The GAP-f Prioritization Working Group develops and maintains a clear, high-impact drug portfolio in collaboration with subject matter experts and members from other GAP-f Working Groups. This group monitors new results from ongoing research, in conjunction with anticipated policy changes and guidelines implementation on the ground. This group:

• Supports and facilitates paediatric drug optimization processes to identify priority products, and associated target product profiles;
• Reviews and maintains an integrated, prioritized, and staged product portfolio to guide GAP-f work;
• Maintains a watching brief on various technologies and on phase I through phase III adult drug development to ensure GAP-f is engaged as early as practical;
• Facilitates research prioritization across diseases to identify and prioritize key drug optimization gaps;
• Works with the Clinical Research and the Product Development Working Groups to establish best practices related to optimal study design and streamlined regulatory processes to advance the highest priority paediatric products across the continuum of a product’s life cycle.

The Clinical Research Working Group surveys the landscape of studies related to the GAP-f portfolio and facilitates the design and implementation of missing high-quality clinical studies to inform the dosing, safety, and efficacy of new medicines for children. This group:

• Coordinates efforts to address research gaps identified by the Prioritization Working Group, formulates critical research questions, identifies the most optimal and feasible study designs and ensures rapid generation of critical evidence to support the regulatory approval and inform the use of new drugs and formulations in collaboration with disease specific expert groups;
• Provides technical support as needed to other research networks that are undertaking studies relevant to the GAP-f portfolio;
• Contributes to GAP-f efforts to coordinate dialogue with pharmaceutical companies, clinical research networks, and relevant regulatory agencies to accelerate bespoke paediatric clinical studies;
• Identifies strategic clinical trial units (CTUs) and sites to maximize enrolment capacity and ensure that clinical research and data management meet registrational standards by providing periodic training as well as capacity building;
• Works with all collaborators to ensure efforts are performed efficiently and that the various research networks work in concert while also maintaining sufficient flexibility to respond to new clinical information;
• Partners with the Product Development Working Group on discussions to support the development of fit-for-purpose PIPs and PSPs; and
• Collaborates with the Product Access and Treatment Delivery Working Group to coordinate post-marketing safety and effectiveness studies and  contribute to national pharmacovigilance efforts.

The Product Development Working Group accelerates product development, regulatory filings, and commercialization of products in the GAP-f portfolio and engages with regulatory and normative bodies to optimize regulatory pathways. This Group:

• Works together with the Product Access and Treatment Delivery Working Group to align on capacity requirements, validation plans and batch manufacture for products moving from development and into commercialization.
• Liaises with the generic companies to develop appropriate, accelerated commercialization plans based on market estimates and rollout planning received from the Product Access and Treatment Delivery WG.
• Establishes incentives to catalyze various stages of the product life cycle, including market incentives and increased visibility to collaborative partners;
• Negotiates licensing terms with innovators such as the expansion of a license even if there no new science but new demand.
• Monitors innovator progress against commitments.

The Product Access and Treatment Delivery Working Group works to ensure that the products developed are available in a timely manner to the children who need them. This is done by identifying and collaborating with relevant partners to define and implement plans to accelerate the scale up of treatment regimens of GAP‑f products and monitor their safety and effectiveness. The primary role of this working group is to ensure effective coordination across the many critical stakeholders in this work so that GAP-f focal products reach those in need of them in the fastest time possible. This Group:

• Provides demand side input into upstream development activities to ensure pipeline products are fit for purpose and optimal for use as they progress through the development cascade.
• Delivers an appropriate forecast for GAP-f focal products to inform upstream steps in development;
• Works with the Product Development and Regulatory Affairs Working Group to ensure the timing and scale of manufacturing are synchronized to procurement milestones and to identify priority countries for registration;
• Develops efficient introduction and uptake strategies for each product in the GAP‑f portfolio and align the timing of this work to the release of new guidelines and product availability;
• Maps country-by-country partners working on new product introduction and proactively identify groups for collaboration in countries where there are introduction gaps, to ensure no children are left behind;
• Develops a communication and advocacy plan to ensure buy-in and alignment on common product goals, and targeted and purposeful outreach with key stakeholders;
• Develops product adoption and uptake dashboards at global level for GAP-f focal products, starting with DTG 10mg, and use this as a model for collaborative uptake monitoring across countries;
• Collaborates with the Clinical Research Working Group to coordinate post-marketing safety and effectiveness studies as well as contribute to national pharmacovigilance and data collection and monitoring efforts; and
• Shares learnings and best practices from product introduction to support access strategies for pipeline products.