When Arif Aziz learned last fall about a new independent study project that was bringing together MBA candidates and PhD students in health sciences and engineering to map the global market for stem cell therapies, he jumped at the opportunity.
“I couldn’t believe it when I saw the posting,” said Aziz, an MBA candidate at the Rotman School of Management at the University of Toronto. “I thought to myself, ‘This is what I want to do.’ ”
The for-credit project — part of a unique collaboration launched in fall 2016 between Rotman and U of T’s Medicine by Design initiative — offered Aziz a chance to combine his business training with his expertise in regenerative medicine. He completed a postdoctoral fellowship at the Sprott Centre for Stem Cell Research at the Ottawa Hospital Research Institute before making the leap to industry to work as a consultant in the bioscience sector and pursue his MBA.
“We have all this cool science,” said Aziz, part of the five-member team, which also included three PhD candidates from the laboratories of Medicine by Design-funded researchers and another student from Rotman’s MBA program. “So how can we commercialize it? How can we translate it into something that impacts society?”
These are key questions that researchers, doctors, life sciences companies and investors are grappling with in the global race to harness stem cells to improve treatments for conditions such as stroke, diabetes and liver disease. U of T has long been at the forefront of regenerative medicine research, starting in the early 1960s with the identification of blood stem cells by biophysicist James Till and hematologist Ernest McCulloch.
Medicine by Design is building on this legacy of excellence by bringing together more than 100 researchers from across U of T and its affiliated hospitals, along with hundreds of postdoctoral fellows and graduate students, in collaborative teams to accelerate breakthroughs in regenerative medicine. With its commercialization partner, CCRM, the initiative is also driving Toronto’s regenerative medicine ecosystem and propelling new therapies to market — and ultimately to patients — more quickly.
Toronto has seen significant clinical translation and commercialization activity in regenerative medicine in recent months. In December, bioscience giant Bayer AG and venture capital firm Versant Ventures announced a $225 million (U.S.) investment — one of the largest Series A launches the bioscience sector has ever seen — to create Toronto-based BlueRock Therapeutics.
Despite this recent success, the student team discovered significant bottlenecks along the global pipeline from the laboratory to the treatment room. They include inconsistencies in preparing patients for clinical trials, technology gaps in manufacturing, unclear regulatory pathways, and lack of planning around who will pay for new therapies — and how much.
To overcome these challenges and ensure new therapies can be successfully commercialized, there needs to be more coordination and integration across the entire regenerative medicine ecosystem, the team told a panel of industry experts on Jan. 26.
“Everyone in this room is stunningly good at their piece of the value chain,” said Will Mitchell, Anthony S. Fell Chair in New Technologies and Commercialization and a professor of strategic management at Rotman, who supervised the project. “But there is room for someone to step up and be the Apple of the regenerative medicine space — someone who not only is involved in the design, but also knows how to integrate all the pieces to make the overall system work.”
The team, which met weekly during the fall term, drew its conclusions after making a list of key players in the sector, mapping out the paths different regenerative medicine technologies take to commercialization, reviewing case studies and interviewing industry stakeholders. Although the students are pursuing different academic paths, they had a common starting point because each has a background in health sciences research. But they also brought complementary strengths to the collaboration, including industry experience and contacts, entrepreneurial skills, current knowledge of the science, and a rigorous business approach to problem solving.
“We all had something to contribute,” said Anna Kobb, a PhD candidate in the laboratory of Rodrigo Fernandez-Gonzalez at U of T’s Institute of Biomaterials & Biomedical Engineering (IBBME).
Medicine by Design Executive Director Peter Zandstra said decades of regenerative medicine breakthroughs in Toronto “have allowed us to build higher and higher peaks of excellence.” He hopes Medicine by Design’s collaboration with Rotman will help cultivate a new generation of bioscience entrepreneurs who will strengthen Toronto as a global hub for stem cell-based therapies and help Canada realize its full potential in the field.
“Regenerative medicine is an area where Canada can lead,” said Zandstra, a University Professor and faculty member at IBBME. “To do that, we all have to work together and understand the relationship between the new discoveries we are making and how those discoveries can impact society through commercialization and health-care changes. This partnership with Rotman — one of the world’s leading business schools — represents a great opportunity to do that.”
For Kobb, who has worked in the medical device industry in the United States, the project highlighted the importance of having a business plan up front for new regenerative medicine technologies. “Having that foresight to know the market space you want to occupy and then having people along the way who can help you identify the different steps you need to go through is crucial,” she said.
Yonatan Lipsitz, a PhD candidate in Zandstra’s laboratory at IBBME, said working on the project has inspired him to embrace a more entrepreneurial role in Toronto’s regenerative medicine ecosystem.
“For me, the take-home lesson from this project is that Toronto can be a global leader in regenerative medicine if we make it happen,” said Yonatan Lipsitz. “We can’t wait for someone else to make it the right place for us, or to attract the perfect person to do it for us. We need to be the ones to put in the effort and take some risks.”
The Rotman School of Management is located in the heart of Canada’s commercial and cultural capital and is part of the University of Toronto, one of the world’s top 20 research universities. The Rotman School fosters a new way to think that enables graduates to tackle today’s global business and societal challenges.
Launched in 2015, Medicine by Design is funded by a grant from the Canada First Research Excellence Fund.