As the work undertaken in our first collaboration with research funded by the Bill and Melinda Gates Foundation (BMGF) on essential medicines is nearing completion, we will host an expert group on November 28th and 29th. Here we will review the work accomplished so far and ensure that the best practices and lessons learned feed into the upcoming revision of the Essential Medicines List for children (EMLc) as well as future PAediatric Drug Optimization (PADO) processes across the spectrum of essential medicines.

This work is also the launching pad for a new phase of collaboration with the BMGF where WHO, CHAI, and other GAP-f partners will expand their collective efforts to assess the appropriateness of formulations included in the essential medicines list, enable prioritization across the disease spectrum, and prompt matching of new technologies to address paediatric medicine delivery gaps.

Save the date! Upcoming GAP-f webinar

Innovation to Overcome Challenges in Paediatric Formulations Development

Join us for our last GAP-f #BetterMeds4Kids webinar of 2022 on 22 November, 1600 CET/1000 EST/2030 IST (90 minute session).

This webinar will discuss recent successful examples of paediatric formulations developments and collaborative models, including the regulators perspectives on managing paediatric challenges.

Register here for the event.

At the 14th annual conference of the EUropean Paediatric Formulation initiative, held in Rome (Italy), from 20-22 September 2022, Dr. Tiziana Masini presented the GAP-f project on assessing the age-appropriateness of formulations listed on the WHO Model List of Essential Medicines for children, with a focus on antibiotics and medicines for neglected tropical diseases. Based on this analysis, recommendations for proposed changes to the EMLc will be submitted for consideration by the next EML Expert Committee (April 2023). Formulation gaps identified during the project, will be taken forward and addressed by 
GAP-f, including as part of PADO exercises.

The first study evaluating the fixed dose combination of abacavir/lamivudine/lopinavir/ritonavir granules and has been published.
[J Acquir Immune Defic Syndr 2022 Mar 1;89(3):324-331].

The second study evaluating abacavir/lamivudine dispersible tablets and lopinavir/ritonavir granules was completed in September 2022; the results will be presented at the CROI conference in 2023. The latest study, PETITE-DTG, is assessing the pediatric dispersible dolutegravir tablet and has started enrollment in September 2023.

This information, including country lists per category and data presented in the maps, is publicly available on the Medicines Patent Pool (MPP) website’s interactive access to medicines tracker, here.

WHO Good Reliance Practices, OpenWHO Course

Leveraging the work of other regulators or trusted sources is strongly encouraged and can allow to overcome some of the regulatory challenges, including for development and registration of paediatric medicines.

Please share this course widely as it is on open access.

EVA network 6th regional seminar on paediatric HIV in West and Central Africa on 21-23 September 2022, in Cotonou, Benin

The main objectives were to increase diagnostics, optimize ARV treatment, and improve the quality of life of children living with HIV.

The 3-day seminar brought together 95 participants from 13 countries in West and Central Africa. Representatives of the national HIV programs, community workers, healthcare workers, and regional and international partners such as WHO, UNAIDS, Global Fund, Expertise France, CHAI, EGPAF, DNDi, and SOLTHIS, all joined to discuss the specific challenges and identify current needs and potential solutions in the region.

The identification of HIV-infected children, as well as monitoring and maintaining them on treatment, are major challenges across all countries of the region. Being able to share experiences and engage in open dialogue helps to strengthen the practical knowledge base and overall operational capacity of different countries.

Along with establishing a better collaboration between community actors and health care providers and mobilizing resources needed to achieve these acceleration plans, this seminar highlighted the urgent need to prioritize and accelerate the access to new optimized treatments for children living with HIV where only 35% have access to antiretroviral treatment.

Antiretroviral therapy (ART) coverage for infants and children still lags behind treatment coverage for adults. Increased efforts are needed at global and national levels to support national HIV programs in achieving their goals of ensuring that HIV-exposed infants and children are diagnosed early, placed on optimal ART regimens and achieve viral load suppression.

To do this, national HIV programs must quantify, procure, and supply the full range of optimal paediatric ARVs. This includes first-, second-, and third-line treatments, as well as alternative and backbone products needed to deliver WHO-recommended ART for children 0 to 15 years of age and as they grow and transition from one treatment regimen to another. Can now be found online here.

This guidance focused on quantification and supply planning will help to ensure that children living with HIV adhere to their treatment, achieve viral suppression, and live healthy and productive lives.

22 November 2022, 15:00 CET/ 09:00 EST

Neonatal sepsis is a leading cause of neonates and infants mortality that is worsening due to antibiotic resistance. There is an urgent need to develop novel antibiotic treatments to keep pace with rising rates of resistance and to ensure appropriate access and stewardship to these treatments around the world. Join us for a webinar, timed for World Antimicrobial Awareness Week (WAAW), to highlight GARDP’s work in the field of children’s antibiotics as well as raise the need for more Research and Development into drug-resistant neonatal sepsis, stewardship and access to treatments.

Register here for the event.