Global Accelerator for Paediatric Formulations

Mar 28, 2017 - GAP-f Partners ... build on the experience of PHTI partners and be hosted by ... Exploring favourable options for the genesis of the Global.
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The Global Accelerator for Paediatric Formulations (GAPf): Updated framework for collaboration GAP-f Partners Geneva March 28th, 2017

The Global accelerator for Paediatric formulations This is NOT a new initiative! It is a critical component of the global efforts to reach super fast-track targets for children and adolescents (AIDS Free) The Global accelerator is a collaboration framework supported by an innovative financing mechanisms to fast track development of paediatric formulations This collaboration framework builds on existing efforts and aims to promote a faster, more efficient and more focused approach to paediatric formulation development.

Developing and delivering paediatric formulations through collaborative and coordinated action PADO

PROGRAMS

Priority formulations are reliably supplied to countries

Key formulations are prioritised in the context of a public health approach PAWG

Drug optimization PHTI

PAPWG

Priority formulations are procured via a pooled mechanism

IATT

Technical/research work is undertaken to support development of the priority formulations

Priority formulations are included in optimal formulary for selection

Developing and delivering paediatric formulations through collaborative and coordinated action Clinical work Development and introduction

PADO

PROGRAMS

Priority formulations are reliably supplied to countries

Key formulations are prioritised in the context of a public health approach PAWG

Drug optimization PHTI

PAPWG

Priority formulations are procured via a pooled mechanism

IATT

Technical/research work is undertaken to support development of the priority formulations

Priority formulations are included in optimal formulary for selection

Global Accelerator helps us to simplify Prioritisation (PADO/PAWG)

Development and introduction of priority products

Global Accelerator helps us to simplify Development and introduction of priority products

Prioritisation (PADO/PAWG)

UPSTREAM

Development

GAPf

Regulatory (NRAs)

DOWNSTREAM

Introducti on

Research

Regulatory (SRAs)

Procurement

Proposed staged approach: GAPf development and implementation

1. Activities that require little or no additional funding, but advance the Global Accelerator agenda.

2. Global Accelerator will leverage existing investments,

build on the experience of PHTI partners and be hosted by an organization to be determined .

3. Full development of the Global Accelerator

with broad focus on paediatric formulation to be included in existing PPP or as an independent entity. (Pending successful completion of stage 1 and 2)

Proposed recommendations by FDA/EMA to Innovators of ARVs • Engage with WHO PAWG at early stage • Use weight-based dosing in designing paediatric pharmacokinetic (PK) and safety studies. • Include adolescents in initial registrational adult efficacy trials or in parallel with adult studies. • For new drugs in development, begin paeds formulation as soon as there is evidence of potential public Ongoing health benefit for people living with HIV. conversation • Enroll all ages/weight bands concurrently (>4 weeks) with SRAs and other • Ensure acceptability and palatability data key • Initial PSP/PIP submission can be less detailed and regulatory process for subsequent revisions can be simplified agencies and streamlined,

Revised Role and Membership for PAWG • To be the a reference group to provide overall technical advice (clinical/PK/programmatic) to drug and formulation development • To have a formal role in advising manufacturers on the development of their PIPs/PSPs •