The Consortium operates through an innovative approach that engages new partners as needed. Beyond the partners contributing expertise, know-how and resources, the Consortium consults international academics, experts from endemic countries, funding agencies, the WHO and non-governmental organizations.
To ensure rapid development of the new pediatric praziquantel formulation, our strategy comprises two arms:
The Consortium builds a sustainable partnership by:
- Working with credible and experienced partners
- Using an R&D operating model that allows new partners to join as needed
- Performing a regular gap analysis to identify the need for additional expertise, resources and/or funding and pro-actively identify future partners or funding opportunities
The Consortium pro-actively promotes dialogue at all stakeholder levels to help ensure project involvement and support through:
- Continuous and tailored communication of the rationale and background of the project with key stakeholders
- Regular consultation of pharmaceutical, (non-)clinical, and regulatory experts in the field of pediatric medicine and schistosomiasis.
- Early dialogue with relevant health authorities, like ANVISA, WHO PQP, FDA and EMA, to agree on the clinical development plan and achieve registration within the shortest timeframe possible.
- Early dialogue with relevant stakeholders to understand their perspective on the orally dispersible PZQ formulation with the aim to provide preschool-age children and infants in Sub-Saharan Africa and Brazil with fast access to the new formulations.
Through this multi-stakeholder approach, the Consortium continues to work on the full clinical development program, and on registration and access strategies to ensure that the future product can be made available for those young patients in need.
Learn more about our governance structure here.