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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.

Study on the Characteristics of Heart Rate Variability, Body component analysis and accompanying symptoms in 175 Insomnia Patients (불면환자 175명의 심박변이도, 체성분 분석 및 동반증상의 특징에 관한 연구)

  • Ha, Ji-Won;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.21-39
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    • 2010
  • Objectives : This study was to investigate the characteristics of the heart rate variability(HRV), types of insomnia and accompanying symptoms of 175 insomnia patients. Methods : For this study we carried out HRV, Inbody of 175 patients with insomnia who have come to Dongeui oriental hospital of Dongeui university from the period of Janaury 2008 to September 2010. We studied the association of the insomnia patients' age and gender with HRV, accompanying symptoms and the types of insomnia. The information of the accompanying symptoms and types of insomnia was based on each patients' progress note. Results : l. There was no significant differences in the characteristics of HRV between male and female. 2. The most frequent symptom shown among the insmonia patents' was headache(41.14%). 3. Comparing the symptoms between the gender, female patients had more dry mouth, alternative periodic chill and fever, and hot flush symptoms than the male patients. 4. Comparing the symptoms between the age groups(divided in two), the lower age group (20~59) had more dizziness and constipation symptoms than the higher age group (over 60). 5. Comparing the types of insomma between the age group, the higher age group (over 60) had more termination insomnia. 6. The types of insomnia of the entire insomnia patients were onset insomnia (73.1%), maintenance insomnia(20.6%), termination insomma(l7.1 %), shallow sleep (52.6%), listed by order of frequency. 7. The patients who takes hypnotics had more anorexia symptoms than the patients who doesn't take hypnotics. 8. There was no visible differences of the average fractal portrait between male and female. The age group of 20~30yrs. had the highest average fractal portrait, and the age group of 30~59yrs. the second highest, and the age group over 60yrs. the lowest. 9. The average of the regulation reserves of the autonomic nervous system(B2) - was lower than the regulation level of the ANS at the present (Bl). 10. When compared the priority of the function of the ANS, it showed that the proportion of HF($38.61{\pm}29.19%$)was the most, and than VLF($30.65{\pm}23.36%$), LF($20.04{\pm}19.13%$) the least. 11. The average of the compensation level of the central nervous system at present(Cl) - was lower than the compensation reserves of the CNS(C2). 12. The average of the control reserves of the cerebrum(D2) - was lower than the control level of the cerebrum at the present (Dl). 13. There was no visible differences between different sexes and ages in pulse rate. 14. The abdomen fat ratio above the line of the insomnia patients was 77.97% in male and 93.1% in female. Both sexes showed that insomnia patients had more abdomen fat that the standard, and female patients had more abd. fat than male patients. Conclusions : This study shows that the HRV of insomnia patients had no significant differences between gender. Fractal portrait, HF, LF and VLF of the insomnia patients are in inverse proportion to the age. The study of the Body Component Analysis showed that female had more abdomen fat than male, and both gender showed more abdomen fat than the standard. When looked into the accompanying symptoms of the insomnia patients, the symptoms show differences according to gender, age and hypnotics taking, as shown as below. In the entire patients, Headache was the most accompanying symptom. Female had more dry mouth, alternative periodic chill and fever, and hot flush symptoms than male. Higher age groups had more dizziness and constipation as accompanying symptoms than lower age groups. Patients who takes hypnotics had more anorexia than those who dont.

Is Preventive Bilateral Surgery Needed in Case of Bilateral Bullae on HRCT at Unilateral Primary Spontaneous Pneumothorax (일차성 자연기흉의 고해상 CT에서 보이는 반대편 기포의 예방적 기포절제술이 필요한가?)

  • Han, Jong-Hee;Kang, Min-Woong;Yu, Jeong-Hwan;Kim, Yong-Ho;Na, Myung-Hoon;Lim, Seung-Pyung;Lee, Young;Yu, Jae-Hyeon
    • Journal of Chest Surgery
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    • v.40 no.3 s.272
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    • pp.215-219
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    • 2007
  • Background: Due to the advancement of video assisted thoracoscopic techniques, an operation for primary spontaneous pneumothorax is now considered a common procedure. However, whether a preventive operation is necessary when a contralateral bulla is found on High Resolution Computed Tomography (HRCT) at the time of the first primary spontaneous pneumothorax attack is still unknown. In this retrospective study, it was our intension to find whether contralateral bullae are related to the occurrence of pneumothorax. Material and Method: Between January 1999 and April 2006, 550 patients were admitted to the Chungnam University hospital with primary spontaneous pneumothorax, which was confirmed by the HRCT scans in 190 patents. In these 190 patients, 159 had not received a bilateral operation after their first primary spontaneous pneumothorax attack. In these 159 patients, the relationship between the presence of contralateral bullae and the occurrence of pneumothorax was measured. Result: In these 159 patients, 67 had contralateral bullae confirmed inform the HRCT scan, and 92 had no visible contralateral bullae, During the follow up period, 6 patients (8.9%) with contralateral bullae had an occurrence of contralateral pneumothorax, and 5 patients (5.4%) without contralateral bullae had an occurrence of contralateral pneumothorax. (p=0.529 [Fisher's exact test]) Conclusion: In patients with unilateral primary pneumothorax, an HRCT scan is a useful way of confirming contralateral pulmonary bullae. However, the presence of bullae is not a significant predictive sign of an occurrence of contralateral pneumothorax. Also, surgery for pneumothorax is not completely uncomplicated, and bilateral surgery is still doubtful. A further prospective study will be required to find the relationship between the bullae found on HRCT and the occurrence of pneumothorax.

Effect of Oral Healthcare Program of Exemplary Kindergartens for Prevent the Dental Caries in Incheon City, Korea (치아우식증 예방을 위한 모범 유치원 구강건강관리프로그램 효과 - 인천 일부지역 유치원을 중심으로)

  • Ahn, Se-Youn;Hwang, Yoon-Sook;Han, Su-Jin
    • Journal of dental hygiene science
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    • v.13 no.4
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    • pp.501-509
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    • 2013
  • The purpose of the study is to confirm the effect of the oral health management program in exemplary kindergartens for prevent the dental caries. The study performs the survey on the parents about the changes in the oral health behaviors after the oral health education in April 2012 and measures the patient hygiene performance (PHP) index before the education, after the education and 3 weeks after the education to assess the removal capability to plaque on the teeth surface for the children. The analysis is performed on 130 people who join the program and respond the survey. There is no change in the behavior related to the tooth brushing of children after the oral health education. No change is found from the interest in the oral health education (p>0.05) but the recognition in the importance of the tooth positively change, as well as recognition of the tooth brushing method and the reaction to recommending to tooth brushing. The PHP index of children is significantly improved from 3.87 before the education through 2.71 after the education and 3.27 3 weeks after the education (p<0.001). The observation from the patents shows that their children have interest in preventing the cavities including 33.1% after having xylitol and 60.7% after the oral health education. In conclusion, the study confirms the effect of the oral health management program in exemplary kindergartens to prevent the cavities, meaning that it is required to activate the programs and keep implementing the programs including providing xylitol and education for teachers, parents and children to habituate the oral health behavior of the children and completely learn toothbrushing method under continuous management and reeducation.

The knowledge and human resources distribution system for university-industry cooperation (대학에서 창출하는 지적/인적자원에 대한 기업연계 플랫폼: 인문사회계열을 중심으로)

  • Park, Yoon-Joo
    • Journal of Intelligence and Information Systems
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    • v.20 no.3
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    • pp.133-149
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    • 2014
  • One of the main purposes of universities is to create new intellectual resources that will increase social values. These intellectual resources include academic research papers, lecture notes, patents, and creative ideas produced by both professors and students. However, intellectual resources in universities are often not distributed to the actual users or companies; and moreover, they are not even systematically being managed inside of the universities. Therefore, it is almost impossible for companies to access the knowledge created by university students and professors to utilize them. Thus, the current level of knowledge sharing between universities and industries are very low. This causes a great extravagant with high-quality intellectual and human resources, and it leads to quite an amount of social loss in the modern society. In the 21st century, the creative ideas are the key growth powers for many industries. Many of the globally leading companies such as Fedex, Dell, and Facebook have established their business models based on the innovative ideas created by university students in undergraduate courses. This indicates that the unconventional ideas from young generations can create new growth power for companies and immensely increase social values. Therefore, this paper suggests of a new platform for intellectual properties distribution with university-industry cooperation. The suggested platform distributes intellectual resources of universities to industries. This platform has following characteristics. First, it distributes not only the intellectual resources, but also the human resources associated with the knowledge. Second, it diversifies the types of compensation for utilizing the intellectual properties, which are beneficial for both the university students and companies. For example, it extends the conventional monetary rewards to non-monetary rewards such as influencing on the participating internship programs or job interviews. Third, it suggests of a new knowledge map based on the relationships between key words, so that the various types of intellectual properties can be searched efficiently. In order to design the system platform, we surveyed 120 potential users to obtain the system requirements. First, 50 university students and 30 professors in humanities and social sciences departments were surveyed. We sent queries on what types of intellectual resources they produce per year, how many intellectual resources they produce, if they are willing to distribute their intellectual properties to the industries, and what types of compensations they expect in returns. Secondly, 40 entrepreneurs were surveyed, who are potential consumers of the intellectual properties of universities. We sent queries on what types of intellectual resources they want, what types of compensations they are willing to provide in returns, and what are the main factors they considered to be important when searching for the intellectual properties. The implications of this survey are as follows. First, entrepreneurs are willing to utilize intellectual properties created by both professors and students. They are more interested in creative ideas in universities rather than the academic papers or educational class materials. Second, non-monetary rewards, such as participating internship program or job interview, can be the appropriate types of compensations to replace monetary rewards. The results of the survey showed that majority of the university students were willing to provide their intellectual properties without any monetary rewards to earn the industrial networks with companies. Also, the entrepreneurs were willing to provide non-monetary compensation and hoped to have networks with university students for recruiting. Thus, the non-monetary rewards are mutually beneficial for both sides. Thirdly, classifying intellectual resources of universities based on the academic areas are inappropriate for efficient searching. Also, the various types of intellectual resources cannot be categorized into one standard. This paper suggests of a new platform for the distribution of intellectual materials and human resources, with university-industry cooperation based on these survey results. The suggested platform contains the four major components such as knowledge schema, knowledge map, system interface, and GUI (Graphic User Interface), and it presents the overall system architecture.

Psychology and Quality of Life in Cancer Patients on Radiation Therapy (방사선치료 중인 암 환자의 심리와 삶의 질)

  • Yang Jong-Chul;Chung Woong-Ki
    • Radiation Oncology Journal
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    • v.22 no.4
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    • pp.271-279
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    • 2004
  • Purpose: The object of this study Is to investigate sociodemographic and clinical characteristics, psychology, self-esteem and quality of life in cancer patients on radiation therapy and to provide useful information for therapeutic approach to cancer patients on radiation therapy. Materials and Methods: The subjects were 36 patents who had been treated with radiation therapy and 20 normal people. Sociodemographic information and clinical characteristics of cancer patients on radiation therapy were investigated, and symptom checklist-90-revised, Rosenberg Self-esteem Scale for self esteem, World Health Organization Quality of Life Assessment Instrument for quality of life were administered to subjects. And Spearman's correlation analysis was used among these. Result : The tendency of somatization, depression, anxiety and hostility in cancer group were significantly higher than normal group. Self esteem and quality of life in cancer group were significantly lower than normal group. No significant difference was found in comparison of psychology, self esteem and qualify on life according to sociodemographic variables. Among clinical characteristics, in the presence of metastasis in cancer patients, the scores of anxiety, phobia and paranoid ideation were higher In patients with pain, the score of somatization was higher And in case of weight loss, the score of somatization was higher. The higher score of depression, anxiety and hostility were significantly associated with lower self-esteem. And higher score of somatization, depression, anxiety and hostility were significantly associated with lower quality of life. Conclusion: Understanding and management of psychological symptoms, such as somatization, depression, anxiety, and hostility, and pain control are necessary to improve quality of life in cancer patients on radiation therapy.

A Study on the Effect of Patent Management on New Business Development Performance : Focusing on the Mediation Effect of Convergence Expert Cooperation (특허경영이 신사업 개발 성과에 미치는 영향에 관한 연구: 융합 전문가 협동의 매개효과 중심으로)

  • Jeong, Un Seob;Ha, Kyu Soo
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.14 no.4
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    • pp.19-38
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    • 2019
  • This study is a study on the effect of patent management on the performance of new business development, focusing on fusion expert collaboration. In the past, most studies on patent management have been influenced by the quantitative patent index on the business performance. Therefore, research on the effect of patent management on the performance of new business development through the cooperation of fusion experts was very insufficient. Therefore, this study examined the influence of existing patent management on the performance of new business development and the causal relationship between the influence of patent management on new business development performance, focusing on fusion expert collaboration. The results of the hypothesis empirical analysis are as follows. First, patent management showed positive (+) influence on convergence expert cooperation. Patents management has a positive effect on fostering convergence specialists and utilizing convergence experts. Second, patent management has a positive effect on new business development performance. Patent management has a positive effect on the success of the business, the achievement of target sales, the development of new markets, the development of new technologies, and the degree of reflection of customer requirements. Third, patent management mediated by convergence expert cooperation has a negative effect on financial aptitude among new business development outcomes. The results of this study are as follows. First, it is concluded that patent management through mediation of convergence expert cooperation has a positive effect on non - financial performance of new business development performance. Financial performance includes business success and achievement of target sales. Non-financial performance includes new technology development and new market development. Therefore, in order to continuously generate business performance of domestic convergence new business development companies, it suggests that we should make efforts to be linked with new business development performance through revitalization of patent management centered on convergence expert cooperation that has positive (+) influence.

Step-by-Step Growth Factors for Technology-Based Ventures: A Case Study of Advanced Nano Products Co. Ltd (기술기반 벤처기업의 단계별 성장요인: (주)나노신소재 사례 중심으로)

  • Jeong, Chanwoo;Lee, Wonil
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.16 no.6
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    • pp.85-105
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    • 2021
  • In this study, a case study was conducted on Advanced Nano Products Co.,Ltd, a company that was established in 2000 and has the core technology to produce and commercialize nano materials and ultrafine nano powders based on nano technology. Deviating from the general case study, a case study analysis frame was set based on the theory of technology management and industry-university cooperation theory, and cases were analyzed. In this case study, Advanced Nano Products Co.,Ltd. was analyzed from two analytical perspectives: the establishment of a Management Of Technology system within the company and the Industry-Academic Cooperation activity. Based on this theoretical-based analysis framework, company visit interviews and related data research and analysis were conducted. As a result of the study of the case company, it was possible to derive how the technology management and industry-university cooperation affect the growth stage of the company as follows. First, the strategic use of technology management is an important factor in strengthening the competitive advantage and core competencies of venture companies, and for survival and growth of startups in the early stages. Second, strategic use of technology management and patents and establishment of a patent management system are a part of business strategy and play a pivotal role in corporate performance. Third, the human and material infrastructure of universities affects the growth of companies in the early stage of start-up, and the high utilization of industry-university cooperation promotes the growth of companies. Fourth, continuous industry-academic cooperation activities in the growth and maturity stages of a company's growth stage are the basis for activating external exchanges and building networks. Lastly, technology management and industry-university cooperation were found to be growth factors for each growth stage of a company. In order for a company to develop continuously from the start-up to the growth and maturity stages, it is necessary to establish a technology management system from the beginning and promote strategic technology management activities. In addition, it can be said that it is important to carry out various industry-academic cooperation activities outside the company. As a result of the case analysis, it was found that Advanced Nano Products Co.,Ltd, which performed these two major activities well, overcame the crisis step by step and continued to grow until now. This study shows how the use of technology management and industry-academic cooperation creates value in each growth stage of technology-based venture companies. In addition, its active use will play a big role in the growth of other venture companies. The results of this case study can be a valid reference for growth research of technology start-up venture companies and related field application and utilization.

The Effects of Technological Competitiveness by Country on The Increase of Unicorn Companies (국가별 기술경쟁력이 유니콘기업 증가에 미치는 영향에 관한 연구)

  • Kyu Hoon Cho;Dong Woo Yang
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
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    • v.19 no.1
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    • pp.55-73
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    • 2024
  • Unicorn companies are attracting attention around the world as they are recognized for their high corporate value in a short period of time as an innovative business models. Their growth process presents good lessons for the startup ecosystem and have a positive impact on national economic development and job creation. However, previous studies related to unicorn companies are focused on 'event studies' and 'case studies' such as characteristics of founders, environmental factors, business models and success/failure cases of companies already recognized as unicorns rather than a multifaceted approach. The occurrence of unicorn companies and Macroscopic analysis of related factors is lacking. Against this background, this study are considering the characteristics of unicorns examined through previous research and the current status unicorns with a high proportion of technology companies, the purpose was to analyze the impact of the country's technological competitiveness, such as 'technology human resource index', 'R&D index', and 'technology infrastructure index', on the increase in unicorn companies. For statistical analysis, data published by various international organizations, the Bank of Korea, and Statistics Korea from 2017 to 2020 and unicorn company data compiled by CB Insights were used as panel data for 44 countries to be tested by multiple regression analysis. As a result of the study, it was confirmed that the number of science majors had a positive (+) effect on the increase of unicorn companies in the case of technology human resource index, and in the case of R&D index, the total amount of R&D investment had a positive (+) effect on the increase of unicorn companies, while the number of Triad Patents Families and the number of scientific and technological papers published had a negative (-) effect on the increase of unicorn companies. Finally, in the case of technology infrastructure index, it was confirmed that the number of the world's 500th-ranked universities had a positive (+) effect on the increase of unicorn companies. This study is the first to reveal the causal relationship between national technological competitiveness and unicorn company growth based on country-specific and time-series empirical data, which were insufficiently covered in previous studies. and compared to the UN's ranking of the global industrial competitiveness index and the OECD's total R&D investment by country, Korea is considered to have technological and growth potential, while the number of unicorn companies driving growth as leaders of the innovative economy is relatively small, so the research results can be used when establishing policies to discover and foster unicorn companies in the future.

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A Study on Web-based Technology Valuation System (웹기반 지능형 기술가치평가 시스템에 관한 연구)

  • Sung, Tae-Eung;Jun, Seung-Pyo;Kim, Sang-Gook;Park, Hyun-Woo
    • Journal of Intelligence and Information Systems
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    • v.23 no.1
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    • pp.23-46
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    • 2017
  • Although there have been cases of evaluating the value of specific companies or projects which have centralized on developed countries in North America and Europe from the early 2000s, the system and methodology for estimating the economic value of individual technologies or patents has been activated on and on. Of course, there exist several online systems that qualitatively evaluate the technology's grade or the patent rating of the technology to be evaluated, as in 'KTRS' of the KIBO and 'SMART 3.1' of the Korea Invention Promotion Association. However, a web-based technology valuation system, referred to as 'STAR-Value system' that calculates the quantitative values of the subject technology for various purposes such as business feasibility analysis, investment attraction, tax/litigation, etc., has been officially opened and recently spreading. In this study, we introduce the type of methodology and evaluation model, reference information supporting these theories, and how database associated are utilized, focusing various modules and frameworks embedded in STAR-Value system. In particular, there are six valuation methods, including the discounted cash flow method (DCF), which is a representative one based on the income approach that anticipates future economic income to be valued at present, and the relief-from-royalty method, which calculates the present value of royalties' where we consider the contribution of the subject technology towards the business value created as the royalty rate. We look at how models and related support information (technology life, corporate (business) financial information, discount rate, industrial technology factors, etc.) can be used and linked in a intelligent manner. Based on the classification of information such as International Patent Classification (IPC) or Korea Standard Industry Classification (KSIC) for technology to be evaluated, the STAR-Value system automatically returns meta data such as technology cycle time (TCT), sales growth rate and profitability data of similar company or industry sector, weighted average cost of capital (WACC), indices of industrial technology factors, etc., and apply adjustment factors to them, so that the result of technology value calculation has high reliability and objectivity. Furthermore, if the information on the potential market size of the target technology and the market share of the commercialization subject refers to data-driven information, or if the estimated value range of similar technologies by industry sector is provided from the evaluation cases which are already completed and accumulated in database, the STAR-Value is anticipated that it will enable to present highly accurate value range in real time by intelligently linking various support modules. Including the explanation of the various valuation models and relevant primary variables as presented in this paper, the STAR-Value system intends to utilize more systematically and in a data-driven way by supporting the optimal model selection guideline module, intelligent technology value range reasoning module, and similar company selection based market share prediction module, etc. In addition, the research on the development and intelligence of the web-based STAR-Value system is significant in that it widely spread the web-based system that can be used in the validation and application to practices of the theoretical feasibility of the technology valuation field, and it is expected that it could be utilized in various fields of technology commercialization.