A bold new era for the Enterprise

The alliance of funders and stakeholders that established the Enterprise over a decade ago understood the potential to accelerate HIV vaccine development through coordination, collaboration, knowledge-sharing and mobilization of resources.

With multiple efficacy-stage programmes underway and new vaccine concepts in the clinical pipeline, the end goal now seems closer than ever.

The 2018-2023 Strategic Plan aims to affirm the Enterprise’s mission in the context of a transformed landscape—and to engage new stakeholders and funders in a diversified, resilient and truly global alliance relentlessly committed to developing an HIV vaccine as quickly as possible.

Our commitments

Commitment 1

Propelling the vaccine pipeline

Strengthen strategies to align, amplify and accelerate development of vaccines

Commitment 2

Preparing for clinical trial outcomes

Tackle priorities essential to clarifying the roadmap for future access to a vaccine

Commitment 3

Expanding resources and engagement

Enlist a diverse community of partners to support and contribute to the field

Commitment 1

Propelling the vaccine pipeline

Strengthen strategies to align, amplify and accelerate development of candidate vaccines.

The Enterprise can help the field maintain scientific, pipeline and product development momentum in the context of unprecedented late-stage clinical activity. Two issues are particularly salient.

First, as the evolving prevention landscape transforms the dynamics of the epidemic worldwide, vaccine trials are becoming more complex. Second, with diverse stakeholders contributing to HIV vaccine development, we must strengthen knowledge-sharing to enrich the field’s product development mindset, identify synergies of effort and foster more collaboration—most notably in learning from trial outcomes, improving research tools (e.g. animal models, immune assays) and in designing and refining vaccine concepts, particularly if correlates of protection are validated.

GOALS

1.1 Tackle issues in trial design and implementation. Working with trial networks, communities and policymakers, and aligning with complementary efforts, we will foster collaborative solutions to sustain the field’s ability to conduct efficient clinical trials in an evolving prevention landscape.

1.2 Enhance product development knowledge and collaboration. We will host workshops and toolkits that sharpen the field’s product development mindset and enable the scientific dialogue needed to promote collaborative efforts around novel combinations of concepts/components and improving research tools.

IMPACT

This commitment will help to fortify partnerships by reinforcing a common product development language; nurturing innovative vaccine concepts; and supporting future vaccine trials.

Tackle priorities essential to clarifying the roadmap for future access to a vaccine.

With late-stage vaccine programmes anticipating efficacy results in 2021-2022, there is a critical need to mobilize now to prepare for all potential trial outcomes, including vaccine efficacy scenarios. The Enterprise has an important role to play in helping the field align on strategies to overcome potential barriers to licensure, scale-up and access to a safe and efficacious vaccine.

Preparing for success means planning for any outcomes of current and future trials; understanding regulatory pathways—particularly in countries with limited capacity for and experience with vaccine licensure; aligning on preferred product characteristics to focus product improvement efforts; developing access strategies aligned with regional needs and resources; and identifying ways to encourage at-risk investment needed for manufacturing scale-up and deployment.

GOALS

2.1 Clarify regulatory and access pathways. Working with the WHO, regulators, policymakers, communities and product developers and funders, we will facilitate mapping of regulatory and licensure pathways for an HIV vaccine and help advance efforts to forecast demand and define deployment channels. Initial efforts in this area may focus on Sub-Saharan Africa as it is the epicenter of the epidemic and efficacy trial activity.

2.2 Support the development of new business models for late-stage product development. We will convene diverse stakeholders—product developers, industry, research funders, international finance and development agencies, the investment community, local and regional authorities—to catalyze dialogue around novel business models that address the imperatives and risks of late-stage HIV vaccine R&D, scale-up and rollout.

IMPACT

This commitment will help to ensure that, as a field, we are ready to make a safe and efficacious HIV vaccine readily available for the populations that need it most.

Commitment 2

Preparing for outcomes

Commitment 3

Expanding resources and engagement

Enlist a diverse community of partners to support and contribute to the field.

Expanding and diversifying investments in HIV vaccine R&D remains a key priority for the field. The Enterprise has a role to play in engaging new funders, making the scientific case for investment and mobilizing political commitment.

We will ensure that our programmes tackle issues of foremost priority for funders and the field, positioning the Enterprise as an essential partner in mitigating risk, aligning fragmented efforts and amplifying the potential of finite resources. Enhancing engagement in the Enterprise will be critical to our capacity to design, incubate and scale programmes that create value.

GOALS

3.1 Strengthen political commitment and encourage new investment. We will bring scientific rigour to collaborative advocacy efforts aimed at influencing political priorities; driving greater investment in HIV vaccine R&D; deepening engagement with a range of potential funders in the EU, Asia and beyond; and working toward ensuring that industry’s seat at the table fosters opportunities for collaborative action.

3.2 Diversify engagement and expand collaborative action. We will engage relevant stakeholders in designing and delivering programmes that reflect diverse priorities, perspectives and contributions, advance opportunities for collaboration and optimize resources.

IMPACT

When we are successful, the field will be propelled by a broader pool of committed funders and by an Enterprise that is widely recognized for helping diverse stakeholders achieve greater impact.

Overall impact

Our 2018-2023 Strategic Plan will support collaborative solutions to enable three field-wide impacts against which we—and other stakeholders—will measure the field’s progress: a ROBUST PORTFOLIO of promising vaccine concepts; ENHANCED READINESS for the path forward for a successful vaccine; and DIVERSIFIED FUNDING for the field.

Our success will enable the field to build on available data to advance the most promising vaccine concepts and make the best use of resources. Product developers, regulators and health systems will be ready to make a successful vaccine available to populations that need it most. And the field’s R&D priorities will be propelled by an expanded community of engaged funders, partners and donors.