Stimulating development of the most needed formulations

7 March 2016 | ILF/CIPHER Thematic Roundtable on Paediatric ARVs, Geneva, Switzerland (By invitation only)

The global community has identified priorities for future R&D for paediatric ARV formulations through the Paediatric ARV Drug Optimization (PADO) meetings; however, there are many challenges in making these formulations available. Although coordinated procurement efforts have been successful in reducing market fragmentation, the paediatric market is small compared with the adult market, and manufacturers do not have incentives to develop these priority paediatric formulations. Existing regulatory frameworks promote development of paediatric formulations, but implementation of those frameworks may have resulted in inefficient allocation of resources for paediatric R&D. In addition, success in preventing mother-to-child transmission has reduced the number of new HIV infections, making it increasingly challenging to conduct robust clinical trials to assess efficacy, safety and acceptability of new paediatric drugs and fixed-dose combinations across the age spectrum.

For these reasons, alternative financing mechanisms must be explored to ensure availability of the best treatment for infants and children living with HIV in the future. These should build on existing regulatory processes, optimize the investment in paediatric ARVs, and enable a more sustainable development of prioritized products. This requires promoting open dialogue between manufacturers and key stakeholders, such as policy makers, research networks and regulatory agencies.

The main objectives for this discussion were therefore to:

  • Inform attendees from different backgrounds about the gaps between available and most needed paediatric ARV formulations
  • Share information on some existing innovative funding mechanisms and partnerships to support collaborative research and development between the public and private sectors
  • Brainstorm pragmatic approaches to addressing challenges for the rapid development of the most needed paediatric ARV formulations.


Meeting material

  • Related documents
  • Presentations

Welcome and roundtable introduction
Marissa Vicari, International AIDS Society, Switzerland - Manager, CIPHER and Sébastien Morin International AIDS Society, Switzerland - Research Officer, ILF

Presentation

Existing and most needed paediatric ARV formulations
Martina Penazzato, WHO, Switzerland - CIPHER STAC

Presentation

Existing innovative models of collaboration

Presentation

  • DNDi/Cipla Collaboration
    Denis Broun, Cipla - ILF AG member and Sharadd Jain, Cipla - ILF AG member
  • Antiretroviral Pregnancy Registry
    Vani Vannappagari, ViiV Healthcare
    Presentation
  • HIV Cure Initiative
    James Rooney, Gilead Sciences - ILF AG member
    Presentation
  • Critical Path to TB Drug Regimens
    Marco Schito, CPTR
    Presentation
  • Medicines for Malaria Venture
    Andrea Lucard, MMV
    Presentation

A proposal to fast track the development of the most needed paediatric ARVs
Sébastien Morin International AIDS Society, Switzerland - Research Officer, ILF

Presentation

Roundtable discussion: Fast tracking the development of the most needed paediatric ARV formulations
Carmen Pérez Casas, UNITAID

Presentation

Summary and closing comments
Marissa Vicari, International AIDS Society, Switzerland - Manager, CIPHER and Sébastien Morin International AIDS Society, Switzerland - Research Officer, ILF

Presentation