were waiting for the federal government to deliver funding and a plan forward for a genetic medicine ecosystem, and to understand their commitment to the Modern Manufacturing Initiative.

Last article, I summarised the plan put forward by the Australian Academy of Science, the Delta variant was raging, Victoria and NSW were leading the nation in supporting this concept and we were rushing to get our second vaccination. The federal government were rocketing towards a conclusion to the much-anticipated approach to market (ATM)¹. A great deal has happened since that time, including a disturbing trend that ultimately will compound and extend this pandemic. We need to talk about the elephant in the room: vax equity.

The PM speaks

The federal government announced Moderna as the successful ATM responder on 21 December 2021, when Prime Minister Scott Morrison said, “A new sovereign vaccine manufacturing facility will be built in Australia to produce respiratory mRNA vaccines for potential future pandemics and seasonal health issues as part of a new in-principle agreement between the Australian Government, Victorian Government and global mRNA company Moderna”². This initiative should be applauded, but it comes with reservations as we are yet to be convinced this will back Australian research to the extent proposed by the Australian Academy of Science statement ‘National RNA Science and Technology priorities³’. Perhaps we should find solace given Minister Simon Birmingham stated, “Moderna will become a vital part of Australia’s mRNA research and development landscape, bringing investment and opportunities for the entire research sector”².

I was informed that “beyond Moderna specifically, the government will also invest up to $25 million in grants from 2022–23 towards mRNA Clinical Trials Enabling Infrastructure. That should support Australian medical research and medical innovation projects, including with equipment and infrastructure.” I was told “the government is also looking at other opportunities to support an mRNA and RNA ecosystem, and for instance the recent Cooperative Research Centres Project (CRC-P) round that was open in October 2021 specifically identified mRNA projects as being of interest. Additionally, the government is also trying to make sure that there is a well-thought-out approach to supporting the mRNA/RNA community, given the different investments by states, and the different opportunities and areas of potential of RNA, and so that’s ongoing, but I think there will be further progress on that early in the new year.”

And we wait

These initiatives and investments into science are extraordinary. Science is finally getting its turn in the sun, and even mainstream media is acknowledging it — The Sydney Morning Herald lauded the Australian RNA Production Consortium (ARPC) members in its article ‘Who Mattered 2021’⁴. Discussions with some of the research community have however flagged that there seem to be no announcements around the $1.5 billion Modern Manufacturing Strategy touted by Minister Angus Taylor², and many are very anxious about the CRC-P funding. The relatively slow rollout of the funding announcements has ramifications as global pressures force prices up on much of the unique technologies creating a quandary where grant application amounts may fall short of requirements, heightening the adage ‘time is money’.

In an ASX announcement in December 2021, IDT CEO Dr David Sparling said, “The company has successfully delivered on the Monash Institute of Pharmaceutical Sciences (MIPS) COVID-19 mRNA receptor binding domain vaccine candidate project, being Australia’s first locally manufactured cGMP mRNA finished product and clearly showcases IDT’s manufacturing capabilities in this regard.” The announcement noted the company is also waiting to receive feedback on its submission to the Australian Government’s $800m Modern Manufacturing Initiative (MMI) Manufacturing Collaboration Stream Grant Opportunity. At the time of writing, the company is still awaiting notification.

Around the grounds

I have mentioned the commitment and importantly the action of the Victorian and NSW Governments towards massive funding boosts into this sector; I have since learned of the entry of the Australian Capital Territory. Professor Thomas Preiss, an ARPC foundation member, is involved in ANU’s Shine-Dalgarno Centre for RNA Innovation, bringing together experts from across the ACT to focus their collective efforts and expertise to maximise the power of RNA biology, while simultaneously addressing some of the pressing global healthcare issues. I feel this will be a formidable team with over 250 years of collective experience. For the uninitiated the name has immense providence, and I encourage you to check out the scientific rock stars behind this. Recently I also attended the inaugural symposium of the Australian Institute for Infectious Diseases in Melbourne — a collaboration of the University of Melbourne with the Doherty and Burnet Institutes, a $400 million investment by the Victorian Government, and I understand there are an array of commercial collaborators as well.

This brings me to consider other states and their investment into Australia’s sovereign capacity. I recently attended a webinar supported by Life Sciences Queensland (LSQ) titled ‘Medicines of the future: making them here’ — with the descriptor “hear about our vision to develop sovereign capability here in Queensland”. It was encouraging to note Queensland Chief Scientist Professor Hugh Possingham plus a raft of eminent scientists give their vision of the BioManufacturing Alliance (BMA)⁵ established in late 2021. I imagine they are on the road to creating a world-class ecosystem in Brisbane or at least solving a puzzle piece for the whole ecosystem (think RNA production) — that is, if they can convince the Palaszczuk government to invest!

Sounds of silence

Anecdotally, the scientific industry perceives Western Australia as the poor cousin, where the researchers seem to punch well beyond their funding weight with exceptional work — oh what a difference a little investment would make. WA has a strong history of pioneering breakthroughs with genetic medicines: one of the world’s first RNA therapies — the first FDA-approved treatment for muscular dystrophy — was developed in WA. Professor Steve Wilton and Professor Sue Fletcher developed this therapy whilst at UWA, in collaboration with Sarepta Therapeutics in the USA⁶.

Scanning the media statements on the Government of Western Australia website, I could find little to no new funding into this sector specific to a genetic medicine ecosystem. I have contacted Minister Roger Cook to determine if I have missed an investment announcement, but to date I am yet to receive a reply. If this is the case, I concede I am astonished given the substantial contributions to build a national response made by NSW (UNSW RNA Institute) and Victoria (Australian Institute for Infectious Diseases — AIID), plus the establishment of the Shine-Dalgarno Centre for RNA Innovation in Canberra. Adding to this, I noticed news.com.au reported on 6 October 2021, “Mr McGowan claimed his state’s booming economy was propping up the Commonwealth government’s financial Covid-19 relief to other states that had been hard hit by the virus.” I believe this was around the time he handed down a $5.6 billion budget surplus, yet zero support for the national project to enable West Australian scientists to join in the local manufacture of genetic medicines. Understand that WA is one of the wealthiest places on Earth, with a GDP per capita of $100,367. This is a very poor report card, and it amplifies the divide — not something WA would like to have given they just ‘opened the border’. I leave this to you to draw your own conclusions.

Vax equity

It has been described by Professor Brendan Crabb, Director and CEO of the Burnet Institute, that the inequity in vaccine supply to the planet is an own goal — if there are a bunch of unvaccinated communities and the virus is being transmitted, each time it replicates there is a potential to result in another variant, thus prolonging this pandemic. Prof Crabb made this point during the AIID symposium ‘Lessons learnt from COVID: guiding pandemic preparedness and response’⁷; Nobel Laureate Françoise Barré-Sinoussi, Emeritus Professor at the Institut Pasteur and Emeritus Director of Research at the Inserm, echoed the tremendous error in the COVID-19 response with respect to vaccine equity, appearing to lament that we had not learnt from the HIV experience. Barré-Sinoussi stated during the symposium “the inequities is really a critical issue where we did not work enough; we already knew from HIV and still today from COVID we see how much inequities is critical in the response, access to treatment, access to prevention, access to diagnosis. We cannot continue to work like that; we must improve what’s going on in terms of inequity in this world.”⁷

Perhaps Professor Sharon Lewin, the inaugural Director of the Doherty Institute, summed up an interesting alternative to how the rich countries of the world quibbled over the few vaccines, securing so many for themselves, compounding the inequity. She mentioned that at the beginning of the pandemic, the Wellcome Trust were advocating they should just buy 7 billion vaccines upfront and have them for the world; apparently the logistics were there, just no one thought of it! Perhaps this is something to consider not just for future pandemics (not if, but when); perhaps we should be doing this now!

Tremendous endeavours

In my wildest dreams I would never have thought the voice of a few would grow to such a chorus of the cognisant (to borrow a phrase from Professor Damian Purcell). Future Australian researchers may well look back on this pandemic as the critical point where genetic medicine went into warp speed in Australia; it certainly looks that way and a year on from the first of these articles⁸, the outlook could not be rosier. We must not forget our friends in New Zealand — the Malaghan Institute of Medical Research, an independent biomedical research institute based in Wellington, has made a critical investment into its country’s response securing the capacity to create mRNA vaccines when it took delivery of the NanoAssemblr Blaze from Precision Nanosystems9 in Vancouver. This critical step may help secure vaccine equity not just for NZ but surrounding island nations into the future. The efforts of the Vaccine Alliance Aotearoa New Zealand (VAANZ)¹⁰, tirelessly working to collaborate with the ARPC to ultimately form the ANZRPC, are the foundations for a robust commercialisation of NZ research, making Wellington the epicentre for genetic medicines in New Zealand.

The pandemic is not over

I can conclude this article by saying this pandemic is far from over. Vaccines are amazing but are not perfect; variants will continue to emerge so long as the virus is replicating in the community. Get vaxxed and wear a mask indoors or where you cannot socially distance. Raina MacIntyre, Professor of Global Biosecurity within the Kirby Institute, was interviewed by the ABC Sydney local radio recently as mask mandates were being relaxed; her frustration was palpable. This is the single most effective non-medical intervention we can do. I concur with Raina; wear a mask if not to protect yourself, but to protect your family. Raina also suggested the Omicron variant caused more COVID deaths in Australia during January and February 2022 than all of 2020 and 2021 combined. Sobering information given that Shenzhen in China has been locked down¹¹.

References

1. Australian Government Approach to market https://bit.ly/3IFEEkG Accessed 9 Mar 2022.
2. Prime Minister of Australia, ‘mRNA Vaccines to be made in Australia’ https://bit.ly/36kQWlL Accessed 9 Mar 2022.
3. Statement of Priorities Australian Academy of Science https://bit.ly/3urjNwH Accessed 9 Mar 2022
4. ‘Who Mattered 2021’ Good Weekend November 27, 2021 https://bit.ly/36KE1Jm Site accessed 10 Mar 2022.
5. BioManufacturing Alliance https://bit.ly/3izTWx6 Site accessed 10 Mar 2022.
6. UWA signs global deal with US firm to help develop new DMD drugs https://bit.ly/3wxNZJb Accessed 16 Mar 22
7. Australian Institute for Infectious Diseases symposium ‘Lessons learnt from COVID: guiding pandemic preparedness and response’ https://youtu.be/syJ7O0Ph6Lg Accessed 11 Mar 2022
8. Creating a Genetic Medicine Manufacturing Ecosystem https://bit.ly/3IDEqe5 Page 6 Accessed 14 Mar 2022
9. Precision Nanosystems https://www.precisionnanosystems.com/ Accessed 14 Mar 2022
10. VAANZ Alliance https://www.malaghan.org.nz/our-research/covid-19/ Accessed 14 Mar 2022
11. Shenzen locked down https://bit.ly/380OuBe Accessed 14 Mar 2022

Image credit: ©stock.adobe.com/au/wacomka

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