By David Jamieson
As we have discussed in news blogs last year, limited treatment options and sub-optimal formulations have contributed to poor adherence and outcomes for children living with HIV. To improve coordination in tackling the barriers to research and development that remain, major global players are developing an initiative called the Global Accelerator for Paediatric Formulations (to be known as GAP-f), working to build consensus and define the working group’s structure. Formal launch is planned for later this year.
Figure 1 below shows how the GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most-needed drugs and formulations for children.
Figure 1. The GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children. SRAs: stringent regulatory authorities. NRAs: national regulatory authorities (in high-burden countries). Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.
In November 2017, at a meeting convened by His Eminence Peter Kodwo Appiah Cardinal Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, key principles of the GAP-f set the basis for commitments to be known as the Rome Action Plan, which promote three key principles:
- Focusing on priority paediatric drugs and formulations;
- Accelerating development, review, and introduction of paediatric formulations; and
- Collaborating to expedite the development and introduction of paediatric products.
Figure 2 below shows how these principles align with the foundations of GAP-f to address challenges in paediatric drug formulation development.
Figure 2. The GAP-f represents an opportunity to address challenges in paediatric drug formulation development. Challenges are grouped around three areas: dependence on adult drug development, paediatric formulation requirements, and paediatric ARV market. Progress to date in addressing these challenges is depicted along a funnel originating from precursor mechanisms (the existing initiatives that are unified under the GAP-f) and leading up to the GAP-f collaborative model. Legal framework challenges are placed outside of the funnel because of the limited influence of the GAP-f to directly address these. Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.
The team behind the GAP-f is an evolving collaboration between a number of partner organizations, including:
- Clinton Health Access Initiative (CHAI)
- Drugs for Neglected Diseases initiative (DNDi)
- Elizabeth Glaser Pediatric AIDS Foundation (EGPAF)
- Global Fund to Fight AIDS, Tuberculosis and Malaria
- ICAP at Columbia University’s Mailman School of Public Health
- International AIDS Society (IAS, through its Collaborative Initiative for Paediatric HIV Education and Research [CIPHER] and Industry Liaison Forum [ILF])
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT)
- Medicines Patent Pool (MPP)
- Paediatric European Network for treatment of AIDS (PENTA)
- United Nations Children’s Fund (UNICEF)
- Unitaid
- U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)
- World Health Organization (WHO)
is committed to supporting initiatives that will improve the position of children living with HIV, and has supplied paediatric ARVs to many countries. Wesley Kreft, PFSCM’s Director of Global Supply Chain, currently serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.