These interviews were conducted Vismodegib by e-mail, telephone conference calls, and personal contacts. Vaccine development is a long, complex, expensive and risky process. It follows a standard set of stages to demonstrate that a vaccine is safe, immunogenic and protective before it is licensed and marketed (Fig. 1). This requires significant and diverse resources and expertise, and results from the contribution of

several public and private actors. Basic research regarding pathogens and immune responses is supported by a cross-section of academic and government organizations and industry, whereas development-related and clinical research programs are funded primarily by industry. Large vaccine companies are involved in significant amounts of targeted research, but their preponderant role is in clinical and process development. Small biotechnology companies are playing an increasingly important role in the vaccine industry. They are often

started by university scientists, supported by venture capitalists, and apply novel click here technology to translate basic research into vaccine candidates in the early stages of clinical development (phase I and II/proof of concept in humans). If research results are favorable, major vaccine producers will enter into pro-active partnerships to ensure capacity in process development, phase III clinical trials, registration and manufacturing [2], [3], [4], [5], [6] and [7]. While large vaccine companies increasingly externalize research in order to access new areas of science and share the risk of development with partners [8], only they have the necessary expertise and know-how in project management and the various disciplines necessary to achieve vaccine development, Rutecarpine navigate regulatory pathways and manufacture vaccines to international standards. It

usually takes 12–15 years to develop a new vaccine (ranging from 7 years to >20 years). Estimates of the total cost for vaccine development varies, depending on what is measured. If one includes R&D costs on products that fail, post-licensure clinical studies, and improvements in manufacturing processes, these costs can climb to over $1 billion. For vaccine companies, each successful product has to recover not only the costs of its design and development, but also the costs of the unsuccessful candidates [2], [9] and [10]. Vaccine development follows a graduated funnel that involves several stages: basic and applied research, preclinical testing, clinical testing, regulatory approval, production and distribution [2], [3], [4], [5], [6] and [7]. At each of the different stages, even the most promising candidates can fail to perform as anticipated and can be either abandoned or modified and re-tested. Only relatively few vaccines make the jump from the laboratory to clinical trials. The cumulative probability from pre-clinical to launch for a vaccine is 0.22 (0.39 from Phase I to launch; 0.64 from Phase II to launch; 0.