BUSINESS INITIATIVES Centre for Commercialization of Regenerative Medicine: Moving Forward with Regenerative Medicine Commercialization in Canada Stacey Johnson*
“If everyone is moving forward together, then success takes care of itself.” This quote by Henry Ford, the American industrialist who founded the Ford Motor Company, nicely captures the ethos of the regenerative medicine (RM) community in Canada. Or, put another way, “hockey is Canada’s sport [and] stem cells are Canada’s science” [1].
“Hockey is Canada’s sport (and) stem cells are Canada’s science.”
INTRODUCTION Ever since James Till and Ernest McCulloch identified and defined blood stem cells at Princess Margaret Hospital in Toronto, Canada, in the early 1960s, Canadian scientists and engineers have been leaders in the RM field. With over 400 stem cell scientists, 68 research centers, effective networking, and translational support, Canada remains at the forefront of international academic collaborations and industrial research [2]. And it does not hurt that Canada’s Scientific Research and Experimental Development Program is among “the most generous R&D tax incentives in the world” [101].
Director, Centre for Commercialization of Regenerative Medicine, Toronto, Ontario, Canada. *(Correspondence: [email protected])
It was in this prolific environment that the Centre for Commercialization of Regenerative Medicine (CCRM) launched in June 2011. With such a huge brain trust, and the corresponding infrastructure to support basic research, Canada was ripe for an organization focused solely on harnessing all that knowledge and cutting-edge scientific discovery and translating it into commercial products for the marketplace.
ization by unifying dynamic business leadership with high-value translational technology platforms and innovative technologies based on demonstrated excellence in fundamental stem cell and biomaterial science.” CCRM secured matching funds, in cash and in-kind, from its institutional and founding partners, and some of its yearly revenue flows from its industry consortium through membership fees.
The government of Canada, under its Networks of Centres of Excellence program (NCE) —specifically the Centres of Excellence for Commercialization and Research (CECR)—awarded CCRM $15 million over 5 years to fulfill its mission “ to create and sustain a global nexus for regenerative medicine commercial-
CCRM’s industry consortium is a major accomplishment that sets it apart from similar translation centers around the world, where the academic component exists but there is not a strong market pull.
Stem Cells and Development • Vol. 22, Supp. 1 2013 • DOI: 10.1089/scd.2013.0358
CCRM’s industry consortium is special. It comprises around 30 companies that
85
Johnson
represent the key sectors of the RM industry: devices, cells as tools, reagents, and therapeutics. These companies advise CCRM on RM bottlenecks and opportunities in the field and serve as ready receptors for new, best-in- class technologies. According to Peter Zandstra, chief scientific officer of CCRM and professor at the University of Toronto’s Institute of Biomaterials and Biomedical Engineering, “The industry consortium provides sound business advice to CCRM and crucial insight into what industry is doing. If I’m wearing my researcher’s hat, I appreciate that working with CCRM gives me access to key players in the field who are scouring the world for good IP [intellectual property].” As an industry consortium member, whether large multinational or start-up, these companies have access to CCRM’s intellectual property (IP) pipeline — representing over 94% of Ontario’s RM activity— and a 90 - day fi rst look at new IP. They can partner with CCRM on codevelopment projects and sponsor special initiatives, such as the Pfizer- CCRM Innovation Fund. There are special perks such as discounts on fee -for-service contracts, access to technical expertise, and staff /trainees for exchanges, plus CCRM will validate proprietary technologies.
cell reprogramming, stem cell characterization, pluripotent cell expansion, and biobanking, as well as precise gene editing for stem cell engineering. To succeed after government funding ends, CCRM needs to become self-sustaining. The fee -for-service group is revenue generating and will contribute to CCRM’s ability to operate successfully in future years. “Although CCRM is just out of its startup phase, we are aggressively planning for the day when the government will no longer be funding us,” explains Michael May, CEO of CCRM. “ The Board of Directors and executive team regularly take the pulse of CCRM to make sure that we’re on track and following a strategic plan that will lead to being sustainable.” One initiative under way is the future operation of a 20,000 -sq.-ft. good manufacturing practice Cell Therapy Centre that will work alongside the Orsino Cell Therapy Facility at University Health Network and be housed in MaRS Centre Phase 2 (more about MaRS below). With funding allocated by the government of Ontario’s Ministry of Research and Innovation, the center is expected to be operational by the summer of 2014.
“Ontario is already a leader in stem cell research; the next logical step is to build cell therapy manufacturing capabilities in the province to move discoveries to the clinic and then the marketplace,” says Minister of Research and Innovation Reza Moridi. “CCRM is aligned with the hospitals and research institutes in the province and has strong ties to industry— making it the right choice to lead this initiative.”
A strong collaborative network exists in Canada While playwright Tennessee Williams’ vulnerable character Blanche Dubois may have depended “on the kindness of strangers,” [3] CCRM depends on its network of partners and stakeholders, and an R&D-receptive environment to achieve its goals. Toronto’s Discovery District, where CCRM is located, boasts Canada’s largest concentration of research institutes, business incubators, and business support services, spanning 2.5 km in the heart of downtown Toronto, making it the densest geographical center for research in the world [102]. Once MaRS Centre Phase 2 opens its new tower,
Two summers after its launch, CCRM had close to 90 disclosures in its development pipeline and 9 of those had options either initiated or executed. Although the majority were from CCRM’s institutional partners—University of Toronto (also CCRM’s host), The Hospital for Sick Children, Mount Sinai Hospital, University Health Network, Ottawa Hospital Research Institute, and McMaster University— almost one quarter came from other Canadian and international institutions. In 2013, CCRM expanded its Cell Reprogramming and Engineering Platform by creating a distinct fee-for-service offering. CCRM offers footprint-free human
86
Hon. Reza Moridi (center) touring CCRM’s lab as Gordon Keller, Director, McEwen Centre for Regenerative Medicine, looks on (left). CCRM’s Michael May on right.
Stem Cells and Development • Vol. 22, Supp. 1 2013
CCRM: Moving RM Commercialization in Canada Forward
MaRS Discovery District will increase to “over 1.5 million square feet, making it one of the largest urban innovation hubs in the world” [103]. Housed within MaRS Discovery District is MaRS Innovation, a fellow CECR that commercializes promising life sciences breakthroughs from 15 of Toronto’s top universities and research institutes— plus the Thunder Bay Regional Research Institute (16 total). MaRS Innovation supported CCRM in its federal application, and since being funded, any RMbased technologies that are disclosed to MaRS Innovation are now passed on to CCRM for due diligence, and they partner on these opportunities. Very successful at identifying strong life sciences IP and commercializing it, MaRS Innovation was awarded $14.95 million from the NCE, earlier this year, to support it until 2016. The Ontario Stem Cell Initiative (OSCI) is a virtual network of 125 researchers who provide a majority of the IP that comes to CCRM, along with crucial scientific advice, expertise, and strategic leadership. OSCI’s slogan is “Innovate and Challenge Fate,” because their scientists do this everyday through their groundbreaking work. OSCI members currently hold 250 patents. OSCI is led by Janet Rossant, Chief of Research at the Hospital for Sick Children Research Institute, President of the International Society of Stem Cell Research, and co-chair of CCRM’s Strategic Advisory Board. OSCI and CCRM frequently partner to create opportunities in which research and commercialization go hand-in-hand. A recent initiative found organizational
CCRM by the Numbers $15 million budget 30 companies in the consortium 90 disclosures in development 2 years of existence
leaders traveling to China to agree on terms for collaborative opportunities that would bring funding back to Ontario and advance stem cell research in both countries. The Stem Cell Network (SCN), another federally funded Centre of Excellence similar to CCRM, was established in 2001 and awarded $63.62 million until 2012 to enable the translation of stem cell research into clinical applications, commercial products, and public policy. SCN has been supporting more than 100 researchers and 450 trainees at 28 institutions across Canada since it launched. SCN’s success at developing a thriving and collaborative stem cell community in Canada, with marketable IP, laid the foundation for CCRM and OSCI. In its 12 years of existence, SCN has funded, nurtured, and trained the Canadian stem cell community and built it up to what it is today. With its own commercializing efforts, initiated before CCRM was created, the Network has spun off or grown 12 new Canadian companies on the basis of its funded research, research that has led to 140 patent applications and 35 issued patents in the last 3 years alone. SCN says that its researchers have spent around $50 million on basic and translational research since 2001 (personal correspondence with Drew Lyall, executive director, SCN). CCRM now reviews all disclosures originating from SCN’s members. SCN has recently implemented new targeted funding programs, including those focusing on drug discovery and cellular therapies. Grants under the Drug Discovery program, for example, serve as a bridge between basic and clinical research, from general identification of potential compounds to validation and optimization aimed at clinical or commercial use. Currently, SCN has funded 12 Drug Discovery projects that are researching compounds with demonstrated potential to treat leukemia, brain cancer, osteoporosis, spinal cord injury, and other diseases.
Stem Cells and Development • Vol. 22, Supp. 1 2013
Dr. Peter Zandstra, CCRM’s Chief Scientific Officer.
Global collaborations While CCRM’s mandate is to commercialize IP in Canada and create jobs, it recognizes that great RM discoveries are happening around the world. To support the global industry to help it succeed, CCRM wants to commercialize the best technologies no matter where they originate. Two years into its 5-year term, CCRM has initiated a number of collaborative agreements with international translation centers, collaborative networks, and research institutes. Its intention is to bundle technologies into marketable companies, and the issues regarding royalties, where jobs will reside, and so on, will work themselves out on a case by- case basis during the negotiation process. Returning to Henry Ford and his thoughts on collaboration, he said that “Coming together is a beginning, staying together is progress, and working together is success.” Certainly that applies to the field of RM in Canada, where researchers are encouraged and rewarded for collaborating. Only time will show whether this model will work when applied internationally. Fortunately, the collective need is great and therefore the will to succeed is also great.
Author disclosure statement No competing financial interests exist.
87
Johnson
REFERENCES Primary Literature 1. Sornberger J. (2011). Dreams & Due Diligence: Till and McCulloch’s Stem Cell Discovery and Legacy. University of Toronto Press, New York. 2. McCulloch J (the Burloch Group). (2013). The Power of Networks: Regener-
88
ative Medicine in Canada. Unpublished report, written for the Centre for Commercialization of Regenerative Medicine. 3. Williams T. (1947). “A Streetcar Named Desire.” W.W. Norton & Company, New York. Websites 101. Scientific Research and Experimental Development Program. BeneFACT Con-
sulting Group. www.benefact.ca/sred-over view.html 102. Boggs T. Everything you Need. BioBusiness, Jan/Feb 2013. www.biobusiness mag.com /articles /2013jftoronto/toronto .html 103. Mars Discovery District Website for Phase 2 Project. http://marscentrephase2 .com /
Stem Cells and Development • Vol. 22, Supp. 1 2013
“If everyone is moving forward together, then success takes care of itself.” This quote by Henry Ford, the American industrialist who founded the Ford Motor Company, nicely captures the ethos of the regenerative medicine (RM) community in Canada. Or, put another way, “hockey is Canada’s sport [and] stem cells are Canada’s science” [1].
“Hockey is Canada’s sport (and) stem cells are Canada’s science.”
INTRODUCTION Ever since James Till and Ernest McCulloch identified and defined blood stem cells at Princess Margaret Hospital in Toronto, Canada, in the early 1960s, Canadian scientists and engineers have been leaders in the RM field. With over 400 stem cell scientists, 68 research centers, effective networking, and translational support, Canada remains at the forefront of international academic collaborations and industrial research [2]. And it does not hurt that Canada’s Scientific Research and Experimental Development Program is among “the most generous R&D tax incentives in the world” [101].
Director, Centre for Commercialization of Regenerative Medicine, Toronto, Ontario, Canada. *(Correspondence: [email protected])
It was in this prolific environment that the Centre for Commercialization of Regenerative Medicine (CCRM) launched in June 2011. With such a huge brain trust, and the corresponding infrastructure to support basic research, Canada was ripe for an organization focused solely on harnessing all that knowledge and cutting-edge scientific discovery and translating it into commercial products for the marketplace.
ization by unifying dynamic business leadership with high-value translational technology platforms and innovative technologies based on demonstrated excellence in fundamental stem cell and biomaterial science.” CCRM secured matching funds, in cash and in-kind, from its institutional and founding partners, and some of its yearly revenue flows from its industry consortium through membership fees.
The government of Canada, under its Networks of Centres of Excellence program (NCE) —specifically the Centres of Excellence for Commercialization and Research (CECR)—awarded CCRM $15 million over 5 years to fulfill its mission “ to create and sustain a global nexus for regenerative medicine commercial-
CCRM’s industry consortium is a major accomplishment that sets it apart from similar translation centers around the world, where the academic component exists but there is not a strong market pull.
Stem Cells and Development • Vol. 22, Supp. 1 2013 • DOI: 10.1089/scd.2013.0358
CCRM’s industry consortium is special. It comprises around 30 companies that
85
Johnson
represent the key sectors of the RM industry: devices, cells as tools, reagents, and therapeutics. These companies advise CCRM on RM bottlenecks and opportunities in the field and serve as ready receptors for new, best-in- class technologies. According to Peter Zandstra, chief scientific officer of CCRM and professor at the University of Toronto’s Institute of Biomaterials and Biomedical Engineering, “The industry consortium provides sound business advice to CCRM and crucial insight into what industry is doing. If I’m wearing my researcher’s hat, I appreciate that working with CCRM gives me access to key players in the field who are scouring the world for good IP [intellectual property].” As an industry consortium member, whether large multinational or start-up, these companies have access to CCRM’s intellectual property (IP) pipeline — representing over 94% of Ontario’s RM activity— and a 90 - day fi rst look at new IP. They can partner with CCRM on codevelopment projects and sponsor special initiatives, such as the Pfizer- CCRM Innovation Fund. There are special perks such as discounts on fee -for-service contracts, access to technical expertise, and staff /trainees for exchanges, plus CCRM will validate proprietary technologies.
cell reprogramming, stem cell characterization, pluripotent cell expansion, and biobanking, as well as precise gene editing for stem cell engineering. To succeed after government funding ends, CCRM needs to become self-sustaining. The fee -for-service group is revenue generating and will contribute to CCRM’s ability to operate successfully in future years. “Although CCRM is just out of its startup phase, we are aggressively planning for the day when the government will no longer be funding us,” explains Michael May, CEO of CCRM. “ The Board of Directors and executive team regularly take the pulse of CCRM to make sure that we’re on track and following a strategic plan that will lead to being sustainable.” One initiative under way is the future operation of a 20,000 -sq.-ft. good manufacturing practice Cell Therapy Centre that will work alongside the Orsino Cell Therapy Facility at University Health Network and be housed in MaRS Centre Phase 2 (more about MaRS below). With funding allocated by the government of Ontario’s Ministry of Research and Innovation, the center is expected to be operational by the summer of 2014.
“Ontario is already a leader in stem cell research; the next logical step is to build cell therapy manufacturing capabilities in the province to move discoveries to the clinic and then the marketplace,” says Minister of Research and Innovation Reza Moridi. “CCRM is aligned with the hospitals and research institutes in the province and has strong ties to industry— making it the right choice to lead this initiative.”
A strong collaborative network exists in Canada While playwright Tennessee Williams’ vulnerable character Blanche Dubois may have depended “on the kindness of strangers,” [3] CCRM depends on its network of partners and stakeholders, and an R&D-receptive environment to achieve its goals. Toronto’s Discovery District, where CCRM is located, boasts Canada’s largest concentration of research institutes, business incubators, and business support services, spanning 2.5 km in the heart of downtown Toronto, making it the densest geographical center for research in the world [102]. Once MaRS Centre Phase 2 opens its new tower,
Two summers after its launch, CCRM had close to 90 disclosures in its development pipeline and 9 of those had options either initiated or executed. Although the majority were from CCRM’s institutional partners—University of Toronto (also CCRM’s host), The Hospital for Sick Children, Mount Sinai Hospital, University Health Network, Ottawa Hospital Research Institute, and McMaster University— almost one quarter came from other Canadian and international institutions. In 2013, CCRM expanded its Cell Reprogramming and Engineering Platform by creating a distinct fee-for-service offering. CCRM offers footprint-free human
86
Hon. Reza Moridi (center) touring CCRM’s lab as Gordon Keller, Director, McEwen Centre for Regenerative Medicine, looks on (left). CCRM’s Michael May on right.
Stem Cells and Development • Vol. 22, Supp. 1 2013
CCRM: Moving RM Commercialization in Canada Forward
MaRS Discovery District will increase to “over 1.5 million square feet, making it one of the largest urban innovation hubs in the world” [103]. Housed within MaRS Discovery District is MaRS Innovation, a fellow CECR that commercializes promising life sciences breakthroughs from 15 of Toronto’s top universities and research institutes— plus the Thunder Bay Regional Research Institute (16 total). MaRS Innovation supported CCRM in its federal application, and since being funded, any RMbased technologies that are disclosed to MaRS Innovation are now passed on to CCRM for due diligence, and they partner on these opportunities. Very successful at identifying strong life sciences IP and commercializing it, MaRS Innovation was awarded $14.95 million from the NCE, earlier this year, to support it until 2016. The Ontario Stem Cell Initiative (OSCI) is a virtual network of 125 researchers who provide a majority of the IP that comes to CCRM, along with crucial scientific advice, expertise, and strategic leadership. OSCI’s slogan is “Innovate and Challenge Fate,” because their scientists do this everyday through their groundbreaking work. OSCI members currently hold 250 patents. OSCI is led by Janet Rossant, Chief of Research at the Hospital for Sick Children Research Institute, President of the International Society of Stem Cell Research, and co-chair of CCRM’s Strategic Advisory Board. OSCI and CCRM frequently partner to create opportunities in which research and commercialization go hand-in-hand. A recent initiative found organizational
CCRM by the Numbers $15 million budget 30 companies in the consortium 90 disclosures in development 2 years of existence
leaders traveling to China to agree on terms for collaborative opportunities that would bring funding back to Ontario and advance stem cell research in both countries. The Stem Cell Network (SCN), another federally funded Centre of Excellence similar to CCRM, was established in 2001 and awarded $63.62 million until 2012 to enable the translation of stem cell research into clinical applications, commercial products, and public policy. SCN has been supporting more than 100 researchers and 450 trainees at 28 institutions across Canada since it launched. SCN’s success at developing a thriving and collaborative stem cell community in Canada, with marketable IP, laid the foundation for CCRM and OSCI. In its 12 years of existence, SCN has funded, nurtured, and trained the Canadian stem cell community and built it up to what it is today. With its own commercializing efforts, initiated before CCRM was created, the Network has spun off or grown 12 new Canadian companies on the basis of its funded research, research that has led to 140 patent applications and 35 issued patents in the last 3 years alone. SCN says that its researchers have spent around $50 million on basic and translational research since 2001 (personal correspondence with Drew Lyall, executive director, SCN). CCRM now reviews all disclosures originating from SCN’s members. SCN has recently implemented new targeted funding programs, including those focusing on drug discovery and cellular therapies. Grants under the Drug Discovery program, for example, serve as a bridge between basic and clinical research, from general identification of potential compounds to validation and optimization aimed at clinical or commercial use. Currently, SCN has funded 12 Drug Discovery projects that are researching compounds with demonstrated potential to treat leukemia, brain cancer, osteoporosis, spinal cord injury, and other diseases.
Stem Cells and Development • Vol. 22, Supp. 1 2013
Dr. Peter Zandstra, CCRM’s Chief Scientific Officer.
Global collaborations While CCRM’s mandate is to commercialize IP in Canada and create jobs, it recognizes that great RM discoveries are happening around the world. To support the global industry to help it succeed, CCRM wants to commercialize the best technologies no matter where they originate. Two years into its 5-year term, CCRM has initiated a number of collaborative agreements with international translation centers, collaborative networks, and research institutes. Its intention is to bundle technologies into marketable companies, and the issues regarding royalties, where jobs will reside, and so on, will work themselves out on a case by- case basis during the negotiation process. Returning to Henry Ford and his thoughts on collaboration, he said that “Coming together is a beginning, staying together is progress, and working together is success.” Certainly that applies to the field of RM in Canada, where researchers are encouraged and rewarded for collaborating. Only time will show whether this model will work when applied internationally. Fortunately, the collective need is great and therefore the will to succeed is also great.
Author disclosure statement No competing financial interests exist.
87
Johnson
REFERENCES Primary Literature 1. Sornberger J. (2011). Dreams & Due Diligence: Till and McCulloch’s Stem Cell Discovery and Legacy. University of Toronto Press, New York. 2. McCulloch J (the Burloch Group). (2013). The Power of Networks: Regener-
88
ative Medicine in Canada. Unpublished report, written for the Centre for Commercialization of Regenerative Medicine. 3. Williams T. (1947). “A Streetcar Named Desire.” W.W. Norton & Company, New York. Websites 101. Scientific Research and Experimental Development Program. BeneFACT Con-
sulting Group. www.benefact.ca/sred-over view.html 102. Boggs T. Everything you Need. BioBusiness, Jan/Feb 2013. www.biobusiness mag.com /articles /2013jftoronto/toronto .html 103. Mars Discovery District Website for Phase 2 Project. http://marscentrephase2 .com /
Stem Cells and Development • Vol. 22, Supp. 1 2013
