From Bench to Clinic:
A Researchers Guide to Move Candidate Vaccines into Trials
Launched by the Enterprise in October 2013, From Bench to Clinic is a webtool to help researchers most efficiently move their candidate vaccines into first-in-human trials. With a focus on the practical steps that need to be accomplished before a clinical trial can be initiated, this tool is intended to acquaint researchers, funders and advocates with the processes, costs and timelines required for the first phase of product development.
In September 2015, the Enterprise released an update to the From Bench to Clinic guide. In addition to ensuring that the general information in the webtool is accurate and up-to-date, the Enterprise worked with vaccine developers and regulatory experts to include three case studies of real world vaccine candidates and a regulatory comparison table providing an overview of the regulatory environments in different parts of the world.
The information contained in this tool is intended to provide general guidance. Details will vary widely depending on the specific candidate vaccine, the countries involved, and the resources available to investigators at their home institution. While most of the terms and concepts used are not country-specific, United States, Canadian, and European Union regulatory frameworks were employed. Investigators are advised to consult the regulatory agency in their own country for laws and regulations related to the conduct of clinical research. Failure to do so could result in potentially severe penalties for non-compliance. Investigators are also encouraged to consult with their research institutions and funders. Investigators interested in moving their product into first-in-human trials are strongly encouraged to engage experts to guide them through this process.
From Bench to Clinic is intended for all vaccine researchers interested in improving the speed at which they take candidate vaccines into Phase I trials. While the guide takes users through the HIV vaccine development pathway, the considerations, process, timelines and costs are highly relevant to the malaria, tuberculosis, human papillomavirus and other fields.
Three case studies are presented in this webtool delineating how the framework maps on the steps, costs, and timelines in the real world. The case studies are based on past HIV vaccines Phase I clinical trials conducted in the United States, United Kingdom, and Tanzania and allow the user to learn from the experiences and ‘lessons learned’ of different research teams.
The general information in the webtool describes candidates with a single product, but the case studies are all based on a heterologous prime/boost approach. As a result, parts of the roadmaps for case studies are presented in a simplified manner not reflecting the parallel activities required to manufacture and test more than one component needed for priming and boosting. Such instances are described in the case studies and respective timelines and costs are displayed as approximate totals.
Regulatory Comparison Table
The newly added Regulatory Comparison Table facilitates the review of differences in regulatory approval processes for Phase I trials across different countries. It offers a high level overview of the key differences of the regulatory environments in different parts of the world and allows users who are unfamiliar with the process to easily identify areas that require a more careful assessment.
Countries that are presented in this table are the United States, Canada, United Kingdom, and South Africa, and may include additional countries in the future.
Let us Know What you Think
We welcome your comments, ideas and questions. Send us an email to email@example.com and tell us what you think.
From Bench to Clinic is part of the Enterprise’s Timely Topics in HIV Vaccines initiative, a new strategy series to identify and respond to unresolved and emerging priority issues in the field. Roger Tatoud of Imperial College London, proposed the topic and worked closely with Eddy Sayeed of IAVI and others to make it a reality. The Enterprise wishes to thank the following stakeholders for their contributions: Pervin Anklesaria, the Bill & Melinda Gates Foundation, Jim Ackland, Global BioSolutions/IAVI, Song Ding, EuroVacc Foundation, Debbie Douglas, Alliance Coordinating Office, Phil Gomez, PwC, Jane Halpern, DAIDS, National Institutes of Health, Greg Hammond, Canadian HIV Vaccine Initiative, Tom Hassell, IAVI, Dietmar Katinger, Polymun Scientific, Shan Lu, University of Massachusetts, Anita Ng, Canadian HIV Vaccine Initiative, Michael Pensiero, DAIDS, National Institutes of Health, Stuart Shapiro, DAIDS, National Institutes of Health, Dean Smith, Health Canada, Jim Tartaglia, Sanofi Pasteur, Carol Weiss, U.S. Food and Drug Administration. We further want to thank the contributors to the 2015 update as acknowledged in the case studies and the regulatory comparison table.
This tool was supported by a grant from the Public Health Agency of Canada and the Bill & Melinda Gates Foundation. The visual and technical elements of the tool were developed by Form & Function, Canada. Thank you to Polymun for providing some of the images used in the guide.