CFPs: Establish viable Business Models for access to Monoclonal Antibodies in LMICs

Business models must be designed with the objective of enabling affordable and sufficient supply of mAbs in LMICs, with a priority focus on mAbs for infectious diseases. Specific consideration should be given to regional health priorities and community perspectives.

Unitaid’s strategic priorities include malaria, HIV and co-infections, tuberculosis, women and children’s health, and responding to global health emergencies. 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.

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.
• 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.
• 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.

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 they 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:
  • improved and more equitable access to mAbs in LMICs,
  • better health outcomes due to mAbs addressing gaps in the treatment or prevention of infectious diseases, and
  • 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.

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. They 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, they 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.
  • 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.

For more information, visit Unitaid.