Challenge

The UK HIV Vaccines Consortium was supporting and coordinating the development of several new HIV vaccine candidates in academic research groups. Moving those candidates toward clinical trials meant relying on third-party providers for much of the development work, and the consortium needed expert guidance on which providers could deliver services of the quality the program required.

The services in question spanned the path from the laboratory to the clinic, including:

• Preclinical development and toxicology
• Manufacturing process development and GMP manufacturing
• Assay development and batch release
• Cold chain logistics

Academic groups often have deep scientific expertise but limited experience of selecting and working with contract research and manufacturing organizations. With several candidates progressing in parallel, the consortium also needed to understand how each candidate's supply chain would fit within its overall plan of trials.

Solution

Alacrita provided extensive advice on procuring specific vaccine services from third-party suppliers, drawing on consultants with experience of vaccine development, manufacturing, and quality.

The supply chains for a number of the candidate vaccine constructs were assessed for:

• Feasibility: whether suitable providers could deliver each service the candidate required
• Cost: the likely cost of the services needed to take each candidate forward
• Fit: how each supply chain fitted within the consortium's portfolio of planned trials

This gave the consortium an independent view of its supply options across the candidates, to inform its procurement decisions and trial planning.