Theme 4: addressing the translational hurdles in moving personalized medicine (PM) technologies through clinical development to market. Theme 4 analyzes the incentives required to harness the necessary multi-disciplinary, multi-stakeholder, multi-national, and highly collaborative research and development needed to capitalize on public and private sector investments, focusing on funding mechanisms and intellectual property (IP) rights.
Part 1: PM Technology Trajectories
Theme Leader: Tania Bubela, School of Public Health, University of Alberta
There are many legal, organizational, and institutional barriers to clinical and commercial translation of omics research. These include developing the appropriate incentives to promote the development of omics technologies and services that are of value to health systems. This requires a realistic assessment through the development pathway of whether the health system is likely to adopt the technology or service. Because the development of omics technologies engages many actors from different sectors, such as academia and industry, the right knowledge needs to flow to the right actors at the right time. This flow of knowledge is benefited through collaborative networks, but may be hampered by the inappropriate management of intellectual property rights.
The aim of Dr. Bubela’s team is to analyse research and development pathways for PM technologies and services. The team uses a combination of landscaping tools for publications, patents, clinical trials, regulatory approvals, market adoption, and company data, to define the position of Canadian PM developers within the global research and development landscape.
Interested and Engaged Stakeholders: Technology developers, investors, HTA and healthcare system decision-makers.
Part 2: Intellectual Asset Management
Theme Leader: Richard Gold
Intellectual property rights (IPR) play a key role in bringing new technologies to those who can use them. For example, patent laws enable innovating firms to raise the money needed for research and development (R&D) by giving those firms a 20 year period during which they can exclude others from making, using or selling what was invented. The system is premised on the hope that the costs of this 20 year exclusionary period – which may take the form of higher prices and possible preclusion of others from using the invention – are more than offset by the value of the good or service to users. For PM, this means that the health benefits to patients or cost savings to the healthcare system make up for any inconvenience caused to others by the exclusivity.
Ironically, under some circumstances IPR may act counter to innovation and societal good. For example, patents applied too early in the research process may block the free flow of knowledge and research tools, or limit access to new diagnostics and medicines. Thus, recent US Supreme Court rulings have underlined ongoing controversy about what is patentable (genes, biomarkers, genetic tests), promoting confusion amongst PM developers and users. Similarly, longer-range questions over whether and how current patent and other exclusive rights (copyright and database rights, privacy and property rights over human samples) affect whole genome sequencing and other new technology lurk in the background. Such uncertainties can lead industry, universities, and the public healthcare system to under-invest in research and under-use promising technologies, thus slowing public access to PM.
Dr. Gold’s team aims to gather and analyze all policy and academic literature on IPR and related rights relevant to PM and explore the relationship between IPRs and access to cost-effective PM in Canada. The ultimate goal is to raise awareness, provide a road map to existing knowledge, generate new empirical evidence, and develop resources to guide policy-makers, academics and industry in making informed decisions about IPR management.
Interested and Engaged Stakeholders: PM technology developers, investors, healthcare systems policy-makers.