<p>Canadas regulatory system is science-based and relies on risk assessment to inform decisions about which products of biotechnology (and other technologies) are safe enough for commercial application. Since regulation involves the loss of certain liberties, it is imperative that any regulatory regime be as objective as possible. Scientific risk assessment seems to be a good way to produce the information, which guides policy makers since it involves quantitative analysis and the production of seemingly objective data.</p><p>The view adopted by regulators and in current risk assessment practices is that objective means value-free. Therefore, because risk assessment data is scientific it is thought to be value-free but this is not the case. Risk assessment necessarily involves value assumptions. Assumptions must be made at all stages of the production of risk data. This does not mean, however, that risk assessment is hopelessly subjective. The notion of value-free objectivity can be replaced with the view that genuine objectivity arises through peer review and social discourse. Regulators can adopt this understanding of objectivity to acknowledge the value-ladenness of risk assessment data.</p><p>At present, the value assumptions made by industry, government and private scientists during risk assessment go largely unnoticed yet have an effect on the outcome of regulatory decisions. Such assumptions must be recognized in order to ensure that the decisions made about the risks society face are not biased. This is particularly true in the case of biotechnology regulation. The development of the science of biotechnology has occurred concurrently with the development of the biotech industry creating the opportunity for industry-biased risk assessments.</p><p>It is possible to make changes to the existing regulatory regime in Canada in order to avoid some of the major problems associated with unrecognized value assumptions in risk assessment. A complete restructuring of the regime is unnecessary, however. Maintaining the current regulatory structure with some minor changes could address these problems. These changes include: creating an independent review board, making explicit that value assumptions are part of risk assessment in government advisory reports, and enhancing the role of regulators. Canadas regulatory system can better address the risks associated with biotechnology if it acknowledges that risk assessment is value-laden.</p>

Durante los últimos años, se evidencia que, en nuestro país, existe una clara falla en la aplicación del acceso a los recursos genéticos, sobre todo cuando se trata de fines comerciales, ello se muestra en la cantidad de contratos efectuados a la fecha con estos fines (sólo dos solicitudes de acceso a recurso genético con fines comerciales a cargo de SERFOR que están en proceso de atención a la fecha). La presente investigación busca estudiar los obstáculos que se dan en el acceso a los recursos genéticos con fines comerciales de las empresas peruanas exportadoras de productos biotecnológicos. En tal sentido, la investigación considera como objetivo principal analizar las limitantes de las empresas peruanas exportadoras de productos biotecnológicos para acceder a los recursos genéticos con fines comerciales en el período 2015 - 2019. Para ello, se realizó la gestión de la información con la premisa epistemológica de bases de datos conocidas, bases de datos bibliográficas y bases de datos considerados confiables y reconocidos; adicionalmente, se realizó la búsqueda de antecedentes teóricos que sustentan nuestro tema de investigación, nuestro problema principal y sus problemas específicos. Este estudio proporciona argumentos para respaldar esta investigación, analiza la literatura y la información del sector y explora la justificación para respaldar los temas de investigación. A nivel metodológico, se desarrolló un estudio cualitativo a través de entrevistas a profundidad, en las cuales se entrevistó a 13 expertos del tema y la información recopilada ha permitido validar la hipótesis, para luego realizar las conclusiones y recomendaciones correspondientes. / In recent years, it has become evident that in our country, there has been a clear failure in the application of access to genetic resources, especially when it comes to commercial purposes. This is shown by the number of contracts concluded to date for these purposes (only two requests for access to genetic resources for commercial purposes by SERFOR are currently being processed). This research aims to study the barriers that exist in the access to genetic resources for commercial purposes by Peruvian companies exporting biotechnology products. In this sense, the main objective of the research is to analyze the limitations of Peruvian companies exporting biotechnology products to access to genetic resources for commercial purposes in the period 2015 – 2019. To this end, the management of primary information was carried out with the epistemological premise of known databases, bibliographic databases and databases considered reliable and recognized; additionally, the search for theoretical backgrounds that support our research theme, our main problem and its specific problems was carried out. This study provides arguments to support this research, analyzes the literature and industry information, and explores the rationale for supporting research themes. As part of the methodology, the qualitative technique was applied through in-depth interviews, in which 13 experts on the subject were interviewed, and the information gathered allowed the project hypothesis to be validated and the corresponding conclusions and recommendations were made. / Tesis

The aim of this diploma thesis is Bioart, new media art discipline, which is represented by a narrow group of authors. Bioart is often referred to by variety of names and the term itself is not uniformly defined. The work offers a comprehensive definition of the term as an art area that creates space for social reflection of scientific knowledge through its reflection of modern science. The thesis also describes respective artistic, philosophical and historical context of the term. At the same time, the thesis examines aspects of contemporary bioart from the perspective of the artists working in this field of art by interviewing them. The thesis is divided into three main chapters. The first chapter deals with Bioart as a term on theoretical level and introduces the interviewed artists. The second chapter summarizes the historical background of Bioart. The third chapter introduces the overlap of Bioart on ethics, safety and engagement of artists and the public in science. Powered by TCPDF (www.tcpdf.org)

Cette thèse se déploie dans un espace de discours et de pratiques revendicatrices, à l’inter- section des cultures amateures informatiques et biotechniques, euro-américaines contempo- raines. La problématique se dessinant dans ce croisement culturel examine des métaphores et analogies au coeur d’un traffic intense, au milieu de voies de commmunications imposantes, reliant les technologies informatiques et biotechniques comme lieux d’expression médiatique. L’examen retrace les lignes de force, les médiations expressives en ces lieux à travers leurs manifestations en tant que codes —à la fois informatiques et génétiques— et reconnaît les caractères analogiques d’expressivité des codes en tant que processus de convergence. Émergeant lentement, à partir des années 40 et 50, les visions convergentes des codes ont facilité l’entrée des ordinateurs personnels dans les marchés, ainsi que dans les garages de hackers, alors que des bricoleurs de l’informatique s’en réclamaient comme espace de liberté d’information —et surtout d’innovation. Plus de cinquante ans plus tard, l’analogie entre codes informatiques et génétiques sert de moteur aux revendications de liberté, informant cette fois les nouvelles applications de la biotechnologie de marché, ainsi que l’activité des biohackers, ces bricoleurs de garage en biologie synthétique. Les pratiques du biohacking sont ainsi comprises comme des individuations : des tentatives continues de résoudre des frictions, des tensions travaillant les revendications des cultures amateures informatiques et biotechniques. Une des manières de moduler ces tensions s’incarne dans un processus connu sous le nom de forking, entrevu ici comme l’expérience d’une bifurcation. Autrement dit, le forking est ici définit comme passage vers un seuil critique, déclinant la technologie et la biologie sur plusieurs modes. Le forking informe —c’est-à-dire permet et contraint— différentes vi- sions collectives de l’ouverture informationnelle. Le forking intervient aussi sur les plans des iii semio-matérialités et pouvoirs d’action investis dans les pratiques biotechniques et informa- tiques. Pris comme processus de co-constitution et de différentiation de l’action collective, les mouvements de bifurcation invitent les trois questions suivantes : 1) Comment le forking catalyse-t-il la solution des tensions participant aux revendications des pratiques du bioha- cking ? 2) Dans ce processus de solution, de quelles manières les revendications changent de phase, bifurquent et se transforment, parfois au point d’altérer radicalement ces pratiques ? 3) Quels nouveaux problèmes émergent de ces solutions ? L’effort de recherche a trouvé ces questions, ainsi que les plans correspondants d’action sémio-matérielle et collective, incarnées dans trois expériences ethnographiques réparties sur trois ans (2012-2015) : la première dans un laboratoire de biotechnologie communautaire new- yorkais, la seconde dans l’émergence d’un groupe de biotechnologie amateure à Montréal, et la troisième à Cork, en Irlande, au sein du premier accélérateur d’entreprises en biologie synthétique au monde. La logique de l’enquête n’est ni strictement inductive ou déductive, mais transductive. Elle emprunte à la philosophie de la communication et de l’information de Gilbert Simondon et découvre l’épistémologie en tant qu’acte de création opérant en milieux relationnels. L’heuristique transductive offre des rencontres inusitées entre les métaphores et les analogies des codes. Ces rencontres étonnantes ont aménagé l’expérience de la conver- gence des codes sous forme de jeux d’écritures. Elles se sont retrouvées dans la recherche ethnographique en tant que processus transductifs. / This dissertation examines creative practices and discourses intersecting computer and biotech cultures. It queries influential metaphors and analogies on both sides of the inter- section, and their positioning of biotech and information technologies as expression media. It follows mediations across their incarnations as codes, both computational and biological, and situates their analogical expressivity and programmability as a process of code conver- gence. Converging visions of technological freedom facilitated the entrance of computers in 1960’s Western hobbyist hacker circles, as well as in consumer markets. Almost fifty years later, the analogy drives claims to freedom of information —and freedom of innovation— from biohacker hobbyist groups to new biotech consumer markets. Such biohacking practices are understood as individuations: as ongoing attempts to resolve frictions, tensions working through claims to freedom and openness animating software and biotech cultures. Tensions get modulated in many ways. One of them, otherwise known as “forking,” refers here to a critical bifurcation allowing for differing iterations of biotechnical and computa- tional configurations. Forking informs —that is, simultaneously affords and constrains— differing collective visions of openness. Forking also operates on the materiality and agency invested in biotechnical and computational practices. Taken as a significant process of co- constitution and differentiation in collective action, bifurcation invites the following three questions: 1) How does forking solve tensions working through claims to biotech freedom? 2) In this solving process, how can claims bifurcate and transform to the point of radically altering biotech practices? 3) what new problems do these solutions call into existence? This research found these questions, and both scales of material action and agency, in- carnated in three extensive ethnographical journeys spanning three years (2012-2015): the first in a Brooklyn-based biotech community laboratory, the second in the early days of a biotech community group in Montreal, and the third in the world’s first synthetic biology startup accelerator in Cork, Ireland. The inquiry’s guiding empirical logic is neither solely deductive or inductive, but transductive. It borrows from Gilbert Simondon’s philosophy of communication and information to experience epistemology as an act of analogical creation involving the radical, irreversible transformation of knower and known. Transductive heuris- tics offer unconvential encounters with practices, metaphors and analogies of code. In the end, transductive methods acknowledge code convergence as a metastable writing games, and ethnographical research itself as a transductive process.

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各國視生技產業為未來發展的關鍵產業，並積極推動各項政策，使生技產業能快速成長，而生技醫藥市場是促成全球生技產業成長的主要動力，為了增加我國的競爭力，希望藉由與鄰近國家醫藥產業的比較，能更了解台灣生技醫藥產業經營績效。 本研究採用Battese and Coelli (1995)隨機成本邊界法，針對2002-2007年間，日本、南韓、中國、印度與台灣等五個國家，共61家生技醫藥廠商進行實證分析，研究結果如下：(1)研發密集度增加使成本效率降低，五個國家裡，日本最具成本效率。(2)產業平均成本效率值為0.855，且有逐年惡化的趨勢。(3)整體產業平均處於遞增規模報酬階段。(4)整體而言，總要素生產力(TFP)的提升主要是因為規模成分的貢獻，其次為技術的進步，而技術效率變動率對TFP成長率為負影響。(5)各國間雖然TFP變動率不存在顯著性差異，但在規模成分、技術變動率與技術效率變動率等方面存在著顯著的差異。 / Many countries regard biotechnology as a key industry for the future development. Governments often implement a variety of policies to help it grow rapidly. The biotech pharmaceutical industry is the main momentum for the growth of the global biotech industry. The objective of this paper is to measure the productivity and efficiency of the industry among Asian countries, and investigates the sources of the performance changes, and then hope to give some insight into the enhancement of the industry’s productivity. To pursue our goal, we adopt Battese and Coelli’s (1995) stochastic frontier approach to assess 61 biotech pharmaceutical firms during 2002-2007. The main empirical results can be summarized as follows: (1) The R&D intensity is negatively related to cost efficiency; in five countries, Japan has the highest cost efficiency. (2) On average, the cost efficiency is about 0.86, and has become worsen year after year. (3)Most of time, the industry is characterized with the increasing returns to scale. (4) The growth of total factor productivity (TFP) is mainly attributed to the scale efficiency change, and technical progress accounts for a minor source. However, technical efficiency deteriorates over time. (5) Among countries, the TFP growth rates have no significant differences, but the components show apparent differences.

近年來中國大陸以其廣大的市場及較低的人力成本優勢，成為外資及台商競相投資的市場，台灣各產業莫不以進入中國市場為營運發展的重要目標。國內生技製藥產業在這一波投資中國熱中，也嘗試從生產、銷售、行銷、代工及研發等不同面向切入，以掌握商機及尋求企業的永續經營與成長。 本論文著眼於研究台商生技製藥公司在進入中國大陸市場時，所選擇的海外直接投資之進入模式分析。並以John H. Dunning對外投資之折衷理論為研究架構，從「所有權優勢」、「區位優勢」及「內部化優勢」等構面，來分析台灣生技醫藥公司的中國市場進入模式。藉由國內生技製藥公司的企業訪談及上市櫃公司公開資訊的分析，以及次級資料與公開報導的整理，以瞭解台商生技製藥公司在大陸的直接投資進入模式及影響投資決策的關鍵因素及公司優勢。 本研究共訪談國內四家生技製藥公司。研究發現，生技製藥台商在中國市場的進入模式選擇，主要可能受到區位優勢決定因素的影響，而決定因素則可分為市場導向、資源取得導向及風險評估等三項。本研究將有助於瞭解國內生技製藥業，在中國進行跨國經營與投資的決策考量，並裨益國際企業領域及國際策略管理的理論與實務發展。 / Over the past years, China has attracted much investment from Taiwan companies and foreign companies due to its advantages of board markets and low-cost labors. Companies in Taiwan also set “enter China market “as a goal in their business planning. Upon this wave of “Invest China fever” , the domestic Biotech & pharmaceutical companies have no doubt approached their business target by entering China market through different operations, that is, production, sales, marketing, out-sourcing, and research & development, etc to catch the opportunities and sustainable growth of business The objectives of the study were to analyze the entry mode of China market Taiwan biotech & pharmaceutical companies have conducted their foreign direct investment (FDI). Based on the theory of the eclectic paradigm of FDI initiated by John H. Dunning as a research framework, from the perspectives of Ownership advantages, Location advantages, and Internalization advantages, the analysis for the entry mode of FDI and the Key factors as well as company advantages to affect the decision were employed to examine both the primary data and secondary data. Primary data consisted of the interviews of domestic pharmaceutical companies and the data statistics from the Market Observation Post System (Taiwan stock market). Meanwhile, secondary data was collected from the news and the reports of the journals, magazines, and the websites. Four Biotech-pharmaceutical companies were interviewed in this study. The result shows that Location advantages may be the major factors for FDI in China of Taiwan companies. The factors consist of market -oriented, resources -oriented, and risk assessment factors. This study will contribute the strategic considerations for Taiwan international companies that operate foreign Biotechnology and Pharmaceutical business in China. This study also suggests the strategy for the international business and international management both in theory and the practice.

本研究主要探討生技產業公開說明書之風險因子揭露對首次公開發行公司5年內的獲利能力做研究，想得知風險因子的揭露是否會影響公司獲利時間的長短。本研究以美國生技產業首次公開發行公司為研究對象，樣本期間為1997年至2012年。 許多文獻指出越來越多公司在尚未獲利前即先行上市，但公司未來的前景及獲利能力卻充滿高度的不確定性，而透過資訊的揭露可使該不確定性下降，因透過揭露，投資者可以了解公司營運狀況及表現，對公司價值能做較正確之判斷， 此時願意提供資金給公司營運，充足的資金使公司未來獲利機會上升。 本研究參考過去文獻，建立資訊揭露的四級指標加上風險因子所揭露的項目多寡，系統性地衡量生技公司公開說明書之風險因子，並以存活分析檢測假說。實證結果顯示：風險因子的內容描述越著重在某些特定資訊，例如：顧客資訊、重要員工資訊、量化資訊的表達、公司未來不確定性、財務需求時，公司未來獲利能力機會大增，而當更進一步的探究時，又發現對顧客資訊和量化資訊的表達越具體，越詳細時，也會使公司未來獲利機會上升。 / This study investigates whether disclosure of risk factors in the prospectus will influence the probability of the biotech firms to attain profitability. Data is collected for biotech companies of U.S IPOs issued from1997 to2012 as the research sample. Many extant empirical evidences indicate that the proportion of firms going public prior to achieving profitability has been increasing over time. There is considerable uncertainty regarding the long-term economic viability of these firms at the time of going public. Disclosures in the prospector may mitigate the effects of ex-ante uncertainty about firm’s value, and disclosures are potentially important means for management to communicate firm performance and governance to outside investors. Therefore, firms can raise more money by disclosing more information in IPO prospectors, because more information reperesent lower uncertainty between investors and firms.This study uses risk factors in the prospectus as concern issue and expects that the quantity of risk factors and the content or description of risk factors will influence the uncertainty and would mitigate investors’ concern. Referring to past literature, this study builds four-class index for disclosure score and uses two classifications of risk factors to systematically measure risk factors in the prospectus. The empirical results show that a biotech IPO with more information or some specific information of risk factors, like disclosures of main customers and key employees, will experience good performance after IPO. In addition, more detail descriptions in quantitative risk factors and customers’ information contributed to better performance in the future. In conclusion, disclosure of risk factors in the prospectus are related to firms’ probability of profitability after IPO as expected.

二十一世紀是知識經濟的時代，傳統製造業所看重的有形資本已不足以維持企業優勢，無形的智慧資本在新型態的企業競爭中所扮演的角色日顯重要。各行各業都有無形資產，種類性質因產業而異，傳統製造業重視營業秘密、商譽，高科技產業的專利則是公司競爭力的核心，而屬於知識高度密集產業的生技產業更需要重視智慧資本的管理。生技產業的結構複雜，價值鏈長、分工專業、產品開發期漫長，在產品成功上市之前的開發時期中，公司資產多屬於無形的智慧資本，無法從傳統的財務報表觀察其真正的企業價值。相較於其他產業，生技公司更必須訴求於正確的無形資產管理方式，方能成功兌現其智慧資本。 本研究先藉由文獻回顧統整台灣生技產業的相關現況、過去相關智慧資本管理研究以及研發管理等議題，歸納出一般性共識與管理原則。接著依循這些重點，訪談三家台灣生技公司的經理人，包括台灣微脂體、中裕新藥與因華生技，深入了解台灣產業經營實務與現況，探討其智慧資本中的人力、組織與關係資本在個案公司內的蓄積方式，從研發管理模式、組織制度設計與智財管理等面向進行綜合比較。 本研究認為研發能量與知識管理在組織制度中的蓄積，是台灣業界經營管理上常見的盲點，台灣生技新藥業者多重視新技術的研發，普遍對智慧資本其他面向的重視程度不高，但對生技產業而言，扣除資金與技術後，公司的長期競爭力往往都是在組織發展的過程中累積而來的，忽視知識管理與組織制度的養成，對於企業長久發展有關鍵性的負面影響。研究中的個案最終都必須往累積組織資本的方向邁進，若不針對組織資本的蓄積設計恰當的管理方法，為研發人才設計合適的制度與生涯發展管道，將研發團隊的知識能量內化為企業自有資產，只期望以短期的數據績效取得資金支持，忽視智慧資本的管理與培養，並非生技產業長久經營之道。建議生技公司除了聘僱專業經理人處理資金與股東的關係外，也要重視研發長與策略長在組織中的地位，大膽給予權利，調整組織的運作模式，設計出能累積公司能量的專案管理流程，才是生技公司創造競爭力之本。 / In the era of knowledge-based economy, the tangible assets highly-valued by traditional manufacturing industry is no more enough solely to maintain industrial competency. Intangible intellectual assets become more and more important in modern commercial competitions. The intangible assets exist and vary according to different industries. Traditional manufacturing industry looks highly upon trade secrets and brand reputation while patent is the core competency to high-tech companies. Biotech industry belongs to a high knowledge-intensive business and should emphasize more on the management of intellectual assets. Biotech industry is characterized of a complicated system, a long value chain, specialized divisions of labor, and a prolonged timeline of product development. The company assets before the successful commercialization of a product are usually intangible intellectual property and a biotech company during this period cannot be accurately evaluated from traditional financial reports. Hence, compared to other business, biotech companies should resort more actively to appropriate intangible intellectual asset management to achieve a successful redemption of its intellectual assets. This thesis will firstly through the literature study depict the current condition of Taiwan biotech industry and important issues on intellectual asset management and R&D management, inducing several principles of management. Further, the study proceeds with the principles induced to examine three new ventures in Taiwan, Taiwan Liposome Company (TLO), TaiMed Biologics, and InnoPharmax. The discussion will elaborate the practice of intellectual asset management of biotech industry in Taiwan, analyzing and comparing the accumulation of human capital, organizational capital, and relationship capital in the three cases. The study proposes that Taiwan biotech companies usually neglect the accumulation and management of R&D capacity and knowledge in the enterprise organization system. The companies in question invest their resources mostly on the development of new technology and less on other intellectual assets. However, in the long run, the competency of a biotech company accumulates while the organization develops, other than the financial capital and technology. The depreciation of knowledge management and organization system will cause fatal influences on the company. The cases in the thesis must eventually develop their own organizational capital. Biotech companies need to devise appropriate management for organizational capital and preferable career paths for researchers and engineers, to internalize the knowledge capacity of the research team into the company assets. It is not beneficial to a biotech company in the long run to expect financial supports with short-termed achievements, instead of the management and cultivation of intellectual assets. It is advised that other than hiring professional manager for investor relations, the biotech company should pay more attention to the function of CRO and CSO in the organization and sufficiently authorize them into full play. It should also focus on the operation of the organization, adjusting and devising program management to accumulate knowledge capacity, to firmly establish the core competency in a biotech company.