Dear All

Despite the challenges of the COVID pandemic, it is vital that we do not lose momentum in addressing the full spectrum of global health issues. GAP-f has continued to push forward the agenda for better medicines for children and we have spent the last few months strengthening and expanding our community of members, supporters and thought partners and we have many of you to thank for your support. Our goals remain ambitious and we are committed to making a positive impact on the lives of children.

Here, we are sharing some snapshots of our work from the past few months, to show you what has been keeping us and our members busy. Read about us, follow us, question us – we are thrilled and humbled to be working together with you in closing the gap in paediatric medicines.

New organizations have joined the GAP-f Network

We are pleased to note that we have grown and are now a network of thirty organisations. Here is the list of our current members.

GAP-f has a new webpage on WHO website

GAP-f has unveiled a new webpage, hosted on the Initiative section of WHO’s website, where we will continue to provide updates and information. Please do visit us there.

#BetterDrugs4Kids webinar series launched

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GAP-f’s new quarterly webinar series, #BetterDrugs4Kids, features deep dives on paediatric drug prioritization, evaluation, development, and delivery, and promotes discussions to close the paediatric treatment gaps.

We kicked off the series with a webinar entitled “Best practices in clinical research for the development of paediatric formulations,” organized and led by our Clinical Research Working Group. The webinar provided an opportunity to reflect on concrete innovations for optimizing efforts and more rapidly generating the evidence needed to inform the development and most appropriate use of new paediatric formulations. The webinar recording can be accessed here.

Our next webinar, led by the GAP-f’s Product Development and Regulatory Affairs Working Group is scheduled for June 16th. We hope to see you there. Please register here , and we will send more details in due course.

WHO publishes Good Reliance Practices and Good Regulatory Practices documents

Reliance approaches are essential to facilitate the regulatory pathways for paediatric medicines and the Good Regulatory Practices provide advice to establish and implement sound, affordable, efficient regulation of medical products. The documents can be found as Annex 10 and 11 respectively in the 55th WHO Expert Committee on Specifications for Pharmaceutical Preparations.

WHO Paediatric Regulatory Network (PRN) holds annual meeting

The meeting, held 14-15 April, convened regulators from 22 countries and other organizations to share regulatory information and achievements in the field of paediatric medicines. The group discussed regulatory updates from the different regions; results of a survey conducted between members on the paediatric regulatory landscapes, challenges and solutions; optimizing reliance and work-sharing between members; experience from WHO-prequalification and WHO Collaborative Registration Procedure for paediatric medicines; and regulatory activities for Covid-19. More information on the PRN can be accessed here.

GAP-f@ CROI 2021

GAP-f’s Clinical Research Working Group of GAP-f performed a population pharmacokinetic analysis to determine the lowest body weight for which children could be treated using available DCV formulations (60 and 30 mg). The possibility to use currently available adult formulations of DCV with SOF could help programmes accelerate expansion of HCV treatment for children globally. This data was recently presented at CROI 2021 and can be accessed here.

The PADO-TB interim review report now available

The Global Tuberculosis Programme at WHO recently published the report of the Paediatric Antituberculosis Drug Optimization (PADO-TB) interim review meeting. The report summarizes the discussions and decisions from the PADO-TB meeting held in September 2020. In particular, meeting participants agreed to prioritize the development of a child-friendly rifapentine formulation (150 mg scored dispersible tablet) that is flexible, can serve multiple indications (e.g. for TB prevention and possibly for TB treatment if recommended for all age groups in the future) and can allow dosing across age groups. PADO-TB meetings provide a forum for clinicians, researchers, financial and technical partners and other relevant key stakeholders to work together and ensure that priority optimal paediatric formulations of TB medicines are investigated, developed and made available to children in a timely manner.

Partners Board

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Paediatric HIV partners launch the new Optimal Formulary and Limited Use List

The sixth edition of 2021 Optimal Formulary and Limited Use List For Antiretroviral Drugs for Children was launched on April 6th.

The Optimal Formulary and Limited- use list has been published since 2011 and has provided clear guidance to country programmes, procurement entities and funding agencies on the essential antiretroviral therapy (ART) dosage forms for children needed to deliver WHO-recommended ART regimens to neonates and children for all lines of treatment. The policy brief , which was launched during a webinar , can be accessed here.

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GAP-f will support the Unitaid agility fund, UnitaidExplore, during the development of their finalists for funding

The valuable support will enable UnitaidExplore to engage with a new technology partner in child-friendly formulations, by contributing expertise to identify and select the best-suited API for their platform technology, with the highest expected impact.

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EGPAF’s Brief on Accelerating Access to Optimal Child-Friendly Antiretroviral Formulations for Children Living with HIV: Lessons Learned from Eight Sub-Saharan African Countries shares key lessons learned from project implementation across the eight countries in order to guide the rapid uptake of new paediatric ARV formulations in the future. It includes key barriers to rapid, quality, and sustainable transition to new paediatric formulations and actions taken to overcome those barriers. In addition to summarizing the lessons learned, it also proposes recommendations to inform future transitions to optimal paediatric ARV formulations.

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Watch Dr Rachel Musoke , a paediatrician working at Nyumbani Children’s home in Kenya as she shares her experiences as well as hopes for the future for paediatric HIV treatment. Hear too from Jacque Wambui’s and Jerop Limo’s who both live with HIV as they speak on why better paediatric options are still so important.

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DNDI have launched their 2021-2028 strategy and children are at the forefront of the work they plan to undertake. We look forward to working together in realizing their strategy.

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PATH and Queen’s University Belfast launched a collaborative effort to develop a microarray patch (MAP), also known as microneedle patch, for long-acting delivery of ARVs for children. This project is funded by the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Allergy And Infectious Diseases, and includes partnerships with the University of Liverpool and the Centers for Disease Control and Prevention. It builds upon PATH’s ongoing work developing MAPs for HIV PrEP and advancing MAPs for critical public health needs through their MAP Center of Excellence. The aim is to develop a MAP containing a long-acting ARV for paediatric populations, with a focus on the needs of the youngest age groups.

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MMV’s partner S Kant has received WHO prequalification for its protective medicine for children. Read here to learn more about Supyra® becoming the second seasonal malaria chemoprevention medicine to be prequalified.

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The Access to Medicines Foundation released a publication on Closing gaps in access to medicine for children: how R&D and delivery efforts can be ramped up. The analysis sheds light on a number of game-changing new medicines that could dramatically improve the health of children, provided they reach the patients that need them most. The analysis also considers the immediate opportunities for companies, governments and other stakeholders to accelerate the speed at which new products can reach children in low-and middle-income countries. The findings are based on data collected for the 2021 Access to Medicine Index.

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