My grandmother, at 97, is excited about stem cell research because she sees the possibilities.
Regenerative medicine IS an exciting field. It’s on the cutting edge of science and fans and critics alike debate its merits regularly in the press and in blogs. Every day, we read stories with headlines that proclaim stem cells will cure [insert disease or condition here].
Every day, there IS progress that bodes well for the field. Scientists keep making important advances that will yield therapies, and they develop cells as tools and devices that enable the industry. Here is a recent example.
A significant challenge for the field is moving discoveries through the pipeline so that they may reach the marketplace and benefit patients. The Government of Canada’s Private Sector Advisory Board, in a 2011 report, says that Canada, and other countries, “have lagged […] in translating […] research into products, services and solutions.”
The issue isn’t that there is a lack of good research to commercialize. According to the Ontario Stem Cell Initiative, Ontario’s stem cell researchers are among the most highly cited in the world today and they have secured over 170 patents in the last five years. Evaluating the discoveries being made in Canada and determining which ones should be commercialized is a significant task.
To select discoveries for commercialization or new company creation, a disclosure process is needed. This is how Canada’s Centre for Commercialization of Regenerative Medicine (CCRM) operates: When CCRM receives a disclosure, it is evaluated using a robust assessment process that examines the technology from two key perspectives. The first is Market Readiness/Commercial Strength, meaning whether the technology can be advanced to a defined marketable product. This involves assessing the market potential and competitive landscape for the envisioned product(s); identifying potential licensees from CCRM’s industry consortium; determining the strength of the current intellectual property (IP) position and opportunity for further IP generation; and, evaluating licensing revenue or company creation potential.
In addition to product strength, CCRM then assesses the technology from an Enabling Perspective, which considers the breadth of the technology (e.g. how many products could it potentially enable); internal development time required to reach key commercial milestones; anticipated return on investment; and, the ability of the technology to strengthen internal capabilities at CCRM.
While there may be a great deal of hype surrounding aspects of the regenerative medicine field, only rigorous due diligence should influence the discoveries selected for commercialization. Hopefully that too bodes well for the industry.