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.
- WHO Evidence Considerations for Vaccine Policy Development (Draft) aims to provide early information on the data and evidence that is likely required to support WHO policy recommendations.
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.
EVENTS AND TRAININGS
Clinical Investigator Training Course
FDA Small Business and Industry Assistance
December 6 - 7, 2003
This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products.