New model aims to capitalize on Canada's world-class strength in regenerative medicine

Industry consortium key

A resurgence of interest in the biotechnology sector could propel the Centre for Commercialization of Regenerative Medicine (CCRM) into the sweet spot as it gears up programs and services aimed at moving key discoveries into the marketplace. Funded in 2011 with $15 million over five years through the Centres of Excellence for Commercialization and Research (CECR) program, CCRM has built up a series of networks and collaborative partners aimed at exploiting Canada's world class strength in the field.

CCRM is also set to capitalize on the advances achieved by other organizations, primarily the Stem Cell Network (SCN) — a mature Network of Centres of Excellence — and the Cancer Stem Cell Consortium (CSCC). It is implementing a multi-faceted business model that brings together the best researchers and research institutions to accelerate the development of regenerative medicine (RM) therapies.

CCRM is built around three core programs in cell reprogramming and engineering, cell manufacturing, and biomaterials and devices. Fee-for-service and research contracts are structured around three core thrusts and three outcome areas (see chart). Perhaps most importantly, the CECR has created an industry consortium comprised of 30 companies representing all sectors. Its board of directors is chaired by a US venture capitalist and members include several high-profile Canadian, US and UK researchers and business leaders.

"Canada has a strong contingent of scientists and we're leading in early-stage commercialization through CCRM," says Dr Michael May, CCRM's CEO. "Regenerative medicine could be a Canadian legacy and having the US next door puts us in an unusually good position."

In recent months, promising RM-based firms have successfully tapped the financial markets, most recently with the announcement of an IPO by Fate Therapeutics. And while that funding has yet to impact CCRM substantively, its projections for leveraging external funding call for $100 million in the first five years and $500 million over 10 years.

"It's a stretch target but you need to think that way if you're going to create an industry. We need more money to execute fully on our plan allowing us to do more, bigger and faster. Right now there's a capital limited environment and when that changes we will be in a good position. We have high global recognition that will allow us to access capital when it starts to roll into the system," says May. "The ultimate leverage goal is to attract risk capital and we're doing this now. The immediate priority is further funding for R&D scaling."

building on previous work

Awareness of RM's commercial potential is not new. SCN launched an ambitious initiative in 2006 to pool and develop relevant intellectual property emanating from Canadian institutions. Aggregate Therapeutics Inc (AT) had some initial success in IP pooling but it was unsuccessful in convincing private sector financiers to support the venture— the result of flaws in the model and poor market conditions. By 2009, the AT venture was all but dead.

In a 2010 paper, SCN executive director Drew Lyall examined the AT experience and concluded that, while it stimulated an "unparalleled level of national collaboration and achieved several important objectives" the model failed to de-risk RM IP to the point where the private sector was willing to take over. Lyall noted that a new approach acknowledging the need for further public investment to support product development is being adopted through the CECR program, specifically CCRM.

May is also an enthusiastic supporter of the CECR concept and model and says SCN and AT were definite contributors to the ultimate focus and activities of CCRM..

"There are lots of links and evolutions that led to CCRM including SCN. It built a culture of collaboration and AT was one of those experiments," says May. "The SCN was an NCE and the CECR program is a second type of network that's quite brilliant. It focuses on the ecosystem and networks which is a uniquely Canadian approach. Now we're building an industry consortium that could lead to a new Business-Led NCE."

Within the RM ecosystem, CCRM has establish relationships with several key entities such as the California Institute for Regenerative Medicine (CIRM), with which it has a number of joint projects, including one to establish "gold standard databases". It also has close working relationships with the Cancer Stem Cell Consortium and MaRS?Innovation, a Toronto-based CECR that has expertise in IP management.

In addition to its industry consortium, CCRM has been working to identify the best IP for company creation. May says it has "eight company concepts", some of which will launch in the next year or so.

"You don't want to do it too early. We practice proactive technology transfer by engaging leaders and industry to create companies strategically," he says. "We're also working on several cGMP manufacturing facilities that are being build now. Canada has expertise in bioprocessing and engineers that understand the biology.We're leading in early-stage commercialization through CCRM."

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