ISSUES IN PRODUCT DEVELOPMENT
WGNV recognizes the challenges in translating concepts for novel TB vaccines into potential products. To help address this, WGNV has compiled several resources to provide information about product development and opportunities for technical support.
Resources
TB Vaccine Development Pathway
TBVI, IAVI, Global TB Vaccine Partnership (GTBVP) (2019)
Online tool providing structured development path and gating criteria for TB vaccine candidates, with considerations for target populations, vaccine platforms, market access, implementation, and community engagement.
Preferred Product Characteristics for New TB Vaccines
WHO (2018)
Presents WHO preferences for new TB vaccines, driven by the high medical need for contribution to the fight against TB, in alignment with the End TB strategy.
Evidence Considerations for Vaccine Policy (ECVP) framework
WHO (2022)
A novel kind of guidance for vaccine development stakeholders that aims to provide early information on the data and evidence that is likely to be required to support WHO policy recommendations.
Product Development Plan for a Generic Prophylactic Vaccine For Infectious Diseases
NIAD (2023)
The information provided in this guide is intended to provide an overview for the development of a vaccine candidate to help facilitate a suitable and successful regulatory submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) that will allow for initiation of human clinical trials. This guide is intended for development through Phase 1 human clinical trial testing.
Learn more about TB vaccine R&D, the state of the field, and discover key resources in the our resource pages!
TECHNICAL SUPPORT
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.
Vaccine Development Services
The National Institute for Allergy and Infectious Diseases, US National Institutes of Health (NIAID) offers a collection of preclinical services to support the development of vaccines intended for use in investigation, control, prevention, and treatment of a wide range of infectious agents, including for tuberculosis. This program offers a number of support services for vaccine testing and manufacturing, and is available to investigators in academia, a not-for profit organization, industry, or government with appropriate preliminary data to support advancing the product to the requested stage of the product development pathway.
Click here to learn more about these services.