Taking health discoveries from cutting edge to clinic

    UAlberta researchers tapped for $25M national network to help promising treatments prove their worth with investors.

    By Michael Brown on December 19, 2014

    (Edmonton) Biologically based treatments such as cancer-killing viruses, immune-cell therapies and synthetic antibodies are among the most promising cancer treatments to emerge in the past decade.

    As hopeful as these treatments are, however, they come at a time when health-care systems are financially strained and weary investors want to know who is going to pay.

    To help accelerate these discoveries from the lab through to proof-of-concept, manufacturing and clinical testing, all while keeping them financially and socially viable, the federal government has announced the creation of the $25-million BioCanRx. Led out of the Ottawa Hospital Research Institute by cancer researcher John Bell and CEO Drew Lyall, BioCanRX is one of five recently announced national research networks designed to tackle some of the world’s major health and life sciences issues.

    “Just starting with a premise that your end point is receiving regulatory approval is not getting you into the clinic,” said Tania Bubela, a biotechnology law professor in the University of Alberta’s School of Public Health. Bubela and Christopher McCabe, Endowed Chair of Emergency Medicine in the Faculty of Medicine & Dentistry at the U of A, were included in BioCanRx for their strength in developing the evidence base that is going to be required to get a positive reimbursement decision. “At the end of the day, when you are developing a technology, you have to ensure there is a market, or a health-system payer, willing to fund or reimburse the technology that you have invested in.”

    “Nowadays venture capitalists aren’t keen on understanding whether the science is cool or whether you can get regulatory approval; they are largely interested in whether you are going to be able to get public and private payers to pay for it.”

    To help provide researchers with this timely and critical feedback to ensure the economic viability and effectiveness of therapeutics, McCabe and Bubela created the “value engineered translation” framework.

    Developed with funding from the Genome Canada Personalized Medicine Program and the Stem Cell Network—a previous national research network—the VET analysis uses a combination of forecasting and cost effectiveness to inform which candidate technologies should be advanced to Phase 2 trials and how those trials should be designed, and then provide an evidence dossier for each technology that will be used to attract investment in late-stage translation activities.

    “It is kind of an assessment of health benefit, of resource benefit and of social values as to whether you are moving forward into an empty space where there is likely to be a market,” said Bubela. “Our goal is try to help the science team design their research around the evidence required to take before reimbursement agencies and attract investment.”

    McCabe, one of the world’s foremost health economists, says his and Bubela’s inclusion in this network validates the arguments to research funders about the importance of addressing the evidence requirements of reimbursement authorities in designing clinical translation programs for truly innovative technologies.

    “It is a signal that the translational research community has moved on to recognize the importance of designing translational research programs to meet reimbursement-based market access needs, rather than conventional licensing market access requirements, and that the research being undertaken at the U of A is innovative and world-leading in this regard,” he said.

    Bubela agrees and takes her colleague’s comments a step further. In terms of the legal, economic and social science side of biomedical research, “The U of A is the place to be in Canada,” she said, citing the incredible strength of health law professor Tim Caulfield and his team.

    “You’ve incredible collaborators on campus, a fabulous health technology assessment environment that is led out of the School of Public Health, strong support from provincial funding agencies and a proactive health technology assessment team that is integrated into our Genome Canada work at Alberta Health Services.”

    She adds, “It is the right size university, where you have very interesting science moving on but you aren’t so large that you lose access to decision-makers that you can collaborate with.”

    Other national research networks announced are:

    • Aging Gracefully Across Environments Using Technology to Support Wellness, Engagement, and Long Life – AGE-WELL (Toronto, Ontario)
    • Canadian Glycomics Network – GlycoNet (Edmonton, Alberta)
    • Canadian Arrhythmia Network – CANet (London, Ontario)
    • NeuroDevNet (Vancouver, British Columbia), renewed

    With these new grants, the federal Networks of Centres of Excellence program currently funds 14 networks.