Invitation to Submit Applications for Funding from the Public Health Agency of Canada to Establish and Operate an Alliance Coordinating Office (ACO) in Support of the CHVI Research and Development Alliance - December 1, 2010

 

DISCLAIMER

The purpose of this Invitation to Submit Applications (ISA) is to invite applications for funding for the creation of an Alliance Coordinating Office (ACO) from which one applicant may be selected. The intention is to enter into a funding agreement with the one selected applicant who will establish and operate an ACO to support the CHVI Research and Development Alliance.

However, the Public Health Agency of Canada (PHAC) is under no obligation to enter into a funding agreement as a result of this ISA. Further, PHAC also reserves the right to:

1. Reject any or all applications received in response to this ISA;
2. Accept any application in whole or in part;
3. Cancel and/or re-issue this ISA; and
4. Verify any and all information provided by an organization as part of their application.

Note: PHAC will not reimburse an applicant for costs incurred in the preparation and/or submission of an application in response to this ISA.

NOTES TO APPLICANTS

1. This Invitation to Submit Applications is available electronically in WordPerfect and MS Word formats. To receive an electronic version of this Invitation to Submit Applications, please email the contact person identified below.
2. Any questions or requests for clarification of this document must be submitted in writing by email to the contact person identified below. All questions and requests, along with the associated responses, will be posted anonymously on a “Questions and Answers”. Applicants are encouraged to check this website on a regular basis to keep up-to-date with any posted questions and answers. Questions and requests for clarification will be answered if received at least seven (7) calendar days prior to the date stipulated for submission of completed Applications.
3. To be eligible for funding, applicants planning to submit an application in response to this invitation are required to notify the Canadian HIV Vaccine Initiative Secretariat contact named below no later than January 18, 2011 of their intention to submit an application. The deadline for applications is Tuesday, February 15, 2011.  Please refer to the ACO Application Form for submission requirements. 
4. All inquiries relating to this Invitation to Submit Applications should be directedto the contact person named below. The information gained from all other contacts may be factually incorrect, may not necessarily reflect the opinions of PHAC as related to this project and should not be used for the basis of completing any element of an application. Only the information contained in this Invitation to Submit Applications andaccompanying Application Form and subsequent written information posted on www.chvi-icvv.gc.ca should be considered to accurately reflect the intent of the Government of Canada as related to this funding opportunity.

Contact:

Patricia Milsom
Program Consultant
Canadian HIV Vaccine Initiative Secretariat
Office of HIV Vaccines
Public Health Agency of Canada
200 Eglantine Driveway, Tunney's Pasture AL 1908C
Ottawa, Ontario
K1A 0K9
Phone: (613) 960-0594
Email: secretariat@phac-aspc.gc.ca
Web Site: www.chvi-icvv.gc.ca

TABLE OF CONTENTS

• 1.0 Canadian HIV Vaccine Initiative (CHVI)
  • 1.1 Renewed CHVI
  • 1.2 CHVI Goals
  • 1.3 CHVI Research and Development Alliance
  • 1.4 CHVI Governance
• 2.0 CHVI Research and Development Alliance Coordinating Office (ACO)
  • 2.1 Guiding Principles
  • 2.2 ACO Objectives and Responsibilities
• 3.0 Eligibility and Funding
  • 3.1 Eligible Applicants
  • 3.2 Funding for the Alliance Coordinating Office
  • 3.3 Eligible Expenses
• 4.0 Application, Criteria and Evaluation
  • 4.1 Application Requirements
  • 4.2 Selection Criteria
  • 4.3 Application Review Process
  • 4.4 Funding Approval
  • 4.5 Timeframe
• 5.0 Reporting and Monitoring
  • 5.1 Annual Operational Reporting
  • 5.2 Financial Reporting and Monitoring
• 6.0 General Terms and Conditions
  • 6.1 Conflict of Interest
  • 6.2 Access to Information and Privacy
  • 6.3 Official Languages Act

1.0 CANADIAN HIV VACCINE INITIATIVE

1.1 Renewed Canadian HIV Vaccine Initiative

In July 2010, the Government of Canada (GoC), in collaboration with the Bill & Melinda Gates Foundation (BMGF), announced a renewed Canadian HIV Vaccine Initiative (CHVI). The cornerstone of the renewed CHVI is the establishment of a new CHVI Research and Development Alliance which will bring together leading researchers from the public and private sectors, as well as the international community, to develop innovative solutions to the challenges facing HIV vaccine research and development. Further, the activities of the Research and Development Alliance are expected to align with the Global HIV Vaccine Enterprise’s 2010 Scientific Strategic Plan.

A copy of the CHVI announcement (along with the July 2010 Memorandum of Understanding between the GoC and BMGF) can be found on the CHVI website (www.chvi-icvv.gc.ca).

1.2 CHVI Goals

The CHVI is primarily focused on accelerating the development of a safe and effective HIV vaccine by building on Canada's scientific excellence. Its specific HIV vaccine goals are:

• To advance the basic science of HIV vaccine discovery and social research in Canada and in low-and-middle income countries (LMICs) (particularly in Africa);
• To support the translation of basic science discoveries into clinical research, with a focus on accelerating clinical trials in humans and advancing the development of related technologies;
• To address the enabling conditions to facilitate regulatory approval and community preparedness;

In addition, while an HIV vaccine is being developed, the CHVI will support activities aimed at improving the efficacy and effectiveness of prevention of mother-to-child transmission of HIV (PMTCT) services in LMICs by determining innovative strategies and programmatic solutions related to enhancing the availability, quality and uptake of PMTCT services.

1.3 CHVI Research and Development Alliance

Research and development efforts aimed at developing new technologies (e.g. vaccines) to prevent the spread of HIV have been ongoing for over two decades. In 2009, for the first time, a proof of concept for the efficacy of an HIV vaccine was demonstrated through the RV144 HIV vaccine trial conducted in Thailand.

Developments such as this provide a greater impetus for global HIV vaccine development efforts which are essential for stopping the HIV epidemic worldwide. However, with limited resources, there continues to be an ongoing need to ensure a coordinated and collaborative approach for the research and development both domestically as well as internationally.

 

To meet this challenge, the CHVI will support the establishment of a new Research and Development Alliance comprised of a network of public and private sector organizations, academic institutions with expertise in HIV/AIDS and vaccines fields as well as the international community. The Alliance is intended to harness Canada’s scientific excellence to make a significant contribution to global HIV vaccine efforts. Through the Alliance, innovative solutions, creative synergies and collaborations within the HIV vaccine development community and the broader vaccine community will be fostered. Members of the Alliance will benefit from these synergies and collaborations which will increase opportunities for working relationships and knowledge sharing as the Alliance carves out Canada’s unique contribution to global HIV vaccine efforts.

Canada already enjoys robust research networks in HIV/AIDS, vaccine development and other related fields, and a history of scientific and innovative accomplishments to build upon. Canadians have developed a reputation as successful international brokers and collaborators with strong existing partnerships in place. The Alliance will benefit from past networks and goodwill, to build on the momentum generated from some thirty-eight current recipients of CHVI funding, i.e. new research networks emerging as a result of current CHVI funding of Large Team Grants. For more detailed information on current funding initiatives, please visit the CHVI website at: http://www.chvi-icvv.gc.ca/new-eng.html.

All activities undertaken by Alliance member organizations will be aligned with and contribute to the achievement of the Global HIV Vaccine Enterprise’s (GHVE) 2010 Scientific Strategic Plan.¹ Specific priorities for Alliance member organizations may include (but are not limited to):

• conducting HIV vaccine discovery and social research in Canada and in LMICs;
• training of younger investigators in Canada and LMICs;
• developing project plans and manufacturing of vaccine candidates at existing pilot scale manufacturing facilities to enable movement from pre-clinical research into clinical trials in humans, primarily in LMICs;
• developing supportive technologies that will assist in advancing HIV vaccine development; and
• undertaking capacity building initiatives with national regulatory authorities in LMICs.

1.4 CHVI Governance

Federal government departments and agencies participating in the CHVI are the Canadian International Development Agency, the Public Health Agency of Canada, Industry Canada, the Canadian Institutes of Health Research and Health Canada. The Minister of International Cooperation, the Minister of Health, and the Minister of Industry collaborate on the implementation of the CHVI, with the Minister of Health leading its overall coordination. The CHVI is supported by the CHVI Secretariat which is located at the Public Health Agency of Canada.

A CHVI Advisory Board will be established and will be comprised of up to three representatives from the BMGF, the Director of the Alliance Coordinating Office (ACO), and three external experts and one (non-voting) representative from each of the CHVI departments/agencies. CHVI Ministers will each appoint one external expert to the Advisory Board. The external experts will be drawn from a range of business, scientific and international development sectors to provide the appropriate advice to the CHVI Ministers and the BMGF.

The Board will be co-chaired by a representative of the BMGF and one appointed external expert to be nominated by the Minister of Health, lead Minister for the CHVI, in consultation with other CHVI Ministers.

The ACO is a neutral broker providing advice to the Advisory Board and coordinating activities of the Research and Development Alliance.

Roles and expectations of each organization/structure in relation to the CHVI Research and development Alliance are outlined in the table below:

CHVI Organization/structure	Roles and Expectations
A. Government of Canada and BMGF	Ministers and BMGF make final funding decisions Provide funding support directly to successful recipients
B. CHVI Secretariat	Provides coordination and secretariat support to the Government of Canada participating departments/agencies Administers funding agreement between PHAC and the ACO
C. Advisory Board (comprised of representatives from the BMGF, selected external experts appointed by CHVI Ministers, the ACO Director and representatives from the GoC CHVI departments and agencies (non-voting)	Provides recommendations to GoC and BMGF regarding peer-reviewed projects to be funded. Ensures coherence between CHVI activities and the GHVE 2010 Scientific Strategic Plan Oversees establishment and coordination of Research and Development Alliance
D. ACO	See section 2.2
E. Research & Development Alliance	Members engage in activities to accelerate the development of a safe and effective HIV vaccine by building on Canada’s scientific excellence.

2.0 CHVI RESEARCH AND DEVELOPMENT ALLIANCE COORDINATING OFFICE

2.1 Guiding Principles

The following set of guiding principles should inform the work of the ACO:

• Stakeholder Engagement: The ACO should proactively seek out Alliance members from across industry, government and AIDS Service Organizations, with many forms of expertise representing the full continuum of HIV vaccine research and development activities. This approach will help to ensure the Alliance comprises a diverse set of organizations and researchers, both in Canada and internationally, that are essential to overcome the challenges in developing a safe and effective HIV vaccine.
• Standards of Excellence: The ACO should strive to promote HIV vaccine research and development projects that meet and/or exceed scientific standards of excellence. This will ensure that the Alliance will be a highly credible network, one that is recognized for its excellence in Canada and internationally.
• Collaboration: The ACO should promote a collaborative approach in all aspects of vaccine discovery and development. Efforts should be made to enhance networking and information sharing to build on synergies, complementarities and lessons learned.
• Neutral Broker: ACO activities should be undertaken in an open and transparent manner. The ACO should be perceived as a neutral broker that provides objective advice and assistance to the Advisory Board and to Alliance members. The ACO must avoid conflicts of interest and respect the guidelines described in Section 6.1.

2.2 ACO Objectives and Responsibilities

While adhering to the guiding principles above, the ACO should focus its activities on the two objectives and areas of responsibility defined below:

• Establish, lead and promote the Alliance: The ACO will be responsible for identifying current research and development gaps within the HIV vaccine field and will encourage the development of innovative projects to respond to the identified gaps. The ACO will strive to identify and enhance Canada’s unique niche, strengths and expertise of the public and private sectors. The ACO will establish and promote the Alliance, from the initial recruitment and coordination of members to the facilitation of collaborations and ongoing information exchange in “real time” (including exchanges related to scientific data) among Alliance members.
• Provide administrative support to the Advisory Board: The ACO is responsible for providing administrative support to the Advisory Board. It is anticipated that there will be two meetings per year, with additional meetings as required. The level of resources required to support the Board will be greater in its start-up year, but then should remain fairly constant over the remaining years.

3.0 ELIGIBILITY AND FUNDING

3.1 Eligible Applicants

All registered Canadian not-for-profit organizations with their head office located in Canada are eligible for funding under this program. This includes academic institutions along with non-governmental organizations.

3.2 Funding for the Alliance Coordinating Office (ACO)

The Government of Canada through the Public Health Agency of Canada intends to fund the establishment and administrative operation of the ACO. Funding of up to $3,000,000 has been allocated for the ACO activities and will begin in the 2011/12 fiscal year and end in 2015/16. No additional funding is expected past this timeframe. Maximum funds available for each fiscal year are as follows:

2011/12	2012/13	2013/14	2014/15	2015/16
$600,000	$600,000	$700,000	$700,000	$400,000

The selected applicant will be required to sign a GoC funding agreement that sets out the specific terms and conditions associated with the funding as required under the Treasury Board Policy on Transfer Payments. The agreement will include, among other provisions, specific details in payment processes along with reporting requirements.

3.3 Eligible Expenses

Funding for the ACO is intended to cover all direct expenditures associated with the establishment and operation of the ACO. For example, funding would cover the following eligible expenses:

• Personnel salary and benefits
• Professional services (i.e. communications, translation)
• Travel
• Materials & Equipment (e.g. computers, printers)
• Rent and Utilities
• Networking activities (e.g. forum, conference)

It is expected that the successful ACO organization would provide in-kind contributions, particularly for infrastructure costs. Thus, funding for the ACO is not intended to cover indirect expenses such as corporate services and other overhead expenses. A complete listing of eligible expenses is described in the Application Form.

4.0 APPLICATION, CRITERIA AND EVALUATION

4.1 Application Requirements

Applications submitted to establish and operate the ACO in support of the CHVI Research and Development Alliance must provide information pertaining to:

• Applicant Profile
• Understanding and Plan
• Human Resources
• Operating Budget

A detailed Application Form document has been developed to assist Applicants in preparing their application. An application will be considered complete only if it contains information on all the elements set out in the Application Form.

4.2 Selection Criteria

Applications received to establish and operate the ACO will be assessed on the criteria below and based exclusively on the information provided in the application submitted by each organization.

1. Applicant Profile
   • Degree to which the applicant’s mandate and activities are aligned with the CHVI goals and vision of the Alliance; and
   • Degree to which the organization has demonstrated experience in establishing and sustaining a research and development network.
2. Understanding and Plan
   • Demonstrated knowledge of the gaps, issues and challenges facing global HIV vaccine research and development efforts;
   • Degree to which the applicant demonstrates an understanding of the Alliance’s vision;
   • Degree to which the proposed work plan addresses the key areas of responsibility;
   • Degree to which existing and/or proposed new partners will be used by the applicant to assist in achieving the objectives of the ACO;
   • Demonstrated quality of the risk and performance management approaches required to monitor and measure the success of the Alliance; and
   • Ability to provide services and communicate with Alliance members in both official languages.
3. Human Resources
   • Degree to which the ACO Director has demonstrated leadership capacity in vaccine research and development activities and managerial experience with a particular focus on building and sustaining professional networks; and
   • Degree to which the ACO operates as an independent unit separate from the larger organizational entity in which it operates.
4. Operating Budget
   • Degree to which the not-for-profit organization provides an in-kind contribution to the establishment and operation of the ACO;
   • Degree to which the operating budget fully reflects and links with the proposed program activities and staffing;
   • Degree to which financial resources are tracked and reported separately from the larger organizational entity; and
   • Degree to which the applicant offers value for the funding requested.

4.3 Application Review Process

A panel of experts, external to the Government of Canada and the BMGF (3 to 5 individuals) will be established to review the applications. The external panel will be comprised of individuals with experience and knowledge in the following broad areas:

• HIV vaccine research and development.
• Building and sustaining research and development networks.
• Governance, financial and human resources management.

All Applications will be assessed and provided an overall score out of 100 points. Each selection criteria has the following total number of points available:

• Applicant Profile (20 points)
• Understanding and Plan (40 points)
• Human Resources (30 points)
• Operating Budget (10 points)

For Applicants to be considered for funding they must achieve a passing mark of at least 60% in each selection area. For example, Applicants must score at least 12 points (60% of 20 points) in the Applicant Profile section. Those organizations that don’t receive a passing mark in each selection area will not be considered eligible for funding.

4.4 Funding Approval

The final funding decision will be made by the CHVI Ministers and the BMGF. In making the decision, the CHVI Ministers and BMGF will have the benefit of the advice and recommendations of the Advisory Board and an external expert review panel.

4.5 Timeframe

Applications will be assessed by the expert panel committee within 45-days after the close of the Invitation to Submit Applications. An announcement of the successful applicant will be made by the GoC with the target for the ACO to begin operations on June 1, 2011.

5.0 REPORTING AND MONITORING

5.1 Annual Operational Reporting

The ACO Director will be required to provide a written annual report outlining its activities and accomplishments in the current year as well as plans for the upcoming year. In addition, the ACO Director will be required to provide ongoing briefings to the Advisory Board on the ACO’s activities in establishing and operating the Alliance as part of routine Advisory Board meetings.

5.2 Financial Reporting & Monitoring

The selected applicant will provide a Quarterly Cashflow Forecast and Record of Expenditures in accordance with the funding agreement. This report will provide the basis of payment to the ACO and these expenditures will be subject to a review and audit as requested by the GoC. The financial reporting and monitoring requirements will be included in the funding agreement between the Public Health Agency of Canada and the selected applicant.

6.0 GENERAL TERMS AND CONDITIONS

6.1 Conflict of Interest

The selected applicant (i.e. the organization selected to host the ACO) will not be eligible to receive funding under any of the CHVI programs or activities. Further, the named ACO Director, will be required to submit a Declaration of Interests and Affiliations Form to disclose any circumstance that may place, or be seen to place, him/her in a real, apparent or potential conflict of interest. It will be incumbent upon the ACO Director to update their disclosure in writing, should their personal/professional situation change.

6.2 Access to Information and Privacy

All personal information collected by PHAC about applicants is used to review applications, to recruit reviewers and to administer and monitor the funding agreement. Consistent with these purposes, applicants should expect and agree that information collected by PHAC may be shared with expert review panel members that will review applications pertaining to this ISA.

PHAC is subject to the Access to Information Act and the Privacy Act therefore the requirements of these two statutes will apply to all information under PHAC’s control.

6.3 Official Languages Act

The selected applicant shall ensure that the communications and services between the ACO and the Alliance members be in both official languages. The applicant should therefore include the costs related to official languages requirements in their budget.

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