Target Product Profile:
A Guidance Document
A Target Product Profile (TPP) is a strategic document that outlines the essential criteria that relate to the public health impact and suitability of a vaccine candidate. A well-designed TPP provides a structure to ensure that a vaccine development program defines relevant medical, technical and scientific information required to reach the desired outcome. It facilitates establishment of parameters for advancing and prioritizing a particular candidate in a pipeline. While TPP is extensively used in industry, researchers and developers in academia are less familiar with the need to develop a TPP or how it can benefit development of their vaccine candidates.
In 2015, the Enterprise created a guidance document on TPP for a Preventive HIV Vaccine to help familiarize researchers and developers in academia with the concept of TPP. This guide is designed as an educational workbook with step-by-step instructions and examples from already licensed vaccines. It describes the benefits and utility of a TPP and provides a valuable resource to researchers even at the early stages of HIV vaccine development. In October 2016, the 2nd Edition of the guide was released, which now includes examples of attributes taken from a real-world TPPs for two infectious diseases: Ebola and Zika, as well as a sample TPP for a hypothetical HIV vaccine candidate. With release of the new version of the guide, the Enterprise aims to promote a wider adoption of a TPP as a tool for planning and guiding HIV vaccine research and development.
The Guide Includes:
- What a TPP is and why you need it
- How to develop and modify a TPP
- Guiding questions and considerations to help complete each TPP attribute
- Examples from already licensed vaccines to illustrate how each TPP attribute relates to the overall objectives of the vaccine development project
- An example TPP for a preventive HIV vaccine
The Enterprise wishes to thank the many experts who provided valuable feedback on the guidance document and spent time on numerous revisions of prior drafts. Notable contributions are listed in alphabetical order: Jim Ackland (Global BioSolutions/IAVI), Mark Feinberg (IAVI), Karen Goldenthal (Independent Pharmaceuticals Professional), Jane Halpern (National Institutes of Health); Nick Jackson (Sanofi Pasteur), David Kaslow (PATH), Sanjay Phogat (Sanofi Pasteur), Jerald Sadoff (Crucell), Eddy Sayeed (IAVI), Gretchen Schieber (National Institutes of Health), Rebecca Sheets (Grimalkin Partners), Jim Tartaglia (Sanofi Pasteur), Janet White (Bill & Melinda Gates Foundation), and Vera Wolowodiuk (Nora Therapeutics).
In addition, we would like to thank Jane Halpern (National Institutes of Health) for her time and effort she spent on creating the TPP slide set.