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Newsletter 2023
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Dear partners and colleagues,
In March last year, GAP-f launched its three-year strategy which signaled its expansion into new disease areas and outlined opportunities to test our way of working together on various fronts. We are now in the middle of our strategy implementation, and this is a critical juncture for our growth and evolution. The GAP-f Annual Network meeting on June 21 gave us the opportunity to pause and reflect on what we have delivered and what needs to get done to ensure better access for the children in need. The implementation of our strategy has been a collaborative effort and we have our partners to thank for their contribution.
We are taking this opportunity to officially welcome the Medicines Patent Pool (MPP) in their new role of Vice Chair of the GAP-f Strategic and Coordination Committee, taking over from CHAI to whom we are very grateful for their critical contribution to GAP-f’s first steps. The MPP has been a thought partner since the start of GAP-f, and we look forward to growing our collaboration in exploring synergies and strategic partnership to support the implementation of our strategy.
We are also pleased to share our latest video created with the support of our funders, which showcases the importance of GAP-f in using evidence-based processes to identify and target gaps, and through the involvement of key stakeholders, accelerate the process to make a significant impact on the best formulations being pushed forward across disease areas.
Below, we share snippets of our progress from January – July 2023 and highlight the work of our partners in pediatric medicines. Thank you for being a part of our journey and helping us provide #BetterMeds4Kids.
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MDGH will contribute to the Product Development and Regulatory Affairs (PDRA) Working Group, and in particular provide insight into the shaping of the Paediatric Technologies Innovation Hub.
C-Path will contribute to the Clinical Research Working Group (CRWG), including contributions to the GAP-f Paediatric Data Hub designed to improve the availability, quality and use of real-world data to monitor and optimize treatments. C-Path will also input into the PDRA Working Group and help to identify the most appropriate and effective regulatory tools in the product life cycle.
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Priority paediatric formulations identified for COVID-19 and antibiotics
Paediatric drug optimization (PADO) exercises aim to identify key priority products and their preferred product characteristics for research and development. These exercises, convened by WHO technical departments with input from relevant GAP-f partners, demonstrate the potential impact to better target global efforts on optimal formulations in the context of fragmented, small markets for medicines for children.
The outcomes of two PADO exercises for COVID-19 and antibiotics were launched in March 2023 and are available here and here. Read GARDP’s news report on the antibiotics prioritization process here. Work is currently ongoing by several GAP-f
partners to accelerate the identified priorities through the product life cycle, including active engagement with industry and regulators to optimize approaches to investigate new antibiotics.
PADO exercises have also been completed for Schistosomiasis, Human African trypanosomiasis, Visceral leishmaniasis and scabies/onchocerciasis, the outcomes of these exercises will be gathered in September to release the first ever PADO list for neglected tropical diseases.
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Updates to the Essential Medicines List for Children
The findings of our collaborative project undertaken with support by the Bill and Melinda Gates Foundation on the missing paediatric formulations were presented during a virtual consultation meeting with international experts in paediatric medications and other stakeholders convened by the WHO Essential Medicines team in November 2022.
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One of the aims of this consultation was to identify suboptimal formulations that should be removed from the EMLc and to identify formulations used in countries that may be valuable additions to the EMLc. The output was a submission to the April 2023 meeting of the WHO Expert Committee on Selection and Use of Essential Medicines as part of the biennial update of the WHO Model Lists, proposing changes to the list accordingly. As a result, suboptimal or unavailable formulations of 17 medicines were proposed for removal, and new, age-appropriate formulations of 45 medicines were proposed for addition. The Expert Committee’s recommendations and updated EMLc are available here. Click here to read a paper published by GAP-f on the paediatric medicine issues and gaps from healthcare workers point of view.
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GAP-f @ World Health Assembly 76
On 24 May, DNDi, EGPAF and the MPP hosted a World Health Assembly side event on behalf of the GAP-f network which focused on strategies and partnerships to address paediatric treatment gaps and on reviving 2016 World Health Assembly Resolution 69.20 on ‘Promoting innovation and access to quality, safe, efficacious and affordable medicines for children.’ Speakers including those representing Malaysia and Africa CDC reflected on Barriers and opportunities to accelerate introduction and roll out of paediatric drug formulations. A rich panel comprising of panelists from the WHO Foundation, Access to Medicines Foundation, Penta, Global Health Technologies Coalition and the Pan African Treatment Action movement discussed the
fragmented landscape of paediatric drug innovation and access. The recording from the event can be found here.
‘I have never met anyone who’s against children, but people have to be constantly reminded to include them. Those who sign off budgets and priorities: ask the question what does this do for kids?’
Chip Lyons’s closing remarks at the WHA side-event, President & CEO, Elizabeth Glaser Pediatric AIDS Foundation
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GAP-f Private Sector Entities Dialogue
GAP-f’s private sector dialogue was held on 6th June 2023 and featured three unique breakout sessions which focused on specific themes identified across the product life cycle. The three sessions focused on challenges and opportunities in Platform Clinical Trials, Technologies Innovation Hub: Oral Films and Small Volume Procurement: Challenges & Way Forward.
Sessions were co-facilitated by GAP-f partners and industry representatives and gave us a chance to actively solicit industry input and reflections on key areas of GAP-f work.
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GAP-f Annual Network Meeting
GAP-f’s first Annual Network meeting was held on June 21 and provided a unique opportunity for the GAP-f community to learn about the progress made and exchange inspiring ideas. Discussions were held in three thematic sessions framed around GAP-f’s technical working group areas of focus and speakers included representatives from IAVI, PATH and WHO. The panel on clinical research discussed how without a change in approach for overcoming delays for studying therapies in children, new innovative treatment options could already be obsolete when they reach children. On product development, it was discussed how early and regular engagement throughout the life cycle, in particular with regulators is essential for awareness and
alignment on development plans and requirements. On product access and treatment delivery, the topic of discussion was delivering paediatric medicines to populations in small and fragmented markets. It was agreed that key elements to support effective pooled procurement include strong coordination among stakeholders.
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Launch of Paediatric ALD (ABACAVIR / LAMIVUDINE / DOLUTEGRAVIR) FDC Introduction and rollout planning considerations for national programmes
GAP-f partners launched a brief in June 2023 to inform the transition from pDTG + pABC/3TC to the new fixed-dose combination (FDC) dispersible tablet of paediatric ABC/3TC/DTG 60/30/5 mg (pALD) which will provide the regimen in one convenient tablet. Country programmes should begin to plan for generic pALD introduction, ensuring that they are not overstocked with pDTG and pABC/3TC. The GAP-f pDTG Task Team has put forth some considerations for national HIV programmes, implementing partners, and service providers. The document is available in English, with French, Kiswahili, Portuguese and Spanish translations. Please share with colleagues working with national HIV programmes.
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PARTNERS BOARD*
*news and updates from WHO technical departments and GAP-f members
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WHO Global TB programme publishes information notes on the use of bedaquiline and delamanid in children and adolescents with drug-resistant tuberculosis
WHO has released two information notes with practical guidance for clinicians and care givers, as well as community health workers, on the dosing and administration of bedaquiline and delamanid in children and adolescents with drug-resistant tuberculosis. The information notes complement the updated WHO guidelines and operational
handbook on the management of TB in children and adolescents released in 2022.
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World Health Assembly calls for improvements to clinical trials
The World Health Assembly noted the need to advance well-designed and well-implemented clinical trials in a resolution in 2022 (WHA 75.8). There is now an opportunity for identification of shifts needed to better position clinical trials to generate high quality evidence both in normal times as well as pivoting to emergencies. WHO is calling attention to a planned public consultation on the draft guidance on best practices for clinical trials, developed in response to WHA 75.8. Click here to read the supplementary report on implementing WHA resolution 75.8 on strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.
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High-Level Dialogue to Assess Progress on and Intensify Commitment To Scaling Up Prevention, Diagnosis and Treatment of Paediatric HIV and TB December 2022, Vatican City State
The High-Level Dialogue convened between 5th and 7th December 2022, provided an opportunity for stakeholders to build on previous similar consultations on ending paediatric HIV and TB, as well as assessing progress on the commitments made as part of the November 2017, December 2018, November 2020 Pediatric HIV & TB Rome Action Plans. The Dialogue was also an opportunity to adopt specific commitments and present research considerations for advancing R&D and registration of HIV and TB medicines for pregnant and breastfeeding women. The report can be accessed here.
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Medicines Patent Pool expands quarterly reported information on progress of HIV priority paediatric medicines
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As committed at the Vatican in December 2022, MPP expanded its quarterly reported information on the progress of HIV priority paediatric drug formulations (namely, pDTG and pALD). This expanded information, now including registration status and supply volumes disaggregated by country, and which is obtained from MPP licensees, is now available as a downloadable Excel document, from its website at: https://medicinespatentpool.org/what-we-do/addressing-childrens-needs.
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EUPFI upcoming conference
The European Paediatric Formulation Initiative (EuPFI) annual conference, EuPFI2023, will take place from 19th - 21st September 2023 in Glasgow, Scotland. The EuPFI Conference is an event dedicated to formulating better medicines for children. Please register here and more information can be found here.
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Penta brighter future award
Fondazione Penta ETS intends to award seven prestigious international prizes to recognize and celebrate champions going the extra mile to improve the health outcomes of children and pregnant people living with infectious diseases globally. Click here for more information on the Penta brighter future award.
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