Canadian Stem Cell Strategy: Questions & Answers
Canada has the power to create a new world – one in which we are able to reduce suffering and death from heart attacks, cancer, diabetes and other devastating and debilitating diseases. With the advancements made in stem cell research, it’s within our reach. Not 30 years from now – but in 10.
Why do we need a stem cell strategy?
- Because a revolution in medical care is coming: Just as the digital age introduced products and services that previously had only been dreamed of, the cell therapy age will produce treatments and cures for chronic diseases.
- Because our health care system needs relief: Canada’s health care costs exceed $200 billion a year, two-thirds of which goes to treating incurable diseases. Cell therapies could dramatically reduce the use of health services and substantially improve the quality of life and health of Canadians.
- Because the economic payoff is enormous: Building a flourishing cell therapy and regenerative medicine industry in Canada will create thousands of knowledge economy jobs, spur company creation and growth, and stimulate prosperity.
- Because we’re very good at this: Two Canadians (Drs. James Till and Ernest McCulloch) proved the existence of stem cells in the early 1960s and paved the way for subsequent generations of Canadian scientists who continue their legacy as world leaders in field. Recent initiatives led by the Stem Cell Network, the Centre for Commercialization of Regenerative Medicine and CellCAN have positioned Canada as one of the world’s top stem cell nations.
- Because we work well together: Through the Stem Cell Network and other networks, our world-class researchers have been working in close collaboration for almost 15 years. Across the country, our stem cell scientists are pooling their efforts to come up with new treatments for devastating diseases.
- Because we have the tools: Recent public and private investments in networks and infrastructure have put Canada in position to succeed in the emerging field of advanced cell therapies. Hubs are forming in British Columbia, Alberta, Ontario and Quebec.
- Because we have the right environment: With a universal health care system, excellent clinicians and state-of-the-art facilities, Canada is a highly desirable place to conduct the kind of clinical trials needed to deliver new cell-based treatments to patients.
Why do we need this Strategy?
- Because we need to pull together: No single group — scientists, medical clinicians, health charities, philanthropists, industry, investors, government — can make this happen on its own. It will take a concerted effort. The Strategy brings those groups together and sets out a road map to move the science forward toward new therapies for Canadians.
- Because the time is now: The next 10 years will see more and more scientific advances make the leap from the research lab to the treatment room. Canada is in a strong position to lead the coming wave of development as the global cell therapy industry undergoes explosive growth and delivers new treatments and cures.
Are there ethical concerns about stem cell research?
- There are no ethical concerns regarding adult stem cells: Stem cells have been in common use in cancer care for more than 40 years. Every time a bone marrow transplant succeeds in saving a cancer patients’ life, it is thanks to the adult hematopoietic stem cells that rebuilt his or her blood supply to fight off the leukemia. Scientists describe adult stem cells as undifferentiated cells found among those that have already transformed into specific kinds of cells. Adult stem cells can renew themselves and can differentiate to maintain and repair tissue and organs. Scientists also use the term somatic stem cell instead of adult stem cell when they are referring to cells of the body — as opposed to the germ cells, for example.
- Induced pluripotent stem cells: There was considerable media attention following the discovery of embryonic stem cells in 1998. However, in 2006 Japanese researcher Dr. Shinya Yamanka found a way to produce stem cells with the same pluripotency as embryonic stem cells using adult cells. The process involves taking an ordinary cell, usually a skin cell, and introducing several genes to “reprogram” it into a pluripotent cell. The discovery, which earned Dr. Yamanaka the Nobel Prize, has largely eased ethical concerns posed by embryonic stem research by providing a viable alternative source of pluripotent stem cells. The first human clinical trials using these iPS cells are underway.
Why not business as usual?
- Because other countries are moving quickly: While no one country has yet taken the lead, several recognize the potential health and economic opportunities to be seized:
- California has invested $3 billion over 10 years to clear the path so that more research can be translated into therapies that can be delivered in clinics.
- Japan has committed $1 billion and brought in new laws to speed development and approval of new therapies.
- The United Kingdom has made stem cell research and development a national priority, with new investments to position it to compete globally.
What’s the goal?
5 to 10 in 10: The goal is for Canada to lead the way in bringing five to 10 breakthrough therapies to the clinic within 10 years that will transform the health-care landscape.
What’s the investment?
- The request: The plan calls for $1 billion in private support over the next 10 years, and funds are being committed now. The Strategy calls for the Government of Canada to invest $500 million over 10 years. This will support a far-reaching, achievable plan that will bring economic prosperity to Canadians, and better health outcomes and cures to the world.
In a nutshell, what’s the Strategy about?
- It’s about saving lives and creating prosperity: This is a 10-year plan to create a vibrant, internationally recognized stem cell industry in Canada that can speed the translation of research discoveries into new cell-based therapies, products and technologies. It will mean Canadians will have access to effective new treatments and will reduce the burden of disease on caregivers. It will create jobs, enhance productivity and strengthen our economy.
Who came up with the Strategy?
- Concerned and motivated Canadians: The Stem Cell Strategy is the product of a 18-month consultation process conducted across the country and led by a Joint Strategy Working Group whose members included leaders from:
o Canadian Stem Cell Foundation
o CellCAN Regenerative Medicine & Cell Therapy Network
o Centre for Commercialization of Regenerative Medicine
o Health Charities Coalition of Canada
o Ontario Bioscience Innovation Organization
o Ontario Institute for Regenerative Medicine
o Stem Cell Network
- National consultation: Together, they canvassed the country to craft the Strategy, holding workshops and roundtable discussions to consult with more than 100 experts and stakeholders including scientists, medical doctors, health charity champions, administrators, industry and business leaders, and philanthropists.
- The sum of the parts: The knowledge gained from those sessions formed the basis of Following Through: Realizing the Promise of Stem Cells — A Canadian Stem Cell Strategy & Action Plan. The Strategy is backed up by an in-depth study conducted by analysts at KPMG. The Strategy was reviewed and endorsed by an international panel of leading thinkers in the field of stem cell research and regenerative medicine — experts from both academia and industry, including:
o George Q. Daley (Chair), Samuel E. Lux IV Professor of Hematology/Oncology, Harvard Medical School; Director, Stem Cell Transplantation Program, Children’s Hospital Boston, Boston, MA;
o Gregory Bonfiglio, Founder & Managing Partner, Proteus Venture Partners, Portola Valley, CA;
o Julia Levy, Co-founder and former President & CEO and Chief Scientific Officer, QLT Inc., Vancouver, BC;
o Geoff MacKay, President and Chief Executive Officer, Organogenesis Inc., Canton, MA;
o Chris Mason, Professor of Regenerative Medicine Bioprocessing, Advanced Centre for Biochemical Engineering, University College of London, London, UK;
o Debra Mathews, Assistant Director for Science Programs, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD;
o Stephen Minger, Global Head, Research and Development for Cell Technologies, GE Healthcare Life Sciences, London, UK;
o Martin Pera, Professor Stem Cell Sciences, University of Melbourne, Walter and Eliza Hall Institute and The Florey Neurosciences Institute; Program Leader of Stem Cells Australia, Melbourne, VIC, Australia.
What’s in the Strategy?
- A prescription for transformative change: The Stem Cell Strategy is aimed at creating a successful, internationally recognized cell therapy and regenerative medicine industry that will take research discoveries — wherever they are made — and turn them into new treatments, technologies and products. Along with improving health outcomes for Canadians, the industry will boost economic prosperity: Canada will emerge as a leading global player in the burgeoning multi-billion-dollar cell therapy market. “Made in Canada” could be the hallmark of cell therapies, just as “Made in Switzerland” is for quality timepieces. It would also create thousands of new knowledge economy jobs through the growth of existing companies and the creation of new ones.
- Five strategic pillars: The Strategy is built on five pillars to develop new breakthrough therapies and build a thriving cell therapy industry in Canada. They include:
- Multidisciplinary science: Embracing and optimizing Canada’s uniquely multidisciplinary foundation of assets, expertise and networks to turn discoveries into new treatments.
- Market-driven commercialization: Creating a vibrant stem cell/regenerative medicine ecosystem that helps cell-therapy-based companies grow.
- Advanced cell manufacturing: Building on Canada’s strong foundation of bioengineering expertise and cell processing infrastructure to emerge as a global cell manufacturing leader.
- Regulatory enablement: Catalyzing the development and growth of a cell therapy industry to improve health outcomes and increase prosperity for Canadians.
- Clinical trials leadership: Bolstering Canada’s clinical trial capabilities and infrastructure through better coordination and strategic funding to become a preferred global destination.
How will the Strategy be implemented?
- In three phases: The Strategy would begin with a seeding phase for its first three years to catalyze implementation of initiatives. This would be followed by maturing and operating phases during which financial commitments will ramp up, with federal funding providing one-third of total funding and non-federal sources supplying two-thirds.
- To maximize results: An ambitious and transformative initiative of this size and scope needs national oversight. The Strategy proposes that national leadership, oversight and accountability for implementation be provided by an independent secretariat, agency or the appointment of a chief executive officer or chief scientific officer.
How will success be measured?
- By the numbers: Along with Canada leading the way to bring five to 10 new therapies or treatments to the clinic, clear performance measures will be put in place, including:
- Number of clinical trials and their stage of progression;
- Number of patients treated;
- Number of jobs in the manufacturing sector and associated businesses;
- Implementation of streamlined regulations for cell therapies/breakthrough technologies;
- Reduction in product approval times;
- Number of international scientists attracted to Canada;
- Retention rates for stem cell scientists in Canada;
- Revenue generated from sales of stem cell and cell-related products and;
- Revenue from manufacturing.