Mature Industry Research Articles

When an FDA Drug Approval Makes Mainstream News: The Announcement of Zulresso, A Media Case Study

Media coverage following U.S. Food and Drug Administration (FDA) drug approvals is generally found in two sectors: bioindustry news and the financial markets. The March 19, 2019 FDA announcement of its approval of the postpartum anti-depression biopharmaceutical Zulresso from Sage Therapeutics also elicited unusually high levels of media response in the mainstream media. This case study (1) details the total media news response following the FDA approval announcement regarding Zulresso, (2) compares that media response with the mainstream media coverage for Aimovig, a Novartis and Amgen treatment, which received the most mainstream coverage in the group of 2018 FDA novel drug approvals, and (3) compares the media coverage for three recent FDA drug approvals, Mayzent, Dovato and Evenity, to demonstrate a normative media response pattern. Findings include demonstration of Zulresso coverage across all major mainstream media outlets, well in excess of its mainstream media comparator, Aimovig. The three recently-announced comparators received the anticipated media coverage in the bioindustry and financial markets segments, while the two mainstream candidates, Zulresso and Aimovig, both received more and/or more timely media coverage in the bioindustry and financial markets media sectors three recent drug approval comparators. No determination could be made as to whether the mainstream media response to Zulresso was a singular incident, or the signaling of a sea change due to the maturation of the biotechnology industry.

Alternative technological learning paths of Taiwanese firms

ABSTRACTThe OEM–ODM–OBM paths of technological learning of late-comer firms are well documented in previous studies. Taiwan is one of the leading countries taking this traditional path. By using five cases of Taiwanese firms in mature industries like machinery, electronics parts, food processing and furniture, and in an emerging industry like 3D camera, explore alternative technological learning paths. It aims to explain how alternative paths happened and evolved overtime. Four alternative learning strategies were found: independent suppliers, startups, path breakers and specialization in high-valued activities. Government financial incentives for R&D and new product/system development beyond existing activities under OEM/ODM arrangement; supports from universities, public research institutes to develop sophisticated technological and innovative capabilities; and assistance from international trade promotion agencies, and government-sponsored industrial associations for accessing new and niche markets in advanced countries are important for firms to pursue these alternative technological learning paths.

A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly focused on HF methods to ensure success from that perspective. However, the development of across-the-board strategies that can address other critical factors is necessary. No previous scientific research has outlined and addressed the problems considering the QSR and the needs of key stakeholders. For that purpose, this effort presents a narrative review of how the HF requirement for medical devices and combination products developed, as well as the issues and the interventions that have taken place to address the bottlenecks. Some essential considerations such as notorious knowledge-based and process-based gaps are discussed. Similarly, because of the demands of a changing QSR, attention is brought to the need to align key stakeholders, namely manufacturers and HF service providers (HFSPs). Also, the development of an industry (HFSPs) maturity assessment tool and future research for that purpose are proposed.

A revised perspective on innovation policy for renewal of mature economies – Historical evidence from finance and telecommunications in Sweden 1980–1990

What is the role of innovation policy for accomplishing renewal of mature industries in Western economies? Drawing upon an unusually rich dataset spanning 9752 digitized archival documents, we categorize and code decisions taken by policymakers on several levels while also mapping and quantifying the strategic activities of both entrant firms and incumbent monopolists over a decade. Our data concerns two empirical cases from Sweden during the time period 1980–1990: the financial sector and the telecommunications sector. In both industries, a combination of technological and institutional upheaval came into motion during this time period which in turn fueled the revitalization of the Swedish economy in the subsequent decades. Our findings show that Swedish policymakers in both cases consistently acted in order to promote the emergence of more competition and de novo entrant firms at the expense of established monopolies. The paper quantifies and documents this process while also highlighting several enabling conditions. In conclusion, the results indicate that successful innovation policy in mature economies is largely a matter of strategically dealing with resourceful vested interest groups, alignment of expectations, and removing resistance to industrial renewal.

Integrated Biodiversity Infrastructure for Decision Making

The Atlas of Living Australia (ALA) is an Australian Government supported collaborative partnership of organisations that have stewardship of Australian biodiversity data. The ALA (www.ala.org.au) provides research infrastructure that enables delivery of biodiversity information to over 45,000 unique users in research, industry and government per annum. It delivers impact and enables research excellence in fields such as biodiversity, environmental management, ecology and genetic sciences. Integrated and consistent infrastructure and processes are fundamental to increasing value of collections and associated data. The Atlas of Living Australia has a mature industry engagement program that provides data standardisation, quality and analytical services to decision makers in all tiers of Australian government (local, state and federal). This program is built on formal partnerships between data providers (collection institutions) and analytical services (such as Virtual Laboratories and Research and Science Clouds www.ecocloud.org.au). The provision of high quality, authoritative data is critical to utilisation and uptake of these services and sector sustainability. This presentation will showcase data service and analytical methods for decision makers within the Australian context. It will also explore how international efforts such as DiSSCo assist in data stewardship, cultural change and system enhancement.

Impact of modifying conventional chlorine dioxide stage to hot chlorine dioxide during rice straw pulp bleaching on pulp, paper and effluent characteristics

Paper industry being a mature mega-scale industry is focusing on process oriented technical modifications to reduce dependency on wood fibers and resource utilization. In this research study, conventional chlorine dioxide (D0) bleaching method was modified to hot chlorine dioxide (DHT) with an aim of reducing the effluent load with special concern to chlorolignin compounds. These compounds were measured by gas chromatograph equipped with ECD detector. The chlorophenols, chlorocatechols, chloroguaiacols, chlorovanillins, chlorosyringols and bromophenols were reduced by 9%, 50%, 34%, 47%, 17% and 31%, respectively under DHT based sequence at same dose of chemicals. The general environmental parameters i.e. COD, BOD, TS, colour, lignin and AOX also got reduced in DHT based sequence. The modification of D0 to DHT was found to be effective as effluent quality was enhanced without compromising the optical and strength properties of cellulosic paper even at low dose of chlorine dioxide.

The Road to Practical E-Textiles Is Smooth as Silk

The work of Zhang et al. describes a method for 3D-printing a triboelectric generator composed of silk fibroin (SF) and a conductive core of carbon nanotubes (CNT). The resulting SF@CNT fibers offer a roadmap toward energy harvesting fabrics within E-textiles.

Innovation capability in geographically dispersed R&D teams: The role of social capital and IT support

The internationalization of R&D activities has become crucial for small and medium-sized enterprises (SMEs) to create sources of competitive advantage. This research aims to analyze the role of social capital and information technology (IT) in enhancing knowledge sharing and innovation capabilities in the particular context of SMEs with geographically dispersed R&D teams. The study uses structural equation modeling (SEM) and fuzzy-set qualitative comparative analysis (FsQCA) to investigate data from an online survey of 265 R&D managers in Italian manufacturing SMEs with responsibility for at least one international R&D team. The results reveal the critical role of structural social capital and IT in enhancing knowledge sharing and innovation capabilities. The research contributes to existing knowledge and provides useful insights for marketers by highlighting how social capital, also in combination with IT, strengthens SMEs' competitiveness even when they operate in a mature industry.

Review a Decade of BP’s Technology Roadmap on the Next Generation Biofuels Development

Philip New-the ex-CEO of BP Biofuels proclaimed in 2007: the emergence of biofuels involves two value chains-agriculture and energy, where both mature industries are connected to new national/regional policy. This has opened various opportunities for developing countries to tie business relationships through BP’s investment into non-food next-generation biofuels (NGB) feedstocks farming. This study reviewed all BP’s NGB development projects undertaken from 2006 until 2016. Secondary data was collected through media, corporate websites/reports and newsletters. Next, the NGB development projects were mapped into a technology roadmap (TRM). From this case study, it is hoped that BP’s pursuance on the NGB development could be referred by other oil companies that would have a similar intention of the NGB developers.

PERFORMANCE OF INDIAN CEMENT INDUSTRY: DRIVERS, MODELS AND EMPIRICS

A firm’s performance depends on efficient management of economic resources. Performance is usually a function of firm-specific economic factors and macroeconomic factors. In other words, an efficient allocation, management and manipulation of these factors is required to enhance profitability. This study attempts to identify some factors to understand how and to what extent these factors influence the profitability of the Indian cement industry. Seven hypotheses were framed. Panel data of 146 firms were gathered over a period of 22 years, spanning from 1996 to 2017. Thereafter, a Fixed Effect Regression (FER) model was fitted to the data. Results suggested that both firm-specific (e.g. size of firm; age of firm; fixed asset turnover) and macroeconomic variables (e.g. GDP; inflation; export intensity) made a significant impact on profitability of this industry. The findings of this study should assist managers as well as policy makers to frame sustainable policies of this mature industry. This research fulfills a need for a study that shows the degree of contribution of firm-specific and macroeconomic factors to profitability of the Indian cement industry.

‘When the Dust Doesn’t Settle’ – GDPR Compliance One Year In

The European Union’s General Data Protection Regulation (GDPR) took effect on May 25, 2018. In the year since then, companies have had mixed success in fully implementing it. Organizations’ experiences with the GDPR have varied depending on their industrial sector, global presence, and maturity. The same can be said for the many consultancies and third parties that companies have enlisted to support their compliance efforts. Based on our own experience with providing such support to companies seeking compliance, we have concluded that both consultancies and companies fall into two camps: Those expecting to complete large-scale GDPR efforts on or about May 25, 2018, and those who have realized that this date marked the beginning of a much longer, and possibly transformational journey toward data privacy. Some of this gap is a product of the GDPR’s uniqueness as compared with systems-level security controls, which are the bread and butter of many consulting firms. In contrast with Service Organization Controls (SOCs), the GDPR makes a concerted effort to refrain from prescribing rigid steps toward achieving data privacy compliance. This challenge is compounded by the continued realization that data privacy and data driven products are matters that are deeply engrained in the ways that large-scale organizations operate and generate competitive advantage in today’s global economic climate. In this article, we identify and describe practices we have observed on a global scale and across industries as companies attempt to implement privacy requirements, address regulatory gaps, and navigate this new privacy landscape. We discuss technical, business, and process level constraints and opportunities for advancing the goal of embedding privacy into the product life cycle and provide examples for others to learn and build from.

Innovative Chemicals and Materials from Bacterial Aromatic Catabolic Pathways

Summary To drive innovation in chemical and material applications beyond what has been afforded by the mature petrochemical industry, new molecules that possess diverse chemical functionality are needed. One source of such molecules lies in the varied metabolic pathways that soil microbes utilize to catabolize aromatic compounds generated during plant decomposition. Here, we have engineered Pseudomonas putida KT2440 to convert these aromatic compounds to 15 catabolic intermediates that exhibit substantial chemical diversity. Bioreactor cultivations, analytical methods, and bench-scale separations were developed to enable production (up to 58 g/L), detection, and purification of each target molecule. We further engineered strains for production of a subset of these molecules from glucose, achieving a 41% molar yield of muconic acid. Finally, we produce materials from three compounds to illustrate the potential for realizing performance-advantaged properties relative to petroleum-derived analogs.

Redistributing food manufacturing: models for the creation and operation of responsive and agile production networks

The food industry is a mature industry where its profit margins are thin and its R&D failure rate for new products is substantial. Both facts indicate that decent return on development investment cannot be provided and that the food industry cannot still rely on its traditional way of thinking and innovating. New product development cycles should involve not only the product itself but also the entire manufacturing and distribution network. Hence, collaborative manufacturing and servitization models are key elements for the rapid transformation of the new food industry. Moreover, recent developments in technology have the potential to shift manufacturing production away from large scale manufacturing plants to a network of distributed, smaller scale localized and customizable manufacturing facilities. Such a network is the crucial enabler for the on-demand manufacture of new or even, existing food products to rapidly respond to the consumers´ demands.

Information Leaks and Voluntary Disclosure

We study firms’ voluntary disclosures in a world of potential information leaks. We find that managers adapt their disclosure strategy to the likelihood and expected scope of leaks. An increasing likelihood fosters voluntary disclosure if leaks merely expose the manager’s information endowment and impedes disclosure if leaks in addition uncover the content of the manager’s information. We identify a non-monotonic effect on voluntary disclosure if the scope of information leakage is uncertain, i.e., if leaks reveal the information content with positive probability. Our results imply that information leaks are likely to increase voluntary disclosure whenever investors have difficulties interpreting the economic consequences of the leaked information. This is typically the case in industries with complex business models and innovative products. In mature industries, leaked information replaces voluntary disclosure. Our findings may help explaining mixed empirical evidence on voluntary disclosure in different reporting environments.

The Indian film industry in a changing international market

India has a longstanding reputation for its acclaimed film industry and continues to be by far the world’s largest producer of films. Nevertheless, domestic demand for films appears to be waning as in a number of developed countries with mature film industries. Hence, the econometric analysis in this paper is particularly timely as with demand for films in Indian cinemas falling it is important to identify those factors that make films appealing for Indian audiences. An original dataset is utilised that includes data on all Bollywood films released in India between 2011 and 2015. Account is taken of the potential endogeneity between variables through the use of the generalised method of moments approach. Results are used to demonstrate how the Indian film market can continue to have a significant positive impact on the Indian economy. The discussion highlights appropriate film production company strategies and government policy responses that should be considered to ensure the continued success of the Indian film industry both domestically and in an increasingly competitive international market.

The Aluminum-Ion Battery: A Sustainable and Seminal Concept?

The expansion of renewable energy and the growing number of electric vehicles and mobile devices are demanding improved and low-cost electrochemical energy storage. In order to meet the future needs for energy storage, novel material systems with high energy densities, readily available raw materials, and safety are required. Currently, lithium and lead mainly dominate the battery market, but apart from cobalt and phosphorous, lithium may show substantial supply challenges prospectively, as well. Therefore, the search for new chemistries will become increasingly important in the future, to diversify battery technologies. But which materials seem promising? Using a selection algorithm for the evaluation of suitable materials, the concept of a rechargeable, high-valent all-solid-state aluminum-ion battery appears promising, in which metallic aluminum is used as the negative electrode. On the one hand, this offers the advantage of a volumetric capacity four times higher (theoretically) compared to lithium analog. On the other hand, aluminum is the most abundant metal in the earth's crust. There is a mature industry and recycling infrastructure, making aluminum very cost efficient. This would make the aluminum-ion battery an important contribution to the energy transition process, which has already started globally. So far, it has not been possible to exploit this technological potential, as suitable positive electrodes and electrolyte materials are still lacking. The discovery of inorganic materials with high aluminum-ion mobility—usable as solid electrolytes or intercalation electrodes—is an innovative and required leap forward in the field of rechargeable high-valent ion batteries. In this review article, the constraints for a sustainable and seminal battery chemistry are described, and we present an assessment of the chemical elements in terms of negative electrodes, comprehensively motivate utilizing aluminum, categorize the aluminum battery field, critically review the existing positive electrodes and solid electrolytes, present a promising path for the accelerated development of novel materials and address problems of scientific communication in this field.

Hyperspectral and thermal temperature estimation during laser cladding

Although there is no doubt about the tremendous industrial potential of metal additive manufacturing techniques such as laser metal deposition, the technology still has some intrinsic quality challenges to overcome before reaching its industrial maturity. Noncontact in situ monitoring of the temperature evolution of the workpiece could provide the necessary information to implement an automated closed-loop process control system and optimize the manufacturing process, providing a robust solution to these issues. However, measuring absolute temperatures is not self-evident: wavelength-dependent emissivity values vary between solid, liquid, and mushy metallic regions, requiring spectral information and dedicated postprocessing to relate the amount of emitted infrared radiation to the material temperature. This paper compares the temperature estimation results obtained from a visible and near-infrared hyperspectral line camera and a conventional short-wave infrared (SWIR) thermal camera during the laser melting and cladding of a 316L steel sample. Both methods show agreeing results for the temperature distribution inside the melt pool, with the SWIR camera extending the temperature measurements beyond the melt pool boundaries into the solid region.

Benthic Conservation Features and Species Associated With Subsea Pipelines: Considerations for Decommissioning

Oil and gas pipelines that lie exposed on the seabed can function as “artificial reefs”, providing habitat for fish and benthic species, including some that are listed under conservation designations. As the offshore hydrocarbon industry matures, operators and national governments must decide whether decommissioned pipelines should be left in situ or removed for onshore disposal. In most jurisdictions, there is a requirement to evaluate the environmental consequences of different pipeline decommissioning options in a comparative assessment. To do this effectively requires an understanding of the associations between pipelines and fauna. Pipeline operators routinely collect video footage for inspection and maintenance purposes using remotely operated vehicles (ROV). This footage has the potential to provide insight into interactions between the marine environment and offshore pipelines. This study uses inspection footage from eight pipelines to quantify the presence and abundance of species and features listed under a number of EU and UK conservation designations; 12 such features and species were observed on the pipelines or neighboring sediments. The soft coral Alcyonium digtatum was present in the highest densities on pipelines located on mud, while Sabellaria sp. and Echinus esculentus were more common on pipelines in sand. Gadoids, anemones and hermit crabs were also frequently observed around pipelines. The study also suggests that faunal identification from ROV footage depended on image resolution, ROV speed and altitude, and lighting, and taxa <50 mm in size could not be reliably classified. The results suggest that removal of pipelines will remove established colonies of epibenthic species, some of which have conservation value. The ecological significance of this loss, however, must be weighed against the broader considerations during pipeline decommissioning including cost, technical feasibility and impacts to other marine users.

Fluorescent silicon nanomaterials: from synthesis to functionalization and application

Abstract In the last decade, we have witnessed the giant achievement in the field of silicon materials. Among of them, fluorescent silicon nanomaterials have attracted considerable attentions owing to their unique advantages, including strong fluorescence coupled with robust photostability, rich resource support, low cost, industrial maturity, and good biocompatibility. Extensive efforts are devoted to developing effective methods for the synthesis and functionalization of fluorescent silicon nanomaterials with different nanostructures, facilitating the promotion of this promising material for myriad optical applications. In this review article, we systematically summarize representative progresses for the design and synthesis of fluorescent silicon nanomaterials during the last decade. We also present an in-depth description of functionalization strategies toward fluorescent silicon nanomaterials, with a particular focus on organic ligands-modification, doping and biological species-modification methods. Furthermore, typical optical applications (e.g., bioimaging, sensing, anti-counterfeiting and anti-bacterial applications) are introduced based on latest research achievements. Finally, future trends and current challenges are highlighted as a roadmap proposal for research in this field.

Spatial Analysis of Big Data Industrial Agglomeration and Development in China

Nowadays, our daily life constantly creates and needs to utilize tremendous amounts of datasets. Fortunately, the technologies of the internet, both in software and hardware, have the capability to transmit, store, and operate big data. With China being the most populous country in the world, developing the big data industry is, therefore, seen as an urgent task. As generating industrial agglomeration is important for forming a mature industry, this study aims to characterize the phenomenon of big data industrial agglomeration in China, and to identify the factors for developing the big data industry using spatial analysis approaches and GIS technology from a geographer’s perspective. The problems and strengths of these representative cities are discussed, from which the solutions and the possible directions for the future are also provided. The findings argued that China is still at the primary stage of the development in the big data industry. Only several cities had the presence of a strong agglomeration, but the intercity space spillover was weak. However, comparing the changes in industry distribution, the trend of agglomeration have appeared, and the benefits of industrial agglomeration have also worked. The principal factors of the big data industry and its agglomeration include the support of government and the outstanding higher education agglomeration. In addition, it was also noted that each city has its own characteristics and potentials to attract more big data enterprises, talent, and investment.