“…Since then, we have been increasingly emphasizing the need to focus on therapies with novel targets or novel designs, as well as precision medicine opportunities wherever appropriate so we can provide the most benefits for patients in need. 5 Figure 3 Pfizer’s new molecular entities (NMEs) versus product extensions (PE) success rates for Phase II, Phase III, and Approval from 2016 to 2020. Success rates are defined as in Fig.…”
Section: Attrition Drivers In Lifecycle Managementmentioning
Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer’s Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company’s ‘lightspeed’ paradigm.
“…Since then, we have been increasingly emphasizing the need to focus on therapies with novel targets or novel designs, as well as precision medicine opportunities wherever appropriate so we can provide the most benefits for patients in need. 5 Figure 3 Pfizer’s new molecular entities (NMEs) versus product extensions (PE) success rates for Phase II, Phase III, and Approval from 2016 to 2020. Success rates are defined as in Fig.…”
Section: Attrition Drivers In Lifecycle Managementmentioning
Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer’s Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company’s ‘lightspeed’ paradigm.
“…To better understand the role of innovation in breakthrough drug and vaccine development, the article analyzed recent results for assets developed using different types of innovation [ 22 ].…”
The COVID-19 pandemic has severely tested humanity, revealing the need to develop and improve the medical, economic, managerial, and IT components of vaccine management systems. The vaccine lifecycle includes vaccine research and development, production, distribution, and vaccination of the population. To manage this cycle effectively the proper organizational and IT support model of the interaction of vaccine lifecycle management stakeholders is needed—which are an innovation ecosystem and an appropriate virtual platform. A literature review has revealed the lack of methodological basis for the vaccine innovation ecosystem and virtual platform. This article is devoted to the development of a complex approach for the development of an innovation ecosystem based on vaccine lifecycle management and a virtual platform which provides the data exchange environment and IT support for the ecosystem stakeholders. The methodological foundation of the solution, developed in the article, is an enterprise architecture approach, CALS technologies, supply chain management and an open innovation philosophy. The results, presented in the article, are supposed to be a reference set of models for the creation of a vaccine innovation ecosystem, both during pandemics and periods of stable viral load.
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