Co-development Of Products Research Articles

Involving Youth with Intellectual and/or Developmental Disabilities as Collaborators in a Comparative Effectiveness Trial: A Community-Engaged Research Approach

BackgroundPractices to include youth with intellectual and/or developmental disabilities (IDD) are necessary to design and implement research that specifically meets the behavioral health needs of this population. This article describes a protocol for engaging youth with IDD as collaborators in a comparative effectiveness clinical trial using a community-engaged research (CEnR) approach. MethodsOur engagement protocol, guided by the Community Engaged Research (CEnR) Framework, emphasized harm avoidance, accessibility, demonstrated value, capacity bridging and co-learning, shared power and equity in decision-making, accountability and respect, and transparent communication. We involved seven youth with IDD in a Youth Advisory Committee (YAC) and four youth with IDD in a Summer Scholars program, ensuring consistent and structured engagement throughout the study. ResultsYouth with IDD maintained high levels of engagement in both the YAC and Summer Scholars Program with 100 % retention across two years. Youth used multiple modalities to provide feedback on aspects of the research project, resulting in study modifications, the co-development of products, and tangible improvements in the accessibility and relevance of the study for youth with IDD. ConclusionResearchers and clinicians seeking to engage the historically underserved population of disabled youth in clinical trial research can leverage our findings to enhance the accessibility and inclusivity of their studies.

Requirements for regulatory acceptance of biomarkers

SummaryGenerally, biomarkers could increase the success rate of medicinal product developments and as a consequence accelerate the availability of new therapeutics with an improved benefit–risk relationship. Therefore, patient identification based on predictive biomarkers is becoming increasingly important in all therapeutic areas [1]. The increasing use of predictive biomarker-guided-personalized (precision) medicine warrants the discovery of novel biomarkers as measurable indicators of physiopathological conditions [2]. Biomarkers can be used for diagnostics and prognostics, monitoring disease progression, but also to select the most effective therapy and to predict the treatment outcome [3, 4]. The current article provides a short focus on the regulatory definition of a biomarker and the biomarker qualification process of the European Medicines Agency (EMA). With the evolving landscape, the new Regulation (EU) 2017/746 on in vitro medical devices (IVDR) [5] introduces important changes in the EU legal framework for IVDs especially by legally defining for the first time “companion diagnostic” devices (CDx). Challenges in the codevelopment of CDx and medicinal products are highlighted to provide scientific–regulatory considerations in this complex regulatory field.

Analysis of Factors Related to Variation in Dissolution Profiles Estimated from Continuously Conducted Dissolution Tests of Generic Products.

The development of generic pharmaceuticals involves a bioequivalence study to ensure the therapeutic equivalence of the test formulation to the original innovative product. The formulation characteristics of generic products are expected to be maintained in the long term after approval. This study analyzed the factors contributing to the changes in the dissolution profiles of approved products during their life cycles. Cumulative data on the dissolution similarity of 1675 products of 127 ingredients tested by official laboratories in Japan were assessed according to Japanese bioequivalence guidelines with slight modifications. The products showing dissimilarities in dissolution profiles were analyzed for reporting year, therapeutic category, co-development, physical properties of the active pharmaceutical ingredient (API), and suspected reasons for dissolution change. The increase in the number of dissimilar products is related to the co-development of generic products. Although the solubility of the API was not associated with the dissolution change in the analysis of the total dissolution data, control of the API particle size is suggested to be important for drugs with poorly soluble APIs. Additionally, a risk factor for dissolution changes in the test solutions at a certain pH was the presence of acidic or basic residues. These results indicate the importance of proper development through a thorough evaluation of the formulation and process factors affecting the dissolution properties throughout the product lifecycle.

Exploring relational norms in exporter-importer product innovation co-development: A qualitative study

This research investigates the role of relational norms in facilitating importers' engagement in product innovation co-development with exporters. Through a qualitative approach, we conducted interviews with top managers of small and medium-sized enterprises (SMEs) involved in exporting activities in France. Guided by the theoretical framework of Relational Exchange Theory (Macneil, 1980; Dwyer et al., 1987), our study uncovers the significant potential for successful product innovation co-development when importers actively contribute as knowledge sources and co-developers. Additionally, we highlight the importance of cooperation, continuity expectations, and equity norms as external factors that shape the co-development process of new products between exporters and importers. By comprehending and embracing these relational norms, exporters can strengthen their collaborative endeavors with importers and effectively drive the co-development of innovative products.

Towards a whole-system framework for wildfire monitoring using Earth observations.

Fire seasons have become increasingly variable and extreme due to changing climatological, ecological, and social conditions. Earth observation data are critical for monitoring fires and their impacts. Herein, we present a whole-system framework for identifying and synthesizing fire monitoring objectives and data needs throughout the life cycle of a fire event. The four stages of fire monitoring using Earth observation data include the following: (1) pre-fire vegetation inventories, (2) active-fire monitoring, (3) post-fire assessment, and (4) multi-scale synthesis. We identify the challenges and opportunities associated with current approaches to fire monitoring, highlighting four case studies from North American boreal, montane, and grassland ecosystems. While the case studies are localized to these ecosystems and regional contexts, they provide insights for others experiencing similar monitoring challenges worldwide. The field of remote sensing is experiencing a rapid proliferation of new data sources, providing observations that can inform all aspects of our fire monitoring framework; however, significant challenges for meeting fire monitoring objectives remain. We identify future opportunities for data sharing and rapid co-development of information products using cloud computing that benefits from open-access Earth observation and other geospatial data layers.

Stakeholder engagement in gender and climate change policy processes: Lessons from the climate change, agriculture and food security research program

IntroductionWith the rapid increase in climate shocks and hazards, policies governing climate change have proliferated while the integration of gender considerations to address gender-differentiated needs and impacts has remained a challenge. Stakeholder engagement is touted as a critical ingredient in climate change decisions and governance at different levels to achieve equitable outcomes. However, effective methods and outcomes of gender-responsive stakeholder engagement processes for climate change policy development are rarely published.MethodsWe apply the framework of 10 principles for effective agricultural research for development programs to analyze the stakeholder engagement processes in the context of the CGIAR's Research Program on Climate Change, Agriculture and Food Security gender and climate change policy projects. We analyze both primary and secondary data to understand the categories of stakeholders engaged, methods of engagement, the outcomes and lessons learned across five regions.Results and discussionOur results show that analysis of the existing policies and programs is a very critical entry point for identifying the points of leverage, the types of stakeholders to engage and how to engage them in the processes that focus on integrating gender in climate policies. Co-learning and co-development of knowledge products cultivate interest and commitment among stakeholders to address gender dynamics, although systematic monitoring and evaluation remains a challenge. This has implications for effective stakeholder engagement in mainstreaming gender in climate policies and evidence-based policy formulation for sustainable agriculture and food systems. Working with influential stakeholders, with the capacity and interest to address gender considerations yields more positive results. Mechanisms to address power relations need to be in place for gender considerations to be voiced and integrated and include women in decision-making processes.

374 Therapeutic Class Labeling of EGFR Companion Diagnostics (CDxs)

OBJECTIVES/GOALS: Review all approved companion diagnostics (CDxs) labeling for therapeutic class language. Examine the regulatory pathways of CDx products whose labels contain therapeutic class labeling. Develop recommendations for pharmaceutical industry professionals on best practices in the co-development of CDxs and oncology therapeutic products. METHODS/STUDY POPULATION: Literature discussing companion diagnostics was reviewed from EBSCOhost, PubMed, and OVID. The Intended Use language within CDx labels on the Food and Drug Administrations “List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)” website were reviewed on November 1, 2021 for therapeutics class language. For CDx products with therapeutic class label language, the regulatory history was evaluated to determine the development approach taken to achieve the language. RESULTS/ANTICIPATED RESULTS: A total of 45 CDxs were identified, of which only 2 contained therapeutic class labeling, both of which were devices for the identification of epidermal growth factor receptor (EGFR) mutations for the treatment of non-small cell lung cancer (NSCLC). Three additional EGFR CDxs were approved; however, they did not contain therapeutic class labeling. The first CDx was the Cobas EGFR Mutation Test V2, which received therapeutic group label language as an update on October 27, 2020; however, prior to the therapeutic class labeling, three oncology products were named in the Intended Use: Tarceva (erlotinib), Tagrisso (osimertinib), and Iressa (gefitinib). The second CDx to incorporate therapeutic class labeling was the ONCO/Reveal Diagnostic Lung and Colon Cancer Assay upon initial approval on July 30, 2021. DISCUSSION/SIGNIFICANCE: EGFR CDxs are the first to shift towards therapeutic class labeling. Indication, molecular alterations, and mechanism of action of the approved therapeutic class products, number of products approved, as well as CDx analytical and clinical validation influence class label relevance. Discussions with the FDA are encouraged early in development.

Bridging the research-implementation gap in avian conservation with translational ecology

AbstractThe recognized gap between research and implementation in avian conservation can be overcome with translational ecology, an intentional approach in which science producers and users from multiple disciplines work collaboratively to co-develop and deliver ecological research that addresses management and conservation issues. Avian conservation naturally lends itself to translational ecology because birds are well studied, typically widespread, often exhibit migratory behaviors transcending geopolitical boundaries, and necessitate coordinated conservation efforts to accommodate resource and habitat needs across the full annual cycle. In this perspective, we highlight several case studies from bird conservation practitioners and the ornithological and conservation social sciences exemplifying the 6 core translational ecology principles introduced in previous studies: collaboration, engagement, commitment, communication, process, and decision-framing. We demonstrate that following translational approaches can lead to improved conservation decision-making and delivery of outcomes via co-development of research and products that are accessible to broader audiences and applicable to specific management decisions (e.g., policy briefs and decision-support tools). We also identify key challenges faced during scientific producer–user engagement, potential tactics for overcoming these challenges, and lessons learned for overcoming the research-implementation gap. Finally, we recommend strategies for building a stronger translational ecology culture to further improve the integration of these principles into avian conservation decisions. By embracing translational ecology, avian conservationists and ornithologists can be well positioned to ensure that future management decisions are scientifically informed and that scientific research is sufficiently relevant to managers. Ultimately, such teamwork can help close the research-implementation gap in the conservation sciences during a time when environmental issues are threatening avian communities and their habitats at exceptional rates and at broadening spatial scales worldwide.

Organic food corporate image and customer co-developing behavior: The mediating role of consumer trust and purchase intention

The impact of organic food corporate image on customers' surpassing purchasing behavior is absent in prior literature. Based on the S–O-R framework, the current study focuses on organic food member customers to explore the influence of corporate ability (CA) image and corporate social responsibility (CSR) image of organic food company on the consumption behavior and co-developing behavior of customers. The consumer samples came from 269 member customers of an organic food enterprise in southwest China. The results show that organic food company CA and CSR image positively affect consumer trust and co-developing behavior. CSR image enhances consumer trust and co-developing behavior than CA image does. Additionally, consumer trust and purchase intention play a multi-step mediating role in the relationship between corporate image (CA and CSR) and consumers' co-developing behavior. In conclusion, our findings provide new insights for understanding the relationship between the corporate image of organic food and the co-developing behavior of customers. The research results provide support for organic food companies that can effectively promote consumer trust, continuous purchase, and active engagement in the co-development of products and services by creating an image of ability and social responsibility.

Classification coding of production systems for identification of platform candidates

Production platforms present an attractive solution to managing increasing product variety in production systems. Forming production systems platforms can potentially facilitate changeable manufacturing and co-development of products and production systems. One of the first steps in developing a production platform is the identification of the potential candidates. A scheme for classification coding of production systems is presented. Coded production systems can be compared across a manufacturer’s departments in order to identify commonalities between systems, and thus identify candidates for platform development. The production system classification code consists of four sub-codes with four to ten digits each describing physical or logical characteristics on production system or cell levels. The four sub-codes are structured into blocks of classification code, which digitally represent and describe complete production systems. They facilitate the comparison and identification of similarity and commonality patterns using the code digits and values. A production system case study is used for illustration and is represented as a block of code following the developed coding scheme. The production systems classification code can be used as a decision support tool in the early phases of production systems platform development, and for capturing information on the rationale, structure, processes and enablers of flexible and changeable production systems.

Integrating evidence of land use and land cover change for land management policy formulation along the Kenya-Tanzania borderlands

Abstract This paper presents an overview of the scientific evidence providing insights into long term ecosystem and social dynamics across the northern Tanzania and southern Kenya borderlands. The data sources covered a range from palaeoenvironmental records and archaeological information to remote sensing and social science studies that examined human-environmental interactions and land use land cover changes (LULCC) in the region. This knowledge map of published LULCC research contributes to current debates about the drivers and dynamics of LULCC. The review aims to facilitate both multidisciplinary LULCC research and evidence-based policy analyses to improve familiarity and engagement between LULCC knowledge producers and end-users and to motivate research integration for land management policy formulation. Improving familiarity among researchers and non-academic stakeholders through the collation and synthesis of the scientific literature is among the challenges hindering policy formulation and land management decision-making by various stakeholders along the Kenya-Tanzania borderlands. Knowledge syntheses are necessary; yet, do not fully bridge the gap between knowledge and policy action. Cooperation across the science-policy interface is fundamental for the co-production of research questions by academics, policy makers and diverse stakeholders aimed at supporting land management decision making. For improved co-development and co-benefitting outcomes, the LULCC scientific community needs to mobilise knowledge for a broader audience and to advance co-development of relevant and meaningful LULCC products.

Integrated product-process modelling for platform-based co-development

Changeable manufacturing and platform-based co-development of products and manufacturing systems are becoming increasingly relevant for industrial manufacturing in order to respond to volatile markets, increased product variety and shorter product life cycles. However, in order to conduct platform-based co-development, it is necessary to manage the relations between the product domain and the manufacturing domain. This paper proposes an approach and meta-model for developing company-specific ontologies, which can be used for modelling the portfolio of components, processes and equipment and their interrelations as a basis for co-evolution. Developing such a model has implications for developing and utilising changeable manufacturing, which is also analysed in this paper.

Investigating the Transition towards Changeability through Platform-based Co-development of Products and Manufacturing Systems

Increasing product variety, rapid new product introductions, volatile market demands, and pressure for cost reductions are among the main drivers for developing changeable and reconfigurable manufacturing systems constituting platforms that can be developed and utilized jointly with product platforms. However, methodologies to support platform-based co-development of products and manufacturing systems remain limited in previous research, including lack of knowledge on successful practices for the platform-based co-development project and process. Therefore, the objective of the research presented in this paper is to identify practices for platform-based co-development of products and manufacturing systems through a case study of a company that has successfully transitioned towards changeability through platform-based co-development. The findings cover various aspects of the co-development process and project, providing initial insight into how to enable joint development of products and manufacturing systems, in order to achieve changeability and reconfigurability.

Using Gene Drive Technologies to Control Vector-Borne Infectious Diseases

After years of success in reducing the global malaria burden, the World Health Organization (WHO) recently reported that progress has stalled. Over 90% of malaria deaths world-wide occurred in the WHO African Region. New tools are needed to regain momentum and further decrease the burden of malaria. Gene drive, an emerging technology that can enhance the inheritance of beneficial genes, offers potentially transformative solutions for overcoming these challenges. Gene drives may decrease disease transmission by interfering with the growth of the malaria parasite in the mosquito vector or reducing mosquito reproductive capacity. Like other emerging technologies, development of gene drive products faces technical and non-technical challenges and uncertainties. In 2018, to begin addressing such challenges, a multidisciplinary group of international experts published comprehensive recommendations for responsible testing and implementation of gene drive-modified mosquitoes to combat malaria in Sub-Saharan Africa. Considering requirements for containment, efficacy and safety testing, monitoring, stakeholder engagement and authorization, as well as policy and regulatory issues, the group concluded that gene drive products for malaria can be tested safely and ethically, but that this will require substantial coordination, planning, and capacity development. The group emphasized the importance of co-development and co-ownership of products by in-country scientists.

Managing Technology Uncertainty Under Multi-Firm New Product Development

The growing sophistication of component technologies and the rising costs of product development require firms to collaborate in the development of new products by pooling their resources and entering into resource or cost-sharing arrangements. However, the management of new product development that occurs jointly between a technology supplier and its industrial customer presents a new set of challenges. While such vertical collaboration enables each firm to focus on what it does best and achieve certain economies of specialization, it also introduces new issues associated with the alignment of decisions and incentives that have to be managed alongside conventional performance and timing uncertainties of new product development. In this paper, we conceptualize and formulate the co-development of products involving two firms and examine the implications of two collaboration mechanisms found in industrial practice. We term these approaches which involve sharing of the development cost and sharing of the development work, investment sharing and innovation sharing, and find that they have subtle effects on the degree of product innovation and profits of individual firms, depending on the nature and extent of technological uncertainty, product development cost structure, and complementary relationships with other products. We consider both exogenous and endogenous technology uncertainty, and study the impact of investment and innovation sharing on a firm's technology consideration set, product qualities, and profits. Conditions under which firms should consider one mechanism over the other and over single firm product development are proposed. Our analysis shows that, while investment sharing plays an important role in environments with higher levels of technology uncertainty, innovation sharing can result in greater quality improvements and profits if firms are able to manage the distributed product development process more efficiently. We translate our analytical findings into a managerial framework and illustrate it with examples from the industry.

The Sustainable Co-Design of Products and Production Systems

The challenges in designing products and production systems are becoming increasingly complex due to more changeable customer demands, frequent product updates, and the requirements for resource efficiency. Established design processes are often unable to readily accommodate these rapid changes. In addition, incremental benefits are often achieved through existing sustainable design approaches due to inability to fully assess the impacts of product design improvements and their associated implications within production facilities. This highlights the need for more integrated design processes that enable seamless co-development of products and production systems. This paper examines the current interrelation and interaction of these design processes from the resource efficiency viewpoint, proposes a novel sustainable ‘Co-Design’ model, and discusses the ecological benefits of co-designing future products and production systems.

Open collaboration in the public sector: The case of social coding on GitHub

Open collaboration has evolved as a new form of innovation creation in the public sector. Government organizations are using online platforms to collaborative create or contribute to public sector innovations with the help of external and internal problem solvers. Most recently the U.S. federal government has encouraged agencies to collaboratively create and share open source code on the social coding platform GitHub and allow third parties to share their changes to the code. A community of government employees is using the social coding site GitHub to share open source code for software and website development, distribution of data sets and research results, or to seek input to draft policy documents. Quantitative data extracted from GitHub's application programming interface is used to analyze the collaboration ties between contributors to government repositories and their reuse of digital products developed on GitHub by other government entities in the U.S. federal government. In addition, qualitative interviews with government contributors in this social coding environment provide insights into new forms of co-development of open source digital products in the public sector.

Benefits of Customer Codevelopment of New Products: The Moderating Effects of Utilitarian and Hedonic Radicalness

There is growing belief in the value of actively involving customers in innovation, commonly referred to as customer codevelopment or cocreation. These strategies are generally believed to be beneficial, although contingent views are prevalent. A widely espoused contingent view is that the positive contribution of customer codevelopment is dependent on the degree of radicalness (or innovativeness) of the products being developed. Some work argues that customer codevelopment is more useful for incremental innovation, whereas other work claims that customer codevelopment is more valuable when innovation is radical.This research makes an important contribution to this discourse by making a distinction between utilitarian radicalness and hedonic radicalness. Utilitarian radicalness refers to the degree to which an innovation is novel in terms of technology and functionality, whereas hedonic radicalness refers to the degree to which an innovation is novel in terms of sensorial, emotional, or symbolic aspects. Hypotheses about the contribution of customer codevelopment to market success depending on levels of utilitarian and hedonic radicalness are tested using dual‐respondent data about a large sample of innovation projects. The findings suggest that the contribution of customer codevelopment to market success is positively moderated by utilitarian radicalness and negatively moderated by hedonic radicalness. This underlines the importance of taking not only the level, but also the nature, of radicalness into account when making decisions about customer codevelopment.

Corporate sustainability in emerging markets: insights from the practices reported by the Brazilian retailers

Abstract Sustainable development depends on more sustainable consumption and production patterns, which respond to basic needs and bring better quality of life while minimizing the use of natural resources so as not to jeopardise future generations' needs. Retailers play an important part in this change due to their privileged position between supply and demand. Despite of that, research on retail sustainability is still emerging. Therefore, this paper aimed to identify the reported practices and management approach employed by Brazilian retailers to make the shift towards sustainability. To do so, it was carried out a content analysis of the practices reported by eight Brazilian retailers – the top four of the supermarket and the department store segments. The analysis revealed some important findings: a primary focus on internal practices mainly social issues regarding their relationship with employees and community; few internal eco-efficiency activities implemented mainly in new or “green stores” that focus on impacts' remediation rather than on the elimination of their causes; an incipient approach on sustainable supply chain management and consumer awareness; and that sustainability practices are not integrated into a management system. This set of results is the first attempt to shed light on the way how the Brazilian retail industry is dealing with sustainability issues and one of the few in the emerging international literature, thus contributing to both. Therefore, it can be used as a base to further and more in-depth research regarding issues such as the implementation of sustainable supply chain and co-development of sustainable products and processes; the effects of the sustainability practices on organizational performance and competitivity; how to manage sustainability integrated into the organization management system; the causes of the differences between domestic and multinational retailers' approaches and results; sustainability practices in others segments of the retail industry based on the framework employed in this paper; etc. Finally, some limitations should be taken into account when employing these findings: the fact that they reflect the data quality self-reported by each organization in 2010 and that they encompass a small number of cases.

A Co-Evolution Model for Prediction and Synthesis of New Products and Manufacturing Systems

A model for predicting the future codevelopment of new products and manufacturing systems is presented. The model incorporates a set of manufacturing co-evolution hypotheses that promote association between manufacturing systems and product variants throughout their shared evolution courses based on a biological analogy. It shows the impact of the different co-evolution states particularly the imperfect co-evolution, which can be remedied by predicting new systems and products. A novel mathematical technique for co-evolution knowledge synthesis is used to analyze the relationships between manufacturing capabilities and product features and discover the human synthesis knowledge implicit in their codevelopment. A set of rules and linear system of equations is formulated to discover such knowledge. The co-evolution model is mathematically established using Cladistics and trees reconciliation techniques that are used extensively in Biology. The model is validated by data sets of milling machine tools and the corresponding machined prismatic parts. The application of the developed model yields suggested directions for the future planning and development of the analyzed machine tools and potential new products features, products and variants that would further sustain and prolong the useful life of the current manufacturing capabilities and systems.