08 November 2018
Article by Tamra Sami, published in BioWorld on November 6,2018.
Australia is considered one of the first movers in the regenerative medicine (RM) space, with more than 70 institutes and companies working in the sector across the country.
But to capitalize on its technical capabilities, it will need to be strategic if it is to reach its potential to be a major player in Asia Pacific.
To that end, AusBiotech established a Regenerative Medicine Advisory Group in 2016 to provide advice on trends in the regenerative medicine space and to advocate on key issues, AusBiotech CEO Lorraine Chiroiu said during the AusBiotech conference in Brisbane last week.
Industry incubator MTPConnect gathered feedback from 60 key stakeholders via surveys, interviews and workshops to develop recommendations and priority action items for Australia to take a leading place in the regenerative medicine sector, MTPConnect CEO Dan Grant told attendees.
“Australia already has a strong base, with more than one-fourth of universities and half of research institutes having a strong focus on regenerative medicine,” he said, noting that 300 research labs and 1,200 researchers are currently involved in RM projects.
While we're small, we're smart, we've got great infrastructure in place and we're geographically advantaged by being on the doorstep of Asia.
Dr Dan Grant, CEO of MTPConnect
Industry estimates peg the global RM market to reach A$120 billion (US$86.4 billion) by 2035, and if Australia could capture 5 percent of that market it could create 6,000 new jobs and bring in A$6 billion in annual revenue, Grant said.
MTPConnect released a report during the conference that assesses Australia’s strengths and weaknesses and recommends priority areas to capitalize on global opportunities.
The overarching vision is to create an end-to-end world-leading value chain from discovery to delivery that grants Australian patients access to world-class RM therapies, creates jobs and enables the export of Australian therapies to the world.
The report highlights a five-point action plan that would focus on:
- Building capability to develop the sector and attract and retain world-class talent;
- Promoting collaboration across the value chain for a
- Funding to secure long-term investment and commercial success;
- Regulation and policy to create a clear market access
pathway that is aligned with global markets; and
- Infrastructure to build Australian manufacturing capability in stages to become an export hub in the Asia Pacific region.
Focus on serving Asia
“East Asia will be a leader and may well be the corridor that produces more regenerative medicine than anywhere in the world,” said Regeneus Ltd. CEO John Martin during a panel discussion. Korea, Japan and China will be the key drivers, he said, and Australia has the potential to lead the charge as an industry.
“There’s a good reason why Australian companies are winning in Japan with regenerative medicine,” Martin said. He praised Japan Prime Minister Shinzo Abe for bringing together government policy, industry investment and academia to turn Japan into a global hub for regenerative medicine.
Japan brought in a “top-down strategy and a new radical pathway that drew global attention,” Martin said, adding that Regeneus “turned to Japan early on rather than looking at Europe or America, and that is working in our favor.”
The report highlights Australia’s strengths in Asia when it comes to cell handling and manufacturing, and when asked about feedback from Asian partners about those capabilities, Grant told BioWorld that both within and outside of the report consultation process, “we and others have engaged with a number of international organizations to explore and confirm that Australia could be well-positioned to act as an export hub to Asia countries.”
“Cell and tissue manufacturing requires highly skilled individuals and high levels of quality assurance, which Australia provides,” Grant said along the sidelines of the conference.
“This includes tests for quality control to ensure therapeutic products are free from microbial contamination, which is another area in which we have significant capabilities.
“Australia’s general manufacturing strengths and point of difference within the region is deemed to be for low volume, highly technical, and high value products, so the opportunity is there to expand manufacturing capacity and capability to support commercial-scale manufacture of locally and internationally developed therapies.
“And when you think of the shortened supply and logistics chain for RMs, and that Asia Pacific will have 90 percent of the global middle class population growth from 2015 to 2022, our proximity to Asia does gives us a competitive edge, particularly if we can scale up over time,” he said.
Emerging funding sources
Although Australia has seen an uptick in available funding for biotechnology in general, investors are skittish about regenerative medicine due to its immaturity. Government has invested in the sector some, but VC investment outside of government will be required to boost research translation and commercialization.
“There are unique challenges for regenerative medicine, challenges which can impact a project’s attractiveness to a potential investor,” Grant said. “I’m talking about things like the relatively immature state of the sector and the fact that RM is neither a product, device, nor medical procedure. It is often a combination of all three. The short shelf-life of many RMs and the pressure that that puts on supply chains is also a consideration.
“Maintaining a focus on delivering therapies that address specific clinical needs for patients is important,” he said.
“That’s good news from a health and well-being perspective, but it also means we’ll be better placed to secure that strong and diverse pool of funders and venture capital we’re all looking for. We’ll also look at effectively leveraging the Medical Research Future Fund to help build the RM sector, and if we can better align activities with government priorities, that will also help encourage investment.”
When asked about the immediate next steps, Grant said collaboration is critical, which is why MTPConnect sought buy-in from key contributors from the medical and research sectors as well as from industry and government.
The next immediate step will be to establish a central coordination group, or catalyst group, to coordinate and connect stakeholders to ensure the group meets the goals in its five-point plan to prioritize skills development, improve collaboration, secure investment, evolve regulations and enhance manufacturing capability.
“Ongoing success will require focus, persistence and the entire sector working together, but I’m optimistic we’ll get there,” Grant said.
“Regenerative medicine is a global sector, and the fact that location is less important when it comes to discovery means our ambitions for the sector’s growth are also realistic.
"Our relatively small size hasn’t hampered us in developing world-leading therapeutics in the past like the cervical cancer vaccine, Gardasil.
“While we’re small, we’re smart, we’ve got great infrastructure in place and we’re geographically advantaged by being on the doorstep of Asia,” he added. “There’s a real opportunity for Australia to become a regional hub in this field for Asia Pacific.”