Creating a Genetic Medicine Manufacturing Ecosystem: Part Three.
Close to a year ago I wrote in the first article of this series with the theme “and we wait”- for the Federal Government to deliver funding and a plan forward for a genetic medicine ecosystem plus 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 toward 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 made a move the ATM announcing Moderna as the successful responder on the 21st Dec 2021 when the Prime Minister Scott Morrison announced “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. I applaud this initiative with some reservations as I am 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 I 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 reliably informed by a government officer 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 are amazing, the investment into science is extraordinary, science is finally getting it’s turn in the sun – even mainstream media is acknowledging it – The Sydney Morning Herald lauded the Australian RNA Production Consortium (ARPC) members in their article ‘Who Mattered 2021’4.
My discussions with some of the research community have knocked a little wind out of my sails though, there seems 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 it’s ASX announcement in December 2021, IDT’s 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, they still are awaiting notification.
Around the grounds
I have mentioned the commitment and importantly the action of the Victorian and New South Wales Governments toward massive funding boosts into this sector, I have since learned of the entry of the Australian Capital Territory. Prof Thomas Preiss, an ARPC foundation member, is involved in the ANU’s “Shine-Dalgarno Centre for RNA Innovation” bringing together experts in RNA biology from across the ACT region to focus their collective efforts and expertise to maximise the power of RNA biology, while simultaneously addressing some of the pressing global health care issues. I feel this will be a formidable team with over 250 years of collective experience. For the uninitiated the name has immense providence, I encourage you to understand the scientific rockstars behind this – check them out here: https://jcsmr.anu.edu.au/research/centres/rna-research-development-hub/about Recently I attended the inaugural symposium for the Australian Institute for Infectious Diseases in Melbourne- it is the collaboration between the University of Melbourne, The Doherty and the Burnet Institutes, a $400 Million investment by the Victorian Government, plus I understand there is an array of commercial collaborators as well. A big tick to the Honourable Minister Jaala Pulford.
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 Limited (LSQ) entitled ‘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 Professor Hugh Possingham, Queensland Chief Scientist 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. Who knows what we are missing discovery wise? Consider 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 USA10.
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 The Hon Minister Roger Cook to determine if I have missed an investment announcement, 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) plus the establishment of the Shine-Dalgarno Centre for RNA Innovation at ANU – Canberra. Adding to this I noticed news.com.au reported on 6th Oct 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 A$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.
It has been described by Prof Brendan Crabb, Director and CEO of the Burnet Institute, that the inequity in Vaccine supply to the planet is an own goal, to explain this – consider if there is 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. Brendan made this point during the AIID symposium ‘lessons learnt from Covid: Guiding Pandemic Preparedness and response’6
The 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, she appeared to lament we had not learnt from the HIV experience. Françoise stated during the AIID symposium6 “…. 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”.
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. Sharon mentioned during a meeting, the Chief Operating Officer of the Welcome Trust said that at the beginning of the pandemic, the Welcome Trust were advocating they should just buy 7 billion vaccines upfront and have them for the world. It was not an issue for manufacturing, apparently, the logistics were there, just no one thought of it!
Perhaps this is something to consider not just for future pandemics (not an if… but a when), perhaps we should be doing this now!
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 Prof 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 articles7, 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 NZ, has made a critical investment into their country’s response securing the capacity to create mRNA vaccines when they took delivery of the NanoAssemblr Blaze from Precision Nanosystems8 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)9, Dr Kylie Price and her team, tirelessly working to collaborate VAANZ with the ARPC to ultimately form the ANZRPC are the foundations for 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 stating, this pandemic is far from over, Vaccines are amazing yet not perfect, variants continue to emerge whilst there is virus replicating in the community.
Get Vaxxed and wear a mask indoors where you cannot socially distance. Prof 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 not to protect yourself, but to protect your family. Raina also suggested the COVID-19 variant, Omicron, killed more people 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.
By Peter Davis
1.Australian Government Approach to market https://www.industry.gov.au/news/enabling-australias-onshore-mrna-manufacturing-capability-approach-to-marke
Site accessed 9Mar22.
2. Prime Minister of Australia” https://www.pm.gov.au/media/mrna-vaccines-be-made-australia” Site accessed 09Mar22
3. Statement of Priorities Australian Academy of Science https://www.science.org.au/supporting-science/science-policy-and-analysis/projects/statement-national-rna-science-and-technology-prioritiesSite accessed 09Mar22
4. ‘Who Mattered 2021’ Good Weekend November 27, 2021 https://www.smh.com.au/interactive/2021/gw-australians-who-mattered/
Site accessed 10 Mar 22.
5. BioManufacturing Alliance https://www.lsq.com.au/life-sciences-queensland-and-springfield-city-group-in-collaboration-to-partner-health-services-and-manufacturing-in-queensland/ Site accessed 10 Mar 22
6. Australian Institute for Infectious Diseases symposium ‘lessons learnt from Covid: Guiding Pandemic Preparedness and response’ https://youtu.be/syJ7O0Ph6Lg Accessed 11 March 2022
7. Creating a Genetic Medicine Manufacturing Ecosystem https://issuu.com/westwick-farrowmedia/docs/lab_and_life_scientist_apr_may_2021 Page 6 Accessed 14 Mar 2022
8. Website Precision Nanosystems https://www.precisionnanosystems.com/ Accessed 14 Mar 2022
9. VAANZ Alliance https://www.malaghan.org.nz/our-research/covid-19/ Accessed 14 Mar 2022
10. UWA signs global deal with US firm to help develop new DMD drugs https://www.news.uwa.edu.au/archive/201304125569/research/uwa-signs-global-deal-us-firm-help-develop-new-dmd-drugs/ Accessed 16 Mar 22
11. Shenzen locked down https://www.smh.com.au/world/asia/china-locks-down-all-of-tech-hub-shenzhen-as-covid-cases-rise-20220314-p5a4c5.html Accessed 14 Mar 2022