Dr. Jack Whitescarver is Chairman (pro bono) of HEAL Alliance. Peter A. Jensen is CEO (pro bono) of HEAL Alliance. The Governance will be significantly modelled after the Coalition for Epidemic Preparedness Innovations (HEAL Alliance) governance model. HEAL Alliance is a global public health commons problem and solution with robust best practice governance principles. HEAL Alliance is engaged in discussion to form a mission alignments and a governance structure to be aligned with participating research and development (R&D) institutions, potential government and philanthropic funders, industry partners and other key stakeholders such as regulators, care providers and the global public health community. HEAL Alliance will be governed by a Board made up of experts from founding partners, industry, governments and non-governmental organisations. It is chaired by Dr. Jack Whitescarver, with Erick Iverson, as vice-chair (on sabbatical). The board is advised on decisions such as prioritising pathogens and selecting industrial partners by the Scientific Advisory Committee (SAC). The SAC chairman will be nominated by HEAL Alliance Board and elected by 51% of the SAC members. A Joint Coordination Group (JCG) will coordinate the HIV Cure and Vaccine development efforts of HEAL Alliance partners. The JCG chairman will be nominated by HEAL Alliance Board and elected by 51% of the JCG members.
The HEAL Alliance Board will govern HEAL Alliance. A management team led by the CEO will coordinate day-to-day operations through a core Secretariat node in London and other nodes with distributed capacities worldwide. A Scientific Advisory Committee (SAC) will advise HEAL Alliance on scientific matters and a Joint Coordination Group (JCG) will coordinates HEAL Alliance activities with other actors across the end-to-end spectrum of HIV/AIDS Cure and Vaccine R&D and HIV eradication proof-of-concept planning and delivery.
HEAL Alliance Board
The HEAL Alliance Board (the Board) is the highest decision making body of HEAL Alliance, and has supreme decision-making authority for all funding, policy, and product development aspects of HEAL Alliance operations. The Board will:
- Provide governance and fiduciary oversight
- Ensure that the organization is managed effectively by the CEO and the Secretariat, in accordance with legal and regulatory requirements
- Define directions and policies for pursuing the organization’s mission, and ensure the organization follows plans and budgets that are in line with it
- Approve plans, programmes, budgets, fundraising strategies, and operational policies (including a conflict of interest policy, risk management framework, and scales of staff salaries and benefits)
- Perform tasks and functions necessary for the attainment of the organization’s mission, including the delegation of any of its powers or decision-making authority to the CEO, and the establishment of working groups and committees as it deems necessary for the performance of its functions
- Set the conditions under which any tranche of HEAL Alliance funds will be released
- Oversee the ongoing establishment and maintenance of the Board
- Oversee the ongoing establishment and marketing of the HEAL Smart Impact Bond funding mechanism
- Authorize the CEO to execute on decisions not falling under his/her delegation of authorities
- Consider such other matters related to HEAL Alliance as may be referred to it by the CEO
The composition of the Board reflects the main stakeholders committed to fulfilling HEAL Alliance mission. In the startup phase, the Board will be composed of: (1) 3-5 HIC government representatives; (2) 3-5 LMIC government representatives; (3) 2-3 philanthropic funder representatives; (4) 3-4 private sector financial industry representatives of major global syndication banks who have engaged with the HEAL Smart Impact Bond issue by HEAL Alliance; (5) 1-2 representatives from civil society/NGOs/patient organizations; (6) 1-3 members in their individual capacity; (7) 1-3 members of pro bono legal firms their individual capacity, (8) 1-5 members of participating R&D institutions in their individual capacity. Subcommittees and constituencies can also be established at their discretion, including a funders group across HIC, philanthropic and LMIC organizations. The Chairman is Dr. Jack Whitescarver. HEAL Alliance CEO will be a voting member of the board.
Observers, Scientific Advisory Committee (SAC) and Joint Coordination Group (JCG)
A number of organizations participate in the Board as observers (with the right to speak, but not to vote): Proposed members include (1) WHO; (2) Chair of the HEAL Alliance Scientific Advisory Committee; (3) Chair of HEAL Alliance Joint Coordination Group.
Scientific Advisory Committee (SAC) Members and Non-voting members of SAC will advise the Board.
Joint Coordination Group (JCG) Members and Non-voting members of JCG will advise the Board.
HEAL Alliance is governed by a Board made up of experts from founding partners, industry, governments and non-governmental organisations. It is chaired by Dr. Jack Whitescarver. Board Meeting Documents will be published on the HEAL Alliance Blockchain.
Three operating principles serve as the foundation of the HEAL Alliance strategic and business framework:
1. Open; Inclusive and Transparent
Global access arrangements will be negotiated in contracts between HEAL Alliance and R&D developers to ensure affordability and availability in Low and Middle Income Countries (LMICs). The license price of IP developed through or with the support of HEAL Alliance should not be a barrier to access.
2. Market Capital; Funding for R&D Projects and delivery on Mission
HEAL Alliance is inspired by the Gavi Vaccine Bond model. Projects will be funding at participating R&D institutions who engage in the RFP process and the HEAL Alliance IP Commons and the HEAL Alliance Immunotherapy Cure Centers Model with the HIV Cure Center and the Cancer Immunotherapy cure center. Bona fide dedicated capacities should be reimbursed for their direct and indirect costs and all expenditures will be distributed, recorded and reported on on the HEAL Alliance Blockchain.
3. Shared Benefits; Measurement and Reward of actual performance and participation
It is anticipated that IP developed with HEAL Alliance support of R&D will generate licensing revenues via the HEAL Alliance IP Commons. In the event that R&D developed with HEAL Alliance support does develop economic value, agreements between HEAL Alliance and participating developer will ensure either that HEAL Alliance investment is reimbursed and that the economic value is shared through royalties of the HEAL Alliance IP Commons framework agreement. Any rewards that accrue to participating R&D developers should be proportionate to the level of risk undertaken and to the relative value and performance nature of the R&D, the infrastructure, the IP or other contributions the participating R&D developer has delivered.
The CEO is responsible for executing the decisions made by the Board, providing operational management and executive authority for all funding, policy, and product development aspects of HEAL Alliance operations. The CEO serves as the legal representative of the organization, and is empowered as decided by the Board to sign deeds, contracts, agreements and other legal documents necessary for the organization’s operations, within the limits of Delegation of Authority policy approved by the Board.
The CEO is supported by a Secretariat structure with:
- core support services: executive leadership support; finance; IT, administration & human resources (could be provided as a service by a larger host organization); external relations; policy relations; business development; legal; fundraising, advocacy and communication support.
- R&D development coordination: technical support and administration of HEAL Alliance mission development operations, including joint oversight of mission development activities implemented by HEAL Alliance beneficiaries and consultations with the Scientific Advisory Committee as appropriate.
- clinical & regulatory coordination: optimization of collaborations and partnerships for an enabling regulatory environment across the mission ecosystem; support of task forces or committees appointed by the HEAL Alliance Joint Coordination Group to generate clinical trial designs and regulatory science innovations; seeking of sustainable and mutually beneficial solutions to liability protection; identification and capitalization of suitable clinical trial infrastructures.
- portfolio management, monitoring & evaluation: ongoing assessment of HEAL Alliance portfolio against HEAL Alliance strategy, objectives and KPIs; the selection and oversight of the work of auditors assessing HEAL Alliance implementation of R&D policies, resource allocations, operations and management and overall compliance to HEAL Alliance statutory provisions and standards.
The secretariat operates through a core node in London and other nodes in committed partner organizations around the world. Under direction of the CEO, the Secretariat will:
- establish management procedures, including developing an agile and continuously developing business plan for approval from the HEAL Alliance Board;
- recruit the necessary staff to fulfil the functions of the Interim Secretariat, including core executive leadership support services, coordination of mission development and clinical & regulatory affairs, monitoring & evaluation services;
- develop consolidated work plans, including plans and budgets for the Interim HEAL Alliance Secretariat;
- develop the necessary operational guidelines to be approved by the Interim Board;
- provide project management and monitor progress of activities against HEAL Alliance milestones;
- develop reports on finance including costing and funding requirements;
- coordinate resource mobilization strategies;
- provide the administrative support to the Interim HEAL Alliance Board, the Interim Scientific Advisory Committee, and the Joint Coordination Group;
- conduct activities to meet communication, advocacy and fundraising needs;
- disseminate information relating to HEAL Alliance;
- provide additional services as required
Scientific Advisory Committee
The HEAL Alliance Scientific Advisory Committee (SAC) is the principal advisory group to the Board and the HEAL Alliance Secretariat on scientific matters important to the operations of HEAL Alliance. This includes, but not limited to:
- Recommending priority pathogens for consideration of HEAL Alliance focus and support.
- Develop descriptions for Request for Proposals (RfPs).
- Reviewing proposals submitted in response to RfPs for mission research and development programs targeting priority pathogens.
- Recommending to the Board funding of proposals aiming to move mission candidates for priority pathogens from the preclinical stage to proof-of-concept demonstration in humans.
- Recommending the continuation or cessation funding of HEAL Alliance-supported research efforts at the end of defined program milestones for HEAL Alliance-supported mission development programs.
- Monitoring progress of HEAL Alliance overall mission portfolio, and reviewing the overall quality of progress of HEAL Alliance scientific operations.
- Updating the HEAL Alliance Board on important new research developments in science and technology relevant to achieving HEAL Alliance mission.
- Providing scientific input, as requested by the HEAL Alliance Board, to inform their efforts to advance solutions for overcoming obstacles to successful and expedited end to end development and delivery efforts for mission targeting HEAL Alliance-prioritized pathogens
The Board may decide to seek advice from the SAC for other scientific matters relevant to the operations of HEAL Alliance. Final decision-making about the issues addressed by the advice and recommendations from the SAC rests with the Board or the CEO. The SAC has no executive function in the operations of HEAL Alliance. The HEAL Alliance Secretariat facilitates the work of the SAC. The SAC acts independently of all the governing structures of HEAL Alliance, including the HEAL Alliance Board, the CEO and the HEAL Alliance Secretariat, the HEAL Alliance Joint Coordinating Group, and the HEAL Alliance Champions.
The SAC is composed of a group of 23 qualified individuals, or more, representing core areas of scientific expertise needed to advise the Board. In addition there is one observer invited from the WHO, with the right to express views but not to vote. There are also 3-4 industry experts, or more, to the SAC as non-voting members (i.e. observers), who are not representatives of individual companies but nominees of the constituency of multinational biopharmaceutical companies in participation with HEAL Alliance. The combined expertise of the advisory committee reflects the end-to-end spectrum of mission development, covering the following areas of core scientific expertise: (1) Public health significance of HIV/AIDS Cure and Vaccine and Eradication; (2) Cure and Vaccine R&D, including biochemical engineering, vaccine immunology, vaccine adjuvants and vaccine delivery systems, biobanking and sample sharing, early phase R&D, including expertise on preclinical and animal models, and clinical assays; (3) Cure and Vaccine manufacturing, including formulation, manufacturing platform technologies, good manufacturing practices (GMP), quality control and quality assurance, scale up bulk manufacturing, stockpiling and distribution; (4) Cure and Vaccine licensure, including regulatory affairs and CMC requirements for global vaccines, IP management, safety, risk/benefit assessment and bioethics; (5) Cure and Vaccine implementation, including cure and vaccine procurement and intervention deployment for mission in cooperation with HEAL Alliance members.
The members of the advisory committee serve in their personal capacity as independent experts, and refrain from promoting views and policies of the institution for which they work. Members of the advisory committee are appointed to serve for an initial term of two years. This two-year term may be renewed once, but to facilitate diversity of expertise, the term is only renewed for maximum 2/3 of the membership at the same time. To allow for continuity in the operations of the advisory committee, there is an option for the Chair to renew his or her term (such option to be triggered at the HEAL Alliance Board’s discretion), but only twice. The Chair can act for a maximum of eight years. The Board reviews bi-annually the composition of the SAC, and may actively seek to attract nominations reflecting other needed areas of expertise. Prior to being considered for membership, nominees are required to complete a Declaration of Interests form. An updated Declaration of Interests form must be submitted for review to the HEAL Alliance Board 14 days prior to each Scientific Advisory Committee meeting. Potential conflict of interests are managed in accordance with HEAL Alliance Conflict of Interest Policy.
The main criteria guiding selection of members are technical expertise in line with the categories above, diversity of stakeholders (academia, governmental agencies, private sector and civil society/NGOs/patient organizations), geographic representation, and gender balance. Securing the technical competencies and the diversity of stakeholders reflecting the end-to-end of cure and vaccine development and application is given priority when selecting members. Geographic representation and gender balance is given due consideration, including securing representativeness from hot spots for emerging and re-emerging infectious diseases.
Joint Coordination Group
The different programmatic priorities of the various coalition partners of HEAL Alliance necessitate a mechanism by which the HEAL Alliance coalition partners align among themselves, and coordinate their own activities across the end-to-end spectrum of cure and vaccine development for mission. To fulfil this function, a Joint Coordination Group (JCG) has been established for HEAL Alliance partners to share information, promote alignment and encourage coordinate their efforts to secure efficient use of resources for R&D of cure vaccine candidates against mission.
The JCG promotes coordination and supports efforts for the alignment of funding, R&D implementation, regulatory processes, procurement and stockpiling actions between HEAL Alliance Members and partners positioned at different levels of the end-to-end cure and vaccine spectrum for mission. It aims to optimize response planning related to large scale clinical efficacy testing, scale up manufacturing, regulatory approval and large scale procurement of cure and vaccines beyond the day-to-day scope of HEAL Alliance operations. In addition to serving a coordination function, the JCG serves a joint advisory function to the Board, and facilitates the involvement of HEAL Alliance partners for the strategic direction and policy oversight for HEAL Alliance operations.
The JCG will be represented by partners who have signed a Memorandum of Understanding (MOU) committing to contributing to fulfil the HEAL Alliance mission. In principle, three types of coalition partners will exist:
- Funders: commit tangible assets and delegate the decision-making authority for the use of these assets to the Board.
- Co-funders: commit financial resources or infrastructure to R&D development through their own mechanisms.
- Facilitators: This third type of partner does not commit tangible assets, but commits to HEAL Alliance mission by addressing other critical areas of end-to-end mission development. These may concern normative guidance on data sharing and clinical trial design during emergency response, or accelerated regulatory assessment and approval pathways. Examples of partners here include R&D implementers (e.g. MNCs, research institutes, PDP), regulators and normative bodies (e.g. US FDA, EMA, WHO PQ, AVAREF), procurers and distributors at the global level (e.g. Gavi).
Each member of the JCG is entitled to appoint one representative to the JCG. Each member of the JCG is expected to express the views and policies of the institution(s) they represent.
The composition of the JCG during the startup phase will consist of: The WHO (proposed); HEAL Alliance (represented by HEAL Alliance Chairman and CEO; HEAL Alliance Chair of the SAC); core funders and co-funders (e.g., BARDA, EC, IMI, and NIH); public and private sector implementers/innovators (e.g. MNCs, research institutes, PDPs); regulators and normative bodies (e.g. US FDA, EMA, WHO PQ, AVAREF, national academies of medicine or science), procurement and distribution partners (e.g. Gavi). An independent Chair of the JCG is appointed by the Board.
Other committees and advisory working groups
The Board may establish other committees or advisory working groups to address specific issues, depending on need and after some time from HEAL Alliance inception:
- Joint Steering Committees (JSCs) may be established to oversee programs or projects co-funded with others. JSCs may be delegated the oversight of such programs and projects, reporting to the HEAL Alliance CEO. HEAL Alliance Secretariat staff or individuals appointed by the HEAL Alliance Secretariat will compose these, as well as representatives from other co-funding organizations, and potentially representatives from the implementing organization.
- Ad hoc Advisory Working Groups may be established to inform the HEAL Alliance Board, the CEO, SAC and JCG with evidence-based recommendations on various issues across the end-to-end spectrum of HEAL Alliance operations, but with no binding commitment for decision making.
HEAL Alliance Champions
The HEAL Alliance Champions group serves as an advocacy platform; comprising a group of ambassadors of and champions for HEAL Alliance mission, contributing to the mobilization of political and financial capital. Members include political champions, advocacy leaders in fields relevant to HEAL Alliance mission, representatives from countries, public and private sector organizations with strategic interest in mission development. Key functions include: (1) to manage perceptions / advocate for mission and policy change at global and local level; (2) to promote achievements and communicate results to global, regional and local audiences; (3) to link with other fora, groups and platforms for public dialogue and collaboration among stakeholders in the mission; (4) to fundraise.
Legitimate and effective governance arrangements are essential. This requires a number of organizational principles to be in place: Accountability; Public trust; Political legitimacy; No conflict-of-interest; Transparency; Independence / Neutrality; Public interest representation; Flexibility / Nimbleness; Global health responsibility. The HEAL Alliance Secretariat is developing policies and procedures to operationalize these principles. These will be finalized by the end of HEAL Alliance interim period of operation and include:
- Conflict of Interest (COI) policy and a Register of Conflicts;
- Dispute Resolution policy and procedures;
- Financial Framework, including an audit policy, procedures for maintaining financial records and evaluating the financial health of HEAL Alliance;
- Funding policy including: ratio thresholds between sectors and caps in shares of total funding by single entities, to ensure independence of HEAL Alliance strategy development over time; ratio thresholds between sustainment and project-based funding to allow for flexibility of funding upon need;
- Salary policy, earmarking wages to standard market equivalents in the respective countries where HEAL Alliance staff operates by profession;
- HR policy;
- Access policy according to which: target product profiles reflect normative directions; provided by the WHO, technical requirements proposed by the HEAL Alliance advisory working groups and are publicly available; terms of reference agreed early on with industry partners for reasonable cure and vaccine development costs and cure and vaccine pricing;
- HEAL Alliance IP Commons and licensing policy that focuses on HEAL Alliance mission, and which revolves around principles of non-exclusivity, non-rivalry, and where possible, transferability and open innovation principles;
- Stringent Procurement policy and standard operating procedures to select and retain providers for required activities ensuring efficiency and quality of services over time;
A risk/reward sharing policy, whereby a mechanism will be put in place to recoup a fair and reasonable return in the event that a HEAL Alliance funded product becomes very profitable for a private entity;
- Risk Management framework;
- CEO Delegation of Authority policy, clarifying the decisions the CEO can make only when formally authorized by the Board
- Other policies as deemed necessary and / or appropriate
Inspired by the CEPI governance principles.