Bringing it all together: The Global Accelerator for

Bringing it all together: The Global Accelerator for

Bringing it all together: The Global Accelerator for Paediatric Formulations (GAP-f) Slide 1 Martina Penazzato (WHO) and Paul L. Domanico (CHAI) www.gap-f.org Disclosure Relations that could be relevant for the meeting Company names Sponsorship or refund funds

None Payment or other financial remuneration None Shareholder rights None Other relations None

Reference: https://www.cgr.nl/CGR.nl/media/CGR.nl/Gedragscode/Format-of-disclosure-slide-for-speakers-at-refresher-training-meetings.pdf Slide 2 www.gap-f.org Our most vulnerable will need our help GAP-f will make an important contribution to ensure success of Sustainable Development Goal (SDG) 3: ensure healthy lives and promote wellbeing for all at all ages: o Accelerate access to the most needed paediatric formulations for HIV and other highburden infectious diseases in LMICs. o Will help reduce child mortality and end AIDS and combat other communicable diseases. The best drugs or dosage formulations are NOT AVAILABLE to treat children. o Clinical evidence is lacking to define appropriate pediatric doses.

o Pediatric formulations do not exist for most drugs. o Time to market (product development and uptake) lags adult products by over a decade! GAP-f plans to cover all infectious diseases and use lessons learned in HIV. GAP-f efforts on HIV pediatric drugs will be used as Proof of Concept. Slide 3 www.gap-f.org Slide 4 Formal collaboration across sectors to ensure accelerated development and uptake

A collaboration platform supported by an innovative financing mechanism that promotes a faster, more efficient and more focused approach to paediatric clinical and formulation development and introduction. www.gap-f.org GAP-f Objectives Establish relationships with key donors to support entire product lifecycle. Create and maintain a product portfolio that addresses treatment needs Support development of flexible and fit for purpose PIP/PSP in collaboration with innovators. Coordinate clinical research goals . Provide market analytics to support decisions across stages of program lifecycle. Design, implement, and fund product commercialization plans.

Coordinate efforts between suppliers, innovators, research networks, regulators, procurers, MOH, MOF, etc. Deploy a business model that is more efficient, sustainable, and disease agnostic. Slide 5 www.gap-f.org Slide 6 Operationalizing GAP-f PRIORITIZES & EVALUATE Scientific Advisory Board

Clinical Research DELIVER Product Access Treatment Delivery DEVELOP Business Development Product Development Regulatory Affairs www.gap-f.org Slide 7

Purpose-Built Mixed Funding model Prioritization NIH EU Unitaid Gates Industry PEPFAR Uptake

The goal is to develop an innovative but coordinated funding mechanism that leverage both public and private investments www.gap-f.org Slide 8 GAP-f is already delivering Providing guidance on how to accelerate R&D for paediatric ARVs Advocating and enabling simplification of regulatory frameworks www.gap-f.org

Slide 9 And accelerating existing work Guiding product selection aligned with Global Guidelines Supporting programmes to transition to optimal regimens www.gap-f.org Slide 10 Next Steps

A business plan will be finalized later this year. It will clearly define how we partner, make decisions, and deliver as well as propose opportunities on new funding approaches. We will continue discussions with our non-HIV partners to articulate the value of the GAP-f initiative. We will reach out to industry partners to refine our plans, secure support, and most importantly to begin work to accelerate the development of new treatment options for children. Finally, prioritization will continue based on the PADO model for HIV, and for TB and HEP by the end of the year. Stay connect and give us your feedback! www.gap-f.org

Slide 11 THANK YOU! www.gap-f.org Toolkit for research and development of paediatric antiretroviral drugs and formulations In collaboration with experts from the Paediatric Antiretroviral Working Group Available at http://www.who.int/hiv/pub/research-dev-toolkit-paediatric-arv-drug-formulation/en/ https://globalhealthtrainingcentre.tghn.org/research-toolkit-paediatric-antiretroviral-drug-and-formulation-development/

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