Progress in implementing WHA66.22 Health R&D Demonstration Projects Open-ended meeting of Member States 2-4 May 2016 Dr Zafar Mirza Coordinator PHI 1 International Clinical Trials Registry Platform
Identification of Health R&D Demonstration Projects - 1 22 Projects were identified by the 6 WHO Regional Offices through public calls A Global meeting of experts selected 8 projects in December 2013, using agreed criteria Proponents were asked to submit further information on innovative aspects of their projects Through guidance from WHO Executive Board and with the help of former Chair and Vice Chair of CEWG, four projects were finally selected for implementation
The first four selected Demonstration Projects 1, 2. The leishmaniasis global R&D & access initiative DNDi + USFDA 3. Exploiting the pathogen box: an international open sourc collaboration to accelerate drug development in addressing diseases of poverty MMV 4. Development of easy to use and affordable biomarkers as diagnostics for types II and III diseases ANDI + China NDI, et al.
Identification of Health R&D Demonstration Projects - 2 WHA67(15): (3) requested the Director-General to expedite the process of the remaining four projects, in addition to the four already agreed, and to report on progress to the 136th session of the Executive Board Workshop to improve the remaining four projects in Rio de Janeiro, 27-28 August 2014 Revaluation of projects by the former chair and vice-chair of CEWG and 6 Member States (Observers) 3 additional projects qualified as Demonstration Projects
The Selected Demonstration Projects 1. The leishmaniasis global R&D & access initiative DNDi + USFDA 2. Exploiting the pathogen box: an international open source 4 collaboration to accelerate drug development in addressing diseases of poverty MMV 3. Development of easy to use and affordable biomarkers as diagnostics for types II and III diseases ANDI + China NDI, et al. 4. Development of vaccine against schistosomiasis Fiocruz (Brazil) 5. Development of an open source multiplex point of care (POC) diagnostic device for the differential diagnosis of fever or sepsis THSTI (India) 6. Demonstration of the potential of a single dose malaria cure of artemether-lumefantrine through reformulation in a nano-based drug delivery system CSIR (South Africa)
What are these projects and how can they help in advancing the agenda of R&D financing and coordination?
Aims of Demonstration Projects Projects are geared at developing new treatments, improvement in existing treatments, diagnostics and a vaccine They aim at demonstrating new ways to conduct R&D New treatments : - new medicines for leishmaniasis - new compound series for new medicines Improved treatments : - single dose treatment for malaria Diagnostics : - development of biomarkers as diagnostics - development of PoC multiplex diagnostic - diagnostics for leishmaniasis Vaccines: - development of vaccine for schistosomiasis
DNDi + USFDA The leishmaniasis global R&D & access initiative Optimizing leishmaniasis R&D projects through guiding principles such as cross-regional collaboration of existing networks, open-innovation and sharing knowledge, equitable access to new products, and sustainable funding secured through existing and new funding mechanisms. Candidates treatments have been selected for preclinical studies Pharmacokinetic data is being analysed for Miltefosine Clinical trial synopsis is ready for scientific review for a new treatment regime for PKDL to be undertaken in Sudan Xenodiagnostic and quantitative PCR is on-going in Bangladesh for diagnostic development. US$ 2,301,609 were disbursed for the first year (2015-16) Amount required for the period 2016-20: US$ 22 million
Exploitation of "Pathogen box": An International Open Source collaboration to accelerate drug development MMV The scope of the project covers the entire neglected diseases' area. Basic principles include open access, delinking of cost and price, R&D capacity building in endemic countries through challenge grants. 5 new robust series to be delivered in 1 st year for further drug discovery optimization focused on at least 2 different pathogens Identification of 5 new resistance mechanisms or targets Endemic Region Challenge Grants in 2 nd year Countries involved in research: India, Ghana, Brazil US$ 1,360,000 were disbursed for the first year (2015-16) Total budget for 4 years: US$ 9.8 million
ANDI + China NDI + African Partners Development of easy to use and affordable biomarkers as diagnostics for types II and III diseases Delinkage, collaboration, licensing and IP approaches that secure access to R&D outputs and final product Formal launch of the project in November 2015 Initial focus on schistosomiasis, malaria and sleeping sickness. Screening of antigens for schistosomiasis and malaria Cell phone based diagnostic platform Partners from China, Egypt, Nigeria and Kenya. US$ 1,672,556 were disbursed for the first year (2015-16) Budget gap for the first 5 years: US$ 18 million
THSTI, India Multiplexed Point-of-Care test for acute febrile illness Delinking of R&D cost from the cost of final product; innovative licensing approaches that secure access; capacity building and local production in developing countries For efficient point-of-care differential diagnosis of acute febrile illness between Malaria, Dengue, Typhoid/Paratyphoid, Leptospirosis, Scrub Typhus and Chikungunya. No such multiplex Dx is available at present Partnership with Finland Generation of reference sera panel for different tropical fever etiologies. Generation of multiplex assays cassette US$ 1,672,556 have been requested for first 10 months, have been approved by an ad-hoc committee but the project is waiting, as no funding is available. Total budget: US$ 18 million
Development of a vaccine against schistosomiasis based on recombinant Sm14 Fiocruz, Brazil Multiple south-south and north-south collaborations; delinking; access policy 30 year old project 2 Phase 1 clinical trials have been successfully completed Clinical trail is being planned in Senegal. US$ 400,000 have been approved by the ad-hoc committee for first 10 months but the project has been waiting for funding since then, as no funds are available.
Fiocruz, Brazil Demonstration of the potential of a single dose malaria cure through a nano-based drug delivery system Delinkage (push funding to keep product affordable); data portal to ensure sharing of key scientific data; the intellectual property strategy will focus on ensuring affordable access for low and middle income countries especially those endemic to malaria. Artemether-lumefantrine, 1 tablet instead of 24 tablets If successful, other anti-malarials will be included using the same nanobased technology / platform $5 million over 36 months are expected. Nothing has been disbursed. No resources are available.
Current Funding Status of the Global Observatory on Health R&D & Selected Demonstration Projects Observatory Project 1 DNDi + USFDA Project 2 MMV Project 3 ANDI + China NDI, et al. Project 4 Fiocruz (Brazil) Project 5 THSTI (India) Project 6 CSIR (South Africa) Ad-hoc* Committee s funding recommendation Yes No Recently qualified as a demonstration project Funds disbursed No Yes No No No funds available No funds available *Ad-hoc Committee established in 2015, with members from all WHO regions; reviewed twice per year progress of the demonstration projects and of the observatory; made recommendations for approval by the TDR Joint Coordinating Board on allocation of available funds.
Current Funding Status as of 07 April 2016 US$ millions (m) R&D Demonstration Projects Global Observatory on Health R&D Budget for 2014-2017 US$ 73.5 m US$ 11.5 m Total Budget for 2014-2017 US$ 85.0 m Pooled Fund received or pledged * US$ 7.45 m 1 Designated Fund received US$ 0.82 m 2 Matching Fund 3 received or pledged * US$ 1.02 m 4 Available Matching Fund, pending developing country contributions Current Funding Gap US$ 1.56 m 5 US$ 74.15 m * pledged referrers to funds that are expected to be deposited according to countersigned agreements 1 Pooled fund received or pledged: Brazil, India, Norway, South Africa & Switzerland 2 Designated fund received for the Observatory: France, Switzerland and the United States 3 Matching fund referrers to funds that are set on the basis of half a dollar for each dollar contributed by developing countries 4 Matching fund received or pledged: Norway and Switzerland 5 Matching fund made available until September 2016: Switzerland
Key Questions for consideration by the Openended meeting 1. How to urgently fill the funding needs for the initiation of the 3 last projects and for next year's funding allocation for all six projects? 2. Time line for the projects: Currently these are planned until the end of 2017. What will be their future beyond 2017?