• 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.

• Microbiology and Biotechnology Letters
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• v.50 no.4
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• pp.533-547
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• 2022

This study investigated the hair growth effect of Schisandra chinensis extract (TS-SC) and TS-SC fermented by Lactobacillus plantarum (TS-SCLF) on human dermal papilla cells (hDPCs). The production of vascular endothelial growth factor (VEGF), insulin-like growth factor 1 (IGF-1), keratinocyte growth factor/fibroblast growth factor 7 (KGF/FGF-7) and hepatocyte growth factor (HGF), transforming growth factor beta 1 (TGF-β1) were examined. The secretion rates of VEGF and KGF/FGF-7 were high in TS-SC, and the secretion rates of IGF-1 and HGF were high in TS-SCLF. TGF-β1 was inhibited in a concentration-dependent manner in all samples. Gene expression of VEGF, IGF-1, KGF, HGF and alkaline phosphatase, relevant to hair growth, were examined. The data revealed that TS-SC and TS-SCLF successfully promoted hair growth in hDPCs. The IGF-1 gene was expressed in a dose-dependent manner in TS-SCLF. These results indicate that TS-SC and TS-SCLF fermented extract effectively promoted hair growth and gene expression relevant to hair growth in hDPCs. Used in clinical trials the test substance 'CMK-LPF01' showed a statistically significant increase in the number of hairs at 8 weeks, 16 weeks, and 24 weeks compared to before product use, and a change in hair growth, a secondary efficacy evaluation variable. Through additional research in the future, it is expected that "CMK-LPF01" can be developed as a functional material that can help alleviate symptoms of hair loss.

• The Journal of the Korea Contents Association
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• v.11 no.12
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• pp.870-883
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• 2011

The primary purpose of this study is to examine the relationship between market orientation and new product performance in a manufacturing firms, and examines how product quality, employee satisfaction, and innovation speed play a mediating role between market orientation and new product performance. Based on relevant literature reviews, this study posits three mediators, that is, product quality, employee satisfaction, and innovation speed as key determinants of new product performance. And then we structured a research model and hypotheses about relationship between these variables. A total 159 usable survey responses of Korean food/pharmaceutical firms have been employed in the analysis. The data were analyzed with Amos12.0K. The results be summarized as follows: First, market orientation had a positive influence upon product quality, employee satisfaction, and innovation speed. Second, two mediators of employee satisfaction, innovation speed had a positive influence upon new product performance. Third, employee satisfaction had a positive influence upon product quality and innovation speed. According to the result of this research, a manufacturing firms have to focus on the market orientation and understand the role of product quality, employee satisfaction, and innovation speed mediators on the process between the market orientation and the new product performance.

• Journal of Microbiology and Biotechnology
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• v.31 no.3
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• pp.419-428
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• 2021

To efficiently recycle GH78 thermostable rhamnosidase (TpeRha) and easily separate it from the reaction mixture and furtherly improve the enzyme properties, the magnetic particle Fe3O4-SiO2-NH2-Cellu-ZIF8 (FSNcZ8) was prepared by modifying Fe3O4-NH2 with tetraethyl silicate (TEOS), microcrystalline cellulose and zinc nitrate hexahydrate. FSNcZ8 displayed better magnetic stability and higher-temperature stability than unmodified Fe3O4-NH2 (FN), and it was used to adsorb and immobilize TpeRha from Thermotoga petrophilea 13995. As for properties, FSNcZ8-TpeRha showed optimal reaction temperature and pH of 90℃ and 5.0, while its highest activity approached 714 U/g. In addition, FSNcZ8-TpeRha had better higher-temperature stability than FN. After incubation at 80℃ for 3 h, the residual enzyme activities of FSNcZ8-TpeRha, FN-TpeRha and free enzyme were 93.5%, 63.32%, and 62.77%, respectively. The organic solvent tolerance and the monosaccharides tolerance of FSNcZ8-TpeRha, compared with free TpeRha, were greatly improved. Using naringin (1 mmol/l) as the substrate, the optimal conversion conditions were as follows: FSNcZ8-TpeRha concentration was 6 U/ml; induction temperature was 80℃; the pH was 5.5; induction time was 30 min, and the yield of products was the same as free enzyme. After repeating the reaction 10 times, the conversion of naringin remained above 80%, showing great improvement of the catalytic efficiency and repeated utilization of the immobilized α-L-rhamnosidase.

• KIPS Transactions on Computer and Communication Systems
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• v.10 no.12
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• pp.329-342
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• 2021

The pharmaceutical industry is experiencing a productivity crisis with a low probability of success despite a long period of time and enormous cost. As a strategy to solve the productivity crisis, the use cases of Artificial Intelligence(AI) and Bigdata are increasing worldwide and tangible results are coming out. However, domestic pharmaceutical companies are taking a wait-and-see attitude to adopt AI platform for drug research. This study proposed a research model that combines the Value-based Adoption Model and the Innovation Resistance Model to empirically study the effect of value perception and resistance factors on adopting AI Platform. As a result of empirical verification, usefulness, knowledge richness, complexity, and algorithmic opacity were found to have a significant effect on perceived values. And, usefulness, knowledge richness, algorithmic opacity, trialability, technology support infrastructure were found to have a significant effect on the innovation resistance.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.18 no.9
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• pp.356-365
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• 2017

Most studies of the effects of corporate patents on managerial performance conducted to date have been based on internally-generated patents. However, global pharmaceutical and biotechnology companies acquire patents not only from internal research and development (R&D), but also through university-industry collaboration and purchase. Focusing on this issue, our study collected patents from various sources, including internal R&D, purchased patents, and university-industry collaboration, to examine the real effects more accurately. Additionally, our study used a finite time lag model to consider the time lag between patent and corporate performance. The results of the quantitative analysis of the relationship between patents and corporate financial performance revealed that patent quantitative levels had less impact on sales than other types. However, quantitative patents levels appeared to have a significant impact on market value. Moreover, quantitative patent levels appeared to moderate impact on corporate profit. Patents acquired by internal R&D had the greatest impact on market value, while purchased patents had the greatest impact on corporate profit and sales. The purchased patents had a significant effect on financial performance in the pharmaceutical and biotechnology companies because of the long time required and expense associated with R&D. Overall, the results of this study provide the basis for global pharmaceutical and biotechnology companies to configure an optimal patent portfolio.

• Journal of Technology Innovation
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• v.24 no.1
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• pp.143-167
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• 2016

The purpose of this study is to analyze changes of innovation activities and their performance in pre-IPO and post-IPO of KOSDAQ IPO listed companies in medical and pharmaceutical fields, which require high R&D investment, from 2000 to 2005 in Korea. The innovation efficiencies of the IPO companies were measured before and after three years based on the DEA model. The financial data and patent information of the listed company during total 6 years, which were 3 years before IPO and 3 years after IPO, were collected. The main results of this research are as follows. First, it took an average 12.86 years until IPO in the start-up of the IPO companies in the pharmaceutical sector, and innovation was on average more active than the IPO before. R&D investment was higher than the IPO before, and the number of the applied patent during 3 years after IPO was 16.67 which was increased from 8.43 during 3 years before IPO. In addition, the average scope of technology of the IPO companies was expanded from 11 to 22 technology fields during previous 3 year and after 3 year each, and financial growth after IPO was lower than the previous IPO. Second, the financial performance of R&D investment and the performance of patent activity were weakened in the efficiency after the IPO, and the integrated performance from the patenting activities and the R&D investment was decreased after the IPO. Finally, the efficiency of the financial performance of the patenting activity was lower than the efficiency of the financial performance of the patent and R&D investment and patent activities under the R&D investment. In particular, the inefficiency of the firms' patenting activities performance after the IPO was caused by the decreasing return to scale, according to the results of this study. This results implicate that the expansion of R&D investments through the IPO had not lead to the financial performance of the market, and that the overall inefficiency since the IPO is due to the inefficiencies at the stage for the outcome of innovation activity rather than the output obtained through the R&D investments that appear to lead the performance of the market.

• Journal of Technology Innovation
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• v.9 no.1
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• pp.167-187
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• 2001

Bioindustry is rapidly changing. Many biologists redefine biotechnlolgy as 'reprogramming the genetic codes of living things to suit cultural and economic needs and desires.'We regarded this change as the 'paradigm shift'in bioindustry. The genome research is reorganizing agricultural and environmental industries as well as a pharmaceutical industry. By analysing patent data granted in the United States from 1997 to 1999, we tried to explore the international patterns and trends of technological innovation in bioindustry, especially in the genome research. As the result, we could find that the United States'monopolistic position in the bioindustry was consolidated by the genome research. Competitive positions in the countries such as Japan and Germany, however, have been aggravated continuously. Korean inventors weren't also active in many biotechnological areas as comparing to developed countries such as US and UK. Especially, the gaps between Korea and developed countries in genome research were greater than any other areas.

• Journal of Ginseng Research
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• v.40 no.2
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• pp.113-120
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• 2016

Background: The present study aimed to compare the relative abundance of proteins and amino acid metabolites to explore the mechanisms underlying the difference between wild and cultivated ginseng (Panax ginseng Meyer) at the amino acid level. Methods: Two-dimensional polyacrylamide gel electrophoresis and isobaric tags for relative and absolute quantitation were used to identify the differential abundance of proteins between wild and cultivated ginseng. Total amino acids in wild and cultivated ginseng were compared using an automated amino acid analyzer. The activities of amino acid metabolism-related enzymes and the contents of intermediate metabolites between wild and cultivated ginseng were measured using enzyme-linked immunosorbent assay and spectrophotometric methods. Results: Our results showed that the contents of 14 types of amino acids were higher in wild ginseng compared with cultivated ginseng. The amino acid metabolism-related enzymes and their derivatives, such as glutamate decarboxylase and S-adenosylmethionine, all had high levels of accumulation in wild ginseng. The accumulation of sulfur amino acid synthesis-related proteins, such as methionine synthase, was also higher in wild ginseng. In addition, glycolysis and tricarboxylic acid cycle-related enzymes as well as their intermediates had high levels of accumulation in wild ginseng. Conclusion: This study elucidates the differences in amino acids between wild and cultivated ginseng. These results will provide a reference for further studies on the medicinal functions of wild ginseng.

• Journal of Korea Technology Innovation Society
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• v.10 no.3
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• pp.406-430
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• 2007

Most pharmaceutical licensing deals are made in the early stage of drug development. While this development process is not unique for complicated technology, a special feature of drug development is that it is highly regulated and a well-defined process. Its statistics in terms of costs and chances of technical success have been researched extensively. This enables relatively detailed calculations as benchmarks for actual deals to be made. Based on such calculations and on the analysis of licensing terms in published agreements, various companies offer quite expensive information, databases, software programs and consultation services to help establish what might be reasonable economic terms in a licensing deal. Over the years, pharmaceutical royalties have been the subject of various articles in journals. Most specific on this subject was the article on determining pharmaceutical royalties. Many other articles are about a more general nature deal with determining reasonable royalty rates, evaluating and underpinning the empirical value and usefulness of the 25% rule. The object of this article is to provide a relatively simple analytical approach based on the major economic terms underlying pharmaceutical licensing deals. The aim is to enhance the understanding of the relations between the major factors involved. Details are disregarded, as generally, where the terms of licensing deals depend on predictions over a considerable length of time, the value of detail is limited. Some specific issues addressed by the approach are the impact on profits of large investments, high risks and long development times characteristic of drug development, the consequent strong impact that the ultimate sales levels and operating margins may have on what might be considered a reasonable royalty rate, and the relationship between upfront payments and milestone payments to be paid during pharmaceutical development and the royalties due once the drug enters the market.