WP1: Project Coordination and dissemination of project results

Issaka Sagara (USTTB)

PfTBV Kick-off meeting, Bamako, 10-12 October 2019

TBV CONSORTIUM

Project Coordination (WP1)USTTB – Dr. Issaka Sagara

Project Management, Finances, Administration, Communications, M&E

Scientific Advisory Committee (ESAC)

External Experts

Project BoardPrincipal Investigators of each Institution and EDCTP Observer

Data and Safety Monitoring

Board (DSMB)

GOVERNANCE

EDC

TP –

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WP2Capacity Building

WP3-6TB Vaccine

Trials

WP7Community

Studies

WP8Vaccine

Manufacturing

Clinical Trial Team

Objectives

• To establish and implement an organizational structure which can handle day-to-day management and assign and coordinate activities for governance boards and committees.

• To efficiently pursue opportunities and resolve risks.

• To conduct the contractual management of the project including establishment of the Consortium Agreement, Material Transfer Agreements, Reports to EDCTP and other stakeholders, and protecting Intellectual Property when appropriate.

• To develop and implement an approach for communication, dissemination and exploitation of the project results.

Overall description

• The Project Coordination Team (PCT) will have a project management function and provide support to the WP leaders• The PCT will act as the interface between the

Consortium and EDCTP. • The PCT will provide the Project Board with the

necessary information required for the board to fulfil its mandate through regular teleconferences and annual consortium meetings.

Appointment of Project Coordination Team

The PCT will include:•an experienced scientific project manager•an administrative project manager•a finance and administrative support staff •all working under the leadership of the lead coordinator (Issaka Sagara, USTTB).

Overall Consortium Management (1)

• The PCT will organize and chair the annual consortium meetings and follow up on decisions made.

• The PCT will monitor the work plan, support WP leaders, supervise the progress reports, project achievements and propose ways to optimize the project including resource allocation.

• It will act as the interface between the consortium and the EDCTP and ensure the timely progress and quality of the deliverables.

Overall Consortium Management (1)

• The PCT will organize the project launch (kick-off) meeting to discuss the strategic plan and standardized procedures and monthly WP team meetings.

• The PCT will also coordinate the annual consortium meetings to foster collaboration and networking.

• Annual rotating Network meetings will be organized where all PIs, field Investigators, National Malarial Control and Ministry of Health officers will be invited.

• The PCT is further responsible for the administration of the overall budget and distribution of partner shares as defined in the Grant and Consortium Agreements.

Day-to-Day Project Management

• The PCT will establish management processes to meet the deliverables of the PfTBV project.

• USTTB will organize:

• the project launch (kick-off meeting) and subsequent WP team (monthly),

• Project Board (quarterly)

• Consortium (annual) meetings.

• The PCT will also coordinate periodic reporting

Submission of Scientific and Financial reports to EDCTP

•The PCT shall:•submit periodic scientific reports•a final report, and a final financial report on behalf of the consortium.•all partners will provide input to these reports.

External Scientific Advisory Committee (ESAC), Ethics Advisor, and Ethics Board• The ESAC will be comprised of renowned and independent scientists from

the vaccine development and testing fields. • The role of the ESAC is to provide expert scientific and technical advice and

recommendations to the consortium. • The final selection and appointment of the ESAC members will follow the

decision-making mechanism established by the Project Board. • The ethics advisor will be an independent expert in bioethics (CV will be

shared with EDCTP), and the ethics board will include relevant independent experts to monitor ethics issues and provide input to periodic reports to EDCTP.

• The scheduling and agenda for the semi-annual meeting of the Project Board with the ESAC will be organized by the PCT.

Data Safety and Monitoring Board (DSMB)

• The PCT will also be responsible for establishing the DSMB and completing the required forms.

• The scheduling and agenda for the DSMB meetings will be organized by the PCT and based on the trial schedule. Ad-hoc teleconferences and other meetings will be organized on a case-by-case basis and will follow the procedures established in the DSMB agreement.

Dissemination of project results

• All major findings will be made publicly available to the scientific community through scientific publications and communications in relevant media.

• Consortium members will seek to present and disseminate our findings to key opinion leaders for accelerated advancement of an affordable malaria vaccine.

• We will also be devoted to reach a broader audience in the EU and sub-Saharan Africa through presentation of PfTBV project results in popular science magazines and on institutional web sites.

Impact assessment

• The impact of the PfTBV consortium objectives will be assessed continuously by producing an annual impact assessment report.

• Indicators of impact include numbers of:• Publications

• press releases

• invitations to speak at international conferences.

• All partners will be involved in dissemination activities, and USTTB will hold the coordinating role.