The Pharmaceutical Value Chain—An Introduction

Vaccine Innovation Meta-Model for Pandemic Contexts

“…The fast-track vaccine R&D model depicts, from the firm to the global level, the reorganization of the activities required to develop, manufacture, and deliver safe and effective vaccines at pandemic speed. Unlike traditional R&D models that bring the defined stage-gates (S 1 -D 1 :S 15 ) occurring sequentially [e.g., 21,22,24], the first meta-model entity presents most of them running in parallel, as advocated by Lurie et al [3] and Drury, Jolliffe, and Mukhopadhyay [31]. The beginning of one stage not conditional on the completion of the other, combined with a shorter duration of stage-gates, resulted in a reduction of vaccine time-to-market of approximately 11 years, when compared to the works of Biswas [21], Velho et al [56], Van de Burgwal et al [24], and Plotkin et al [9].…”

“…First, the workstreams, stages, and gates resulting from the encoding process were organized according to the Vaccine Innovation Cycle by Van de Burgwal et al [24], but linearly. Considering the traditional R&D process, the duration of the stages was established based on the works by Biswas [21], Velho et al [56], Van de Burgwal et al [24], and Plotkin et al [9]. In light of the emergency/pandemic contexts, the stages had their duration and temporal disposition adjusted based on the studies composing the corpus of analysis, as well as the timelines of the COVID-19 pandemic from the American Journal of Managed Care (AJMC) and World Health Organization (WHO) [57,58].…”

“…The highlighted bars show the sequencing and duration of the stages in the pandemic context, which were defined based on the interpretation of the arguments present in the studies comprising the corpus of analysis, as well as on the timelines of the COVID-19 pandemic from the AJMC and WHO [57,58]. The faded bars, in turn, show the sequencing and duration of the stages in the traditional context, which were established from the works by Biswas [21], Velho et al [56], Van de Burgwal et al [24], and Plotkin et al [9]. The circles represent the points where the path forward for the next stage is agreed to, named gates (D, U, and T 1 ), and the values between parentheses indicate the absolute frequency of the stagegates within the corpus of analysis.…”

“…In this regard, research efforts have been made toward understanding the impacts of R&D in the value chain of vaccine innovation. Most recently, the Pharmaceutical Value Chain Model by Biswas [21] linearly described the R&D stages for pharmaceutical compounds from target to launch. Likewise, the Drug Discovery, Development, and Deployment Maps by Wagner et al [22] thoroughly represented the therapeutic development processes for biologicals.…”