MAPGuideⓇ
Equitable Access Toolkit
Target Product Profile Obligations in Funding Agreements
Target Product Profiles (TPPs) set out the desired characteristics for innovative vaccines, therapeutics, diagnostics or medical devices. The WHO develops TPPs for priority products (or Preferred Product Characteristics for product classes at early stages of development), however funders, product development partnerships and/or innovators may also develop TPPs or target characteristics for products in their portfolios. TPPs that are developed in consultation with relevant stakeholders, including patients, can be used to guide R&D activities and increase the likelihood that an end product will be appropriate and adoptable for all of the patients that need it.
TPPs are generally developed with minimum and optimum characteristics, and the ability of a potential partner to develop and manufacture a product that at least meets the minimum target characteristics is often a consideration for funders when evaluating funding applications and/or deciding whether to continue funding for a particular product. An expected product profile per the developer’s funding application may then be included as an appendix to a funding agreement (potentially as part of an access plan or product development plan), along with commitments from the funded partner to undertake product development activities intended to achieve the target characteristics.
Additionally, project governance mechanisms may include periodic review of product development progress against the TPP, a mechanism for agreeing updates to the expected product profile, and “go/no go” milestones or decision points to enable a funder to discontinue funding if a product will not meet the desired characteristics. Funders may also retain an option or “first right” to provide further funding where the results of an early stage project indicate that a target profile can be met. These mechanisms may be particularly important for earlier stage R&D when there is limited information available about the likely characteristics of the end product at the point when a funding agreement is signed.
Examples from the MAPGuide
[Developer] will use reasonable and diligent steps to (i) conduct all clinical trials specified in the [Integrated Product Development Plan] to meet the Minimum TPP and keep the [Funder] promptly informed of any information impacting the Product’s ability to meet the Minimum TPP thereunder or that is otherwise deemed to impact the Project or timelines by three (3) months or more […]
Related definitions: Minimum TPP.
Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Novavax (Developer) signed in relation to a USD $83 million grant from the Foundation to Novavax. Partner types: philanthropic funder, industry; Product type: RSV vaccine; Development stage at signature: late stage clinical trials. Read in context.
Availability & supply – Develop a product, technology with a Target Product Profile (TPP) suitable for LMICs.
Source: taken from a USD $34.8 million funding agreement between CEPI (Funder) and the University of Oxford and Barinthus Biotherapeutics (Developers). Partner types: non-profit funder, industry/academic institution; Product type: MERS vaccine; Development stage at signature: early stage development. Read in context.
[I]f requested by the Foundation, members of the Company’s technical team will meet with Foundation programmatic representatives at least once quarterly via teleconference or onsite visits at Company facilities to provide an update on any of the Projects, with such updates to provide a level of detail sufficient to assess the status of such Projects against the applicable scopes of work and TPPs (as applicable).
Source: taken from a strategic relationship letter agreement between the Gates Foundation (Funder) and Lumira Dx (Developer) signed in connection with a USD $20 million share purchase and USD $18 million loan from the Gates Foundation. Partner types: philanthropic funder, industry; Product type: point of care diagnostics; Development stage at signature: unknown.
The Company and Exscientia will manage the pipeline of hits and leads such that there is an appropriate balance of projects and resources to deliver [****] lead candidates [****] and will prioritize leads based on their ability to meet the TPP criteria, including activity against multiple species within virus families. The pipeline and leads will be reviewed by the Joint Steering Committee and must be acceptable to the Joint Steering Committee (such acceptance not to be unreasonably withheld).
Source: taken from a global access commitments agreement between the Gates Foundation (Funder) and Exscientia (Developer) signed in connection with a USD $35 million investment by the Gates Foundation. Partner types: philanthropic funder, industry; Product type: anti-infective therapeutics for future pandemic preparedness; Development stage at signature: discovery.
How will development of a TPP be coordinated as part of end-to-end access planning?
Will the TPP form part of an access plan annexed to the agreement?
Are affordable and sustainable pricing commitments aligned with any target pricing identified in the TPP?
This toolkit has been built based on the data in the MAPGuide and the GHIAA team’s experience of negotiating and implementing agreements. We intend that the toolkit will evolve and expand over time based on input from MAPGuide users and availability of new agreements showing examples of alternative approaches. We welcome ongoing constructive dialogue around these materials and encourage you to contact us or fill in our feedback survey to share your thoughts, questions and suggestions.
