Theme 4: Intellectual Property and Commercialization

“New models and creative strategies in knowledge management, intellectual property, and commercialization are needed to support multi-disciplinary and multi-sectoral collaborative initiatives designed to move precision medicine from research to clinical application.”

Theme Lead:

Tania Bubela, School of Public Health, University of Alberta

Theme Team:

Richard Gold, Faculty of Law, McGill University
Yann Joly, Faculty of Medicine, McGill University
Katherine Bonter, Montreal Heart Institute
Nadine Beauger, IRICOR

The translational process for innovative PM technologies is challenging. Multiple associated technologies – the therapy, companion diagnostic and sometimes diagnostic platform – must all navigate complex R&D and regulatory environments in a coordinated fashion to become a health care product. This substantial challenge is further complicated by the frequent involvement of multiple developers across the associated technologies and the iterative, non-linear path of innovation. The failure of any one technology within a bundle may mean failure for all, and lack of co-ordination of the translational processes imposes significant costs.

The goal of this theme is to work with the Canadian R&D community to develop evidence-based best practices to improve co-ordination among stakeholder engaged in PM research R&D. We need to develop creative strategies in knowledge management, intellectual property, and commercialization to facilitate the collaborative networks that can bring precision medicine technologies to market. The Canadian innovation and regulatory environments differ from those in other major markets, such as the United States, Japan and Europe, and therefore require specific analysis.

 Objectives:

(1) Identify key stakeholders in IP and knowledge management in the Genome Canada Genomics and Personalized Health (GAPH) projects’ collaborative networks
(2) Identify common and unique translational challenges faced by the GAPH projects
(3) Synthesize research and practices in the development of strategic responses to challenges and best practices, by the GAPH projects and similar initiatives globally
(4) Provide direct support to teams through briefing documents and educational resources on IPRs, commercialization strategies, and their intersection with the regulatory environment.

Objectives will be achieved through an assessment of the best practices of and challenges faced by the GAPH teams, multi-stakeholder workshops specifically targeted to address identified challenges, summary reports, best practice guidelines, legal briefs, and training.