Identifying unmet patient needs for lymphatic filariasis
In February, the DNDi in India office and the Indian Council of Medical Research organized a clinical experts’ meeting on lymphatic filariasis (LF), bringing together researchers and clinicians from India, Ghana, the US, the Netherlands, and Japan, as well as representatives from WHO, USAID, the Bill & Melinda Gates Foundation, JICA, and the LEPRA Society.
The objective was to identify the unmet needs for the treatment of LF patients in Asia and to define the target product profile (TPP) for LF case management in Asia. After identification of the main gaps in patient case management, two TPPs were drafted, one to treat infected persons (symptomatic or asymptomatic) and the second to stop progression of the disease (probably reverse pathology).
Building alliances against neglected tropical diseases
As India moves toward elimination of key NTDs like LF and visceral leishmaniasis (VL), DNDi in India hosted a meeting of the NTD Platform-Building Alliances against Neglected Tropical Diseases in May. The creation of the Alliance, in February 2016, was spurred by the Global Network for Neglected Tropical Diseases, an international advocacy organization focused on raising the profile of and mobilizing resources for NTDs, and which has helped catalyze coalitions internationally, particularly in donor countries like the UK and Germany.
The Alliance will build on this experience in its function as a platform for all NTD stakeholders in India. One of its first actions was the sending of a community sign-on letter to the Prime Minister’s Office highlighting the importance of keeping NTDs on the BRICS agenda this year as India holds the presidency of the group.
Strengthening clinical research capacity
With the aim of improving the capacity of clinical trial sites and laboratories in conducting research, DNDi in India organized training in Good Clinical Practice and Good Clinical Laboratory Practice at Rajendra Memorial Research Institute (RMRI), Patna, in June 2016, for investigator teams from DNDi, RMRI, Médecins Sans Frontières, Chapra district hospital laboratory, Hajipur district hospital and the National Institute of Pharmaceutical Education and Research.
The objectives of the training were to enable clinical investigators, laboratory technicians, pathologists, nurses and clinical monitors apply the concepts and principles of good clinical practices and international ethical standards in the conduct of clinical trials and observational research, as well as understanding the specificities of clinical trial regulations in India.
New trial to determine cases of PKDL in previously treated leishmaniasis patients
Between 2012 and 2015, DNDi conducted a study to assess the feasibility of using three new treatment regimens to treat visceral leishmaniasis at public health facilities in Bihar, which led the Indian National Kala Azar Elimination Programme to revise its treatment recommendations. Following a request for evidence from the national programme on the occurrence of post-kala-azar dermal leishmaniasis (PKDL) in this large patient cohort, DNDi in India is now seeking to determine the proportion and timing of patients developing PKDL for each of the three new treatment regimens.
All 1761 VL patients treated in the initial study in two districts of Bihar (Patna and Saran/Vaishali) with any of the three new treatment regimens have been invited to participate in the study. At a follow-up visit at least 24-months after VL treatment, participants are assessed for history and clinical manifestation of PKDL. Suspected PKDL cases will be screened with a rapid diagnostic test, and probable PKDL patients referred to the Rajendra Memorial Research Institute for parasitological confirmation. Patient recruitment is expected to be completed by June 2017, with preliminary reports in late 2017.
How to ensure sustained VL elimination in India?
In November 2016, national and international researchers and operational experts met in New Delhi to launch the SPEAK India consortium. The consortium will aim to develop a post-elimination agenda for visceral leishmaniasis in the Indian subcontinent. Participants worked on defining the research questions to improve our understanding of transmission to inform the post-elimination strategy, and formulated a roadmap to transfer technology on vector biology, disease modelling and diagnostics from international partners.
SPEAK India, funded by the Bill & Melinda Gates Foundation, is a partnership between the Indian Council of Medical Research, the National Vector-Borne Disease Control Programme, the London School of Hygiene and Tropical Medicine, and DNDi.
Partnering with Indian universities to boost open-source drug discovery
In a new open-source drug discovery project called the Open Synthesis Network, DNDi drug discovery projects are brought into academic chemistry teaching labs in a bid to help identify new chemical entities for neglected tropical diseases. DNDi shares its drug discovery data from active projects with academic chemistry departments, and benefits from the synthetic efforts and intellectual design input of students of medicinal chemistry. Participating students get a rare opportunity to observe a real-life drug discovery project in action, and can contribute to the initiative through design and synthesis of target molecules as part of their wet lab training. All data is shared amongst the participating institutions and students in an “open source” environment.
In 2016, DNDi in India office signed a Memorandum of Understanding with two institutes, the Indian Institute of Technology, Gandhinagar and the Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management (NMIMS) to participate in this novel crowdsourcing chemistry student project.
Antimicrobial resistance: identifying public health priorities for India
The mission of the Global Antibiotic Research and Development Partnership – a recently launched joint initiative of DNDi and the World Health Organization – is to work with public and private sectors to develop and deliver new treatments for bacterial infections where drug resistance is present or emerging, or for which only inadequate treatment exists.
In December 2016, in collaboration with Indian Council of Medical Research, DNDi convened experts and stakeholders in the field of drug-resistant infections in India to advance the understanding of the most pressing medical needs and research and development gaps – including infections and patient groups, national regulations, diagnostics, surveillance factors – and identify strategies to address them. The group also looked at the current Indian landscape in antibiotic R&D and explored collaboration opportunities and ways to capitalize on existing networks.