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Newsletter November 2021
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Dear all,
We are pleased to share and celebrate some highlights from the past few months that have helped advance our shared agenda on better medicines for children. We have also been diligently working on GAP-f’s strategy for 2022-2024, that will take into consideration our expansion into new disease areas and cross cutting activities to shape the future of GAP-f. Stay tuned as we launch this strategy in January 2022!
On behalf of the GAP-f Network, we would like to thank you for being a part of our journey in helping close the gap in paediatric medicines.
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GAP-f Webinar Series
GAP-f’s quarterly webinar series covers a range of paediatric-focused topics that span the broad range of the network’s activities. These webinars are a vehicle to share best practices across therapeutic fields and promote innovations that can help accelerate the development of better medicines for children. A summary of the most recent webinars is as follows:
Strategies to facilitate accelerated registration of optimal paediatric medicines- June 2021.
Watch here.
Accelerating introduction and access to paediatric treatments – September 2021.
Watch here.
Targeting R&D on priority paediatric formulations to maximize health impact in children – November 2021.
Watch here.
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PAediatric Drug Optimization standard procedure launched
GAP-f recently launched the PAediatric Drug Optimization standard procedure. GAP-f’s first guidance document shows steps to undertake a paediatric drug optimization exercise and identify key priority products for research and development.
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GAP-f viewpoint on COVID-19 Published
GAP-f viewpoint entitled “Pediatric COVID-19 Therapeutics - Seizing the Right Research and Development Opportunities to Accelerate Access for Children” has now been published in the Pediatric Infectious Disease Journal – PIDJ. Click here to read more!
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Revision of the Essential Medicines List for Children
The meeting of the 23rd WHO Expert Committee on the Selection and Use of Essential Medicines took place from 21 June to 2 July 2021. The Expert Committee reviewed 88 applications to update the WHO Model List of Essential Medicines (EML) and WHO Model List of Essential Medicines for Children (EMLc). The Expert Committee evaluated the scientific evidence for the comparative effectiveness, safety and cost-effectiveness of the medicines in question and recommended the addition of 17 new medicines to the EMLc. The Committee also recommended new indications for 27 medicines already listed on the EMLc, and new formulations for 11 medicines. The recommended changes bring the total number of medicines on the EMLc to 350 from 336 in 2019. The
updated list can be found here.
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5th HIV PAediatric Drug Optimization Meeting
The HIV Department at WHO convened the 5th HIV PAediatric Drug Optimization Meeting (HIV-PADO) which was held virtually from September 28-October 15. The meeting focused on discussing new technologies and neonates, leading to the development of a new priority list, watch list, and research questions. you can learn more by listening to this webinar.
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Launch of Rapid Communication of WHO TB recommendations
WHO’s Global Tuberculosis Programme has recently issued a Rapid Communication to help national TB programmes and other stakeholders prepare for the key findings, considerations and changes related to the diagnosis, treatment and care of TB for children and adolescents, which will be introduced in the new consolidated WHO guidelines on the management of TB in children and adolescents. The guidelines and operational handbook will be published by WHO in early 2022.
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Hepatitis C guidelines
The Global Hepatitis Programme at WHO held a guidelines meeting from 18-21 October to consider the important opportunities to advance access to HCV care and treatment for children and adolescents, with the recent approval of several DAA regimens for use in younger children aged 3 to 5 years, as well as in older children and adolescents, alongside pharmacokinetic modelling work to support use of adult formulations of sofosbuvir and daclatasvir in children. The aim was to align the DAA recommendations in HCV infected adolescents and children down to 3 years and treat all above 3 years with pangenotypic DAAs recommended for adults.
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Two companies developing potentially game-changing medicine delivery mechanisms for children are the latest recipients of UnitaidExplore funding. Finnish company DelSiTech and British enterprise FluidPharma have each been awarded funding following the latest call for applications under Unitaid’s pioneering agility mechanism. The grants awarded through this call build upon Unitaid’s significant work in the field of paediatric formulations for HIV, TB and malaria treatments, and support the mission of the GAP-f network.
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The BENEFIT Kids project, funded by Unitaid and led by the Desmond Tutu TB Centre, Stellenbosch University, aims to improve access to better treatment and prevention of multidrug-resistant tuberculosis in children. The project, conducted in collaboration with the WHO and partners in South Africa, India, the Philippines, Thailand and the US including TB Alliance, UCSF, Johns Hopkins and others, was launched in 2019. Significant progress has been made. Most recently, initial results from a systematic review and individual
patient data meta-analysis of children treated for rifampicin-resistant TB contributed to new WHO guidelines for TB management in children.
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EGPAF's E2A webinar discussed practical ways that communities and caregivers can support children living with HIV in their transition to paediatric dolutegravir (pDTG): Read more here. EGPAF has also created a tool to enhance dialogue between caregivers and children to enhance adherence to treatment. The tool shows how to work with caregivers to ensure children correctly and consistently take their medication across age groups: Read more here.
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Development of paediatric ritonavir-boosted darunavir (DRV)/r, is a priority for children failing DTG-based treatment and has been listed as a PADO priority since 2013. In September 2020, in partnership with Unitaid and under the Optimal grant, CHAI launched an RFP for an incentive program to catalyze the development of paediatric DRV/r to improve access for children living with HIV. In June 2021, Laurus Labs was awarded the incentive contract as the generic development partner and is developing paediatric DRV/r 120/20 mg dispersible tablets.
This World AIDS Day, join CHAI for a webinar on Transforming HIV Treatment for Children: Early Learnings from Paediatric Dolutegravir 10mg Introduction, hosted together with Unitaid. Register here.
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Join activists, advocates, researchers, students, and scientists this World AIDS Day for the official screening of Penta's award-winning documentary, SUN & PETALS - a 12-minute story and painting about mothers and children during the early days of HIV/AIDS. Watch the documentary's trailer here.
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Participate by going to brighterfuture.capsule.video to record a wish for mothers and child survivors. It only takes one minute. Let's hear from your communities, institutions and friends how to paint a brighter future for child health research.
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Join @Penta_ID and the film participants on December 1st on Twitter Space to discuss the film, zero mother-to-child transmission strategy, and what the future holds.
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