CIHR’s Commercialization and Innovation Strategy

November 2005

Table of Contents

1. Introduction
2. Defining and Framing CIHR's Role in Commercialization and Innovation
3. Partnerships
4. Strategic Directions
5. Operational Dimensions
6. Evaluation of Outcomes
7. Conclusion

1. Introduction

We are in the midst of a profound revolution in health research, one that is characterized by convergence of ideas, multidisciplinarity and speed. Remarkable progress is being made in understanding the molecular basis of life. The biological, natural, social, engineering and information sciences are being harnessed to detect early stages of disease, explore new pathways to drug discovery, and build a new generation of medical devices. Virtually all fields of study are converging around the challenges and opportunities presented by human health and the eradication of disease. This revolution in health research is creating transformative new technologies and industries.

In the 21st century, health research and innovation will be central to Canada's future. Optimizing investments in health research is the key to improving the health of Canadians, building sustainable, evidence-based, leading-edge health care and public health systems, and developing the transformative new technologies of tomorrow. It was with this vision that the Canadian Institutes of Health Research (CIHR) was created five years ago. In that brief period, CIHR has become a model to the world's health research community.

Commercialization and innovation have a major role to play in making Canada a leader in health research and its translation and to be 'the partner of choice' for others looking to establish and/or expand their R&D programs.

CIHR's Commercialization and Innovation Strategy is the result of continuous consultations with members of Governing Council, CIHR's 13 Scientific Directors, partners and stakeholders, who identified both the challenges arising from gaps in the commercialization and innovation pipeline, as well as the opportunities presented from health research. CIHR then assessed how Canada can address these challenges and opportunities through its mandated objectives.

The strategy is comprised of four primary directions - Research, Talent, Capital and Linkages. The focus is primarily on the early stages in the commercialization and innovation pipeline -where CIHR-funded efforts can directly lead to the development of new products and technologies that will improve the health of Canadians, strengthen the health system, and contribute to the growth of Canada's economy.

This document outlines CIHR's current initiatives that will encourage the capacity of universities and teaching hospitals to interact with partners responsible for delivering the benefits of health research. It offers vehicles to support seed funding for pre-competitive research development of projects deemed to possess commercial potential, provides opportunities for entrepreneurial training and provides support for technology transfer process elements and infrastructure.

All initiatives are driven by peer review, scientific excellence, high ethical standards, public and private partnerships, accountability, and, most importantly, the health of Canadians. The Institutes are integral to these activities and they, along with external partners, will continue to provide advice on and, as appropriate, co-fund existing or planned commercialization and innovation activities.

Success with this strategy will establish Canada as an innovative and authoritative contributor to health-related knowledge translation. It will create health benefits for Canadians while supporting the creation of economic value from research, and improving Canada's position in the world's knowledge-based economy.

2. Defining and Framing CIHR's Role in Commercialization and Innovation

CIHR has defined Knowledge Translation (KT) as "the exchange, synthesis and ethically-sound application of knowledge-within a complex system of interactions among researchers and users-to accelerate the capture of the benefits of research for Canadians through improved health, more effective services and products, and a strengthened health care system." (CIHR Innovation and Action: Knowledge Translation Strategy 2004-2009, July 2004).

Commercialization and innovation, for the purpose of this strategic plan, refers to the KT processes by which research is translated through knowledge, expertise and skilled people between the science base and its user communities contributing to the economic competitiveness, effectiveness of public services and policy, and quality of life of Canadians.

In Canada, sustained investments in research by both the federal and provincial governments, have gone a long way to creating an internationally-recognized health research community. In turn, Canadian academic institutions have increasingly recognized the opportunity and responsibility to translate research discovery into practise and where possible produce economic value for Canadians from the fruits of publicly funded research.

Remarkable progress has been made over the last 20 years in elucidating fundamental mechanisms of disease. For example, this research has included discovery of genes, their protein products which are involved in disease, and the identification of the molecular pathways disrupted by disease. Canada is an acknowledged world leader in these areas of research, which are key to the drug discovery process. Identification of small molecules that bind and modulate the activity of defined protein targets is the current paradigm for drug discovery.

However, despite this remarkable progress in fundamental science, there is now a substantial and growing gap between new discoveries and the necessary innovations that will lead to new drugs, treatments and/or cores for disease.

There remain challenges in developing an optimum return to Canadians from public investments in health research:

• Canada's large geography and low population density, combined with a federated political structure, makes it difficult to build the critical mass of scientific talent, business expertise and capital, necessary for speed and impact.
• Start-ups of new companies that arise from academic discoveries frequently occur too early. As a result, many Canadian biotechnology and biopharmaceutical compounds and innovations are under-financed and built on narrow and risky scientific and/or technical platforms.
• Industry, in the biopharmaceutical and technology device sectors and venture capital community, have not been adequately engaged in the early stages of the research process, to provide the 'market-pull' or 'demand-side' to complement the 'push' from the products of publicly-funded research.
• CIHR's considerable investment in research training provides people skilled in research. However, technology transfer, commercialization and innovation require highly-skilled and properly-trained managers. People with the right blend of science and business skills are in short supply in Canada and around the world.
• Clinical research is a key 'bench to bedside' link. Unless the training and careers of clinical researchers are better supported, and the specialized facilities required for clinical research are available to clinical researchers in Canada, this will limit CIHR's and Canada's capacity for commercialization and innovation.
• Interactions between academia and industry have sometimes raised questions of ethics and integrity, as well as concerns that commercialization opportunities need to be properly evaluated and may not always be for the public good.

Despite these structural challenges, Canada enjoys a number of strengths. These include:

• A newly energized, internationally recognized and growing health research community. For example, Canadian researchers rank number one in the world in citation impact of cancer and stem cell research;
• CIHR leadership in partnership with industry to facilitate health research in academic centres;
• A publicly funded health care system and the new CIHR/CFI Clinical Research Initiative (CRI) that will better enable clinical research;
• A tradition of networking and national and international partnerships that started with the federal NCE program, and has been greatly extended through the creation of CIHR's 13 Institutes, and CIHR's innovative multi-disciplinary, multi-site, and multi-sectoral research programs [Team Grants, New Emerging Teams (NETs), Collaborative Health Research Projects (CHRP)];
• CIHR's creation is now recognized internationally as a model for how to organize, define and fund health research in the 21^st Century.

To summarize the above analysis, Canada faces four gaps in building a health-driven knowledge-based economy that can be addressed through four strategic directions:

1. Enhance our knowledge and research creation performance by continuing to grow our country's investments in the very best health research.
2. Develop the talent that is so critical to all aspects of the health economy.
3. Develop an integrated, cohesive and knowledgeable capital to bridge the gap between public and private sector support and facilitate the growth of high risk small businesses.
4. Build strong people linkages covering the entire chain from discovery to end product that is so critical for economic development.

3. Partnerships

Partnership is at the heart of any successful commercialization and innovation. Commercialization and innovation of health products and/or services is complex, and complementary expertise typically resides among a number of stakeholders. CIHR recognizes this and embraces the principle of inclusiveness and engagement of partners in its planning, programming and evaluation.

Therefore, the success of this strategic plan is dependant upon the engagement of both the academic research community and the private, public and charitable non-government organizations (NGOs) communities. Perhaps more than any other activity at CIHR, the Commercialization and Innovation Strategy will engage the private sector and the public sector's economic development agencies of regional, provincial, federal and international communities.

Furthermore, CIHR's Research Translation Programs (RTP) branch will proactively seek to support research priorities of CIHR's Institutes. Through its partnership programs RTP will engage members of the pharmaceutical and biotechnology communities, and others where CIHR shares areas of strategic research interest.

4. Strategic Directions

To address the challenges and take best advantage of Canada's strengths, CIHR's Commercialization and Innovation Strategy has developed four strategic components:

1. Research - Building the research core
2. Talent - Developing Canadian expertise
3. Capital - Facilitating growth
4. Linkages - Strengthening interactions between relevant communities

Each will be realized through a series of programs and initiatives, national platforms and other activities, some of which are described below. There are areas of the commercialization and innovation process that are not CIHR's niche, and others where liaisons and dialogue have yet to be developed. The commercialization and innovation process is long and complex. CIHR's general principle is that, as commercial viability increases and scientific risk decreases, the private sector should assume increasing responsibility. For example, CIHR would typically avoid funding later-phase clinical trials of new therapeutics that require regulatory approval. But if these trials generate new research questions about a new drug's benefit, then CIHR will collaborate with industry and others.

4.1. Research - Building the Research Core

As the country's largest funder of biotechnology related research, CIHR is acutely aware of its responsibility to develop innovative programs and outstanding research that position Canadian health researchers at the leading edge of science.

Clinical Research:
Investment in clinical research will be achieved through increased operating funds for clinical research as outlined in CIHR's Clinical Research Initiative. Examples include new uses for existing drugs, pharmaco-economic studies, testing of drugs for 'orphan' diseases, and therapies based on combinations of drugs.

Drug/Device Development Initiatives

Drug Development Programs facilitate the advancement of promising drug compounds to subsequent commercial and clinical development through licensing and spin-off enterprises, and through Canada's contract research organizations (CRO) community. For example a major new national initiative is providing access to chemical libraries and high through-put screening facilities, linked informatics, and IP expertise for both academic and industry sectors.

Technology Development Programs promote the engagement of Canadian scientists in research projects that will advance research tools and techniques, where invention, application and development, rather than new discovery, will be the primary goal. For example a partnership with the Health Technology Exchange and the Ontario Ministry of Research and Innovation, as well as a partnership with the Natural Sciences and Engineering Research Council (NSERC) to develop Collaborative Health Research Projects (CHRP), illustrate CIHR's devotion to collaborative, technology development.

4.2. Talent - Developing Canadian Expertise

It is widely recognized that the Canadian health innovation system does not have a critical mass of people who possess the necessary scientific, managerial and entrepreneurial skills. CIHR has and will continue to launch a series of initiatives to boost the talent of health research capacity, including:

Science to Business (S2B) Program:
The S2B program will encourage qualified PhDs in health research to pursue MBAs at the business schools of Canadian universities, with a focus on health sciences and biotechnology. Through partial support from these schools, trainees will pursue careers in management, regulatory affairs, public policy, patent law, and other specialties required to improve capacity and performance of commercialization and innovation.

Commercialization Management Grants (CMG) Program:
The Commercialization Management Grants program will provide recent MBA graduates with opportunities to work in academic technology transfer offices to acquire critical experience and expertise in the identification and evaluation of the commercial potential of health research innovations.

Internship Opportunities enable trainees the opportunity to complete placements in organizations within the technology commercialization community. Currently CIHR supports universities and research hospitals, in collaboration with non-academic organizations through the tri-council Intellectual Property Mobilization (IPM) program, to train personnel in the essential aspects of technology transfer and commercialization. This training includes hands-on experience with appropriate mentoring in the institutions involved and in organizations such as small- and medium-sized enterprises, government departments, venture capital firms and/or other suitable organizations in Canada and abroad. In partnership with Western Economic Diversification and the Natural Sciences and Engineering Research Council (NSERC), CIHR also provides funds to Westlink Innovation Network to train interns in the process of successful commercialization of new inventions through three eight-month work terms in the technology-commercialization community.

Industrial Fellowships in Health will provide doctoral graduates with an opportunity to gain industrial R&D experience. The Fellowships will be co-supported by CIHR and industry and will stimulate academic-industrial research collaborations in addition to providing critical experience to the trainees.

CIHR's Clinical Research Initiative will improve opportunities in training and career support for health researchers in clinically related disciplines. In partnership with industry, this initiative will develop and sustain the next generation of clinician and related researchers. For example the Randomized Controlled Trials (RCT) Mentoring Program will develop future leaders in trials research who can direct the conception, design and implementation of randomized controlled trials. In addition a web-based certificate program will be introduced and designed to increase the number and quality of health care professionals able to contribute to clinical trials.

4.3 Capital - Facilitating Growth

Capital will enable financial, human and other resources to enhance opportunities of successful commercialization of CIHR-funded discoveries. Through this strategic arm, CIHR will identify, enable and enhance new models for commercialization. This will be accomplished by increasing awareness among current and future stakeholders of the commercialization potential of health research.

Innovative Program-Building:
CIHR will improve the probability of success for commercialization and innovation of intellectual property (IP) derived from CIHR-funded research through its Proof of Principle (PoP) program. Launched in 2001, PoP selects IP identified technology transfer offices at universities and research hospitals and provides peer reviewed grants that position it for commercial development and regulatory approval. Given that this program reduces risk, CIHR expects the private sector to increasingly share costs as product discoveries and innovations proceed through the development process.

Intellectual Property Mobilization (IPM) Technology Transfer Program:
This program facilitates the uptake of discoveries and innovations by an established industry and finance community. It strengthens the technology transfer activities at institutions where discoveries and innovations are generated.

Clinical Research:
CIHR will also participate in the support of the development of centres, platforms and expertise in specialized facilities for clinical research.

Ethical Perspective:
Conscious of the issues that arise from the academic/industry interface and the potential for ethical conflict between profit and the public good, CIHR will lead an industry/university effort that will review and propose standards for ethical conduct of projects in the commercialization and innovation arena.

Strategic Investor Panel:
The capacity of the innovation system to commercialize products and services for the public good varies considerably among health research fields. A panel comprised of health innovation strategic investors, with expertise in the translation of strategic health research initiatives, will evaluate the latest trends and propose models that would enable CIHR to become an international leader of knowledge for best practices in commercialization and innovation of health research.

4.4 Linkages - Strengthening Interactions

Promoting linkages within and between the private sector, finance and health research communities will facilitate strategic collaborative projects and strengthen capacity and impact of all elements of the strategy.

Bringing Partners Together:
To enhance opportunities for public-private partnership, CIHR will undertake outreach programs with communities that will optimize Canadian human and financial resources in health research. CIHR will lead in enabling the academic and private sector research communities to reach out and discuss how best to translate research outcomes from CIHR supported research into better products and services for the public good.

Integrated partnering in strategic initiatives:
The Scientific Directors will be engaged at the conceptual stage in the development of strategic collaborative projects.

Active membership in the Institute partnership activities:
Participation in the Assistant Director Partnership committee and Institute Advisory Board partnership activities.

4.5. Summary Table

5. Operational Dimensions

Delivery of CIHR's Commercialization and Innovation Strategy will be carried out in close conjunction with CIHR's Institutes. Collaborative programming will typically be with one or several Institutes, where it is anticipated Scientific Directors will champion strategic initiatives relevant to their specific research agendas. Delivery of these and other cross-cutting initiatives will typically occur through the Research Translation Programs unit of the Research Portfolio.

Fundamentally a priori eligibility for CIHR support through commercialization and innovation initiatives will complement CIHR's Blueprint 2007and KT Strategy. Strategic relevancy of programs will be measured through rigorous scrutiny of the policy, design and implementation levels and the mutual leveraging of CIHR's funds with non-federal funds.

Programs are typically formulated and proposed through a multi-stakeholder focus group while progress, evaluation and performance are carried out by a CIHR standing committee. A management board may be utilized to provide operational and strategic advice and feedback. This enhances and complements CIHR commercialization and innovation programming effectiveness but does not replace accountability to relevant CIHR standing committees.

The Research Translation Programs (RTP) Branch will identify and support opportunities for partnering and collaboration with Institutes maximizing programmatic impact and encouraging coordination.

6. Evaluation of Outcomes

The Commercialization and Innovation Strategy will be evaluated on its deliverables, including:

• Improved collaboration between academia and industry, including a shared understanding of the ethical framework governing collaboration;
• Increased value of intellectual property developed with public funds, and more successful company start-ups and growth;
• Accelerated drug and device development, which would ensure prompt delivery of discoveries to community, caregivers and patients;
• Highly-qualified, scientific personnel in industrial management, regulatory affairs, finance and law;
• An improved culture of entrepreneurial academics in Canada's universities and hospitals
• Recognition of Canada as a knowledge leader and world resource in best practices in health research commercialization and innovation.

7. Conclusion

CIHR's commercialization and innovation strategic plan is focused and robust. It is based on a diagnosis of the current gaps in the innovation pipeline from discovery to the marketplace. It recognizes that CIHR cannot act alone but rather must collaborate with many others to achieve both a supply push and a market pull in commercialization and innovation. The strategy incorporates initiatives (such as the CRI) which will strengthen health research in Canada. Finally, this strategy explicitly recognizes that excellence, as judged by peer review transparency, inclusivity, integrity and the public good, are overarching values that permeate all CIHR activities.

Date modified:

2005-12-21