• 보건의료산업학회지
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• 제14권1호
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• pp.55-65
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• 2020

Objectives: To provide guidance for agency planning by identifying barriers faced by Korean pharmaceutical companies in global regulatory affairs. Methods: A questionnaire survey on global regulatory affairs was administered by email to personnel at Korean pharmaceutical companies. From a total of 60, 28 responses were collected. Respondents' companies were classified as small-sized or large-sized, based on whether their annual sales amounted to KRW 100 billion. Results: Small-sized companies were experiencing greater difficulties in receiving drug approvals from advanced countries, particularly during the Investigational New Drug (IND) and Good Manufacturing Practice (GMP) processes. Conclusions: Support measures to specifically help small-sized companies enter more advanced markets and further improved global regulatory guidelines that can meet large-sized companies' expectations are needed. Moreover, domestic and global regulatory standards should be harmonized to benefit both groups.

• 유통과학연구
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• 제5권2호
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• pp.17-34
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• 2007

한국 제약산업은 제약회사의 수와 거래선의 수가 많고, 다품종 소량생산체제이며 동일성분의 경쟁품이 많은 실정이다. 이러한 실정 하에서 통합물류가 물류원가 절감 및 효율적인 배송에는 적절한 방안이라고 할 수 있으나 기업마다 다른 배송 조건 문제, 다품종 소량주문의 적기 배송 문제 등 회사 특유의 서비스 제공 등에 한계가 있어서 경쟁적 매출증가에 문제점이 있다 하겠다. 이와 같이 물류원가는 절감해야하고 영업효율성은 증대시켜야 하는 두 가지 문제를 두고 다음과 같은 대처방안을 제시하고자 한다. 첫째, 제약회사 간 품목 공동마케팅 실시. 둘째, 규모가 비슷한 3개 회사 이하 합동 배송실시. 셋째, 매출이 큰 제품은 도매상과 유통 일원화 협약. 넷째, 도매상이 제약 물류 서비스하도록 준비. 다섯째, 거래선의 협조 등이다. 결론적으로 한국제약산업에서 통합물류가 필요하지만 산업의 특성상 중소제약회사는 완전 통합물류는 매출이 감소할 것이라는 가정하에 그 시행이 어려울 것으로 판단되는 것이다.

• Journal of Pharmaceutical Investigation
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• 제38권6호
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• pp.429-432
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• 2008

Drug delivery systems (DDS) have entered mainstream in the pharmaceutical industry in the recent years. Major pharmaceutical companies as well as small or medium-sized biotechnology companies are developing various DDS-based products. We have established Drug Delivery System Company Database, which is an online searchable database of companies that develop DDS-based products and technologies or supply formulations and/or materials. Company summary, products and key technologies are listed in the database. DDS technology fields also include administration routes and indications of drugs. DDS terminologies, Statistical analysis, Useful Links, Glossary and Comments pages are also provided.

• 산업경영시스템학회지
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• 제46권4호
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• pp.74-92
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• 2023

The computer system validation consulting industry is growing as domestic GMP companies' overseas exports or advancements increase, and computer system validation has been mandatory in Korea since the 2010s, but domestic CSV consulting companies are small in size and have a short history, revealing many shortcomings in terms of service quality and customer satisfaction when conducting consulting. Research related to consulting has been mainly focused on management consulting and IT consulting, and research related to computer system validation is very insufficient. This study confirmed the effect of consultant competency and service quality on consulting performance, customer satisfaction, and intention to renew contract when performing computer system validation through empirical research on food, pharmaceutical, cosmetics, and medical device companies, which are representative companies in the GMP industry. As a result, it was confirmed that consultant competency and service quality had a significant effect on consulting performance, customer satisfaction, and intention to renew contract. In addition, it was confirmed that the reputation and expertise of consulting companies had a moderating effect on the relationship between consultant competency and consulting performance.

• Molecules and Cells
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• 제45권5호
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• pp.284-290
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• 2022

Exosome, a type of nanoparticles also known as small extracellular vesicles are gaining attention as novel therapeutics for various diseases because of their ability to deliver genetic or bioactive molecules to recipient cells. Although many pharmaceutical companies are gradually developing exosome therapeutics, numerous hurdles remain regarding manufacture of clinical-grade exosomes for therapeutic use. In this mini-review, we will discuss the manufacturing challenges of therapeutic exosomes, including cell line development, upstream cell culture, and downstream purification process. In addition, developing proper formulations for exosome storage and, establishing good manufacturing practice facility for producing therapeutic exosomes remains as challenges for developing clinical-grade exosomes. However, owing to the lack of consensus regarding the guidelines for manufacturing therapeutic exosomes, close communication between regulators and companies is required for the successful development of exosome therapeutics. This review shares the challenges and perspectives regarding the manufacture and quality control of clinical grade exosomes.

• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Journal of Yeungnam Medical Science
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• 제38권4호
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• pp.308-317
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• 2021

Cancer is the leading cause of death and is on the rise worldwide. Until 2010, the development of targeted treatment was mainly focused on the growth mechanisms of cancer. Since then, drugs with mechanisms related to tumor immunity, especially immune checkpoint inhibitors, have proven effective, and most pharmaceutical companies are striving to develop related drugs. Programmed cell death-1 and programmed cell death ligand-1 inhibitors have shown great success in various cancer types. They showed durable and sustainable responses and were approved by the U.S. Food and Drug Administration. However, the response to inhibitors showed low percentages of cancer patients; 15% to 20%. Therefore, combination strategies with immunotherapy and conventional treatments were used to overcome the low response rate. Studies on combination therapy have typically reported improvements in the response rate and efficacy in several cancers, including non-small cell lung cancer, small cell lung cancer, breast cancer, and urogenital cancers. The combination of chemotherapy or targeted agents with immunotherapy is one of the leading pathways for cancer treatment.

• 대한본초학회지
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• 제30권5호
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• pp.7-13
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• 2015

Objectives : The purpose of this study was to examine the prescription intention of Korean medicine doctors on botanical drug.Methods : The subjects in this study were 340 Korean medicine doctors in Korean medical institutions, on whom a survey was conducted from July 1 to August 31, 2014.Results : The factors that affected the prescription decision making of the Korean medicine doctors were drug superiority, level of Interest, Recognition, marketing of sales associates of pharmaceutical companies and satisfaction with information provided by those companies. When the internal consistency of the variables was measured, that was above 0.8.Conclusions : Accordingly, well-planned education and promotion efforts are required to encourage Korean medicine doctors to put more prescription intention in botanical drug. This study had some limitations : First, the subjects were selected in a manner to allow for the convenience of this researcher, and the findings might not be generalizable. Second, there was a problem with the time for the study in that there were quite fierce disputes on botanical drug at that time. Third, the majority of the subjects run their own hospitals, and the number of them was small. So it's not possible for them to represent every Korean medicine doctor.

• 대한본초학회지
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• 제27권2호
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• pp.1-16
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• 2012

Objective : To investigate the current status of prescription drugs in Oriental medical institutes and to draw up a future plan for the revitalization of Oriental medical health insurance, this survey has been performed. Method : The survey has been made with 321 doctors working at Oriental medical institutes in Daegu and Kyungbuk areas for a period of 3 month from June 1, 2010 until September 1, 2010. Result : 1. When it comes to the current status of the use of herbal drugs in Oriental Health insurance, most of doctors surveyed prescribe insurance drugs, and they prescribe insurance drugs to patients, who are less than 20% of total patients visiting their clinics. 2. The awareness of Herbal Health Care Drugs is investigated. When it comes to the understanding of the difference between insurance drugs(powder type drugs) and granular type drugs, doctors admit that they differ only in one aspect, whether or not their being covered by health insurance. Based on the survey results on the understanding of insurance coverage of granular type drugs, doctors, even though they long for granular type drugs to be accepted as insurance drugs, are worrying whether the number of outpatients might dwindle due to increased insurance co-payments. They also point out that the biggest obstacles in the expansion of the granular type drugs as insurance drugs are the lack of understanding of the government and the objection of the Health Insurance Review and Assesment service (HIRA) for fear of increased insurance claims. 3. Upon investigation on Oriental medicine doctors' understandings of herbal pharmaceutical industry, it is found that doctors' responses on pharmaceutical industry are not all positive ones('new product development and neglect of R&D infrastructure' and 'smallness of industry'). When it is investigated what area needs the greatest improvement in herbal pharmaceutical industry, 'securing sufficient capital, good manufacturing, and strengthening quality control', is the highest. 4. When it is asked what are the most needed in order to improve herbal health insurance medicine, responses such as 'the increase in the accessibility to and the utilization of Oriental medical clinics through the diversification of the means of prescriptions', 'the improvement of insurance benefits(cap adjustments)', 'increase the proportion of high quality medicinal plants', 'the ceiling of co-payments(deductible) at 20,000 won or more', 'expansion of the choices of formulations', 'formulational expansions of tablets and pills', and finally 'admittance and expansion of granular type drug as insurance drug' are the highest. 5. Upon investigating the general characteristics of the current status of the usage of Oriental health care herbal drugs, the followings are observed. First, the frequency of use of health insurance drugs by the doctors who use health insurance with general characteristics shows similar differences in case of total monthly sales amount (p<0.001), average number of daily patients (p<0.05). Secondly, as to the willingness of the expanded usage of insurance drugs, similar differences are observed in case of total monthly sales amount (p<0.05). 6. Upon investigating the general characteristics of the perception of Herbal health care drugs, the followings are observed. First, inspecting general characteristics and insurance claims due to increased co-payments(deductible amount) reveals similar differences in case of working period (p<0.01) and in case of total monthly sales amount (p <0.01). Secondly, inspecting general characteristics and the obstacles that hinder granular type drugs from being accepted as health care insurance drugs shows similar differences in case of working period (p<0.05). 7. Upon investigating the general characteristics of the understanding of Oriental Herbal pharmaceutical companies, the followings are observed. First, opinions on the general characteristics of pharmaceutical companies, when examined with variance analysis, shows similar differences in case of total monthly sales amount (p<0.05). Secondly, when opinions are examined on general characteristics and the problems of herbal pharmaceutical companies, similar differences are found in case of working period (p<0.01) and in case of total monthly sales amount (p<0.001). Lastly, opinions on the general characteristics and reforms of pharmaceutical companies, similar differences are observed in case of working period (p<0.001). 8. Upon investigating the general characteristics of the improvement of insurance Herbal drugs, the followings are observed. First, regarding general characteristics and insurance benefits, similar differences are observed in case of working period (p<0.05), in case of total monthly sales amount (p<0.05), and in case of average number of daily patients (p<0.01). Secondly, opinions on the general characteristics and the needs for the improvement of Herbal insurance drugs are examined in 5 different aspects, which are the approval of granular type drugs as insurance drugs, the expanded practices of the number of prescription insurance drugs, the needs of a variety of formulations, the needs of TFT of which numbers of Oriental medical doctors are members for the revision of the existing system, and the needs of adjusting the current ceiling of the fixed amount and the fixed rate. When processed by the analysis of variance, the results show similar differences in case of average number of daily patients (p<0.01). Conclusion : From the results of this study the first measures to take are, to reform overall insurance benefit system, including insurance co-payment system(fixed rate cap adjustment), to expand the number of the herbal drugs to be prescribed matching with insurance benefit accordingly, and to revitalize herbal medicine insurance system through the change of various formulations. In addition, it is recommended to improve the effectiveness of herbal medicine by making plans to enhance the efficacy of herbal medicine and by enabling small pharmaceutical companies to outgrow themselves.

• 기술혁신연구
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• 제22권2호
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• pp.157-183
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• 2014

본 연구는 2004년부터 2008년까지 8년간 국내 제약 기업들을 대상으로 소유 집중도가 기업의 연구개발투자에 미치는 영향을 실증적으로 분석한다. 특히 소유 경영 체제 또는 전문 경영 체제가 소유 집중도와 연구개발투자 간의 관계에 미치는 영향을 분석한다. 분석 결과 최대주주 지분율과 연구개발투자는 역 U자 형태의 상관관계가 있으며, 소유 또는 전문 경영 체제 여부는 역 U자 관계의 강도에 영향을 주는 것으로 나타났다. 즉, 전문 경영 체제하에서는 소유 집중도가 낮을 경우 소유 집중도의 추가적인 증가는 대리인 비용을 줄여 연구개발투자를 소유 경영 체제하에서 보다 더 크게 증가시키지만, 소유 집중도가 높을 경우 소유 집중도의 추가적인 증가는 지나친 위험 노출 증가에 대한 고려로 연구개발투자를 소유 경영 체제하에서 보다 더 빠르게 감소시킨다.