In this edition of the Bulletin, we highlight the progress of the Working Groups in the first half of 2016, and share information on new developments.
Stop TB Partnership Bulletin on Working Groups
15 August– Geneva, Switzerland - The Working Groups of the Stop TB Partnership provide inputs on critical strategic issues for TB globally, based on which the Coordinating Board takes decisions. One of the strategic goals of the Partnership is to strengthen support for the working groups and to facilitate collaboration between them. The Partnership identifies opportunities and gaps for new partners to engage in Working Groups (WGs) through ongoing and regular dialogue.
Working Groups sends regular updates to the Stop TB Partnership Secretariat on their activities and upcoming events. We highlight the progress of the WGs in the first half of the year 2016 and share information on new developments and information of their work.
I. Implementation Working Groups:
A. Working Group on Global Drug-resistant Initiative (GDI)
The Working group on Global Drug-resistant Initiative (GDI) serves as a multi-institutional, multi-disciplinary platform organizing and coordinating the efforts of stakeholders to assist countries to build capacity for programmatic management of DR-TB (PMDT) in the public and private sector.
A statement on the situation of drug-resistant TB in Papua New Guinea was issued by the WHO Representative Office.Recognizing the serious DR-TB problem in Papua New Guinea, the Government of Papua New Guinea in coordination with all partners established an emergency response team (ERT) in August 2014. The ERT assists in raising high-level advocacy, resource mobilization, planning and monitoring of implementation of the national response to DR-TB. Subsequently, an accelerated response plan was developed in January 2015 and the government and partners have been further increasing their efforts to address the issue.
As part of continued support for the country’s effort, the Western Pacific Regional Green Light Committee (rGLC) conducted its annual mission to Papua New Guinea in May 2015 and made a series of recommendations. The rGLC is a group of international TB experts to support public health response to address drug-resistant TB across the Western Pacific Region. Although the next rGLC mission is planned later this year, significant progress has already been observed.
The purpose of the document is to provide an update on the progress made since May 2015 and WHO’s position to further support country’s efforts.
This document can be accessed here:http://www.wpro.who.int/papuanewguinea/areas/tb_leprosy/daru_update/en/#.Vv6JBB78mPA.email
DR-TB STAT, an officially recognized task force of the Global Drug-Resistance Initiative (GDI) since July 2015, continues to host monthly meetings to facilitate the introduction of bedaquiline and delamanid under program conditions. The group, which was formed in response to the "Call to Action" on new drug introduction, began meeting in May 2015 and has reviewed the progress of new drug introduction in key countries, including South Africa, India, Indonesia, Georgia, the Philippines, Lesotho, Kenya, Swaziland, Peru and Vietnam. Multiple stakeholders have come together during the calls to help troubleshoot issues in new drug introduction.
The group also produces a global "snapshot" on progress of new drug introduction. The snapshot numbers as of June 2016 are below:
More data can be accessed at http://stoptb.org/wg/mdrtb/taskforces.asp?tf=4
- Current number of patients on BDQ under program conditions: 4521
- 2048 South Africa, 228 Belarus, 184 Georgia, 87 Armenia, 53 Swaziland, 1008 Russia, 35 Indonesia, 8 PNG, 32 Lesotho, 15 Peru, 95 Kazakhstan, 6 Kenya, 42 Viet Nam, 3 Philippines, 12 Latvia, 15 Estonia, 18 Haiti, 2 India;
- Total number CU= 766
- Current number of BDQ orders from GDF: 4257
- Current number of patients on DLM under program conditions and CU: 180 according to company
- 7 from MSF in Belarus, 9 from MSF in Armenia, 21 from MSF in Georgia, 30 from MSF in South Africa/Khayelitsha, 8 Latvia, 10 Estonia, 2 Kazakhstan (and 70 course just cleared customs) = 267 total
- Current number of DLM orders from GDF: 900
New drugs approved by regulatory authorities, notably bedaquiline and delamanid, as well as re-purposed drugs classified as Group 5 in the WHO Companion Handbook to the 2011 Guidelines for Programmatic Management of Drug-resistant Tuberculosis (PMDT) are increasingly being introduced in the treatment regimens for MDR-TB and XDR-TB patients. Given the essential role of the regional Green Light Committees (rGLCs) as the primary point of contact for country guidance and advice on PMDT, it is very important that rGLC members and PMDT consultants are fully au fait with current WHO policy recommendations on the use of new drugs, as well as those in Group 5. Therefore a series of workshops have been conducted by the WHO for the rGLC members and their respective rGLC Secretariat Focal Points, whilst encouraging countries and partners to make use of the rGLC mechanism to ensure that treatment principles and drug orders are aligned with WHO guidelines.
Three out of the five planned workshops have been conducted and the report of the latest workshop on new DR-TB drugs for SEAR and WPR held at Bangkok, Thailand in February 2016 can be found:Report on experience sharing workshop on the introduction of new drugs for DR-TB treatment in SE Asia and WP regions.
B. Global Laboratory Initiative ( GLI)
The Global Laboratory Initiative (GLI) is a network of international partners dedicated to accelerating and expanding access to quality assured laboratory services in response to the diagnostic challenges of TB, notably HIV-associated and drug-resistant TB. The GLI provides a focus for TB within the framework of a multi-faceted yet integrated approach to laboratory capacity strengthening.
The GLI continues to develop products under its strategic priorities for 2016-2017, including analyzing the landscape and developing a guide for NTP managers on diagnostics connectivity solutions, updating its microscopy network accreditation assessment tool to include other diagnostics in tiered networks, developing a standardized template for template for national TB diagnostic network planning, refining its Xpert MTB/RIF training modules in anticipation of product advancements, collaborating with the GDI to develop second-line line probe assay training modules for lab technicians and clinicians, and collaborating with the WHO Global TB Programme in developing indicators and targets for laboratory strengthening under the End TB Strategy.
The semi-annual meeting of the GLI Core Group took place in Kampala, Uganda on 22 July in tandem with a conference marking the launch of the GLI Africa, a regional initiative for TB laboratory strengthening. A survey of GLI members was conducted in May to help guide the working group’s communications, product development and refine its future strategic priorities.
C. TB/HIV Working Group
No updates provided at this moment.
D. Subgroup on Public-Private Mix (PPM) for TB Care and Control
The Subgroup on Public-Private Mix for TB care and control was established by the Stop TB Partnership's DOTS Expansion Working Group to help develop global policy on PPM and assist countries to develop and implement national policies and guidelines to engage all care providers. Advocacy for PPM is the main function of the PPM Subgroup.
The activities of the PPM Working Group for the year began with the 11th Global Meeting on PPM for TB Care and Prevention held in Mumbai, India from 29 February to 2 March 2016. The theme of the meeting was “Working with frontline private providers: innovations in scaling up collaboration and regulation”. The meeting was organized by the WHO, Geneva-based PPM Secretariat in collaboration with India’s’ Revised National TB Control Programme and PATH which helped in the local organization of the meeting and also in arranging field visits to selected sites of a large scale innovative PPM project being implemented in Mumbai. The meeting was very well attended by representatives of all stakeholders including national TB programmes of 15 countries in Asia and Africa; the grant portfolio managers for most of the participating countries and the TB advisor of the Global Fund; representatives of other technical, financial and development partners; members of the civil society and patient representatives. The objectives of the meeting were:
1. Review global progress and problems in scaling up private sector engagement in TB care and prevention;
2. Discuss innovations in engaging private practitioners and frontline care providers, including laboratories and pharmacies, through collaborative and regulatory approaches;
3. Make field visits to an ongoing innovative project to engage private practitioners practicing in the slums of Mumbai;
4. Discuss strategies to scale-up and replicate innovations in collaboration and regulation of private care providers in the context of the new End TB Strategy
A summary report of the 11th meeting along with a link to the presentations from the meeting is attached here.
The first meeting for 2016 of the PPM Core Group took place on the last day of the PPM Working Group meeting at the same venue in Mumbai, India. The Core Group had a roundtable discussion in which the members gave their reflections of the just concluded Global PPM Meeting. Overall, the Core Group members felt that the PPM meeting was a success and was well-organized with interactive participation from countries and partners. Possible venues for the 2017 PPM Working Group meeting were discussed and it was agreed to hold the second face-to-face meeting of the Core Group around the Union World Conference in Liverpool, UK in October 2016. A summary report of the Core Group meeting is available.
A teleconference of the PPM Core Group was organized on 29 June 2016. The Core Group members agreed to hold the second Core Group meeting at Liverpool on 26 October 2016 between 10:00 and 14:00. The members also provided suggestions for the agenda items for discussion at the Liverpool meeting. For the 2017 full PPM Working Group meeting, it was agreed that the focus should be on PPM in Africa and two possible venues – Addis Ababa and Nairobi – were proposed. A final decision on the venue will be taken at the Liverpool Core Group meeting. The list of current Core Group members was also reviewed during the call. It was proposed to increase the number of NTP managers as not all would be able to attend every Core Group meeting. The Core Group members are expected to submit suggestions for new members currently active or interested in implementing innovative PPM approaches in countries. The proposed candidates may be then examined by the Core Group for inviting to join the group and its future meetings and activities.
E. Childhood TB Subgroup
The Childhood TB sub-group works with the objective to promote research, policy development, the formulation and implementation of guidelines, the mobilization of human and financial resources, and collaboration with partners working in relevant fields (including maternal and child health, the extended programme on immunization, and HIV) to achieve the goal of decreased childhood TB mortality and morbidity.
During the first half of 2016, the core team of the childhood TB subgroup had a conference call on 23 February to plan for the year ahead. The next core team call will take place on 19 July to prepare for the annual meeting of the childhood TB subgroup which is scheduled to take place on Wednesday 26 October in Liverpool, UK.
Since the beginning of the year, the Chair, the Secretariat and core team members have provided technical assistance to Nepal, Sri Lanka, Myanmar, and have been involved in the Philippines and Zimbabwe programme reviews and have participated in various meetings, including: the Pan African Thoracic Society Lung Conference; the UNICEF meeting on integration of childhood TB in MCH, HIV and Nutrition programmes; the IMPAACT annual meeting; and the Union Europe Regional meeting. All the above events were supported either by WHO or partner organizations.
The core team is seeking new members representing the WHO South East Asia and Western Pacific regions and the subgroup will also elect a new chair after the annual subgroup meeting in October.
F. End TB Transmission Initiative
The End Tuberculosis (TB) Transmission Initiative (previously the Infection Control sub-Working Group) supports the global fight against TB, by focusing its efforts on preventing and controlling the transmission of TB. We are an interdisciplinary professional group working in TB and dedicated to reducing, and ultimately ending, the transmission of tuberculosis worldwide.
In the first half of the year, the ETT working group developed their 2016 work plan and budget based on their strategic priorities for 2016. One of the approved activities was the appointment of a part-time coordinator who will coordinate the implementation of the work plan. The core group met once on 23 May 2016. However, members of the core group work in smaller groups on specific topics and uses any opportunity that brings them together.
On the 30 June 2016, the group closed out the 2015 work plan which included activities in Myanmar, India and Ethiopia, promoting the application of germicidal UV (GUV) in health facilities. They had conducted assessments, procured quality-assured fixtures with a known fixture-output and contracted a top-notch consultant to develop a Manual on maintenance of GUV systems.
In the second half of 2016, they will continue the GUV related activities focusing on the development of a business model for specialized private companies who can be contracted by National TB Programs to maintain the GUV system in public facilities, to overcome the main problem with GUV systems: their maintenance.
In October 2016, the group will help URC to organize a two-day meeting for GUV stakeholders in South Africa.
Other highlights in this reporting period was the development of a monitoring framework for airborne infection control. The framework could be considered in the WHO policy update which was rescheduled to the second half of 2016. First steps of the policy update are to define the scope of the updated guidelines, develop the list of priority topics, discuss the composition of the Guideline Development Group (GDG), define PICO questions and consider experts to be involved as systematic reviewers.
The GDG (10-20 members) should be balanced in terms of geography and gender and should provide diverse perspectives: Chair (and preferably guideline methodologist), technical experts, end-users (NTPs), groups affected by potential recommendations, evidence assessment experts and other technical experts (guideline development, economist, equity human rights and gender).
II. Research Working Groups / New Tools Working Groups
The Working Groups on New Drugs, New Diagnostics, and New Vaccines share a common purpose:
• Provide coordination and communication platforms for stakeholders to strengthen development of new tools to eliminate TB
• Create effective mechanisms of exchange and dialogue between the Stop TB Partnership and research communities
• Accelerate collaboration and coordination across multiple stakeholders (public health, not-for-profits, companies, research funders) involved and interested in TB R&D
• Provide fora to discuss challenges in TB R&D, identify solutions, and build consensus on key issues and questions related to TB R&D.
• Provide the latest advances and input on R&D for new TB tools and contribute to the development of and monitoring of the Global Plan to Stop TB
A. Working Group on New TB Vaccines (WGNV)
The purpose of the Working Group on New TB Vaccines is to facilitate the development of new, more effective TB vaccine by promoting collaboration and coordination amongst multiple stakeholders. The Working Group serves as the mechanism of exchange and dialogue between the Stop TB Partnership and the research community, provides a forum to discuss challenges to TB vaccine development and identify solutions, and to build consensus on key issues and questions related to TB vaccine research and development
In light of increased support for the New Tools Working Groups, an in person leadership meeting was held in Washington DC.The Working Groups acknowledge the importance of the development of new tools in the fight to eradicate TB, and sought to better integrate the New Tools Working Groups with the work of the Partnership.To this end, outcomes of the meeting included:
1) Creation of a joint Quarterly New Tools Working Group Newsletter.
2) Bi-monthly leadership calls.
3) A commitment to supporting the Partnership through creation of educational materials, scientific support of Partnership initiatives, and engagement with diverse constituents to promote investment in R&D and to support investments in researchers devoted to theeradication of TB.
4) The development of joint initiatives focused on innovation in the creation of New Tools.
The Working Group on New Vaccines is also partnering with the other New Tools groups on a Union Conference symposium to be held in Liverpool on October 27th from 1:30 - 3:00PM titled
“Reframing resistance: Research and Innovation to Improve Patient Care and End Drug-Resistant TB”.
The Working Group has begun planning for the 5th Global Forum on TB Vaccines, which will take place in late 2017. More details on the 5th Global Forum will be forthcoming.
The group is also in process of setting up an Advocacy Subgroup. More information will be forthcoming.
Finally, the Working Group is committed to promoting the development of support of young investigator, particularly those living in TB affected communities.The Working group will work closely with the Partnership to develop these opportunities.
B. New Diagnostics Working Group (NDWG)
The New Diagnostics Working Group (NDWG) is one of the seven working groups of the Stop TB Partnership. It supports the Partnership in its goal of eliminating tuberculosis (TB), in particular by promoting the development and evaluation of new TB diagnostic tools. The NDWG is a network of experts representing stakeholders from academia, NGOs, multilaterals and governmental institutions, TB high-burden countries, industry, and the patient community.
The ultimate goal of TB elimination and the targets of the End TB Strategy and the Global Plan to End TB cannot be achieved without strengthening latent TB infection (LTBI) management. This strongly depends on the performance of diagnostic tests that can reliably identify individuals at risk of progression to active TB disease, thus enabling targeted preventive therapy and contribute to end transmission. To support this goal, new and better tools need to be developed and deserve high priority in the TB research agenda.
To address this need, the New Diagnostics Working Group (NDWG) established a Task Force on LTBI and test of progression (http://www.stoptb.org/wg/new_diagnostics/ltbi.asp) coordinated by Dr. Alberto Matteelli of the University of Brescia. In the first part of the year, the task force prioritized leading the process for the definition of a target product profile (TPP) for a test of progression, the preparation of a guide for study design and evaluation of new diagnostics, and the promotion of overall re-thinking of the LTBI model and the implications for diagnosis.
In May, the NDWG launched an online consultation to gather input from a group of stakeholders representing researchers, endemic countries, governmental and non-governmental organizations, test developers and the patient community. Participants had the opportunity to evaluate the key performance and operational characteristics as defined in the TPP in order to build large consensus.
On 1 July 2016, the NDWG convened an expert group with task force members and key experts in LTBI in Milan, Italy, hosted by San Raffaele Research Institute, in order to present the results of the consultation and finalize a consensus-based TPP document. Participants also discussed a concept overview on the continuum from LTBI to active TB to promote consensus on standard terminology for LTBI and LTBI diagnostics, as well as an advanced draft on the guidance document for study design to evaluate new tests for WHO endorsement. Proceedings of the meeting, including a meeting report and the presentations will be posted on the NDWG website.
For more details on the NDWG, please visit http://stoptb.org/wg/new_diagnostics/
C. Working Group on New TB Drugs (WGND)
The Working Group on New Drugs (WGND) has a mandate to accelerate the development of effective and affordable new therapies for TB. It acts as a forum to facilitate global collaborations and joint projects for the development of new TB drugs. To eradicate TB in the 21st century, a continued multi-year worldwide commitment, research and vigilance is important to ensure a consistent pipeline of new antimicrobials. With its diverse membership, including representatives of public and private sector, academic laboratories, the industry as well as regulators, representatives of affected communities and those in a position to provide funding and support, the working group remains a unique mechanism for ensuring a consistent pipeline of drug candidates.
In July, the WGND organized a planning workshop to prepare for a global collaboration of key players using oxazolidinones. The purpose of the meeting was to discuss the potential for improved TB drug therapies involving these compounds. The planning meeting took place at the NIH in Bethesda, Maryland where scientists, experts, and key players in development came together to map the landscape of knowledge, identify those participants who’s participation would be vital to this collaboration, and plan for a larger meeting in the fall.
In collaboration with the WGNV and NDWG, the WGND has also developed a quarterly New Tools Working Groups Newsletter to highlight working group activity, major developments in their fields, and upcoming events to further collaboration. Additionally, as a major resource for tracking global TB drug development, the WGND is working with web designers to recreate their website. The new website will feature an enhanced and integrated pipeline which offers users a new experience in interacting with the information. Users will be able to click seamlessly through current and past projects and will be able to view associations between compounds, regimens, trials, trial sites, and developers for both drug discovery and clinical development.
The Working Group on New Drugs plans to hold a meeting in conjunction with the EMBO Conference on Tuberculosis: “Progress Updates on Global TB Discovery and Preclinical Activities” in Paris, France. This meeting is open to all registrants of the EMBO Conference. Further, the WGND Annual Meeting will be held in conjunction with the Union World Conference on October 26th. Please see the WGND website (www.newtbdrugs.org) for more information.
For more information on the Stop TB Partnership, please visit: http://www.stoptb.org/ or write us at email@example.com