Fast tracking development of priority ARV formulations
16 July 2016 | CTA/ILF/CIPHER Thematic Roundtable on Paediatric ARVs, Durban, South Africa (By invitation only)

The global community has identified priorities for future development of paediatric ARV formulations through the Paediatric ARV Drug Optimization (PADO) consultations; however, there are many challenges to making these formulations available. Existing regulatory frameworks promote development of paediatric formulations, but implementation of those frameworks has been slow and sometimes inefficient. To help optimise global resources and efforts towards developing the most needed paediatric ARVs formulations, alternative models of collaborations and innovative financing mechanisms which build upon existing regulatory processes, optimize the investments in paediatric ARVs and enable a more sustainable development of prioritized products need to be explored. This requires promoting an open dialogue between key stakeholders such as drug manufacturers, policy makers, research networks, donors and regulatory agencies.

This meeting, convened by the Global Pediatric Antiretroviral Commitment-to-Action (CTA) and the International AIDS Society’s (IAS) Industry Liaison Forum (ILF) and Collaborative Initiative for Paediatric HIV Education and Research (CIPHER), followed up from the ILF/CIPHER Thematic Roundtable on Paediatric ARVs: Stimulating development of the most needed formulations, which took place on 7 March 2016 in Geneva, Switzerland. It also built upon the political commitment resulting from a high level dialogue on access to HIV testing and treatment which was convened by The Pontifical Council for Justice and Peace, UNAIDS, PEPFAR, and Caritas Internationalis in April 2016, as well as upon the ongoing work conducted on paediatric ARVs by the Pediatric HIV Treatment Initiative (PHTI), a partner of the CTA.

The set-up of the meeting was such that an open and interactive dialogue was promoted and supported to discuss opportunities for collaboration and develop a shared vision for making paediatric formulations suitable for low- and middle-income countries more quickly available.



Meeting material

  • Related documents
  • Presentations
  • Multimedia

Welcome
Sébastien Morin International AIDS Society, Switzerland - Research Officer, ILF

Presentation

Opening remarks
Gottfried Hirnschall, WHO, Switzerland and Linda-Gail Bekker, Desmond Tutu HIV Centre, South Africa - IAS President

Presentation

Framing the rationale for a new mechanism to fast track development of the most needed paediatric ARVs formulations
Martina Penazzato, WHO, Switzerland

Presentation

Roundtable discussions

  • Roundtable discussion I: Fast tracking the approval of new drugs
    Facilitator: Linda Lewis, CHAI, United States
  • Roundtable discussion II: Fast tracking the development of priority formulations
    Facilitator: George Siberry, PEPFAR, United States
  • Roundtable discussion III: Funding a global accelerator for paediatric formulations
    Facilitator: Jennifer Cohn, EGPAF, United States

Presentation

Summary and closing comments
Greg Perry, MPP, Switzerland and Marissa Vicari International AIDS Society, Switzerland - Manager, CIPHER

Presentation

Fast-tracking development of paediatric ARVs
Martina Penazzato, WHO, Switzerland