Commercialization: Push to market not just about the bottom line

March 16, 2007

By Roman Zakaluzny
The Ottawa Business Journal

Accompanying her father on business trips to the developing world, a young May Griffith said she saw too many other children her age with eyes clouded over from disease and infection.

Any problem with the cornea, the eye's protective shield, can eventually lead to blindness, an affliction all too common outside the developed world.

"My dad did a lot of work in the tropics, and I used to tag along. (I) saw kids with clouded corneas," she recalled. She was shocked at the prospect of slowly going blind and not being able to get treated.

Today, Dr. Griffith is an associate professor at the University of Ottawa's faculty of medicine, as well as a senior scientist at the Ottawa Health Research Institute (OHRI). Her research at the OHRI's Sprott Centre for Stem Cell Research on artificial corneas, she hopes, will one day help people in the developing world see again, thanks to transplantation.

She manages a team of scientists working on artificial corneas, made of recombinant collagen. Eight years ago, Dr. Griffith and her colleagues gained an international reputation when they created the first artificial equivalent to human corneal tissue that worked.

The corneas - already transplanted successfully in animals - works as scaffolding: existing adult stem cells in the patient, such as those that form into nerve cells or tear-producing cells, are able to expand into the transplanted tissue.

The technique to manufacture the corneas is Dr. Griffith's. Mass production of it one day, provided the corneas are successful in human testing, will likely be a job for private industry. In between, the process will need to be commercialized.

Helping to facilitate that is the OHRI, she said.

"The tech transfer office at both the OHRI and the University of Ottawa have been very helpful," said Dr. Griffith. "If we identify a potential interest from industry, they help us set out research agreements with these people, and also licensing."

The 105 scientists and medical doctors working in six disciplines at the institute are well served, said its COO Robert Hanlon. Inventions are constantly working their way through the patenting system at the institute, and many of them are examined deeper for licensing possibilities with the private sector or the creation of a potential spinoff company.

"We have a commercialization program, which we call the technology transfer program, that helps all of our researchers deal with any sort of inventions and licensing agreements and spinoff companies," Mr. Hanlon. "There's always invention disclosures coming in that have to be strategized over and worked out on how best to move them to the marketplace."

Four companies have spun off OHRI since its inception six years ago and dozens of patents have been issued, he said. The OHRI itself is a merger of several smaller, similar institutes around since about the late 1980s. According to Mr. Hanlon, commercialization activity like Dr. Griffith's is set to pick up soon.

"When health research started getting off the ground in 1988, we had about $1 million in research," he said. "This year, we have some $75 million a year in research.

"The Ottawa Health Research Institute scientists expect more and more commercialization over the next few years," he added. "Research has matured in the last few years, and we expect to see more commercialization benefits to the residents of Ottawa, and to the residents of Canada."

Research funding for Dr. Griffith's corneas came from grants and charitable donations from organizations like the Organ Donation and Transplant Association of Canada. The resulting patent belongs to the university and OHRI. However, said Dr. Griffith, both of them consult with her to decide on the best way to move the items to market.

"(The university and the OHRI) always consult with the professors," she explained. "So they would do what the scientists would want. Of course, they would make recommendations on how to go about it."

"The invention's not worth anything without the collaboration of the inventor," agreed Mr. Hanlon. "Most often, there's further work that needs to be done. We work closely with the scientists to develop a strategy that's viable, and meets their economic interests as well."

Private industry, naturally, is looking for a return on investment. Dr. Griffith, however, also has personal interests, like taking the product or a form of the product to people in underprivileged countries.

Both goals, she said, are possible at the same time.

"We're certainly looking at companies," she said. "But a lot of blindness occurs in the Third World, so we are also looking at non-commercial licenses as well."

She pointed to several World Health Organization initiatives. WHO often works with big pharma to provide drugs for free or at a reduced cost to patients in the developing world.

Her team has different versions of the same synthetic corneas patented. Some, she suggested, could go exclusively to not-for-profit ventures like the above, mass produced for people who need them but can't afford them

"That would be ideal," she said. "An ideal industry partner would be one that would do that. Obviously it would be a proportion, and (doing it) can't hurt their bottom lines. But there are a lot of companies who would do that, those with philanthropic arms to them."

Deciding on whether a particular piece of intellectual property is more appropriate as a commercial product or provided free in the public domain, or both, is a juggling act, said Mr. Hanlon.

"You're always trying to look at what's the best thing for the invention," he said. "Occasionally, it's better to make the invention available in the public domain, without a commercial path. That depends on the particular invention."

If all goes well, Dr. Griffith said she hoped to have the artificial corneas on the market before the end of the year. First, however, there's administrative red tape to work through.

"Right now, we have submitted paperwork for regulatory approval," she said, in Canada, the U.S. and others. "The main thing now is funding: we need industry funds to take it to clinical trial, because that's extremely expensive."

Once that happens, Dr. Griffith said, more people around the world will, hopefully, see again, thanks to artificial corneas.

"I have two sisters who are artists, and I also paint and sculpt," said Dr. Griffith. "I can't imagine life without vision."

Note: Reproduced with permission from the Ottawa Business Journal.