Making personalized medicine a health-care winner
Posted by Bryan Alary on March 26, 2013
The U of A’s Christopher McCabe and Tania Bubela are leading a new four-year project aimed at bringing together the scientists who develop personalized medicine technologies, industry partners who invest in their research and development, regulators who decide whether treatments are safe and health systems that decide whether to use and pay for the technologies.
McCabe said there have been big promises about personalized medicine revolutionizing health care by tailoring treatments to the biological makeup of individual patients and lowering costs. The promises haven’t matched with the reality, he said, with researchers, industry investors, regulators and health providers coming to the table with different expectations that do not necessarily fit together.
“Our objective is to show how this can be realigned so that fewer failures make it to late-stage development,” said McCabe, Endowed Chair of Emergency Medicine in the Faculty of Medicine & Dentistry.
The $4.6-million project—called Personalized, Accessible, Cost-Effective applications of ‘Omics technologies, or PACE Omics—received $2.4 million in funding from Genome Canada and the Canadian Institutes of Health Research, via Genome Alberta, on March 26.
McCabe explained that when scientists and their investors develop new technologies, their research programs are aligned with meeting regulatory approval and not with whether a product is commercially viable or a good value for buyers—usually the health-care system. That misalignment results in wasted investments for technologies that are not good value or do not live up to expectations.
Even when products do successfully make it through research and regulatory hurdles, they are often delayed coming onto the market because they are very expensive, lack proper evidence to prove their worth and, as a result, get bogged down in challenges and appeals.
“If we can reduce the amount of time that’s lost in that activity, it’s a win for the patients, it’s a win for the health systems and it’s a win for the investors,” McCabe said.
Multi-centre research collaboration
PACE involves two dozen researchers, health officials and industry representatives with backgrounds in medicine, health economics, health policy, public advocacy, law and ethics. The team includes U of A researchers from the Faculty of Medicine & Dentistry, the Faculty of Law and the School of Public Health, and scientists from McGill University, the University of Edinburgh, the University of Regina and the University of North Carolina.
“There isn’t a better university in Canada to launch this type of methods-focused program,” said Bubela, a professor in the School of Public Health whose research focuses on intellectual property law and policy for large-scale research collaborations in genomics and stem cell therapies.
“We have the expertise from the clinical perspectives, the legal perspectives, the economics perspective. And we have a history of working collaboratively on all aspects of the innovation system.”
One of the team’s challenges will be working around a complicated legal and regulatory framework that Bubela says more closely resembles an information hairball than a pipeline. Most personalized medicine technologies involve two parallel research processes—technology to perform a test of a health condition and technology for a treatment. Intellectual property is not necessarily held by the same organizations or companies.
“The environment gets complex very quickly. It’s an issue a lot of policy makers have been grappling with,” said Bubela.
The team's efforts to explore new ways to do clinical trials and patient recruitment, research that raises ethical challenges, will be led by partners at McGill.
Timothy Caulfield from the U of A’s Health Law and Science Policy Group will look at legal issues and the impact of genomics research, public opinion and media representation and how it can affect behavioural change.
Other scientists and industry partners will bring real-world experience in research and development of technologies to treat cancers, treat a rare genetic disease that causes blindness, create personalized diets and improve health care in rural and remote areas.
“This is about trying to change the way our whole industry pursues its core business of developing evidence to support technologies that improve people's health,” Bubela said.
PACE Omics is also being funded by Alberta Innovates - Health Solutions, the U of A, McGill University, Genome Quebec, Alberta Health, and other university and in-kind partners, including patient organizations and industry.