Stem cells have been around for half a century yet therapeutic progress has been slow.
October 8, 2012 was a great day for the global stem cell community when Drs. John B. Gurdon (University of Cambridge) and Shinya Yamanaka (Kyoto University) were awarded the Nobel Prize in Physiology or Medicine for their work in discovering “that mature, specialized cells can be reprogrammed to become immature cells capable of developing into all tissues of the body.”
This was some serious vindication for a field that has had its share of detractors.
The reasons for that are many, including the huge financial investment in a field that has yet to reach its promised potential.
With a lot of activity lately, that could be changing and the Nobel Prize appears to recognize that fact. Dr. Gurdon’s award winning nuclear transfer work took place in 1962. In contrast, Dr. Yamanaka’s successful research to reprogram cells to pluripotency (the ability to differentiate into fetal or adult cells) was only six years ago. Since then, his lab experiments have progressed into a potential therapeutic to restore sight (The Japan Times online Oct. 12, 2012 “Riken to test iPS cells in human trial”).
Commercialization in Canada
So where are we, in Canada, in terms of commercializing stem cell and biomaterials-based products and therapies (i.e. regenerative medicine)?
As far as company creation is concerned, a “MaRS Regenerative Medicine Report” from 2009 identified 11 Canadian companies in this space and today that number is probably closer to 15.¹
Here are some findings from Industry Canada’s “Canadian Asset Map for Stem Cell and Regenerative Medicine” (March 2011):
- The federal government is funding two national organizations that focus on commercializing stem cells and/or Regenerative Medicine (RM):
- the Stem Cell Network, established in 2001, was awarded $63.62 million between 2001 and 2012 to enable the translation of stem cell research into clinical applications, commercial products or public policy. The Network has spun off or grown 12 new or young Canadian companies on the basis of its funded research, research that has led to 120 patent applications and 37 issued patents in the last three years alone;
- the Centre for Commercialization of Regenerative Medicine, launched in June 2011, was established to accelerate the commercialization of RM technologies by bringing together business leadership and innovative stem cell and biomaterial technology development. It will receive $15 million between 2011 and 2015;
- At least 39 Canadian researchers were identified as moving scientific findings from the lab to the clinic, but the actual number is expected to be higher;
- The Stem Cell Network says its approximately 100 researchers have spent around $50 million on basic and translational research since 2001;
- In 2000, clinicians at the University of Alberta published “the Edmonton Protocol” in the New England Journal of Medicine demonstrating the first proof of principle that Type 1 Diabetes could be treated effectively using replacement beta cells;
- Other protocols are underway for multiple sclerosis, graft-versus-host disease, stroke, pulmonary hypertension, neuroblastoma and other diseases that can be treated with stem cells.
“By matching clusters of academic research expertise with the business community, we expect CCRM to play a major role in helping the emerging regenerative medicine field reach its full commercial potential.” — Suzanne Fortier
When the Industry Canada report was being developed, the Centre for Commercialization of Regenerative Medicine (CCRM) was just getting established. With a mandate that focuses solely on the development of foundational technologies to commercialize stem cell- and biomaterials-based discoveries, the regenerative medicine community is watching CCRM with great interest and anticipation.
“By matching clusters of academic research expertise with the business community, we expect CCRM to play a major role in helping the emerging regenerative medicine field reach its full commercial potential,” says Suzanne Fortier, chair of the Networks of Centres of Excellence (the federal body that funds CCRM). “The centre’s work keeps Canada at the leading edge of the world’s efforts to turn research breakthroughs into effective therapies.”
In its first 18 months, CCRM has established formal partnerships with Canada’s academic and business communities and formed global collaborations to help strengthen the translation of regenerative medicine around the world.
“The Canadian and international RM community has been very receptive to CCRM, allowing us to accomplish a great deal in a short amount of time,” says Dr. Peter Zandstra, CSO of CCRM. “We’re proud of the strong industry linkages that we’ve made and firmly believe that relationships with academia and industry will facilitate bridging the commercialization gap.”
A close working relationship with MaRS Innovation, another federally funded centre for commercialization of research, adds additional commercialization clout to the community. MaRS Innovation commercializes the life sciences in Canada and shares its considerable expertise and experience with CCRM.
Adds Dr. Michael May, CEO of CCRM: “We won’t commercialize everything, nor will it happen immediately. But we’ve made strategic partnerships and hired the right people to see RM commercialization flourish in Canada. CCRM is driven to make Canada the ‘go to’ place for global RM investment and Canadian discoveries available to patients to improve their lives.”
As scientific progress takes time, so too does the investment that goes into turning discoveries into safe, viable products for the market. Despite the immense pressure to succeed and expectations from media and the public that stem cells are the “holy grail” of medicine, strong regulatory enforcement is designed to prevent premature product adoption until safety and efficacy have been confirmed.
We all know that the turtle beat the hare in Aesop’s fable. Here too, slow and steady will win the race.
1. The Centre for Commercialization of Regenerative Medicine has partnered with several RM companies not included in the 2009 MaRS report.
Stacey Johnson is the Communications Manager with the Centre for Commercialization of Regenerative Medicine (CCRM). CCRM is developing a Canadian asset map in regenerative medicine that will be available for distribution in 2013. Please e-mail Stacey.firstname.lastname@example.org to be put on the list to receive a copy.
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