Early Phase Clinical Trials 2015 Program Details

More details coming soon…

Neurodegenerative diseases of aging are among the least understood and most undertreated diseases in Canadian medical research. As Canada’s population ages, neurodegenerative diseases of aging such as Alzheimer’s, Parkinson’s, and amyotrophic lateral sclerosis (ALS) are placing a large and increasing burden on society. If ignored, the costs to manage these diseases will rise ten-fold within a generation. Meeting this challenge requires pioneering approaches to accelerating treatments.

The Weston Brain Institute (the “Institute”) was established to accelerate the development of safe and effective therapeutics for neurodegenerative diseases of aging while using a fast and innovative granting process to provide support to researchers.

To achieve this, the Institute addresses gaps and inefficiencies in research funding by supporting high-risk, high-reward projects while leveraging world-class business and scientific expertise to build a fast and flexible granting process.

Institute definitions:

  •  Neurodegenerative diseases of aging: Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal dementia, multiple system atrophy, progressive supranuclear palsy, and mild cognitive impairment as prodromal to one of these diseases.
  • Translational: Applied research towards developing therapeutics for the prevention and/or treatment of human disease (e.g. development of small molecule drugs).
  • Therapeutic: A pharmacological approach (including small molecules, biologics, cell therapies and vaccines, including drug repositioning and repurposing), medical device, surgical intervention, or magnetic or electrical brain stimulation; but not complementary approaches such as exercise, acupuncture, foods, or dietary or nutritional supplements. Therapeutics can be for symptomatic relief, disease modification, or prevention.

Section 1: General Information

Institutions and individuals affiliated with and applying through or on behalf of institutions (collectively, “Applicants”) should carefully discuss the Program announcement and the terms of this document with the appropriate office at their institution before submitting an application. The submission of a Letter of Intent (“LOI” and collectively “LOIs”) or a Proposal does not bind either the Institute or the Applicants by any commitment to provide or receive funding, respectively. Successful Applicants will be required to agree to terms substantially similar to those contained in this document and the Institute reserves the right to alter, delete or add additional terms in the grant agreement between the successful Applicants and the Institute.

The Institute reserves the right to accept or reject any or all applications at its discretion and to negotiate the terms of the specific grant agreement with Applicants.

Section 2: Eligibility of Applicants

he Institute is only able to accept Letters of Intent (“LOIs” and each an “LOI”) and Proposals (“Proposals” and each a “Proposal”) from institutions (or individuals affiliated with and applying through or on behalf of institutions) that are Canada Revenue Agency qualified donees in Canada. Funds can also be used to support the Canadian portion of collaborations with members from other geographies.

Only researchers at or above the level of Assistant Professor or equivalent are eligible to apply as the Principal Applicant. Collaborators must be at the post-doctoral level or above.

Applicants may appear in any role on any number of LOIs.

A LOI submitted pursuant to this Program does not need to be approved by the relevant institution on whose behalf or through which the LOI is being submitted. However, any Proposal submitted pursuant to this Program must be approved by the institution on whose behalf or through which the Proposal is being submitted.

Section 3: Funding Specifications

Overall funds: The Institute is prepared to commit up to $4.5 million to fund projects selected through this Program and application process. The Institute may choose not to fund any projects or to exceed this budget.

Funds available per project:

  • Up to $1,500,000 per project to be used over up to 4 years.
  • Funds will be granted only for direct costs that are appropriate and justifiable for the work proposed.
  • Each item and its cost must be clearly described in the budget.
  • Funds cannot be used for equipment purchases, computer purchases, travel expenses to scientific conferences/meetings, administrative costs or indirect costs, unless prior written approval from the Institute has been obtained.
  • The grant amount may not be for the full amount requested.
  • Up to 35% of the funds can be used to bring unique international resources into Canadian-led work.

Any grant provided by the Institute pursuant to this Program shall be directed to the institution and not to the individual affiliated with and applying through the institution. Responsibility for the planning, direction, and execution of the proposed project will rest solely with the Applicants. If the funded project has significant commercial success, the Institute may request repayment or reallocation of grant funds at the discretion of the Institute to be used for further research funding.

Multiple institutions: In the event of collaboration between multiple institutions, it is the responsibility of the Principal Applicant to distribute/manage funds appropriately.

Full or partial support of projects: The Institute can support a full project or parts of any project. If the application is for part of a larger project, the criteria for granting will be applied only to the part of the project proposed. Applicants should make clear what part of the larger project the Institute funding would support.

Conditional funding and milestones: Grants are conditional on grantees meeting pre-determined milestones and providing deliverables, including submission of progress reports and participation in Institute sponsored assessment meetings. Continued support is not automatic and is contingent upon the progress reports being favourably reviewed by the Institute.

Supplemental funding: The Institute encourages grantees to seek additional funds to further their work once the term of the initial grant has expired. The Institute has no guaranteed policy for renewal or continuation of grants. The Institute may, at its discretion, seek to further support clearly successful projects. Grantees are also eligible to apply for funding through other Institute programs.

Section 4: Application Process

The application process consists of two stages: Letters of Intent and Proposals. Each LOI will be peer reviewed by a scientific review committee. Applicants whose LOIs meet the review criteria and are favourably reviewed will be invited to submit a Proposal. Proposal instructions and feedback from our scientific review committee will be forwarded along with the invitation. Complete Proposals will be peer reviewed by the scientific review committee.

The LOI stage of the application process is a significant stage of evaluation. Typically, only a small proportion of applicants are invited to submit full proposals, and of those, many will be funded. This ensures LOIs are easy to submit so no good ideas are missed and that those taking the time to write full proposals have a very good chance of being funded.

Those invited to submit a proposal will have optional access to a clinical trial design expert to assist with designing the trial (e.g., sample size and statistical power calculations, protocol development, and/or data management) to maximize likelihood of success of the Applicants.

No appeal process is currently available.

Grant agreement must be completed within 6 weeks of notification of selection as a grantee. If grant agreement is not completed at this point, the Institute reserves the right to cancel the grant.

The Institute, at its sole discretion, may change the timeline of the application process.

Section 5: Review Criteria

Criteria considered when reviewing LOIs:

  • Background: Is there sufficient data from the previous stages of therapeutic development to warrant the next stage of testing and the proposed trial? Is the preliminary data compelling?
  • Experimental approach: Are the overall strategy, methodology and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Is the study designed with the proper considerations for key design elements such as the length of the trial (including regulatory and REB milestones), leadership structure, specific outcome measures/endpoints, inclusion/exclusion criteria for randomization and subject recruitment and retention plans? How likely is the hypothesis to be proven or disproven?
  • Impact: If successful, will the project accelerate the development of therapeutics for neurodegenerative diseases of aging in a significant and impactful way?
  • Others as needed

Additional criteria considered when reviewing Proposals:

  • Experimental approach: Is the trial well designed and are common pitfalls addressed in the experimental plan? Have all key design elements been addressed, including sample size, power calculations, number of arms, and drug procurement (including cost, international shipment and intellectual property issues)?
  • Development plan for the therapeutic: Are there clear next steps after this study to continue development if successful? If unsuccessful?
  • Therapeutic Impact: Is there enthusiasm for the therapeutic? Does the therapeutic address the disease-specific etiology and/or symptoms? Do the outcomes answer an interesting question that will have an impact in the field?
  • Team and environment: How well-suited are the team and environment for this work? Does the work take advantage of unique features of either? Is there a biostatistician and/or data management team member(s) for the trial?
  • Budget and timeline: Are the proposed budget, milestones and length appropriate for the research proposed? These are secondary considerations after the other criteria have been weighed.
  • Other as needed

Section 6: Reports and Assessments

Grantees must complete the following if a grant is awarded:

    • Milestone Reports. Payments are tied to successful completion of project milestones mutually agreed upon by the Applicants and the Institute. A milestone report is due prior to each scheduled payment being made. Templates for the milestone report will be provided by the Institute.
    • Progress Reports. A progress report includes a written report with budget and, if requested by the Institute, a telephone discussion with the Principal Applicant and/or data underlying the research (solely for use in assessing progress). Progress reports are due annually unless otherwise notified by the Institute. Templates for the progress report will be provided by the Institute.
    • Assessment Meeting. At least one Applicant on the grant must attend an assessment meeting to report on the progress of the project and have the opportunity to meet other funded researchers. This does not need to be incorporated into the budget. Assessment meetings will be held once a year unless otherwise notified by the Institute. Additional key personnel may also attend if approved by the Institute. Travel expenses to required assessment meetings will be covered by the Institute per Institute guidelines.
    • Foundation Member Visits. With prior consent of Applicants, Foundation members may wish to visit researchers to see project work underway. These visits are not mandatory, and the Institute hopes that grantees will welcome this opportunity.
    • Financial Accountability. Grantees are expected to account for the moneys expended under any Institute grant; any moneys spent either not in accordance with the approved research project or prior to pre-approval of any material change in the project are both (i) recoverable by, and subject to restitution by the grantees, to the Institute and (ii) may be cause for immediate termination of funding by the Institute. Any funding provided beyond what is needed for the agreed upon research must be returned to the Institute at the completion of the research funded by the Institute.

Section 7: Confidentiality

The Institute treats all LOIs, Proposals, research projects and associated research information (collectively, the “Confidential Information”) in confidence using reasonable care in protecting such Confidential Information from disclosure to third parties who do not participate in the grant review process and Institute assessments. All Confidential Information will be used by the Institute and its scientific review committee for the purposes of reviews and assessments, and will be shared only in accordance with the sharing policy as set out herein. Notwithstanding the foregoing, Confidential Information shall not include any information that:

  1. was generally known to the public prior to the effective date of this Program announcement;
  2. becomes generally known to the public through no unlawful or unauthorized act by any recipient of Confidential Information; or
  3. was independently developed by the Institute or its scientific review committee without reference to the Confidential Information.

If the Institute or any of its scientific review committee members is requested to disclose Confidential Information pursuant to a legal or governmental proceeding, the Institute shall give the Applicant or other owner(s) of such Confidential Information notice of such disclosure request as soon as is reasonably practicable.

Section 8: Other

Liability and Indemnity

Each Applicant pursuant to this Program acknowledges and agrees in responding to the Program announcement that the Applicant shall have no claim against the Institute, and its respective representatives, related companies or affiliates, should such Program response be unsuccessful for any reason. Each Applicant hereby remises and releases the Institute, its representatives and affiliates, from any cause of action, complaint, or claim in connection with the RFA process and its outcome.

The Institute’s role in grants awarded pursuant to this Program is that of a funder. The Institute is not the sponsor of funded projects. As such, the Institute will not assume any liability associated with funded projects and each Applicant who is ultimately awarded a grant pursuant to this Program releases the Institute from any and all liability with respect thereto and further indemnifies the Institute, and its respective representatives and affiliates, from any claim or loss whatsoever associated with the applicable grant.

Intellectual Property Policy and Intellectual Property Agreements among Collaborators

The Institute acknowledges that any intellectual property (“IP”) that arises from research funded through this Program, including discoveries, is not the property of the Institute.

The Institute does require that researchers and collaborators agree on any material IP issues prior to submission of a Proposal.

Publication and Sharing Policy

The Institute expects results of funded research to be published as rapidly as possible in the open access scientific literature or other forms of publication that are readily available to the research community, unless such publication will jeopardize the Applicant’s right to secure patents or copyrights necessary to protect the Applicant’s ownership. Such publication should be consistent with high standards of scientific excellence and rigor, and provide sufficient detail so the research community can benefit from the findings from or in connection with the funded project.

A lay person abstract of the research proposal must be submitted prior to funding. A lay person abstract of the research results must also be submitted no later than 2 months from the date of grant expiration. These abstracts may be made available to the public by the Institute.

Any presentation, releases, papers, interviews, publication or other forms of communication dealing with the awarded project or the results from the awarded project must acknowledge the funding provided by the Institute, in a manner proportionate to the contribution of the Institute. Any other use of the Institute’s intellectual property, including its name, logo or trademark requires prior written permission of the Institute.

All tools (i) funded by and (ii) that result from funded projects should be made readily available to the research community either freely or at reasonable prices within 3 months of study completion. If sharing of such tools will jeopardize the Applicant’s right to secure patents or copyrights necessary to protect the Applicant’s ownership, then such tools should be made available as soon these rights have been secured. The Institute may let the public know of these tools so other researchers know they are available.

The Institute requires any clinical trial awarded under any of its funding programs be registered with clinicaltrials.gov, PDTrials.org, or other appropriate public registry.