Under the globalization trend¡Aeven the still growing industry of Taiwan Biopharmaceutical will meet the same developing rule ¡C Many of the Biotechnology or Pharmaceutical companies are not satisfied with the local market here in Taiwan¡Athey are not only trying efforts to make efficiency of the limited resources of Taiwan itself¡Abut have had take China market into consideration during make company business plan¡C There is no doubt that Taiwan¡¦s BioPharm insutry are moving their steps into mainland China, especially since 1990 when China slowly open the free market to the world capital ¡CMany of them have had achieved much success , yet many companies found difficulties and entry barriers much as well¡C So far¡Athere is still no any research or survey about how Taiwan BioPharmaceutical are doing in China? What were their strategy for the market¡Hwhat are the facing problems or challenge in China? What are the solutions to cope with ?...and so on¡C In this thesis¡AIt content both field study¡Bcompany interview and questionnaire survey to gather the first hand data from industry that could picture the real situation about the Taiwan BioPharmaceutical companies in China so far¡C Furthermore ,by analyze the data¡AIt could get the conclusions and findings that help the industry realized what are main problems for the China market and what could be the most successful strategy ,too¡C It shows ¡AChina is the future market for globe biopharmaceutical industry ¡ATaiwan companies need to build up the niche competency of its own self¡Ayet there still are many problems come form uncertain China government policy¡Bregulation and market game rules to face with ¡C

Dans les trois essais de ma thèse, je prends une perspective processuelle sur la décision organisationnelle d'entrée sur le marché. Le regard processuel est très pertinent pour les entreprises dans les industries à forte intensité scientifique. Dans ce contexte empirique, une entrée sur le marché avec un produit est précédée de tentatives, parfois multiples, en recherche et développement (R & D), qui sont à la fois couteuses et empreintes d’incertitudes. Les tentatives par R&D d'avoir un produit sur un marché non seulement précèdent mais aussi sont plus fréquentes qu'une entrée réussie avec un produit. Pendant la période de tentatives d’entrée, une firme prend de multiples décisions stratégiques tel que, choix d’un marché et d'un collaborateur en R&D, choix d’abandonner R&D sur un marché mais remettre cette décision à plus tard et entrer le marché à nouveau. Ces types de décisions et ses effets sont des thèmes que j’étudie dans ma thèse. / In the three essays of my dissertation, I take a process perspective of market entry and study the drivers and outcomes of strategic decisions that firms make in their efforts towards an eventual product entry. The process perspective is highly pertinent for firms in science-based industries, such as, the biopharmaceutical. In this empirical context, actual product entry is preceded by multiple and frequent attempts in R&D that is not only costly but fraught with uncertainty. In the first chapter, I study the drivers of a firm’s decision to collaborate with a market incumbent upon new market entry. In the second chapter, I investigate the antecedents of a firm’s decision to re-enter a previously exited market. In the last chapter of my dissertation, I study the market-level drivers of a re-entering firm’s eventual R&D project performance in the market.

Drugs for treating rare diseases had been neglected by the pharmaceutical industry for a long time, due to the complex and costly drug R&D process as well as a small unprofitable market. Since its introduction in 1983, the Orphan Drug Act (ODA) has sought to prompt the innovation of drugs for minority diseases by reducing the regulatory and economic barriers. The incentives of the ODA have been effected through market protection, tax credit, fee waiver and grants to increase the accessibility of orphan products for the public. The number of orphan drugs available in the market has risen sharply from just ten in the decade before 1983 to over 400 since 1983. This increase implies a substantial improvement of the healthcare of patients suffering rare diseases and a success of the orphan drug legislation with the aim to motivate the development and manufacture of products that have low commercial potentials. Although it is evident that the ODA has successfully stimulated drug companies to develop numerous orphan products, treatments are very expensive. The sales of blockbuster orphan drugs have provided drug companies with unusually highprofit margins and limited patient access to treatments. The dilemma presented by the ODA reflects many of the issues currently faced by policymakers. In this thesis, we have analyzed the long-term evolution of the biopharmaceutical industry. In particular, we have examined drug discovery in the period of random screening, rational design and network collaboration, and explored the influence of the ODA. We have taken the theory of the sectoral system of innovation, and combined it with the complex adaptive model of innovation, and found that the complex version of that theory is capable of explaining the comprehensive drug innovation system. A Multi-agent Based Model has been introduced to identify and analyze the dynamics of bio-pharmaceutical innovation. The model has explored the roles of the main players in the sector and the influence of their relationships embedded in the process of orphan drug innovation. Through this model, we have investigated the mechanisms of how the incentives stimulate orphan drug innovation during the period from 1983- 2012. Moreover, the model has been applied to solve the dilemma of the ODA through analyzing how to achieve the best trade-off between orphan drug developments. Drawing upon the results of the simulation, we provide a sound basis for adjusting the ODA incentives to strikes an appropriate balance between stimulating orphan drug innovation and providing benefits to society, propose some resolutions to the ODA, while also to motivate orphan drug development in a financial way. The Advice for other countries planning to enact the orphan drug legislation and directions for further research suggested by this model have been put forward.

No description available.

Made available in DSpace on 2016-03-15T14:17:06Z (GMT). No. of bitstreams: 2 2.pdf: 2275371 bytes, checksum: 0069b965e4de6a8233ddb51b3d97ba1b (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2012 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / Os testes de monitoramento ambiental representam importante ferramenta de verificação da qualidade do ar ambiente de áreas onde preparações estéreis são produzidas e controladas quanto a possíveis contaminações. Define-se riscos como potencial perigo de ocorrer um dano ao processo ou, em termos de saúde, reações adversas às pessoas expostas a ele. Descrever os perigos envolvidos no processo de monitoramento ambiental, a segurança na execução destes testes e a avaliação dos resultados obtidos pelos mesmos, seu controle e monitoramento, além de propor melhorias foi o objetivo principal desta dissertação. A ferramenta qualitativa HACCP foi escolhida, pois se aplica a todas as etapas de um processo baseada no prévio conhecimento do mesmo visando à prevenção de falhas. Todos os princípios da ferramenta HACCP foram aplicados ao Programa de Monitoramento Ambiental de uma indústria biofarmacêutica. O diagnóstico dos potenciais perigos que cercam o processo e seus impactos foi propiciado com a análise de riscos realizada. Com a análise de riscos do processo de monitoramento ambiental conclui-se que o mesmo é seguro, robusto, apresentando resultados confiáveis e compatíveis às condições reais do ambiente monitorado. / The environmental monitoring tests are an important tool for checking the quality of ambient air in areas where sterile preparations are produced and controlled for possible contamination. Risk is defined as a potential demage to the process or, in terms of health, adverse reactions to people exposed to it. Describing the hazards involved in the environmental monitoring, the safety in performing these tests and the evaluation of results obtained by them, their control and monitoring, and to propose improvements was the main goal of this dissertation. The HACCP qualitative tool was chosen because it applies to all stages of a process based on prior knowledge of it, preventing failures. All the principles of HACCP tool were applied to the Environmental Monitoring Program of the biopharmaceutical industry. The diagnosis of the potential dangers surrounding the process and its impact was facilitated with the risk analysis performed. With the risk analysis of the environmental monitoring process it was concluded that it is safe, robust, showing reliable results consistent with the real conditions of the monitored environment.

近年來在相關產業與政府的努力及人才培育之下，我國許多生技研究已有初步的規模且可說是居於亞洲領先地位。然而，這些技術在商品化應用的階段卻一直沒有重大突破與發展，難以將研發成果的實質效益挹注到產業中。研發成果商品化的過程中，必須兼備技術面、法律面、財務面、管理面的考量，面面俱到才能將初萌的技術逐步發展為成熟的商品，進而在市場上獲取實質利潤，再將獲得的資源挹注於研發活動，形成良性循環。 研發成果商品化的策略視產業特性而截然不同，在「生技醫療產業」中，因其具有「受衛生主管機關高度管制」、「商業化認證需時」、「行銷國際化」的特性，在法規面的複雜度較高，且為專案成功與否的關鍵因素之一，進行商品化評估時必須熟悉相關醫藥法規，才能著手為專案發展做正確的規畫 ，極度仰賴「跨領域」、「高度技術」與「熟稔特殊商業技巧」的人才。依各國藥物法規的不同，商品化的開發時程也受此影響，生技製藥產業之技術及研發成果必須將為達到法規規範的要求而必須投入的時間、資金、人力等各項資源納入總體可行性評估之考量依據。。因法規具有地域性，本研究無法齊備全球各國，將以美國及台灣為研究主體，台灣的法規深受世界公認醫藥法規先進的美國影響，熟知美國的法規可以預估台灣法規機構的思路；且美國藥品市場佔全世界最大規模，此外，美國也極有可能成為潛在合作廠商之所在地，因此本研究將比較美國與台灣之醫藥法規，並評估在技術研發的過程中，衛生主管機關之要求對於技術商品化過程中所產生的影響。 明確、具科學性、可預期性的法規環境能降低製藥產業於研發過程中的不確定性，提高廠商投入的意願。衛生醫療政策及藥政管理政策直接影響到醫藥法規的訂立，政府制定的法規將引導產業發展的方向，對於藥品市場有極重要的影響。一個好的政策應該能夠與國家的總體背景相匹配，法規要求應與國家發展程度及國家內需市場成比例。台灣生技製藥產業目前的困境之一，就是國內廠商在開發新藥時，為了符合台灣衛生主管機關訂定的高標準法規必須投入更多的成本，但台灣卻沒有足夠的內需市場得以支撐，造成擁有豐厚資源的國外廠商可以將符合世界（十大先進國）高標準的藥品進入台灣市場，但國內廠商卻無法立足。為解決此困境，台灣廠商一定要設法將業務範圍擴大到外需市場，以獲取足以支持藥物發展所需的資金成本。因此，了解國內、外之藥物相關法規，做出能符合各國法規要求的產品，為踏出國際外銷市場的第一步；此外，各國的智財法以及與商業相關的法律，還有其之間的互相關聯，都是技術商品化是否能夠成功至為重要的關鍵因素。本文擬就藥物法規面為討論之主軸，其間輔以智財、商業相關構面，對生技製藥產業之技術商品化之過程做一探討。在本研究所選的個案—核子醫學藥物，是眾多創新產品的一種，如果能把握技術、智財、法規、法律、國際商業運作，很有可能為台灣的藥業打開另一片天。 / In recent years, we have already developed some achievements in biotech researches in Taiwan and are in a leading position in Asia under the efforts of government and industries. However, these technologies still are slowly developed to the commercialized phase. Thus, the achievement of these researches does not benefit industry substantially. In the process of commercialization of biotech research, we have to consider all the aspects, including technology and regulation, intellectual property, finance and management. With a well-rounded development plan, technologies in the bud will gradually develop to a mature commodity, and earn fiscal profit in the market. The profit will consequently contribute to research activity. A virtuous circle will be formed. The strategies of commercialization differ considerably among industries. Regarding biopharmaceutical industry which has the properties of highly regulated by competent authorities, time consuming, heavy capital, and global marketing, the regulation assessment is not only complicate but also critical to project implementation. The required documents according by regional authorities will be a decisive factor to consider the development plan including the estimated timetable, needed resources. Due to the regulation system in US affected a lot legislation for laws in Taiwan , America and Taiwan will be the prior topics in this research. A well-developed legal framework and protection of intellectual property rights is the prerequisite for building an ideal environment where the biotechnology and pharmaceutical industries can flourish. In order to improve the environment for these industries, in recent years the government has approved the amendment and execution of related laws and regulations. Amendments have been made to related tax benefit and incentive measures of investment. Other amendments have been made which have allowed R&D results to be more easily transferred to academia and industry. Looking into the future, under the joint cooperation of industry, academia and research institutes, and with the government’s policy to fully promote the sector, it is believed that Taiwan will have well developed in the near future.