GLOBAL ACCELERATOR FOR PAEDIATRIC FORMULATIONS (GAP-f)
Resources
Rome Action Plan
In November 2017, a High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents was convened by His Eminence Peter Kodwo Appiah Cardinal Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, with PEPFAR, UNAIDS and Caritas Internationalis, and in close collaboration with the World Council of Churches-Ecumenical Advocacy Alliance, the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) and the WHO. Key principles of the GAP-f set the basis of discussion, which led to an action plan including an impressive list of commitments from industry, regulators, UN agencies and other stakeholders.
The commitments from the Rome action plan promote three key principles:
- Focusing on priority paediatric drugs and formulations
- Accelerating development, review, and introduction of paediatric formulations
- Collaborating to expedite the development and introduction of paediatric products.
Action Plan for Scaling Up Early Diagnosis and Treatment of Children and Adolescents
17 November 2017
See the action plan here | See the action plan monitoring tracker here
High-Level Dialogue to Assess Progress and Intensify Commitment to Scaling Up Diagnosis and Treatment of Paediatric HIV
6-7 December 2018 | Pontifical Academy of Sciences (Vatican City)
See the EGPAF/WHO press release “A new push for timely diagnosis and treatment of children with HIV” here
Implementing Optimized Paediatric ARV Formulations Webinar
28 February 2020
See the webinar here
This WHO webinar, convened in collaboration with GAP-f member organizations (PENTA, CHAI, MPP, EGPAF) and GAP-f partners (DNDi, ICAP and Unicef), provides country programmes and key stakeholders with the latest information on optimal paediatric ARV formulations as well as provide an opportunity for an open dialogue regarding immediate challenges and opportunities to accelerate access to better paediatric formulations for children living with HIV.
Prioritization
PADO-TB – List of priority paediatric antituberculosis drug formulations
First Paediatric Antituberculosis Drug Optimization Meeting (PADO-TB 1)
See the PADO-TB 1 meeting report and list of prioritized paediatric antituberculosis drug formulations here
PADO-HIV 4 – Review of priority paediatric ARV formulations
Paediatric ARV Drug Optimization 4 Review
See the summary report and read about the review process here
Paediatric Drug Development Resources
ILF – Policy brief on advance procurement of paediatric drug formulations
The many challenges of developing drugs appropriately formulated for children are compounded by a series of market factors that make these efforts costly and complex, discouraging drug manufacturers – especially generic drug manufacturers – from prioritizing investments in new paediatric treatment options. This brief explores the concept of advance procurement as a method for reducing uncertainty within the paediatric ART market and spurring investment in adapted child-friendly drug formulations. Access the policy brief here.
EMA – Paediatric medicines: Overview
The European Union Paediatric Regulation enables the EMA to stimulate research into the uses of medicines in children and to overview their authorisation.
EMA – European Medicines Agency and European Commission (DG Health and Food Safety) action plan on paediatrics
This action plan takes into account the suggestions made at a multi-stakeholder workshop convened by the European Commission and the European Medicines Agency on 20 March 2018, where ways to improve the implementation of the Paediatric Regulation were discussed.
FDA – Quality attribute considerations for chewable tablets: Guidance for industry
Recommendations on critical quality attributes that should be considered when developing chewable tablets and selection of acceptance criteria that are appropriate and meaningful indicators of product performance throughout the product shelf life.
FDA – Pediatric HIV infection: Drug product development for treatment – Guidance for industry
General recommendations on the development of antiretroviral products for the treatment of HIV infection in paediatric patients (birth to younger than 17 years of age).
2018 Optimal Formulary and Limited-Use List for Paediatric ARVs
Fifth edition of the Optimal Formulary and Limited-use List supporting the transition to optimal WHO-recommended regimens for infants and children.
Presentations
Implementing Optimized Paediatric ARV Formulations Webinar
Bringing it all together: The Global Accelerator for Paediatric Formulations (GAP-f)
Accelerating the development and uptake of the most needed drug formulations for children, AIDS 2018
Penazzato & Domanico – July 2018 | Amsterdam, the Netherlands
The Global Accelerator for Paediatric Formulations (GAP-f): Accelerating the development and uptake of the most needed drug formulations for children
11th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology
Morin, Cohn, Vicari, Domanico, Lewis, Watkins, Pascual, Lee, Sugandhi, Eisenhawer, Pérez Casas, Auton, Siberry, Giaquinto, Penazzato, On behalf of GAP-f partners — March 2018 | Granada, Spain
Peer-reviewed Publications
Mind the Gap: Filling Knowledge Gaps in Paediatric and Adolescent HIV for an AIDS Free Generation
J Int AIDS Soc, 2018, 78(S1)
Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030
J Int AIDS Soc, 2018, 21(S1)
Hepatitis C virus infection in children and adolescents
Indolfi, Easterbrook, Dusheiko, El-Sayed, Jonas, Thorne, Bulterys, Siberry, Walsh, Chang, Meyers, Giaquinto, Wirth, Chan & Penazzato
The Lancet Gastroenterology & Hepatology, 2019, Published online first
Treating young children co-infected with tuberculosis and HIV
Catalysing the development and introduction of paediatric drug formulations: a new global collaborative framework for action
Penazzato, Watkins, Morin, Lewis, Pascual, Vicari, Lee, Hargreaves, Doherty & Siberry
The Lancet HIV, 2018, 5(5): 259-e264
Completion Rate and Safety of Tuberculosis Infection Treatment With Shorter Regimens
Cruz & Stark
Pediatrics, 2018, 141(2)
Challenges of using new and repurposed drugs for the treatment of multidrug-resistant tuberculosis in children
Schaaf, Garcia-Prats, McKenna & Seddon
Expert Rev Clin Pharmacol, 2018, 11(3):233-244
Shortening the decade-long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low- and middle-income countries
Penazzato, Lewis, Watkins, Prabhu, Pascual, Auton, Kreft, Morin, Vicari, Lee, Jamieson & Siberry
J Int AIDS Soc, 2018, 21(S1), e25049
Prevention and treatment of HIV infection in neonates: evidence base for existing WHO dosing recommendations and implementation considerations
Clarke, Penazzato, Capparelli, Cressey, Siberry, Sugandhi & Mirochnick, WHO Paediatric Antiretroviral Working Group
Expert Rev Clin Pharmacol, 2018, 11(1):83-93
Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies
Hume, Lewis & Nelson
J. Med. Ethics, 2017, 0: 1-4
Recommendations for Optimizing Tuberculosis Treatment: Therapeutic Drug Monitoring, Pharmacogenetics, and Nutritional Status Considerations
Choi, Jeong, Koh & Lee
Ann Lab Med, 2017, 37(2): 97-107
Prioritizing the most needed formulations to accelerate paediatric antiretroviral therapy scale-up
Penazzato, Palladino & Sugandhi, on behalf of the PADO 3 Meeting participants
Curr Opin HIV AIDS, 2017, 12:369-376
Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations
Penazzato, Gnanashanmugam, Rojo, Lallemant, Lewis, Rocchi, Saint Raymond, Ford, Hazra, Giaquinto, Belew, Gibb, & Abrams, for the PAWG
Clin Infect Dis, 2017, 64(11):1597-1603
Optimization of the strength of the efavirenz/lamivudine/abacavir fixed-dose combination for paediatric patients
Bouazza, Cressey, Foissac, Bienczak, Denti, McIlleron, Burger, Penazzato, Lallemant, Capparelli, Treluyer & Urien
J Antimicrob Chemother, 2017, 72(2):490-495
Journal Articles
Progress against HIV, malaria and TB is under threat, putting children at risk. Here’s what is needed.
Access to Medicine Foundation, 2019 June 9
Mind the Gap: Filling Knowledge Gaps in Paediatric and Adolescent HIV for an AIDS Free Generation
JAIDS, 2018, 78(S1)
Paediatric and Adolescent HIV and the Sustainable Development Goals: the road ahead to 2030
J Int AIDS Soc, 2018, 21(S1)
Online Resources
EuPFI – European Paediatric Formulation Initiative
With subgroups focused on administration devices, biopharmaceutics, taste masking/testing, age appropriateness, and excipients
Enpr-EMA – European Network of Paediatric Research at the European Medicines Agency
Network of research networks, investigators and centres with recognised expertise in performing clinical studies in childrens
GPFC – Goodman Pediatric Formulations Centre (GPFC)
Rosalind & Morris Goodman Family Pediatric Formulations Centre of the CHU Sainte-Justine
LEAP – Long-Acting / Extended Release Antiretroviral Resource Program
Portal funded by the U.S. National Institutes of Health
MAP-IT Model – Model for Assessment of Pediatric Interventions for Tuberculosis
RTI International, TB Alliance, Unitaid
PaedForm – European Paediatric Formulary
Council of Europe
PDCO – Paediatric Committee
European Medicines Agency
STEP database – Safety & Toxicity of Excipients for Paediatrics
European Paediatric Formulation Initiative
USPFI – United States Pediatric Formulation Initiative
In the context of the Best Pharmaceuticals for Children Act (BPCA) and with groups focused on scientific/technical/regulatory barriers, taste/smell/flavour, economics/partnerships, and use/application of new delivery systems
Photos
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