TB Alliance is one of IMI's Associated Partners. Ana Maria Harkins, its Director of External Affairs, says that the partnership with IMI allows them to expand funding beyond a small and mostly static group of donors
TB Alliance is a non-profit organisation whose mission is the discovery, development and delivery of new and affordable tuberculosis (TB) drugs. As a ‘product development partnership’, TB Alliance seeks out new partners whose skills and resources can be combined with the research and development expertise of their own staff in order to harness the most promising science, wherever it may exist around the world. Ana Maria Harkins, Director of External Affairs, spoke to the IMI programme office about the IMI partnership and how it helps them achieve their goals.
Q. What does your organisation hope to get out of the relationship with IMI?
Ana Maria Harkins: As a product development partnership, we leverage public-private mechanisms to accomplish our work, and the IMI model aligns well with our way of working. Tuberculosis - and neglected diseases of poverty more generally - receive funding from a small and mostly static group of bilateral and philanthropic donors. Our partnership with IMI stems in large part from our goal of engaging with EU-based funding mechanisms to support research and development. IMI brings together many of the main players and we greatly value the resources it makes available, as well as a platform to collaborate with industry, academia and the public sector.
Q. Which projects have you specifically been involved in? What is the nature of your participation?
Ana Maria Harkins: TB Alliance is an Associated Partner in two ongoing IMI projects, pledging over €40 million in in-kind contribution towards the AMR Accelerator Programme and the Integrated Research Platform (IRP) Programme. With our experience in TB drug development, we have been able to contribute to building capacity in conducting regulatory-standard TB clinical trials in Europe. Through ERA4TB, we have contributed two compounds for development, one of which is in Phase 1 trial (the first-ever phase 1 trial in a European setting for TB Alliance) and another is in the preclinical development stage. In EU-PEARL, we are involved in the work package dedicated to TB, where we provide regulatory expertise, knowledge and tools for community and patient engagement. The main goal is to develop a master protocol and elements of a research platform that would enable future phase 2 and 3 TB clinical trials.
As part of the AMR Accelerator Programme (currently at the grant and consortium agreement stage), we will seek to develop and implement an innovative adaptive clinical trial design that can advance the field of TB regimen development. Ultimately, the goal will be to define the therapeutic dose for existing experimental drugs.
Q. What do you think is the benefit of a public-private partnership in health like IMI, as compared to other funding initiatives and programmes?
Ana Maria Harkins: The market failures for therapeutics to combat antimicrobial resistance are well documented. Without political and financial incentives, the industry has little incentive to develop antibiotics. IMI provides resources to incentivise drug development, and an architecture that brings together an array of partners to contribute compounds, perform preclinical and clinical work, exchange data and research learnings and jointly work towards a set of agreed-upon outcomes.
Q. Based on your experience, do you hope to partner with IMI’s successor, IHI?
Ana Maria Harkins: TB Alliance is planning on participating in IHI. Charities, non-profit product developers and foundations have expressed their interest to the European Commission in discussing the role of non-profit organisations under IHI, taking into account the high impact achieved by their participation as Associated Partners in IMI2.
We are looking to have a more pronounced role in IHI, going beyond the status of individual contributing partners and possibly into full members. We also would look for continued inclusion of TB and other epidemic diseases, and for research phases to be end-to-end in order to promote product development that can achieve public health impact.
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