Creating a genetic medicine manufacturing ecosystem

Recently the Australian Government announced the Medical Products National Manufacturing Priority road map¹. This Modern Manufacturing Strategy (MMS) is to be led by industry to assist in scaling up, becoming more competitive and having more resilient supply chains.

One of the key areas identified is high value-add medicines, and it is this segment that can be utilised in creating a genetic medicine manufacturing ecosystem.

Why an ecosystem?

Australia has a proud history of world-class research, at times translating these findings into amazing medicines. We stand tall, wave the flag and laud such forays in global recognition and impact, citing how the latest eureka moment adds to notable achievements of years past from a relatively tiny nation punching above its weight with brilliant Nobel Laureates. Scientific endeavour requires talent, patience, time and funding — a whole lot of funding. Importantly, science of the future needs to coordinate a skill mix of brilliant minds from many disciplines coming together to develop solutions to the questions posed. The scientific tradition of sharing talent to the far corners of the planet may work in our favour in the current pandemic; however, attracting such people is easier when the environment is conducive to them. Indeed, Australia has amazing scientists, respected worldwide. We do have some cool infrastructure, but do we have an ecosystem?

Stem the brain drain

Building an ecosystem has benefits beyond the obvious protection of our IP: the creation of our own medicines morphs into vaccination security and helps the loss of our talent overseas. A recent survey² noted, “Although most respondents indicated a ‘love of science’, many also expressed an intention to leave their research position.”

This survey is a chilling read. It feels like these despondent researchers are leaving in droves or soon will be. The mantra is to promote STEM, get more women in STEM, so where are the jobs in STEM? Perhaps it is time to play this game smarter; to develop an industry in science. This is not just a smattering of research institutes around the country but a concerted approach to integrate an industry leveraging off the human capital we have, creating the capacity.

What would the ecosystem look like?

If Silicon Valley could be translated into Australia, we could create ecosystems in quantum computing, genetic medicines or any number of high-value industries. An ecosystem in this context can be defined as a complex network or interconnected system, building an industry with tangible employment across levels of opportunity. Much has been spoken about developing a facility to create the next vaccine, preparing for a future pandemic, and as the pharma companies line up to receive funding to build the infrastructure, I fear we will miss the golden opportunity this presents.

Scientific solutions to a challenge rarely are plucked from thin air; they require research and the environment to do this effectively. If we are at the precipice of dramatic funding for the manufacturing of medical products, let’s be astute about this. If an ecosystem is to be developed in genetic medicine, there will likely be two main streams: R&D and manufacturing. These are not unrelated; indeed, they are inextricably linked with commonalty of raw materials, scientific IP and technology. To develop sovereign capacity, lessons learnt from this current pandemic must be observed. No number of iron-clad vaccine contracts from big pharma can protect the supply if the foreign government bans the export. Currently, there are global shortages of raw materials, basic laboratory products, value-added consumables such as mRNA, lipids and instrumentation. All this can be secured if a well-thought-out ecosystem is planned and executed — upstream from the actual production and downstream requirements such as fill and finish.

Will the ecosystem be profitable?

This depends on your definition of profitable. For some this is jobs, for others it is monetary wealth creation and for scientists, it is the translation of research into treatments for diseases. All of these have merit, especially if you include the opportunity this presents for our early-career researchers.

To be clear, a clever ecosystem can help with all manner of drug candidates: small molecules, peptides, siRNA and mRNA could easily create veterinary medicines as well. Starting a facility usually has a long wait for a result given the years of research, as well as preclinical and clinical trials. Currently researchers are moving to preclinical trial in desperate need to scale up their candidates, unable to afford the infrastructure to go it alone, forced to send it offshore and at times losing their IP. Much of the final-stage development work is contracted out to companies again offshore. Ideally, it is well within the intellectual scope of Australian academia; we simply lack the necessary resources. There are possibilities for short-term successes.

Tapping into the untapped

The next wave of STEM students in high school is poised to have an advantage beyond a large portion of the world, given the COVID-19 impact on schooling worldwide. The effects of lockdown on the student population in Australia have been significant although we have been particularly fortunate in comparison to elsewhere, considering the US are still not going to school one year down the track. Add the opportunity to recruit to our ecosystem from a global pool anxious to move out of lockdown to clean and green Australia, and this is a substantial opportunity.

The ANZAC collaboration

Australia and New Zealand share many things, compete with passion and collaborate when necessity dictates. There are strategic and cooperative advantages in extending alliances with our close neighbours. The scientific community already has close relationships, and presents readiness to create an mRNA vaccine for both these countries. A quick stocktake of capabilities proves to illuminate the value in working together on this; it is a symbiosis well worth the investment.

Where to start

Behind the scenes, a group of scientists scattered around Australia have formed an alliance. This is a formidable bunch of professors from an array of disciplines recruited for their skill mix to create a genetic medicine facility in Australia. They are ‘the real deal’ — passionate about the science, keen to make a difference for Australia, agnostic to where it will be, they just want it to happen! The group is the Australian RNA Production Consortium (ARPC). Collectively, they have deep expertise in the biology, chemistry, manufacture and use of RNA medicines. ARPC was formed in mid-2020 and has since made submissions to government at various levels, consulting to government consultants in the hope one day this dream will become a reality and these consultants are not simply paying lip service to the ecosystem. Now what is needed is both levels of government and industry/venture capital to back these efforts of the ARPC and fund a new and dynamic ecosystem in genetic medicines. The opportunity is there — we just have to be bold and grasp it with both hands.

References

1. Medical Products National Manufacturing Priority road map. https://www.industry.gov.au/sites/default/files/February%202021/document/medical-products-national-manufacturing-priority-road-map.pdf
2. Research Culture: A survey of early-career researchers in Australia. Christian, Johnstone et al. https://elifesciences.org/articles/60613

Image credit: ©stock.adobe.com/au/unlimit3d

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