Creating a Genetic Medicine Manufacturing Ecosystem: Part 2

by Peter Davis (ATA Scientific, Sales and Applications support)

Creating a Genetic Medicine Manufacturing Ecosystem part 2

In the April / May 2021 issue of Lab + Life Scientist¹  I wrote about the need to create a Genetic Medicine Ecosystem. I am humbled to hear it has had some level of impact. The landscape has shifted from a hopeless pipe dream to firm steps and to the creation of such an ecosystem, from the unlikeliest places. There has been a maturation of groups fundamental to the success of such a concept, and formalised structures in the design stage. State governments may be the key to the ecosystem dilemma, given the apparent lack of action federally to date! So, let’s dive in and learn what’s been happening since then.

Whilst I was delivering a genetic medicine seminar on the 21^st of April at the Doherty Institute, the Victorian Government weighed into the national void by investing a whopping $50M to advance the production of a COVID-19 vaccine. This kicked the nation into overdrive, seemingly caught other governments by complete surprise, and buoyed the Australian RNA Production Consortium (ARPC).

The master plan of a complete ecosystem enjoyed some tinkering around the edges by Therapeutic Innovation Australia, involved in an RNA production Facility at the University of QLD.  This is a much-needed initiative for one of the puzzle pieces.

The Australian Government has at last embarked on a plan with ‘Australia’s onshore mRNA manufacturing capability: approach to market’ led by the Department of Industry, Science, Energy and Resources.

“Building on the success of COVID-19 mRNA vaccines, the Australian Government recognises that mRNA technology is part of the next generation in advanced health care… On 21 May 2021, the government opened this approach to market. It enables manufacturers who can provide mRNA manufacturing capability in Australia to plan a partnership approach with the government to bring forward this capability.” ² 

On the face of it, this looks like a fabulous initiative but will need careful planning given the enormity of the project, requiring an end-to-end, onshore population-scale mRNA capability to be fully operational within a short time frame. Respondents were given only 8 weeks to apply to the approach to market as it closed on the 16^th of July. This is an onerous task for smaller biotech companies which may leave only big pharma capable of responding.  I wait with interest to see if this will be the full ecosystem we are anticipating. Interestingly, the Government may elect not to invest nor have they postulated the investment value. The research community is highly sceptical of this. Will the organisation granted access to this funding be a champion for the research community? Perhaps the grant should force local research collaboration given this is where the most amazing discoveries arise from, ideally it should have researcher governance.

ANZ Alliance and the Australian Academy of Science (AAS)
The ARPC has advised governments on so many levels, it is nice to see they have collaborated with our friends in New Zealand. Now they are ANZRPC. A little over a year ago, 6 motivated and highly driven scientists from across Australia come together to promote the opportunity to manufacture genetic medicines locally, now having the support of The Australian Academy of Science. They collaborated with the AAS for a round table event³  which resulted in a Statement – National RNA science and technology priorities⁴.

“The agreed recommendations from the roundtable are to advance opportunities towards:

• a national mission for the whole RNA science and technology pipeline in Australia, driven by strategic investment and prioritisation across funding schemes. The national mission should provide sustainable, long-term funding for projects from fundamental research to translation

• a local mixed RNA manufacturing ecosystem, including pilot facilities to enable new Australian products to be translated, production of pre-clinical trial components and GMP sovereign manufacturing capability to support clinical trials

• the formalisation of cross-disciplinary coordination to: develop a roadmap for a national RNA science and technology mission; holistically nurture the entire research to translation pipeline; connect the research community to each other and industry

• the facilitation of commercialisation and establishment of a self-sustaining RNA biotech industry through new and existing mechanisms, including incentivising the capture of new intellectual property, the R&D tax incentive and proposed patent box initiative

• schemes to build capacity in entrepreneurial and translation expertise, including facilitating greater mobility between research and industry”⁴

Looking at these recommendations through the lens of a future for STEM, young researchers, local manufacturing and sovereign capacity, they are on target and a scream to the Government NOT to lock up funding with a self-serving corporate entity without interest in engaging with basic research.

The pedigree of the participants is a formidable list of outstanding researchers. The observers to this event were fortunate to witness what will go down in history as one of those rare events of immense importance.

Monash makes a move
Professor Colin Pouton was awarded $5Million from the Victorian government to progress his COVID-19 Vaccine to the clinic. It was exciting to see Colin explain his vaccine concept during the BioForum⁵ recently. This forum was made possible by the BioMelbourne Network with mRNA Victoria as collaborators for the event plus sponsors State Government of Victoria, Department of Jobs, Precincts and Regions and I should acknowledge the speakers – The Hon. Jaala Pulford, Professor Colin Pouton and Dr Amanda Caples. This is no pipedream – the reality is they acquired a NanoAssemblr Blaze for phase 1 clinical trials at IDT Australia (Institute of Drug Technology Limited) – A publicly listed Australian cGMP pharmaceutical manufacturing company based in Melbourne. What a monumental step toward securing local manufacturing led by the researcher! The Victorian Government should be applauded for such an initiative.

Then UNSW arrives
The UNSW RNA Institute will be a science, therapeutics and translational facility driving cross-disciplinary approaches to global challenges in RNA chemistry, biology and medicine. It will be established with a $25 million investment from UNSW as part of a collaborative, RNA Bioscience alliance between NSW universities. Another ARPC founder Professor Pall Thordarson from UNSW Science will lead the UNSW RNA Institute. “An mRNA manufacturing capability would position Australia as a leader in the global research effort to combat emerging vaccine-resistant viruses, such as new COVID-19 variants” …. “More importantly, this is not just about mRNA vaccines. They are only the tip of the iceberg in terms of a whole range of RNA therapeutics that are revolutionising medicine – a field that UNSW has great strengths in and includes novel cancer treatments and RNA-based treatments against the virus that causes COVID-19.”⁶

In partnership with NSW Health, UNSW will also lead the NSW RNA Production and Research Network. This Network brings together four universities – The University of Sydney, University of Technology Sydney, Macquarie University and the Australian National University – plus several medical institutes and hospital-based facilities with the UNSW RNA Institute, to enable an RNA community of practice in NSW/ACT⁶.

Delta rages – in a word… VACCINATE!
As Australia comes to grips with a fresh COVID-19 outbreak of the Delta variant, NSW has stepped up and run hard to vaccinate. The way forward to some semblance of normality is clearly vaccination. Companies are scrambling to resolve their approach to manage this situation. Some are attempting to mandate vaccination; others are taking more carrot than stick tactic, where access will require certified two jabs. Such a passport scheme appears to be effective in encouraging ambivalent people to step up and expose their arm. Whether it’s a ‘vaxed’ or a vexed issue, even the ‘Fair Work Ombudsman has updated its guidelines stating that employers can “direct” employees to get vaccinated where it is “lawful and reasonable”. ‘⁸ What does this mean, and who judges this?

As with many things in life, the key is education, and this cannot be clearer than looking at the ATA Scientific example. We are boasting a high vaccination rate without any encouragement from management. The status will be 100% soon as the vaccination appointments come along. This prompts me to consider why are we finding 100% relatively easily as the national percentage of fully vaccinated is approximately 36%9 – perhaps it is what we do.
 
ATA Scientific supplies instruments to the medical research industry. We are immersed in vaccine research, genetic medicine, COVID treatment research and so much more. We are proud to play our small part in Australia’s response.  Not all our team were immune to the prevailing virus of social media rabbit holes, however requiring a little vaccine 101 and an explanation of how mRNA works.  We certainly are fortunate we can reference peer-reviewed research, and many of these researchers are our direct customers and friends.

Much has been said about the current batch of mRNA Vaccines, specifically developed too fast to trust. The idea that these vaccines came out of nowhere is a failure of scientific communication. They are based on decades of research across multiple fields. This link to the 2020 Nobel Laureate Dr. Michael Houghton on Lipid Nanoparticle RNA Vaccines⁷ describes the journey of mRNA vaccine development eloquently.

And we wait
I concluded my first genetic medicine ecosystem article calling for funding to back the ARPC vision. I borrowed a phrase from Prof Archa Fox ‘the opportunity is there – we just must be bold and grasp it with both hands.’  Let’s grasp the opportunity the Victorian and NSW governments have bestowed, look to the future and all the possibilities from this amazing journey so far and make Australia a global powerhouse of scientific research, democratising medicine!

References:

1. https://issuu.com/westwick-farrowmedia/docs/lab_and_life_scientist_apr_may_2021 Page 6. Accessed 23 Aug 2021
2. Department of Industry, Science, Energy and Resources. Australian Government. Accessed 1 July 2021 https://www.industry.gov.au/news/enabling-australias-onshore-mrna-manufacturing-capability-approach-to-market
3. https://www.science.org.au/news-and-events/news-and-media-releases/can-australia-emerge-covid-19-pandemic-and-build-world-leading-rna-science-based-biotech-industry Accessed 24 Aug 2021
4. Statement – National RNA science and technology priorities
   https://www.science.org.au/files/userfiles/support/documents/statement-national-rna-science-and-technology-priorities.pdf
5. https://biomelbourne.org/bioforum-future-direction-for-mrna-technology-meeting-recording/ Accessed 24 Aug 2021
6. New UNSW institute to spearhead NSW government drive for RNA research: https://newsroom.unsw.edu.au/news/science-tech/new-unsw-institute-spearhead-nsw-government-drive-rna-research Accessed 24 Aug 2021
7. RNA LNP Vaccines Overview – Dr. Michael Houghton https://www.youtube.com/watch?v=h3YeC04IxnI Accessed 24 Aug 2021
8. https://www.abc.net.au/news/2021-08-22/covid-19-frequently-asked-questions-coronavirus-most-asked-2/100394856 . Site accessed 23 August 2021.
9. https://www.health.gov.au/sites/default/files/documents/2021/08/covid-19-vaccine-rollout-update-jurisdictional-breakdown-22-august-2021.pdf Site accessed 23 August 2021