Lifecycle Management Strategies Research Articles

Patent lifecycle management strategies in open innovation projects

Proper implementation of lifecycle management strategies is important for profit maximization in the pharmaceutical industry. This article investigates the ownership of follow-on patents for approved drugs in the USA. We discover that a considerable number of follow-on patents are originally developed by, and issued to, external partners and not drug sponsors. We also find that the use of follow-on patents is more common in some therapeutic areas than in others. Based on these findings, we develop lifecycle strategies to effectively manage and use external patents in open innovation projects. These strategies include proper license contract design, post-FDA-approval acquisition and open innovation.

Product Life Cycle Analysis of Automotive Products on Multi-Purpose Vehicle’s (MPV) Segment

Since 1990, the ever-increasing sales trend of automobiles in Indonesia has made the competition atmosphere much fiercer, particularly for Multi-Purpose Vehicle, the car segment with the highest sales in Indonesia’s automobile market. Therefore, a product life cycle management of automobiles is demanded to secure current position in market or further, to lead the market. This research uses MPV Model A and MPV Model B as a study case for Multi-Purpose Vehicle. Methods deployed are the computation of product line extension, the computation of product line innovation, t-test, Person Index Test, and Importance-Performance Analysis. Results are used to formulate product life cycle management strategies for automobiles of Multi-Purpose Vehicle aimed secure current position in market or further, to lead the market.

A Review on Drug Combination Strategy for Pharma Life Cycle Management

Discovering a new drug and developing it to the clinic is a, time-consuming and expensive process. A successfully developed patented drug enjoys market exclusivity which provides an opportunity to recoup the R&D expenses. Market competition with similar drugs from other companies, patent cliff and entry of generics present a threat to revenue generation. Successful pharma companies employ suitable Life Cycle Management (LCM) strategies, timed to expand the clinical utility of the drug and boost the revenues through new market exclusivities. Drug combination is one such strategy adopted to add therapeutic value and enhance the commercial life of a drug. In this article, we review drug combination as a Life Cycle Management (LCM) strategy adopted for the US Food and Drug Administration (FDA) approved drugs. We analysed New Molecular Entity (NME) approved by the FDA in the decade of 2001-2010 in four therapeutic areas of oncology, central nervous system, alimentary canal and metabolism and cardiovascular. The life cycle of these NMEs was tracked till 2019 focusing on fixed dose and free dose combination. We present case studies on sitagliptin and everolimus belonging to therapeutic areas metabolism and oncology, respectively, and critically discuss the life cycle of these two drugs. Through the presentation of the clinical utility and revenue generated for the drug combinations, we provide insights into drug combination as a life cycle management strategy.

Should Pay for Delay Be a Cause for Concern in Japan?

Yes, it should. Pay for delay settlements have raised concern across the globe and have led to significant competition law scrutiny in the US and Europe. Branded pharmaceutical companies use patent settlements to pay potential generic entrants in order to stay off the market, thereby reducing competition and harming consumers. This conduct has been found to be unlawful by the US Supreme Court and the EU General Court. In Japan, however, such anticompetitive settlements allegedly do not take place, despite offering similar economic incentives to pharmaceutical companies in the second largest pharmaceutical market in the world. This is intriguing and warrants close scrutiny. This article is the first to investigate, based on a comparative analysis with the US and EU whether or not the Japanese pharmaceutical sector is susceptible to pay for delay settlements. We come to the conclusion that the regulatory regime in Japan features the necessary prerequisites to make pay for delay settlements a feasible yet anticompetitive drug lifecycle management strategy. Pay for delay, Japan, pharmaceutical, US antitrust, competition, comparative analysis, theory of harm, Japanese Antimonopoly Act, Europe, patent settlement

Probabilistic Life-Cycle Management Framework for Ship Structures Subjected to Coupled Corrosion–Fatigue Deterioration Processes

Fatigue and corrosion are two major deterioration mechanisms of ship structures. These mechanisms can lead to a reduction of structural safety. When occurring simultaneously, corrosion can exacerbate fatigue crack growth by (1) altering the material property related to fatigue crack and (2) increasing the stress range due to cross-sectional loss. Therefore, to ensure adequate functionality of ship structures, effective life-cycle management, including timely inspections and appropriate repair actions, should consider these two major deterioration mechanisms as well as their coupled effects. In this paper, a probabilistic management framework is proposed for ship structures under coupled corrosion–fatigue deterioration processes. Various uncertainties arising from material properties, coupled corrosion–fatigue modeling, loading conditions, and inspection techniques are considered in the proposed framework. The detrimental effects of corrosion on fatigue crack growth are taken into account in life-cycle optimization of inspection/repair actions. It is found that the effects of corrosion on fatigue can significantly affect the results of the optimal life-cycle management strategy and, therefore, must be properly incorporated in the planning of life-cycle maintenance actions.

MBSE-integrated Parametric Working Surfaces as part of a PLM Design Approach

AbstractThis paper demonstrates a concept for a cross-domain strategy for the sustainable processing and dissemination of product information. Important functional product features are explicitly mapped as working surface information in different domain tools with the help of the contact channel method and are integrated using a model-based systems development approach. The approach uses established state of the art design tools and can be integrated into existing product development processes, knowledge based engineering concepts and product (system) lifecycle management strategies.

Life-Cycle Contract Management Strategies in US Highway Public–Private Partnerships: Public Control or Concessionaire Empowerment?

AbstractPublic–private partnerships (PPPs) are multilateral transactions implemented over long-time horizons; hence, they are complex arrangements that face various forms of uncertainty. These char...

Integrated automation for configuration management and operations in the ATLAS online computing farm

The online farm of the ATLAS experiment at the LHC, consisting of nearly 4000 PCs with various characteristics, provides configuration and control of the detector and performs the collection, processing, selection, and conveyance of event data from the front-end electronics to mass storage. Different aspects of the farm management are already accessible via several tools. The status and health of each node are monitored by a system based on Icinga 2 and Ganglia. PuppetDB gathers centrally all the status information from Puppet, the configuration management tool used to ensure configuration consistency of every node. The in-house Configuration Database (ConfDB) controls DHCP and PXE, while also integrating external information sources. In these proceedings we present our roadmap for integrating these and other data sources and systems, and building a higher level of abstraction on top of this foundation. An automation and orchestration tool will be able to use these systems and replace lengthy manual procedures, some of which also require interactions with other systems and teams, e.g. for the repair of a faulty node. Finally, an inventory and tracking system will complement the available data sources, keep track of node history, and improve the evaluation of long-term lifecycle management and purchase strategies.

Modularization as a system life cycle management strategy: Drivers, barriers, mechanisms and impacts

This literature-grounded research contributes to a deeper understanding of modularization as a system life cycle management strategy, by providing a comprehensive view of its key barriers, drivers, possible mechanisms of implementation and impact. This comprehensive view, arranged into a decision-making–driven ontology, enables a decision maker to systematically identify modularization implementation opportunities in different industrial and service domains. The proposed ontology transforms modularization into a fully operationalizable strategy and contributes to a paradigm shift in the understanding of modularization, from a pure design option (i.e. modularity) to a fully strategic choice that, by nature, impacts on many of the system’s life cycle phases and involves a number of stakeholders.

Life-cycle Asset Management in Residential Developments Building on Transport System Critical Attributes via a Data-mining Algorithm

Public transport can discourage individual car usage as a life-cycle asset management strategy towards carbon neutrality. An effective public transport system contributes greatly to the wider goal of a sustainable built environment, provided the critical transit system attributes are measured and addressed to (continue to) improve commuter uptake of public systems by residents living and working in local communities. Travel data from intra-city travellers can advise discrete policy recommendations based on a residential area or development’s public transport demand. Commuter segments related to travelling frequency, satisfaction from service level, and its value for money are evaluated to extract econometric models/association rules. A data mining algorithm with minimum confidence, support, interest, syntactic constraints and meaningfulness measure as inputs is designed to exploit a large set of 31 variables collected for 1,520 respondents, generating 72 models. This methodology presents an alternative to multivariate analyses to find correlations in bigger databases of categorical variables. Results here augment literature by highlighting traveller perceptions related to frequency of buses, journey time, and capacity, as a net positive effect of frequent buses operating on rapid transit routes. Policymakers can address public transport uptake through service frequency variation during peak-hours with resultant reduced car dependence apt to reduce induced life-cycle environmental burdens of buildings by altering residents’ mode choices, and a potential design change of buildings towards a public transit-based, compact, and shared space urban built environment.

A Capability Maturity Model for Life Cycle Management at the Industry Sector Level

One approach to incorporate environmental sustainability in organisations is the implementation of Life Cycle Management (LCM). LCM is a comprehensive and integrated approach for measuring and managing environmental impacts. Successful sector-wide uptake of LCM has the potential to enable the environmental impacts associated with an industry sector to be efficiently measured and managed in a continual improvement process. There is an opportunity for the New Zealand primary sector to strengthen its competitiveness in the global market place by demonstrating the environmental credentials of its products and supporting the country’s “green and clean” image. Previous research has identified the barriers and enablers to successful LCM uptake by New Zealand primary sector Small and Medium sized Enterprises (SMEs) in a sector-based context. This paper builds on that foundation and presents a Life Cycle Management Uptake Evaluation Framework (LUEF) that allows both individual organisations and industry sectors to identify the key factors affecting successful LCM uptake and assess their level of maturity for each factor. The key factors used in this study are structure, culture, resource availability, LCM strategy, knowledge, market requirements and communication. The study employed a qualitative methodology and used face-to-face interviews with different stakeholders in the value chain for the New Zealand kiwifruit sector to inform the development of the framework. In the framework, each factor is represented as a maturity scale to allow organisations as well as industry sectors to assess their position on the scale. This will help them to create a baseline assessment, both for themselves as an organisation, as well as on an industry sector level. The baseline assessment will allow them to identify areas for improvements, which can be tracked over time by checking the progress on the scales in the individual areas. It can also be used as a communication tool for stakeholders in the supply chain (e.g., growers, post-harvest operators and staff from industry boards). These stakeholders can use the tool to measure and compare performance, including evaluating their own performance against the industry average, as well as performance of the industry sector over time. This is useful to engage these stakeholders and demonstrate that changes (such as reducing carbon footprints) have a positive impact and lead to progress (as well as highlighting any actions that need to be reviewed and adjusted).

Managing on-load tap changer life cycle in tenaga nasional berhad (TNB) distribution power transformers

TNB has developed an asset management framework in accordance with ISO 55001:2014. One of the key elements of the framework is the asset life cycle management. This study presents TNB experience in managing the on-load tap changers (OLTC) over their complete lifecycle to improve performance and reliability. Using failure mode, effect and criticality analysis based on the previous failure data, lifecycle management strategies for OLTC have been identified. It covers the main activities over the lifecycle stages namely design, operation and maintenance. Adoption of new technology in the design, enhancement in condition assessment and effective implementation of condition-based maintenance were amongst the strategies implemented. Finally, these strategies were validated through field evaluation and lifecycle cost analysis prior to the successful implementation throughout TNB.

PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes.

The International Council for Harmonisation Quality Guideline 10 (ICH Q10) describes the Pharmaceutical Quality System (PQS), indicating it is intended to apply throughout a product9s lifecycle, in conjunction with good manufacturing practice (GMP) requirements, in order to achieve quality in a consistent and reproducible manner. Implementation of an effective PQS is essential for a company to achieve product realization, establish and maintain a state of control, and facilitate continual improvement (1). When changes are made during the commercial life of a product, an effective PQS, product and process understanding, and use of quality risk management should ensure that product quality, patient safety, and adequate supply to patients are maintained; this, according to ICH Q10-Annex 1, should provide companies the opportunity to manage post-approval changes (PAC) with reduced regulatory oversight (1). But what exactly constitutes an effective PQS? And how does it support change management for PACs? This paper intends to answer these questions and guide companies to seize the opportunities outlined in ICH Q10-Annex 1, to manage product and process changes within the PQS, and downgrade the level of regulatory submission required. This is the second of a series of PDA Points to Consider papers on technical product lifecycle management; the first paper focused on the technical product lifecycle management strategy including communication and knowledge exchange between Marketing Authorization Holders and Health Authorities.

Carbon footprint assessment of recycling technologies for rare earth elements: A case study of recycling yttrium and europium from phosphor

Rare earth elements are key raw materials in high-technology industries. Mining activities and manufacturing processes of such industries have caused considerable environmental impacts, such as soil erosion, vegetation destruction, and various forms of pollution. Sustaining the long-term supply of rare earth elements is difficult because of the global shortage of rare earth resources. The diminishing supply of rare earth elements has attracted considerable concern because many industrialized countries regarded such elements as important strategic resources for economic growth. This study aims to explore the carbon footprints of yttrium and europium recovery techniques from phosphor. Two extraction recovery methods, namely, acid extraction and solvent extraction, were selected for the analysis and comparison of carbon footprints. The two following functional units were used: (1) the same phosphor amounts for specific Y and Eu recovery concentrations, and (2) the same phosphor amounts for extraction. For acid extraction method, two acidic solutions (H2SO4 and HCl) were used at two different temperatures (60 and 90°C). For solvent extraction method, acid leaching was performed followed by ionic liquid extraction. Carbon footprints from acid and solvent extraction methods were estimated to be 10.1 and 10.6kgCO2eq, respectively. Comparison of the carbon emissions of the two extraction methods shows that the solvent extraction method has significantly higher extraction efficiency, even though acid extraction method has a lower carbon footprint. These results may be used to develop strategies for life cycle management of rare earth resources to realize sustainable usage.

EU and US Approaches to Delayed Access to Generic Drugs by Enforcement of a Patent or SPC Procured by Fraud

This article examines the impact of pharmaceutical patent protection on the introduction of generic drugs on the market. Basing itself on the Court of Justice of the European Union (CJEU) AstraZeneca case and US case law it examines, in particular, the way in which pharmaceutical companies may have created artificial barriers to entry for the market launch of generic drugs, so as to maintain market dominance by way of “life cycle management strategies”. Moreover, it compares the different ways, in which the EU and US have chosen to address the problem of the abuse of regulatory procedures by fraud with its purpose of delaying generic drug approvals. It also seeks to answer the question of whether the existence of a legal entitlement to a patent under the rules of patent law excludes competition-law liability.

Research on Building Information Model (BIM) Technology

All above<strong> </strong>this paper is to give the BIM scientific definition, describes the BIM six technical characteristics and points out the essence of BIM Technology, creatively put forward the mature styling BIM seven technical standards, depicting the BIM Technology Development Tools, and other technical fusion development realize the feasibility of the technical route, show the BIM building life cycle management strategies and methods based on, from the two dimensions of qualitative and quantitative, symbiosis is the example of the fused BIM Technology and energy consumption analysis tool. In the realization of green, smart and sustainable design BIM technology advantages to focus attention, the article finally, the BIM technology in China's engineering practice in the application of the prospects for the future.

Research on Building Information Model (BIM) Technology

All above<strong> </strong>this paper is to give the BIM scientific definition, describes the BIM six technical characteristics and points out the essence of BIM Technology, creatively put forward the mature styling BIM seven technical standards, depicting the BIM Technology Development Tools, and other technical fusion development realize the feasibility of the technical route, show the BIM building life cycle management strategies and methods based on, from the two dimensions of qualitative and quantitative, symbiosis is the example of the fused BIM Technology and energy consumption analysis tool. In the realization of green, smart and sustainable design BIM technology advantages to focus attention, the article finally, the BIM technology in China's engineering practice in the application of the prospects for the future.

An Approach to Sustainable Product Lifecycle Management (Green PLM)

Sustainable development has been, is and will be one of the worldwide main issues. Many initiatives have been launched to drive global conscientiousness to the problem of the impact of manufactured products. In order to become a “green company”, eco-brands and recycling are well understood but many initiatives are in silos and the unintended wasteful impact to other activities in the company is not always noticed. The key of sustainability also covers all the in-between activities and it depends on a real commitment of society, research and manufacturing firms. The factory of the future must have a Green Product Lifecycle Management strategy sharing responsibilities within the whole supply chain that must be achieved through committed people. The present work describes an approach to green product lifecycle involving mainstay phases: design, manufacturing and service, including usability and renewal. The contribution suggests a framework for sustainable product development that takes the whole product lifecycle into account.

Validation process model for product lifecycle management

Nowadays people demand outstanding products: easy-to-use, easy-to-understand, and worry-free. This objective can be ensured only through validation processes that are managed in a quality management system. Manufacturing companies often confuse validation with or reduces it to verification procedures. This is usually due to the unfamiliarity of these companies with managing the complex heterogeneous information necessary for integrating customer voice into testing activities. This paper proposes a model for integrating validation processes into a product lifecycle management strategy, which allows customers to actually feedback on the design. The model achieves a human-centred design through usability-engineering methods and has been tested on the case study of a board game for visually impaired people.

Bridging the gap between product lifecycle management and sustainability in manufacturing through ontology building

Green manufacturing has been a major concern in recent years. As product lifecycle management strategies embrace sustainability within its spectrum of multi-disciplinary efforts, it has become crucial that manufacturing companies have the ability to exchange product and process related data with emphasis on sustainability not only amongst its internal information systems like CAD, CAPP and ERP, but also throughout their supply chain and other stakeholders. Industry demands solutions for interoperability between heterogeneous systems that can account for the necessary semantics in order to establish seamless, unambiguous information sharing of data from a product's cradle to its grave. One of the most promising approaches to overcome these issues is the use of ontologies that serve as interlingua, for translating between local data structures. The present research proposes an ontology that relates sustainability terms to product and process data entities through semantic ties.