Context

Global progress is off-track to meet 2030 targets of ending the AIDS, TB, and malaria epidemics, as well as preventable deaths of newborns and children under five. In addition, the world is increasingly vulnerable to health emergencies which in turn lead to further delays in meeting public health objectives.

While a well-established formulary exists for leading infectious diseases and new options have recently been added, challenges persistent. Challenges are largely due to limited options for vulnerable populations, options with complex implementation requirements, and a lack of vaccines for certain diseases. Innovative solutions are required to help meet the needs of the most vulnerable populations, enable the global response to efficiently advance on targets, contribute to universal health care, and prepare for responding to emerging threats.

Monoclonal antibodies can be developed to treat or prevent a wide range of diseases and have enormous potential to address unmet health needs by providing a faster, more tolerable, and highly efficacious response, complementing other strategies using small molecules and vaccines. They are already transforming modern medicine in high-income countries and hold great potential for the management of major public health conditions in LMICs. In addition, mAbs are one of the quickest medical countermeasures that can be leveraged during a health emergency due to their ability to be quickly isolated from those who have recovered from a disease and provide rapid protection against infection once administered to others.

Despite this promise, however, there is stark global inequity in access to mAbs. Very high prices, insufficient production capacity and limited visibility on demand are amongst the key barriers that compromise the use of mAbs in LMICs. This perpetuates the lack of commercial interest in infectious disease markets and does not incentivize innovation to reduce the cost of production and delivery of mAbs to meet the needs of LMICs.

A paradigm shift in business models and collaboration across sectors is essential to enable the availability, affordability, and acceptability of mAbs in LMICs. Efforts are needed to investigate which products in the pipeline will have a use case most conducive to scaled use in LMICs and what the demand and funding channels for such products could be, with due consideration for other tools that may be available or emerging.

In March 2023, Unitaid co-convened a global, multistakeholder consultation on Novel Business Models for Accessible mAbs for Infectious Diseases in LMICs with the Medicines Patent Pool, Wellcome, and IAVI with support from the Bill and Melinda Gates Foundation. The recommendations from the consultation are summarized in a report available online, highlighting the need for concerted efforts to conduct deep analysis and validation of viable business models including further definition of product use cases, market size, sustainable product portfolios, production capacity, and cost-saving opportunities.

Call scope

Under this call, Unitaid is soliciting proposals to demonstrate feasibility and viability of business models that enable access to an affordable and sustainable supply of mAbs in LMICs, with a priority focus on mAbs for infectious diseases. Establishing proof-of-concept of such business models is expected to catalyse and expand the supply of mAbs in LMICs and to facilitate uptake of optimized processes that reduce the cost of the production and cost of delivery of mAbs.

Unitaid’s strategic priorities include malaria, HIV and co-infections, tuberculosis, women and children’s health, and responding to global health emergencies[1]. Proposals are expected to balance breadth and depth of analysis by taking a comprehensive view of the potential mAbs market in LMICs across disease priorities, while ensuring sufficient depth of knowledge and analysis in the key disease areas being investigated.

As an initial intervention to demonstrate manufacturability and potential for scalability of mAbs in LMICs, submissions under this current Call for Proposals are expected to be limited in terms of budget and duration. Potential for further interventions will be informed by this initial phase of work as well as by the evolution of the clinical pipeline of mAbs for infectious diseases.

Areas of work

Proposals should aim to identify and demonstrate the feasibility of scenarios that could secure sufficient production of mAbs to meet needs for infectious diseases in LMICs and opportunities to reduce the cost of production and cost of delivery of mAbs. Specific consideration should be given to regional priorities and community perspectives.

Proposals to establish viable business models should consider both supply and demand, including opportunities to lower costs and the products that have viable use cases as a result. Specifically, the following elements should be considered:

• Analysis of demand:
  • Targeted market size for specific products, based on overall need and consideration for potential constraints on demand such as funding availability.
  • Potential overall market size for mAbs in LMICs across products, including considerations for different disease profiles (i.e., mAbs for diseases primarily in LMICs, mAbs for diseases with a dual market but a higher prevalence in LMICs, and mAbs for emerging infectious diseases and pandemic threats)[2].
• Analysis of supply models and pilots to demonstrate manufacturability proof of concept:
  • Manufacturing capacity requirements to achieve sufficient scale of production to meet LMICs’ health needs and attain economies of scale.
  • Opportunities that could lower the cost of producing and the cost of delivering mAbs and pilots to demonstrate their effectiveness.
  • Opportunities to ensure that manufacturers leverage optimized technologies and/or processes to lower costs.
  • Pilots to demonstrate the potential role of regional manufacturing and technology transfer, as needed.
• Define the products for which viable use cases can be established:
  • Viable use cases need to be conducive to product launch, sustainable demand and scaled use in LMICs, including in the context of other tools that may be available or emerging for the same disease indication. This must take into account the supply and demand analysis outlined above, including the opportunities to simplify and lower costs of production and delivery.
  • Consideration must be given to implications for health budgets based on potential price scenarios and patient populations.
• Engage with community-based organizations from relevant LMIC regions to ensure their input in analysis of demand, supply, and viable use cases:
  • Community-based organizations need to be engaged at all stages of the work. This should include meaningfully contributing to the depth of knowledge that is required to scope and size market potential, the most promising use cases and formulations, and the business models required to render fit for purpose products equitably accessible.

Note that Unitaid also expects to undertake separate and complementary work in clarifying and harmonizing regulatory processes for mAbs and supporting licensing and technology transfer pathways for mAbs. It is expected that any successful proponent of this Call for Proposals would work collaboratively with partners in Unitaid’s portfolio.

Additional information

Expectations for consortium partners and skillsets

Unitaid expects the following to be reflected in the makeup of a consortium (non-exhaustive):

• Partners with technical expertise in manufacturing of biologic products, including potential opportunities to lower costs and simplify products through optimized processes
• Partners with the expertise to analyze and navigate regulatory pathways for product launch
• Partners with the ability to conduct COGS analysis
• Community-based organizations relevant for the potential product use cases
• Partners with expertise across multiple disease areas, or a mechanism to include representation and input from partners in other disease areas if not included in the consortium itself

Expectations for deliverables

Proposals under this Call for Proposals are expected to outline concrete deliverables that would be achieved during the project implementation. It is expected that such final deliverables of the project will define tangible next steps and interventions, including manufacturing process improvements if required, for the further development and introduction of viable products.

Impact we are seeking

Through this Call for Proposals, Unitaid aims to demonstrate the feasibility and viability of business models that enable equitable access to a sufficient and affordable supply of mAbs for infectious diseases in LMICs, including through optimized processes that can lower costs and simplify products. In particular, Unitaid seeks to define the concrete next steps required to render the most promising products viable and accessible in LMICs.

In the medium-term, as the pipeline delivers further products for prominent infectious diseases in LMICs, the objectives outlined above will contribute to: (1) improved and more equitable access to mAbs in LMICs, (2) better health outcomes due to mAbs addressing gaps in the treatment or prevention of infectious diseases, and (3) financial efficiencies from the uptake of processes that reduce the cost of producing and delivering mAbs. The goal is to establish business models for widespread and equitable access to mAbs to enable the potential of these products to be realized as they emerge from the pipeline and an improved global health response to diseases that predominantly affect people in LMICs.

Additional considerations

Unitaid considers working with communities a critical part of generating demand and strongly encourages adopting inclusive approaches, and the early and continued meaningful engagement of communities towards improving the lives and health of the most vulnerable people. The role of affected communities and planned collaborations with other relevant groups including grassroots community organizations and Civil Society Organizations at all stages of a project/programme including ideation is essential, with this engagement a key determinant for success. Activities should be clearly budgeted in proposal submissions. Community-led approaches are important to consider and adequately fund and resource when designing, planning, implementing, and evaluating activities and programmes.

Unitaid sees value in proposals from South-based lead implementers with experience in leading the implementation of large-scale multi-country projects that support access to health products in LMICs. We also support the meaningful inclusion of South-based sub-implementers, where feasible and relevant, in proposed project implementation consortia. To be clear, Unitaid’s objective of progressively engaging an increased number of lead implementing partners from the global South does not preclude proposals that also include partners from the global North, where their role is deemed complementary and important for the success of the proposal. In all cases, we encourage coordination and collaboration across implementors and seek proposals with regional impact across key LMIC markets and a clear path to global impact.

Unitaid is committed to climate and environmental action in its investments and expect its partners to make similar commitments. Proposals should clearly indicate: (i) Efforts that will be made to minimize carbon emissions from project activities; (ii) Potential opportunities to contribute to broader climate and/or environmental co-benefits, in synergy with core project objectives. More detailed guidance and definitions are provided in the proposal template.

Proposals should be carefully targeted, reflecting focused interventions to establish viable business models for accessible mAbs in LMICs. Proposals should clearly indicate the level of effort and budget for each activity.

Proposals should demonstrate value for money and measurable impact. Proposals should also include analysis of pathways to impact, scalability, and sustainability of key interventions.

Areas out of scope for this Call include clinical trials, implementation research, full-scale implementation, and/or delivery of products.

Process for proposal submission

When developing a proposal, please note the following resources:

• Answers to frequently asked questions relevant to proposal development (this document is regularly updated), please click here [PDF: 200 KB];
• Recommendations from the multistakeholder consultation convened by Unitaid, IAVI, Medicines Patent Pool and Wellcome entitled Novel business models for accessible mAbs for infectious disease in LMICs , please click here.

Applicants should be clear about the underlying assumptions made in their proposed approach and should highlight any major risks or other factors that may affect the delivery of results. Finally, proposals are expected to outline a lean, concrete, and clear pathway to results and impact.

After assessment of the proposals and endorsement by the Unitaid Board all applicants will be officially notified as to whether they will be invited to develop a full grant agreement for Unitaid funding.

[1] See Unitaid Strategy 2023-2027 for more details. Available at: https://unitaid.org/assets/Unitaid_Strategy_2023-2027.pdf

[2] See Novel business models for accessible mAbs for infectious disease in LMICs: recommendations from a multistakeholder meeting convened by IAVI, Unitaid, the Medicines Patent Pool and Wellcome for more details, available here.

Important dates

Submission and format of proposals

Proposals, including all annexes, should be submitted electronically to proposalsUnitaid@who.int. A full proposal consists of the following documents:

• Proposal form with scanned version of signed Front page template, [DOC: 300 KB]
• Annex 1: Log frame and GANTT chart template, [XLS: 278 KB]
• Annex 2: Budget details template, [XLS: 24 KB]
• Annex 3: Organizational details and CVs of key team members [no template]
• Annex 4: Declaration of relevant interest template, [DOC: 21 KB]
• Annex 5: Applicable ethics, anti-discrimination and environmental policies template, [DOC: 21 KB]
• Annex 6: Declaration regarding tobacco entities template, [DOC: 24 KB]
• Annex 7: Anti-Terrorism Declaration template, [DOC: 30 KB]
• Annex 8: Audited financial statements for the past 3 years [no template]

If you have any questions about the application processes throughout any stage of the application review process, please send your queries to the Grant Application Manager:  proposalsUnitaid@who.int

You will find further guidance in the Unitaid proposal process document [PDF: 530 KB]. Additional guidance can be found in the following documents:

• Guidance on Impact Assessment [PDF: 160 KB]
• Financial Guidelines for Unitaid Grantees [PDF: 1,2 MB]
• Unitaid Results Framework [PDF: 1.3 MB]
• Unitaid Scalability Framework [PDF: 466 KB]

• Convite à Apresentação de Propostas: Estabelecimento de modelos de negócio viáveis para anticorpos monoclonais nos países de baixo e médio rendimento
• Convocatoria de propuestas: Establecimiento de modelos comerciales viables para el acceso a anticuerpos monoclonales en países de ingresos medianos y bajos

Webinar on this Call for Proposals: