Developing vaccines for low resource settings through product development partnerships (PDPs)

Development of new vaccines for low resources settings is driven not only by the unmet medical need but also by addressing issues related to vaccine access, availability, affordability, acceptability and sustainability by the multitude of stakeholders involved in the research, development, introduction and scale-up of vaccines for low- and middle income countries (LMICs). The first gap that needs to be traversed is the valley of death between discovery and deployment (http://dx.doi.org/10.1038/453840a). Product Development Partnerships are one mechanism that has been successfully used to accelerate development of vaccines for LMICs. Two case studies will be reviewed: the meningitis A vaccine, MenAfriVac® and the malaria vaccine, Mosquirix®. A second valley of death has been identified in the development of the malaria vaccine (http://dx.doi.org/10.1016/S0140-6736(16)30394-4). To traverse this second valley death, a different way of thinking about vaccine development may be required

Development, Application, and Distribution of the CubeSat System Reference Model

SSWG has been investigating the applicability of MBSE for designing CubeSats since 2011. First phase developed a SysML model of a CubeSat and applied it to the Radio Aurora Explorer. The second phase included modeling behaviors and the third phase included carrying out trade studies. The current phase is the development of a CubeSat System Reference Model (CSRM)

Mission Engineering and the CubeSat System Reference Model

SSWG has been investigating the applicability of MBSE for designing CubeSats since 2011. The first phase developed a SysML model of a CubeSat and applied it to the Radio Aurora Explorer. The second phase included modeling behaviors and the third phase included carrying out trade studies. The current phase is the development of the CubeSat System Reference Model (CSRM). The CSRM provides the logical architecture of a CubeSat space and ground system. The CSRM logical components are reused as a starting point for a mission-specific CubeSat logical architecture followed by the development of the physical architecture during CubeSat development. The mission-specific team is free to adopt a different logical architecture and modify the CSRM to accommodate the change

CubeSat System Reference Model (CSRM) as an OMG Specification

This paper describes the transformation of the CubeSat Reference Model™ (CSRM™) into an Object Management Group® (OMG®) specification, as effected by the International Committee on System Engineering (INCOSE) Space System Working Group (SSWG) from 2016 to 2022. The CSRM is a logical model of engineering artifacts used by a CubeSat mission team to build its mission-specific logical and physical models according to its individual engineering methodology. It is based on Model-Based System Engineering (MBSE) principles, is OMG System Modeling Language (SysML) compliant, is hosted on a graphical modeling tool, and is intended to foster completeness and economies of scale associated with reusability. The OMG, an international standards organization, has a mature, worldwide, and open process for identifying the need for a specification, as well as for soliciting, developing, approving, and distributing a specification. In 2018, the OMG initiated a process to provide the CSRM as an OMG specification. This resulted in the normative CSRM Profile Specification document, the normative CSRM Profile XMI file for import into a graphical modeling tool, and the non-normative CSRM Profile Model. Supplementing these files are the non-normative CSRM Model file and the non-normative CSRM HTML file which allows for exploration and evaluation of the CSRM without the need to acquire a graphical modeling tool and provides sufficient guidance for establishing a mission specific CSRM

Mission Engineering and the CubeSat System Reference Model - Status #2

The International Council on Systems Engineering (INCOSE) Space System Working Group (SSWG) has created the CubeSat System Reference Model™ (CSRM™) intended for use by system architects and engineers as a starting point to develop the physical architecture of the Space and Ground segments of the CubeSat mission of interest to them. The CSRM is based on Model-Based System Engineering (MBSE) principles, is System Modeling Language™ (SysML™) v1.7 compliant, and hosted in a graphical modeling tool. The CSRM has been submitted to the Object Management Group (OMG) and is in the finalization process to become an OMG Specification. With the development of the CSRM nearing completion, the INCOSE SSWG is now researching how features of the CSRM can be used at a higher level to support Mission Engineering (ME). ME, a concept where the mission itself is looked at as a system, is being explored as a means to maintain balance between the spacecraft system, operations (including ground systems), and the mission (the integration of needed capabilities). An earlier paper provided an initial assessment of where the CSRM supports ME activities and where there are areas that require further research. That paper proposed a way forward that included a set of activities needed to completely define what additions would be required to extend the CSRM to fully support ME. One of those activities was to analyze the CSRM for additional artifacts which could be added to the containment tree for key elements of ME activities that do not map to the CSRM. This paper provides the results of performing that activity for two ME activities: the Mission Architecting Activity and the Mission-oriented Systems-of-Systems (SoS) Implementation Activity

Critical Evidence Questions For COVID-19 Vaccines Policy Making

This document lists areas of evidence that would assist SAGE to formulate policy recommendations for consideration by WHO regarding the use of COVID-19 vaccines as they become available. It is not intended as alternative to the lists of requirements for licensure as formulated by regulatory bodies nor does it replace or provide an alternative to the WHO Target Product Profile. Rather it reflects the evidence-needs for COVID-19 vaccine policy making, based on the current scientific thinking, to assist SAGE in deciding upon the optimal use given the limited vaccine supply in order to maximise impact on the pandemic in different populations and epidemiologic settings

WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23–24 March 2015

AbstractRespiratory syncytial virus (RSV) is a globally prevalent cause of lower respiratory infection in neonates and infants. Despite its disease burden, a safe and effective RSV vaccine has remained elusive. In recent years, improved understanding of RSV biology and innovations in immunogen design has resulted in the advancement of multiple vaccine candidates into the clinical development pipeline. Given the growing number of vaccines in clinical trials, the rapid pace at which they are being tested, and the likelihood that an RSV vaccine will reach the commercial market in the next 5–10 years, consensus and guidance on clinical development pathways and licensure routes are needed now, before large-scale efficacy trials commence. In pursuit of this aim, the World Health Organization convened the first RSV vaccine consultation in 15 years on the 23rd and 24th of March, 2015 in Geneva, Switzerland. The meeting's primary objective was to provide guidance on clinical endpoints and development pathways for vaccine trials with a focus on considerations of low- and middle-income countries. Meeting participants reached consensus on candidate case definitions for RSV disease, considerations for clinical efficacy endpoints, and the clinical development pathway for active and passive immunization trials in maternal and pediatric populations. The strategic focus of this meeting was on the development of high quality, safe and efficacious RSV preventive interventions for global use and included: (1) maternal/passive immunization to prevent RSV disease in infants less than 6 months; (2) pediatric immunization to prevent RSV disease in infants and young children once protection afforded by maternal immunization wanes

A Tailored Systems Engineering Process for the Development of CubeSat Class Satellites

The class of small satellites known as CubeSats have grown in popularity and complexity in recent years and have been especially popular with colleges and universities interested in utilizing them both for their value as an educational tool and to conduct science missions. While there have been some tremendously successful CubeSat missions over the years, those that are launched are still more likely than not to be dead on arrival or to fail before accomplishing their objectives. Part of this low success rate, especially of student built CubeSats, may be attributed to the fact that they are often designed in an ad hoc manner, with students working on projects for only a fixed period of time and without a view of the big picture. In contrast, large space-focused organizations utilize Systems Engineering (SE) to standardize processes and improve the odds of mission success. The National Aeronautics and Space Administration (NASA) uses their own SE methodology and it is so complex that the process overview, known as the NASA Project Life Cycle Process Flow can take up an entire wall when printed in full size. While it may not be feasible to apply such a complex SE methodology to most CubeSat developments, they could be improved a great deal by utilizing a rigorous but tailored process of their own. Specifically, CubeSat developers should focus on requirements definition and flow-down, risk analysis and mitigation, cost and schedule management, and integration and interface management. These areas would be aided significantly by developing artifacts such as a Cost Analysis, Risk Analysis, Test and Evaluation Plan, Model Based Architecture, and a Concept of Operations. This paper describes work which aims to develop and implement an optimized SE process for CubeSats intended specifically for student-run projects taking place over the course of a single academic year. It will be implemented on a student CubeSat project at the United States Naval Academy (USNA) and validated by comparing key performance parameters of their project to those of other similar CubeSats developed without using this process. The result of this study will be a tailored SE process that can be applied to virtually any student CubeSat project to improve performance and importantly to increase the chances of mission success