WGNV recognizes the challenges in translating concepts for novel TB vaccines into potential products. To help address this challenge, WGNV has compiled several resources to provide information about product development and opportunities for technical support.
- TB Vaccine Development Pathway developed by IAVI and TBVI, is an online tool that provides a structured development path and gating criteria for TB vaccine candidates. It includes considerations for target populations, vaccine platforms, and market, access and implementation, as well as guidance for planning and operating community engagement activities.
- WHO Preferred Product Characteristics for New Tuberculosis Vaccine presents WHO preferences for new tuberculosis vaccines, driven by the high medical need for contribution to the fight against TB, in alignment with the End TB strategy.
TB Vaccine Product Development Consultative Services
The Bill & Melinda Gates Foundation has recently made pilot grants to two well-established and knowledgeable not-for-profit TB vaccine development organizations - IAVI and TBVI - to provide consultative services to investigators who have novel TB vaccine concepts or candidates but little direct product development experience These consulting services are tailored for individual PIs to discuss and advise on their specific product development needs.
Areas of consultative advice include:
- Product development planning, including development of Product Development Plan and Target Product Profile and provision of tools for monitoring objectives vs. deliverables
- Regulatory strategy and related findings, e.g. pre-IND, IND (FDA, EMA, and LMICs).
- Requirements regarding and design of preclinical strategies, e.g. toxicology.
- How to identify and manage manufacturing partners for process development, clinical manufacture, and distribution of clinical materials.
- Clinical development planning.
- Adherence to GXP requirements.
- Quality assurance across entire process.
If you currently have a novel TB vaccine concept or candidate and would like to access these expert consultative services within the next few months, please contact the CTVD Alliance Manager