• Title/Summary/Keyword: Data exclusivity

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Pharmaceutical Data Exclusivity - Comparative Study and Future Direction in Korea (의약품 자료독점제도의 국가별 현황과 국내 제도의 발전방향)

  • Park, Syl-Vi-A
    • Journal of Pharmaceutical Investigation
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    • v.39 no.4
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    • pp.299-307
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    • 2009
  • Data exclusivity is one of the most important intellectual property rights of pharmaceuticals. During data exclusivity period, third parties are prohibited from relying on the data which the original company has submitted to regulatory authority for drug application. I investigated data exclusivity systems for pharmaceuticals in the US, EU, Canada and Korea. New chemical entities were usually given the longest periods of data exclusivity compared to drugs with new indication or new formulation, although the protection periods varied by country. For new drugs to be entitled to a data exclusivity, strict conditions should be met. Data exclusivity has also been provided as an incentive to promote clinical investigation and drug development for pediatric population or orphan diseases. In Korea, data exclusivity was adopted in 1995 as an additive provision to "drug re-examination" which is to investigate post-marketing safety information of new drugs. It was introduced with few discussion on the purposes or effects of data exclusivity on pharmaceutical industry and pharmaceutical market in this country. I found that Korea's data exclusivity system falls short of considerations on valuing innovation of pharmaceutical research. It is necessary to improve data exclusivity system in order to promote innovative pharmaceutical development and to balance intellectual property rights protection and access to drugs in this country.

Netflix in Indonesia: Influential Factors on Customer Engagement among Millennials' Subscribers

  • AUDITYA, Annisa;HIDAYAT, Z.
    • Journal of Distribution Science
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    • v.19 no.1
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    • pp.89-103
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    • 2021
  • Purpose: This study is to explore how Netflix Customers' Engagement was influenced by Instagram Content, Perceived Price, Exclusivity, and Motivation in the context of Media Streaming and the role of Willingness to Subscribe as the mediating variable. This study underlines millennial's willingness to engage and the form of engagement. Research design, data, and methodology: The data for this research were collected from 100 Netflix's Millennials subscribers who follow @netflixid Instagram. All the results were analyzed and verified using SEM-PLS. Results: Research findings indicated that Willingness to Subscribe, Exclusivity, Motivation, and Instagram Content positively influenced Customer Engagement among Netflix millennials' subscribers. In contrast, Perceived Price had a negative effect on Customer Engagement. Conclusions: As a consequence, the exclusivity that Netflix offers to its audience by a recommendation algorithm has been proven to increase the engagement. This study also disclosed that the most definite form of positive engagement shown by Netflix millennials' subscribers is a behavioral aspect, where they positively recommend Netflix (word of mouth). The study findings can be a reference for the media streaming industry in their efforts to strengthen the engagement with their customers, especially the millennials, and provide knowledge about consumer behavior in digital technology.

The Effects of Luxury Fashion Platforms' Attributes on Consumer eWOM (럭셔리 패션 플랫폼 속성이 온라인 구전의도에 미치는 영향)

  • Kim, Suzy;Hur, Hee Jin;Choo, Ho Jung
    • Journal of the Korean Society of Clothing and Textiles
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    • v.45 no.4
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    • pp.685-702
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    • 2021
  • This study aims to discover how the perceived attributes of luxury fashion platforms affect consumer trust and satisfaction as well as online word-of-mouth intention. Based on a literature review, this study derived four dimensions of perceived attributes: brand assortment size, exclusivity, convenience, and personalization. The paper presents findings from an online survey targeting 359 consumers in their 20s to 30s who had recent experience with luxury fashion platforms. Based on the collected data, a structural model equation analysis was performed using AMOS 22.0 and SPSS 26.0. The findings illustrated that brand assortment size, exclusivity, and personalization had positive effects on consumers' platform trust. In addition, brand assortment size and convenience had a positive impact on satisfaction. Overall, the findings of the study illustrate that perceived attributes of luxury fashion platforms have a significant impact on consumers' platform trust and satisfaction and online word-of-mouth intentions. This study reveals that consumers' trend orientation moderates the effects of consumer attitude and behavioral intention. The academic practice of this study has laid the foundation for understanding mechanisms of marketing strategies by providing the characteristics of platforms in the luxury fashion industry.

The Pharmaceuticals Regime in the KORUS FTA and the TPP Agreement: A Comparative Analysis (한미FTA와 TPP협정의 비교분석을 통한 의약품 분야 국제통상규범에 대한 연구)

  • Yun, Mikyung
    • International Commerce and Information Review
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    • v.18 no.4
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    • pp.165-193
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    • 2016
  • This paper conducts a comparative analysis of the KORUS FTA and the TPP Agreement to assess the current state of affairs in international trade rules for the pharmaceutical industry. Intellectual property rights as well as public health related regulations have evolved to strengthen the position of innovator drug companies. In particular, the TPP Agreement which adopted data exclusivity for biologics for the first time, will set the standard for the future. Apart from this however, the TPP Agreement has not gone further than the KORUS FTA and in some respects, even contains greater policy flexibilities and provisions for market access than the KORUS FTA. Korea should take advantage of such differences when and if she must engage in negotiations to join the TPP Agreement or a renegotiation of the KORUS FTA.

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A Study on Energy Platform Using Data in the US: Based on Opening Platform Model

  • Song, Minzheong
    • International journal of advanced smart convergence
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    • v.10 no.3
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    • pp.41-50
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    • 2021
  • The purpose of this study is to analyze various energy platforms using data in the US and to suggest directions and implications. Some of the leading energy platforms are selected and analyzed based on the opening platform model. We focus on the case analysis of the US utility companies. In case of the horizontal open platform, Green Button sponsor's 'Connect My Data (CMD)' driven by the government invites the utility companies to jointly develop the sponsor's data solution. In case of the vertical open platform, the certification program 'Share My Data (SMD)' allows backward compatibility, because the technical improvement is minimal. The utility companies benchmark Amazon's three-sided market mediation and prefer platform and category exclusivity. For the former, they have data analytics companies like Enervee, Opower and for the latter, they have electronics manufactures and energy service providers (ESPs) like Distributed Energy Resources (DERs). Based on this US case study, we suggest the energy platforms to open their platform for renewable energy supply, energy conservation, high-efficiency products, and residential DER dissemination. To successfully implement the government's energy transition policy, the US platforms should be benchmarked as a business model. Especially, it is needed for them to coordinate a platform ecosystem. To ensure trust in the products and services offered on the marketplace platform, platform's certification program is helpful.

A Model for Machine Fault Diagnosis based on Mutual Exclusion Theory and Out-of-Distribution Detection

  • Cui, Peng;Luo, Xuan;Liu, Jing
    • KSII Transactions on Internet and Information Systems (TIIS)
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    • v.16 no.9
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    • pp.2927-2941
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    • 2022
  • The primary task of machine fault diagnosis is to judge whether the current state is normal or damaged, so it is a typical binary classification problem with mutual exclusion. Mutually exclusive events and out-of-domain detection have one thing in common: there are two types of data and no intersection. We proposed a fusion model method to improve the accuracy of machine fault diagnosis, which is based on the mutual exclusivity of events and the commonality of out-of-distribution detection, and finally generalized to all binary classification problems. It is reported that the performance of a convolutional neural network (CNN) will decrease as the recognition type increases, so the variational auto-encoder (VAE) is used as the primary model. Two VAE models are used to train the machine's normal and fault sound data. Two reconstruction probabilities will be obtained during the test. The smaller value is transformed into a correction value of another value according to the mutually exclusive characteristics. Finally, the classification result is obtained according to the fusion algorithm. Filtering normal data features from fault data features is proposed, which shields the interference and makes the fault features more prominent. We confirm that good performance improvements have been achieved in the machine fault detection data set, and the results are better than most mainstream models.

The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

  • Park, Jeehye
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.223-259
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    • 2020
  • With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

A Research on Emotion Assessment by Touch Sensibility Flicking on Mobile Phone (터치폰 인터랙션의 Flicking에 대한 감성 터치감에 대한 연구)

  • Kim, Ji-Hye;Whang, Min-Cheol;Kim, Chi-Jung;Park, Jea-Un;Moon, Sung-Cheol
    • Journal of the Ergonomics Society of Korea
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    • v.29 no.4
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    • pp.533-540
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    • 2010
  • This study was to suggest the proper level of touch sensibility for twenties while flicking touch phones. A rapid prototype of $480{\times}800$ pixel size was developed for the experiment. Participants were 20 undergraduates, not visually and physically handicapped in using touch phones. 15 different modes, with each mode changing in velocity when flicking the prototype were randomly presented to each subject. The subjects were asked to score what they felt in each mode on a 1-to-6 Likert scale. The data was analyzed by the one-way ANOVA procedure. Each mode showed significant differences in 8 representative emotions except for exclusivity feeling and fresh feeling. Each velocity mode was scaled by the multidimensional scaling technique. Then, vector coordinates in each emotion were obtained by simple regression analysis. 15 velocity modes and each emotion were joint-plotted by the MDS, PROXSCAL. The findings in this study could be basic data for studying affective touch sensibilities in multiple ways.

Effect of Special Order Products and Mobile SNS Promotions on Perceived Brand Luxury and Brand Relationship (스페셜 오더 상품과 모바일 SNS 홍보 전략이 브랜드 럭셔리 및 브랜드 관계에 미치는 영향)

  • Lee, Kyejung;Lee, Eun-Jung
    • Fashion & Textile Research Journal
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    • v.19 no.4
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    • pp.411-420
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    • 2017
  • With the increasing popularization of low-priced luxury markets, maintaining the genuine values of luxury has become crucial for luxury fashion brands to attract customers who want exclusivity and rarity. The world-leading luxury fashion houses have employed a variety of experiential marketing strategies like special order product strategies and mobile SNS promotion strategies, yet little research exists on there the strategies actually positively impact brand luxury images and customer attitudes towards the brand. This study empirically analyzed the effects of customer experience of special order products on perceived brand luxury and brand relationship. Furthermore, the study also tested relationships among perceived brand luxury, brand relationship, and brand loyalty. A survey was conducted with Korean female consumers who had purchase experiences of special order products from the brands. We analyzed the data of MTO-experienced respondents due to the lack of respondents who had experienced custom-made product services. The result indicates the significant effect of experience of MTO on brand relationship; however, we found only a partial support for the effect of MTO on brand luxury. Likewise, we found a partial support for the effect of mobile SNS promotion strategies on perceived brand luxury versus full support for the effect on brand relationship.

The Research on Aesthetic Characteristics of Storytelling Expressed in Modern Fashion Photographs - With a Focus on Steven Meisel's Fashion Photos - (현대 패션사진에 나타난 스토리텔링의 미적 특성 - 스티븐 마이젤 패션사진을 중심으로 -)

  • Park, Mi-Joo;Yang, Sook-Hi
    • The Research Journal of the Costume Culture
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    • v.17 no.1
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    • pp.132-148
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    • 2009
  • The objective of this article is to examine the possibility of 'story-telling' as united concept of causality and subjectivity through sequence combination, and the 'similarity' between object and image in fashion photographs making diversity of meanings. To analyze and investigate the research, as evidential data this paper used the photos of Steven Meisel from 2002 till 2007 Vogue published in Korea, U.S, and Italy, as well as other visual data like graphic collections, catalogs, art-related data and internet data. This research runs both theoretical and positive investigations to suggest the function of story-telling in the Process of opened-communicative roles of fashion photos. Thus this paper investigated Steven Meisel's storytelling in his fashion photos; short moment of event, continuity of time, compound of sequence, and complexity of viewpoint. This paper also studied the aesthetic characteristics of Steven Meisel's fashion photos as categories of overlapped meaning, arbitrariness of interpretation, exclusivity of message, and decoding. The research result suggests that clothing not only includes current age's value but also among social constitutions it includes multilateral characteristics. Ultimately this paper is also making meaning alive by cutting off the chain of 'firm' meanings of fashion photo. That seems like opening the opportunity for correctly understanding fashion's meaning which has the aspects of ambivalence of changing meanings and values by the motivation of context and text.

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