International Development CommitteeWritten evidence submitted by Dr Geoff Coxon, TBD-UK

We are writing to give evidence for the above inquiry with a special focus on the expenditure of research in tuberculosis drug development.

The many UK-based researchers carryout world leading research in the field of tuberculosis (TB) drug development and recently have been coordinated as TB Drug Discovery UK (TBD-UK). Funded by the UK Medical Research Council (MRC), TBD-UK aims to coordinate the UK response to the challenge of tuberculosis and to facilitate the development of new TB drugs co-ordinating academic and industrial researchers. Also, UK-based researchers work closely with international partners in Global Alliance for TB Drug Development (GATB), WHO, and have established Europe wide collaborations supported by EDCTP in the PanACEA consortium.

We applaud the excellent work that DFID currently supports and our written evidence outlines that TBD-UK efforts can be used to greater effect by working with DFID. It specifically identifies that this may be done by funding and development of existing partnerships with GATB and supporting further the efforts to develop a strong European response the TB.

Introduction

TB drugs are the lifesaving treatment that underpin the global case detection and cure strategy. The experience of another mycobacterial disease, leprosy, indicates that reduction in the global burden will require shorter and more effective treatment. The long duration and associated toxicities of current TB treatments limit their application in a real world setting and without better safer and shorter treatment there is little prospect of controlling the present global pandemic. Their discovery and development is long, costly and include many scientists and clinicians globally. Product Development Partnerships (PDPs) are the most effective mechanism to discover the drugs that will achieve the same goal in TB.

At present UK-based researchers are engaged at all stages of the complex drug development process using funds from UK government funded research councils, the Global Alliance for TB Drug Development, the European Union Wellcome Trust and other agencies as set out below.

Increasing the Value for Money of DFID Funds

TBD-UK is an inclusive research-based consortium that brings together leading UK scientists and clinicians in the area of drug development. In early phases of drug discovery partners are pioneering new compound series targeted against TB. TBD-UK is working closely with GATB in the development of a novel compound series. In addition to this we have developed a portfolio of specific projects and initiatives that, in partnership with GATB and others supported by the EU.

For the phase following the identification of a new compound series TBD-UK colleagues are leading players in the PreDiCT-TB consortium (currently engaged in contract negotiation with the IMI initiative) that will develop new strategies to speed the pre-clinical and early phase clinical development of novel drugs. Crucially, TBD-UK members are leading partners in REMoxTB initiative (28 clinical sites internationally), the first regulatory TB clinical trial that is sponsored and funded by GATB. This project has done much to create and develop infrastructure in Africa to deliver regulatory standard trials. Colleagues are also leading PanACEA (Pan-African Consortium for the Evaluation of Anti-tuberculosis agents), a European Developing Country Clinical Trials Partnership funded group managing the clinical development of a range of novel agents and regimens and supporting the development of trials infrastructure at a range of African sites. These initiatives fit with the DFID research strategy 2008–13, and in meeting MDG 6 (target 8) “to have halted and begun to reverse the incidence of TB by 2015”. Importantly, it aligns strategically with DFID’s aid review, “UK aid: Changing lives, delivering results, and “Towards zero infections: the UK’s position paper on HIV in the developing world”.

By funding and developing the portfolio of potential projects between TBD-UK and its various research collaborators including GATB, PanACEA, PreDiCT-TB, the UK can make a much stronger contribution to the eradication of TB. Existing UK academic and industrial expertise could be exploited by improving further the coordination of research collaborations. This could include further support for coordination meetings to develop collaborations, creating specific projects to draw the collaboration together further such as joint capacity development, masters and doctoral training that focuses on TB drug development. The further co-ordination and consolidation of UK researchers in academia and industry would support the UK effort in controlling TB and allow us to expand and sustain our national expertise as we work with partners in developing countries to build their capacity to address TB in high burden countries.

Recommendations

DFID would benefit from having an “open round table” discussion with UK researchers collaborating in TBD-UK.

DFID should investigate ways to collaborate with TBD-UK and GATB and other partners to leverage additional funds towards drug discovery and development through a PDP paradigm.

DFID should consider methods to support projects that would consolidate the work to coordinate the UK TB drug development community further and strengthen their links with research councils UK, academic, NGO and pharmaceutical partners.

October 2011

Prepared 8th March 2012