30 March, 2022

Last year Cartherics teamed up with the Australian Regenerative Medicine Institute (ARMI) and Centre for Commercialization of Regenerative Medicine Australia (CCRM).

In the following interview with ARMI Alan Trounson discusses the importance and challenges Australian experts have and face taking research from the laboratory to the marketplace, as well as the future of regenerative medicine.

Q: What value does this partnership between ARMI, Cartherics and CCRM Australia bring to academic scientists at ARMI?

A: It is a connection between research and industry. The federal and state governments strongly recommend that university research organisations have strong connections to industry and that the funding of proposals will continuously include an upgrading of those relationships. Hence, there’s some very good reason for those connections to be developed with companies like Cartherics that have deep academic origins and connections.

I had an experience of that when I was the President of the California Institute for Regenerative Medicine (CIRM), where industry and academic departments worked hand-in-hand for obtaining funding for major projects regenerative medicine translation and clinical trials. CIRM needed these partnerships to move discoveries through translation to clinical trials in regenerative medicine, which wasn’t happening when an academic-only or a company were sole applicants. Clearly, that is also an issue for effective translation in Australia. I believe partnerships forged between industry and research, such as Cartherics and ARMI, are highly valuable. The presently articulated priorities will attract a lot more funding from federal and state governments.

Q: What needs to change, and what can academic scientists do to foster a stronger translational spirit?

A: First of all, academic scientists can get educated in the critical industry processes that enable private investment and commercialisation of potential products. Business management courses might help, but there is no better experience than to work together with a team that is actually working in this space. They will see first-hand the issues faced in translation and early development that are really quite different from the ones that academic departments anticipate, issues that involve helping projects move into and through translation and into the commercialisation process.

We will be running some courses for our staff, from people who are very skilled in this area. One of the suggestions is that we could extend some of those to ARMI staff to help them understand this process a lot better. I think that would help considerably to be exposed to those opportunities.

Q: What were some of these issues you faced with Cartherics?

A: We didn’t begin the company with any intellectual property; we had to create it. Therefore, we were a little different to other start-up companies. Most will tell you that is not the way to develop a company, but we were able to be successful because some people believed in the ideas that we had, and we were able to generate new intellectual property and patents.

It’s really about being able to position yourself with staff who are committed to meeting essential milestones. I think these are the most challenging things, probably, for academics to understand. These milestones are usually set by the investors or your organisation, and you must address them. These milestones are often called Go-No-Go decisions. There’s rarely a situation in academia where there’s a Go-No-Go decision made. You really must be very focused on achieving set outcomes, and you have to be able to turn things off if they’re not succeeding. If there’s a major problem that needs to be resolved, you must reassess, begin again or change direction.

The focus that’s required is essential, and if that falters, then you tend to get lost in terms of what the expectations are for you to move through this space. It’s a long enough period that is needed to ensure all expectations are made, including those of the clinical trials regulators. If you extend the time, it makes it almost impossible to commercialise or to keep the studies funded (so called the “valley of death” for biotech companies). Frequently start-up funders don’t provide sufficient time and funds for you to do anything except to address those critical milestones efficiently.

Q: What are your observations, with the time spent overseas, particularly in America, about the differences between Australia and America?

A: In the US, there is a much bigger pool of industry working with academia and the flow from industry through academia than back into industry and then back into academia is very common. That’s not a foreign process in America, but it’s very unusual here. We have to create these affiliations as we are doing here with ARMI and create them with one or a number of companies that work in the space you’re interested in. That will be really enabling for converting discoveries into products that can be commercialised and are useful for the community.

There is currently a lack of entrepreneurial industry capacity at the very margins here in Australia. It’s a hard place for people to operate in because there’s very little adequate funding. There is occasional biotech start-up funding, but it tends to be very tied to distant expectations of success, and they’re not always well articulated.

We started without much of the entrepreneurial assistance. If you’ve got good ideas, and you’ve got some well-organised industry people close to you, it should actually work. It’s really a matter of the ideas being sound and that there is a clear unmet need the product addresses. You must make sure that you’re working in a space where there’s a perceived or real need for what you’re developing. And often, that’s not well appreciated.

Q: The Melbourne biotech scene is growing. Does this make you hopeful in increasing this flow between industry and academia?

A: There are great opportunities. There always has been. CSIRO is a great example of being often effective in commercialisation. But relatively, we don’t perform as well as other developed countries. Hence the problems are more about academia not wanting to not get too far into the industry space because they prefer the comfort of the academic environment. Industry can also be very choosy about who they interact with, and we’ve got to get over that.

I think we need our funding bodies to be much more specific about having industry consultants or creating partnerships between the ideas percolating in academic institutions and industry capacity to deliver, in this space that’s enabling, so that you don’t have to go through the whole learning experience over and over and over again.

Q: How do you see the commercialisation of stem cell and regenerative medicine technologies unfold in the next 5, 10 and 15 years?

A: Being involved in the early days of regenerative medicine with a large amount of funding in California was a genuine experience to show how effective you can be to work in this area. I think there is this incredible potential and opportunities in this sector. But it’s a very tough gig, particularly if you’re using cell therapies, because the timelines in clinical trials are long and demanding, more so than for small molecule drugs.

Clearly, it will not be easy, but the potential is dramatic and well worth the investment and involvement. I’m an optimist by nature, and I believe regenerative medicine is really going to come alive with impact in human medicine. Australia was leading back in the early 2000s because we initiated a lot of discoveries in human pluripotent stem cells, but it really went quiet for quite a long period. But I think it’s really moving again now.

There are many opportunities to work with international partners, and our partnership with ARMI and CCRM is one of those examples. We have PhD students that we share as well. So there’s a process of bonding that’s happening with groups like ours. I think more of these compatible partnerships will be enabling and will reduce the number of errors and wrong directions made in product development and commercialisation.