R&D process chain PDF Print E-mail

The complexity of the vaccine R&D value chain


Vaccine research and development (R&D) is a complex and long-term business including many phases, various players scattered over the world and requiring substantial financial investments.

An important complicating factor in vaccine R&D is the lack of continuity in the value chain of vaccine R&D. The lack of commercial incentives to develop new drugs for use in the developing world has led to a dearth of new vaccines for poverty-related diseases.

In the case of neglected diseases it starts often with a lack of fundamental research and funding of the discovery phase, while further downstream the pre-clinical and clinical stages of R&D are characterized by insufficient investments.

A problem of a different nature is the existing gap between basic scientific research, which is usually publicly funded, and clinical development, which is usually funded by pharmaceutical companies or more recently through public-private product development partnerships (PDPs).

Another serious impediment in the R&D process is formed by the broad array of stakeholders along the value chain, often scattered around the world. The interaction between scientific communities, public funders, NGO’s, pharmaceutical and biotech companies, (inter)national regulatory authorities and patient interest groups is often not optimal, because of differences in culture, language, attitudes, rules and procedures.

Ensuring successful delivery of a new product the right connectivity between the various development phases is another crucial factor for fostering optimal dynamics along the entire vaccine R&D value chain.

However, the most elementary principle for optimal process flow is the existence of a sound basis of trust and understanding between the various partners in the value chain is vital for constructive collaboration, for which purpose time, resources, specific expertise and diplomatic skills need to be invested in the R&D process.