Canada: Changes In Canadian Institutes Of Health Research Funding: What Will Become Of CIHR Proof Of Principle Commercialization Grants?

As all Canadian health researchers are undoubtedly aware, CIHR is in the throes of reforming the investigator-driven grants program. Major changes are afoot. Gone are the days of investigators gathering from across Canada to cloister themselves together in Ottawa hotel meeting rooms, fueled by mediocre coffee and chicken-wrap sandwiches, pondering the merits of the grant applications of their peers. The new grant review process is primarily electronic, drawing from a pool of reviewers within the newly formed College of Reviewers. Nostalgia for the past and the intangible benefit of these face-to-face gatherings cannot rival the undeniable efficiencies promised by the new scheme.

The previous Open Funding opportunities (primarily operating grants) will be phased out entirely. CIHR operating grants as well as most other themed CIHR grants will be replaced by two new funding schemes: a Foundation Scheme and a Project Scheme. Available money for grants will not be reserved or apportioned to specific technologies within a technologically distinct peer review committee (such as biomedical engineering, cardiovascular, endocrinology, etc), as had previously been the case for review of operating grants applications.

Foundation Scheme grants will fund individual investigators, for a period ranging from 5 to 7 years, with an annual dollar value of $50,000 to $1.5 million. The grants are awarded on the basis of an individual's track record, while taking that person's proposed research into consideration.

Project Scheme grants will fund projects based on the calibre of the proposed idea. The merits of the proposed work, and to some extent the calibre of the individual or team proposing to conduct the work, is evaluated. Project Scheme grants can be proposed for a 1 to 5 year period, with an ask ranging from $50,000 to $750,000.

Pilot competitions for each of the Foundation Scheme and Project Scheme categories are being conducted. Electronic reviews are happening, and interactive on-line discussions are a reality. There is no turning back. Anecdotally, it seems that the enthusiastic banter of the face-to-face discussions is missing from the interactive comments posted in the pilot competitions. Admittedly, these anecdotes are based on a very small sampling of comments from pilot participants as relayed to this author. Nevertheless, it seems that the health researchers have accepted the change, and a willingness to adapt.

There is one small but notable CIHR legacy grant program that has not yet faded into the sunset of the reformation: the Proof of Principle Commercialization Grant Program affectionately known as "PoP", which has funded commercialization grants since 2001. The PoP program has typically run two competitions per year, and will launch the final competition in June 2015 (application deadline: September 2015). In January 2016 this program will lose its individual identity, but CIHR intends to keep a similar the funding opportunity available under the Project Scheme category. The applicants and reviewers who have been integrally involved with the PoP program through the years are hoping that certain aspects of this unique program will be maintained to that research-derived inventions with commercial potential can continue to be eligible for early stage funding, before a commercial partner is identified. The diverse make-up of the review committee, and the unique method for assessing commercial potential in the grant review process, are but two aspects that have distinguished PoP from most other CIHR grants to date.

In the final program launch for the legacy program of PoP grants, two different phases of grants will continue to be offered. Phase I provides up to $160,000 to academic investigators with projects of potential commercial application, if the intellectual property is not yet licensed outside of the originating university. Phase II provides up to $300,000 to academic investigators to match the funds committed by a commercial partner.

The PoP grant program has provided a niche source of funding not only to academic researchers, but also offered advantages to industrial partners collaborating with such researchers through matching partnered grants. Researchers with commercially relevant projects were able to seek funds to ascertain commercial potential, and bring inventions from a more conceptual stage to a more commercially attractive stage with funds made available through this program. Industry stood to benefit from the PoP program because academic researchers could seek matching funds to complement the investment of a committed industry partner, to obtain proof of principle data to further support promising data, effectively doubling the money available to a project. PoP grant recipients have been the investigators to watch, in terms of future commercialization efforts, start-up companies, and industry collaboration efforts.

The last few legacy programs which have not been fully absorbed into the Project Scheme grants are commercialization grants and certain knowledge translation grants. "Knowledge translation" (or KT) is a term that encompasses (among other areas) policy for health care services and the health care system. The PoP grants have developed a tailored application processes, which cannot be replicated in the common Project Scheme application form. For Example, the PoP application asks applicants about what problematic prior art may have been located (known publications or patents that could deter patentability of their invention); whether the applicant believes there is freedom-to-operate for the proposed commercial plan (read: whether other blocking patents are known to exist); and what the commercial landscape looks like (a review of competing technologies). Savvy PoP applicants address regulatory hurdles, market entry barriers, and identify receptor companies, all in the span of the current 14-page limit application.

With the efficiencies of a common application form for all Project Scheme grant applicants, the nuances of information needed to specifically evaluate commercialization potential of a technology may be lost.

In an effort to ensure a smooth transition, CIHR has advised that a minimum funding threshold will be established for commercialization and KT applications (together), once these are absorbed into the Project Scheme. The dedicated community of PoP reviewers, drawn from technology transfer offices, private industry, commercialization specialists, venture capitalists, patent agents, and successful applicants, is making efforts to advise of ways in which commercialization grants can best be evaluated within the Project Scheme by appropriately identified reviewers within the College of Reviewers. PoP applicants in the legacy application process, are able to request funding for up to $32,000 in commercialization activities, including $15,000 for patenting costs. Such funds typically offset the costs of drafting and filing a patent application within the 1-year term of the award, or address ongoing costs of previously filed patent applications. There is a suggestion that such expenses (assuming specific justification) will be permitted as budget items for any application within the Project Scheme.

By bringing commercialization grants into the Project Scheme, CIHR suggests that commercialization per se need not be viewed as a separate and distinct activity from research. Commercialization of research is ready for prime time. If commercialization grants had remained limited to separate and limited budget, perhaps opportunities would be lost. If commercialization expenses become eligible to all applications asserted within the Project Scheme, perhaps more investigators will be encouraged to embrace commercialization as a natural extension of their research program. Commercialization of technologies developed with CIHR funding is an important step in improving the health of Canadians, and others world-wide. With change can come opportunity.

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