REGENERATIVE MEDICINE
| By Brad Hussey
The Fast Track for Regenerative Medicine Canada is well positioned in a highly competitive global race to scale-up advanced cell manufacturing. Can we keep up with the competition?
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rom penicillin to the Tesla Model 3, every great modern invention that has solved a problem plaguing the human condition has faced a significant hurdle – scaling up from the lab bench to meet demand efficiently and cost-effectively, with no loss in quality. As breakthroughs in regenerative medicine continue to make headlines worldwide, research communities are redoubling efforts to develop sustainable technologies and processes to usher potential cell therapies into the clinic. It is perhaps one of the most technically and logistically complex quests to date in the commercialization of scientific breakthroughs. Overcoming manufacturing challenges so that cell therapies scale out, and up, reliably into affordable and efficacious treatments will unlock a potentially astronomical return on investment in terms of economic activity and improvements in human health. The good news is that Canada, despite having relatively smaller investments from funders compared with the U.K. or the U.S., is poised to make significant headway in advanced manufacturing thanks to a unique home-grown innovation model. “On the commercialization side, there are very few people in the world who really understand what manufacturing a cell therapy at scale may look like – nobody’s done it yet,” explains Philip Vanek PhD, general manager of GE Healthcare’s cell therapy growth strategy. “There is a lot of substantial process development work going on, new technologies that are evolving and new therapeutic indications being pursued [globally]. These things require a huge organizational ecosystem and industrialization effort, and this is where Canada stacks up in terms of the most competitive areas – understanding that industrialization and supply-chain thinking is required for these therapies to become mainstream.” 10 BIOTECHNOLOGY FOCUS October/November 2017
scalable cell and gene therapy manufacturing processes quickly and effectively. In 2015, the federal government of Canada’s First Research Excellence Fund also earmarked $114 million to create Medicine by Design at the University of Toronto. Its research program is devoted solely to research and clinical translation in regenerative medicine.
Culture of collaboration Even if the total investment in advanced manufacturing research pales in comparison to other international programs – the U.K.’s Cell and Gene Therapy Catapult program has invested over £100 million to date in R&D and commercialization efforts, with significant support for cell manufacturing – Canada maintains some advantages. Vanek credits Canada’s unique culture of collaboration and entrepreneurship for keeping the country ahead of the manufacturing curve. He highlights the work of the Stem Cell Network, the Centre for Commercialization of Regenerative Medicine (CCRM, for which he serves as a board member), the Ontario Institute for Regenerative Medicine, the BC Regenerative Medicine Cluster and others for creating an ecosystem here that encourages collaboration within and across traditional disciplines and sectors, including industry. This supportive environment has already borne significant fruit. Last year, GE Healthcare contributed $20 million to match federal funding via CCRM to create the Centre for Advanced Therapeutic Cell Technologies (CATCT), the world’s first cell therapy development facility to adopt a collaborative model of problem-solving between the research community and industry. The facility boasts unparalleled resources in terms of bioprocess technologies and analytical systems, along with a world-class staff, that will allow researchers to develop and optimize
Taping into the talent pool Perhaps the most significant testimonial to the value of Canada’s ecosystem is the creation of BlueRock Therapeutics, announced in December 2016. The result of a US$225 million deal between San Francisco-based venture capital firm Versant Ventures and pharmaceutical giant Bayer AG, BlueRock aims to rapidly develop cell therapies and bring them to market, with an initial focus on treatments for brain and heart ailments. The ability to tap into the deep talent pool of Toronto’s stem cell research community topped the long list of advantages the city offered the start-up. Internationally renowned stem cell innovators Dr. Gordon Keller of the McEwen Centre for Regenerative Medicine, based at University Health Network (UHN) – North America’s largest research hospital – and Dr. Michael Laflamme of the Toronto General Hospital Research Institute have both signed on to BlueRock Therapeutics as cofounders. The new venture was also attracted to Canada thanks, in part, to efforts from the federal government to entice and retain talent in regenerative medicine, as well as CCRM’s unique plan to scale-up stem cell production through CATCT. There may be even more good news on the way for collaborative efforts in regenerative medicine. This past May, the federal government announced a $950 million supercluster funding initiative to stimulate job creation and
We need to create an ecosystem of regenerative medicine innovation in Canada that has a critical mass.
