Dissertations / Theses on the topic 'Pharmaceutical industry Pharmaceutical biotechnology industry'

Thesis (Ph. D.)--University of Oregon, 2007.
Typescript. Includes vita and abstract. Includes bibliographical references (leaves 109-114). Also available for download via the World Wide Web; free to University of Oregon users.

Thesis (Ph.D.)--University of North Carolina at Greensboro, 2007.
Title from PDF t.p. (viewed Oct. 22, 2007). Directed by Nancy Myers; submitted to the Dept. of English. Includes bibliographical references (p. 209-228).

Mini-study project (MBA)--University of Stellenbosch, 2003.
ENGLISH ABSTRACT: This report reviews the global and South African pharmaceutical and biotechnology industries and provides an overview of the changes taking place within these two industries. It highlights the impact this relationship will have on a developing South African biotechnology industry. Since the 1980s the pharmaceutical industry has experienced phenomenal growth in sales and profits. By the mid 1990s drug sales exceeded USD250 billion. Today the pharmaceutical industry is dominated by multi-national corporations with extensive R&D budgets, widespread use of trademarks and patents and complex commercial process technology. However they face threats from depleted product pipelines, patent expiry on billion dollar drug products, generic competition, increases in drug approval times, costs and price pressures. The entrepreneurial biotechnology industry promises to solve a number of the pharmaceutical industry's problems. In recent years biotechnology companies proved more effective in the development of new molecular entities. They promise individualised therapeutics, novel and more efficacious drug discovery and development of preventative treatments. However the decrease in equity financing after 2001 left almost 40% of biotechnology companies with less than 1 year of R&D funding. The industry experienced losses again in 2002 and the world is divided over the ethical, environmental and economic implications of biotechnological applications. The biotechnology and pharmaceutical industries have a symbiotic but antagonistic relationship. The change in this relationship will hugely affect South Africa's ideals of developing a biotechnology industry. Various diseases plague South Africa including HIV/AIDS, TB, obesity, diabetes, hypertension and infective diseases. These diseases will have a huge impact on South Africa's society. Yet only 10% of global R&D funding is committed to third world diseases and existing drugs and treatments are either not effective or too expensive for developing countries. It is in this situation that biotechnology and the development of a biotechnology industry could playa major role in alleviating South Africa's health burden. South Africa is already capable in first generation biotechnology, but third generation applications holds the most promise. Developing countries face various obstacles and challenges, but all boast well for South Africa. The government has committed R400 million (over a three year period) to utilize South Africa's biotechnology potential. Further, the country has highly skilled researchers, indigenous plant and animal species, a diverse population and a favorable exchange rate (low R&D costs).
AFRIKAANSE OPSOMMING: Die projek ondersoek beide die globale en Suid Afrikaanse farmaseutiese en biotegnologie industrieë. Verder word die veranderinge wat plaasvind in die industrieë onder die soeklig geplaas. Die projek beklemtoon die impak wat die verhouding sal hê op 'n ontwikkelende biotegnologie industrie in Suid Afrika. Die farmaseutiese industrie het sedert die 1980s dubbel syfer groei getoon in omsete en wins. Teen die middel 90's het verkope van farmaseutiese middels US$250 miljard wêreldwyd oorskry. Vandag word die farmaseutiese industrie oorheers deur multi-nasionale korporasies met omvattende navorsing en ontwikkelings begrotings, algemene gebruik van handelsmerkte, patente en komplekse proses-tegnologieë. Ten spyte hiervan word die industrie bedreig deur leë produksie-lyne, verval van patente, miljard dollar farmaseutiese produkte, generiese kompetisie, verlengde produk-goedkeurings periodes en prys-mededinging. Die biotegnologie industrie met sy innoveerende eienskappe beloof om verskeie van die farmaseutiese industrie se probleme op te los. Onlangs het biotegnologie maatskappye getoon dat hulle meer effektief is in die ontwikkeling van nuwe molekulêre eenhede. Biotegnologie beloof nuwe en meer effektiewe produk-ontwikkeling asook beter individuele terapieë en voorkomende behandelings. Die industrie staar finansiële krisisse in die gesig. Slegs 40% van biotegnologie maatskappye het voldoende navorsing en ontwikkelings-kapitaal tot 2004. Dit is hoofsaaklik as gevolg van 'n afname in eienaars-finansiering na 2001. Die industrie as 'n geheel het weereens 'n verlies gelei in 2002 en die wêreld is verdeeld oor die etiese, omgewings en ekonomiese implikasie van biotegnologiese toepassings. Die biotegnologie en farmaseutiese industrieë het 'n simbiotiese maar tog vyandige verhouding. 'n Verandering in die verhouding gaan Suid Afrika se ideale om 'n biotegnologie industrie te skep grootliks beïnvloed. Suid Afrika gaan gebuk onder verskeie siektes insluitende MIVNIGS, TB, vetsugtigheid, diabetes, hipertensie en infeksie siektes. Hierdie siektes het 'n groot impak op Suid Afrika se samelewing. Tog word slegs 10% van die globale navorsings en ontwikkelingsfondse aangewend om 'n oplossing te vind vir derdewêreld siektes. Verder is bestaande produkte en behandelings oneffektief of onbekostigbaar vir ontwikkelde lande. Dit is in sulke gevalle waar biotegnologie en die ontwikkeling van 'n biotegnologie industrie 'n groot rol kan speel in die verligting van Suid Afrika se gesondheids-las. Suid Afrika is vaardig in eerste-generasie biotegnologie, maar wêreld wyd hou derde generasie biotegnologie die meeste belofte in. Die tegnologie is tot op hede onderbenut in Suid Afrika. Ontwikkelende lande staar verskeie uitdagings in die gesig, maar Suid Afrika het talle sterk punte. Die regering het R400 miljoen (oor 'n drie jaar periode) beskikbaar gestel vir die ontwikkeling van Suid Afrika se biotegnologie potensiaal. Die land beskik ook oor navorsers van hoogstande gehalte, onbenutte inheemse plante en dier spesies, 'n diverse populasie en 'n gunstige wisselkoers (lae navorsings en ontwikkelings kostes).

This Dissertation investigates the relationship between patent quality and company performance for a sample from the US Biotechnology and Pharmaceutical Industry. The methodology devised comprehensively examines patent worth (patent’s references), patent protection (claims and family patents) and patent quality (references, claims and family patents) to determine their implications on firm leverage (SE, TA), profits (ROE, ROA), and market value (B/M, MCap). The selected sample comprises 1,536 companies, and 285,000 patents from 1999 to 2009. The results show that total revenue just responds to changes in R&D; intensity, and patenting intensity. A 10 percent increase in patent value results in a corresponding increase rate on the market capitalization index for the full sample and a 14 percent increase for the chemicals and allied products group (SIC 28). Increases (10%) in patent protection and quality present average increases of 15 percent on market capitalization for the full sample and 8 percent for the chemicals and allied products group (SIC 28). The medical devices group (SIC 38) results suggest that Mcap increases 10 percent by the same increase in patent value index. Patent protection and quality increases (10%) suggest an average 8 percent increase in Mcap. Results suggest that profits, leverage and market indices respond differently to 10 percent increases in patent value, patent protections and patent quality. The aforementioned effects suggest that the qualitative indexes follow company related market activities and business valuations for the chemical and allied products, and medical devices industrial sectors.

This master thesis report aims to highlight the importance ofinterorganizational relationships between experienced serviceproviders and emerging biopharmaceutical (EBP) companies within theSwedish healthcare industry. A shift in innovation strategiesregarding new pharmaceutical- and medical device products hasprompted a paradigm shift within a complex industry wherecollaborations between organisations has become increasinglycrucial. With a better understanding of how these companiesoperates, increased collaboration efforts could result in a fasterand more precise product development with new products reaching themarket improving the health for people around the world. In order toallow experienced service providers to enhance services towards EBPcompanies, a fundamental understanding of how decision makers withinthese EBP companies prefer to conduct relationships is needed. Wehave examined relationship preferences of EBP companies byconducting a qualitative case study through 14 interviews withdecision makers combined with a quantitative conjoint analysis.Eight factors was identified as important for when EBP companiesdecide to engage with a service provider: cost behavior,professional competence, adaptability, communication, personalrelationship, stability, EBP insight and size. The factorsadaptability, personal relationship, cost and size were used in theconjoint analysis to determine their relative importance which showthat adaptability and cost behavior was of the largest importance.With descriptions of each factor, we have provided a meaningfulguide to action of how to address these factors as a serviceprovider. The relationships is largely investigated as relationshipsbetween contract research organizations (as service providers) andEBP companies, but we have created a framework applicable forservice providers within the healthcare industry in general.

This study addresses the ongoing implications of the realignment of the pharmaceutical industry knowledge base – from small molecule methods to new biomedical technologies – for the competitive positions of traditional pharmaceutical companies and biopharmaceutical start-ups. The theoretical approach draws on the modern theory of the firm and related concepts, to define and develop the concept of the business model. This is employed to guide the empirical analysis, which utilises a combination of data analyses and case studies based on several sources, including detailed company reports and alliance databases. The thesis analyses how the pharmaceutical companies have successfully adjusted their business models to meet the challenge of biotechnology and so retain their powerful position in the industry. Central to this has been the breadth and depth of knowledge transfer through alliance formation. Not only has this been critical to the adjustment process for the large pharmaceutical companies but also for the development of the many biopharmaceutical start ups. Nonetheless the business models of these smaller companies have many weaknesses, which have led to the erosion of the value of their initial strategic assets. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. This has been captured disproportionately by a handful of large fully integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical firms.

This study addresses the ongoing implications of the realignment of the pharmaceutical industry knowledge base – from small molecule methods to new biomedical technologies – for the competitive positions of traditional pharmaceutical companies and biopharmaceutical start-ups. The theoretical approach draws on the modern theory of the firm and related concepts, to define and develop the concept of the business model. This is employed to guide the empirical analysis, which utilises a combination of data analyses and case studies based on several sources, including detailed company reports and alliance databases. The thesis analyses how the pharmaceutical companies have successfully adjusted their business models to meet the challenge of biotechnology and so retain their powerful position in the industry. Central to this has been the breadth and depth of knowledge transfer through alliance formation. Not only has this been critical to the adjustment process for the large pharmaceutical companies but also for the development of the many biopharmaceutical start ups. Nonetheless the business models of these smaller companies have many weaknesses, which have led to the erosion of the value of their initial strategic assets. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. This has been captured disproportionately by a handful of large fully integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical firms.

The principal aim of this thesis is to describe methods of fundamental analysis of three major companies from sectors of Biotechnology and Pharmaceuticals, namely Johnson & Johnson, Pfizer and Amgen. Among used methods we are able to find 2 -- stage discounted cashlow models Free-cashflow-to-equity FCFE and Free-cashflow-to-firm FCFF, Gordon's dividend discount model a relative valuation methods using P/E, P/BV and P/S. Descriptive part of this thesis describes legal and regulatory environment, which has significant impact on the development process of new innovative drugs and therapies. Further it sets investment recommendations and looks closer at investment opportunities in biotechnological companies.

The goal of this Masters Thesis is to analyze three selected industry sectors in the Czech Republic and in Germany. Concretely the industries in focus are engineering, motor vehicle manufacturing and finally pharmacy along with bio- and nanotechnology. Furthermore, factors limiting but also supporting the industry development are identified and described in the Thesis. In the Thesis, analytical instruments will be used, especially the SWOT analysis and benchmarking. The Thesis is mainly intended for managers, employees, consultants and all other direct or indirect interest groups of both Czech and German industry companies and their suppliers but also for potential investors who are deciding whether to enter a market in the CEE region.

I examine investors’ reaction to the announcement of mergers and acquisitions in the pharmaceutical and biotechnology industry from 2002 to 2008. Over this period, investors anticipate the announcements, as demonstrated by the fact that the cumulative abnormal returns are not statistically significant. In addition, I test to determine the effect of excess capacity on investors’ reactions. From 2002 to 2004, investors do not recognize acquisitions as a response to excess capacity, as the excess capacity measures utilized have no effect on the size of the cumulative abnormal return. From 2005 to 2008, however, excess capacity measures have a positive effect on cumulative abnormal return, indicating that investors started to recognize the threat of excess capacity and acquisitions as a response to that threat.

O ácido lactobiônico e seus sais (lactobionatos), compostos que apresentam aplicações na área farmacêutica, foram obtidos via ação do complexo enzimático glicose-frutose oxidorredutase (GFOR)/gliconolactonase (GL) - presente no periplasma de células da bactéria Zymomonas mobilis - imobilizado em alginato de cálcio. Nas reações catalisadas por este sistema enzimático, o pH do meio deve ser controlado em valores ligeiramente ácidos. Para este fim, foram empregados NaOH, KOH ou Ca(OH)2 e, como consequência, os respectivos sais foram formados. O estudo da cinética de formação dos lactobionatos de sódio, potássio e cálcio e do próprio ácido lactobiônico foi seguido das etapas de purificação, caracterização e avaliação da estabilidade físico-química, visando à potencial utilização destes compostos na área farmacêutica. Em ensaios de bioprodução dos lactobionatos de sódio, potássio e cálcio, foram obtidos rendimentos de 74, 77 e 84%, respectivamente. Em bateladas sucessivas de bioconversão, totalizando 96 h de uso do biocatalisador, rendimentos de 80 e 56 % em lactobionatos de cálcio e de potássio foram atingidos. Na etapa de purificação dos sais, foram alcançados teores de pureza de aproximadamente 95%, sendo então procedida a caracterização dos compostos por cromatografia líquida de alta eficiência, espectrometria de massas e RMN de 13C. Nos estudos de estabilidade acelerada, de longa duração e degradação forçada, os lactobionatos de sódio, potássio e cálcio obtidos nos ensaios de bioconversão conduzidos em maior volume reacional, foram inicialmente purificados e, então, comparados frente ao ácido lactobiônico, obtido por troca iônica a partir do lactobionato de sódio, e com o ácido lactobiônico comercial (Sigma-Aldrich). Nos testes de estabilidade acelerada e de longa duração, foi constatada a estabilidade de todos os compostos por até seis meses quando expostos a 30 e 40oC e 75% de umidade relativa. Por outro lado, a presença da lactobionolactona foi identificada nas amostras dos compostos na forma ácida. Com relação aos testes de degradação forçada, os lactobionatos de sódio, potássio, e cálcio e o ácido lactobiônico se mostraram estáveis frente à exposição a soluções ácidas e alcalinas e às temperaturas avaliadas. Contudo, observou-se degradação no tratamento com solução oxidativa, com cinética de degradação de ordem zero para os sais e de segunda ordem para o ácido lactobiônico. Elevadas concentrações de produtos - lactobionatos de sódio, potássio e cálcio - foram atingidas com a utilização do sistema GFOR/GL imobilizado em alginato de cálcio. Considerando o conjunto de informações obtido, quanto à caracterização físico-química dos compostos produzidos, foi demonstrada a estabilidade frente aos diferentes parâmetros avaliados atendendo aos requisitos mínimos legais para sua aplicação na área farmacêutica.
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, CAPES.
Lactobionic acid and its salts (lactobionate) are substances that have several applications in pharmaceutical area. These products were obtained by enzymatic complex glucose-fructose-oxidoreductase (GFOR)/gluconolactonase (GL) present in the periplasm of Zymomonas mobilis cells that were immobilized in calcium alginate. In the reactions catalyzed by this enzyme system, the medium pH must be controlled at slightly acid values. For this purpose, NaOH, KOH, or Ca(OH)2 were used and as a result the respective salts were formed. The kinetic study on the formation of sodium, potassium and calcium lactobionate and lactobionic acid itself was followed by the steps of purification, characterization and evaluation of the physicochemical stability, aiming the potential use of these compounds in the pharmaceutical area. In the assays for the bioproduction of sodium, potassium or calcium lactobionates, yields of 74, 77 and 84% were obtained, respectively. In repeated bioconversion batches, totalizing 96 hours of use of the biocatalyst, yields of 80 and 56% were attained for calcium and potassium lactobionate. In the salts purification step, purity levels of approximately 95% were achieved, and subsequently these compounds were characterized by high performance liquid chromatography, mass spectrometry, and C13 NMR. In the studies of accelerated, long term and forced degradation stability, the production of sodium, potassium and calcium lactobionate was carried out at higher reaction volume. The products were purified and then evaluated together with lactobionic acid that was obtained by ion-exchange from sodium lactobionate, and with a commercial lactobionic acid (Sigma-Aldrich). In the accelerated and long term stability tests, it was demonstrated the stability of all compounds when exposed to 30 and 40oC and of 75%of relative humidity for up to six months. On the other hand, the presence of lactobionolactone was identified in samples of compounds in the acid form. With respect to the forced degradation tests, sodium, potassium and calcium lactobionates and lactobionic acid have shown to be stable after exposing to both acidic and alkaline solutions and the temperatures evaluated. However, degradation was observed in the treatment with oxidative solution, with a zero-order degradation kinetics for the salts forms and second-order for lactobionic acid. High concentrations of products - sodium, potassium and calcium lactobionate - were achieved by using the Ca-alginate immobilized GFOR/GL complex. Considering the set of information obtained in regarding to physicochemical characterization, it was demonstrated the high stability of these compounds in front of different parameters evaluated, endorsing the legal minimum requirements for their application in the pharmaceutical area.

This study aims at introducing and describing a novel multi parameter analysis method to identify potential acquisition targets and to qualitatively and quantitatively evaluate the overall match between a target company and its acquirer. The method was tested with two recent real cases involving each an antibody based biotech company and a large fully integrated pharmaceutical company. The model was validated by comparing two independent antibody companies against the real cases, testing if they would have made better targets. It was found out that the in reality acquired companies scored highest, thus proving the validity of the method. One of the four potential targets got the highest scores for both acquirers. Consequently one of the acquired targets was only the second best match. The still independent companies would not have been better targets. The lowest scoring target company did get identical scores for both acquiring companies. Despite the proper prediction of targets, the scoring did not reveal the true underlying motives for the acquisitions, nor could significant parameters be identified to discriminate between target and non-target. This study adds a novel, valuable tool to the still limited arsenal of methods to qualitatively and quantitatively measure a match between target and acquirer solely based on publicly available data.

Bakgrund: Outsourcing är inget nytt fenomen då transaktionskostnadsteorin formades 1937 som beskrev att företag bör vända sig till marknaden i de fall detta gynnade företaget ekonomiskt. Sedan dess har teorier kring outsourcing förändrats och i dag handlar outsourcing om att kunna fokusera på företagets kärnkompetens och vilka möjligheter och risker outsourcing medför. Läkemedelsbranschen har på senare år börjat outsourca forskning och produktutveckling, vilka ses som kärnprocesser. Det råder därför delade meningar om branschen faktiskt har en kärnprocess. Syfte: Syftet med denna uppsats är att förstå hur och varför läkemedelstillverkningsbranschen outsourcar, om de outsourcade processerna har koppling till företags kärnprocesser och hur outsourcing faktiskt påverkar företaget, både monetärt och icke-monetärt. Metod: Det empiriska materialet insamlades med både kvantitativ och kvalitativ metod. En enkätundersökning genomfördes för att få en generell bild av hur läkemedelstillverkningsbranschen outsourcar för att sedan genomföra tre intervjuer för att få djupare kunskap om varför företag gjort de angivna val kring outsourcing. De intervjuade företagen valdes ut genom ett typiskt urval där företag valdes som svarat utifrån vissa bestämda kriterier. Slutsats: Uppsatsen har belyst att den vanligaste processen att outsourca är tillverkning, men att även forskning och produktutveckling outsourcas till viss del. Detta berodde på att företag upplevde resurs- och kunskapsbrist inom de outsourcade processerna. Studien fann även att sambandet mellan anledningen till och utfallet av outsourcing var svagt. Däremot hamnade den ökade lönsamheten sist inom båda kategorierna. Det påvisades också att det är svårt att definiera en kärnprocess till branschen med anledning av den diversifiering som i dag karaktäriserar branschen. Däremot framkom produktutveckling som den vanligaste kärnprocessen inom företag, där det visade sig att företag inte tenderar att outsourca sin kärnprocess.
Background: Outsourcing is not a new phenomenon. Transaction cost theory was formed in 1937, which described that companies should transfer activities externally when this benefited companies financially. Since then, theories of outsourcing have changed and today, it has been switched to outsourcing of core competencies and a discussion of both opportunities and risks. In recent years the pharmaceutical industry has started to outsource their research and product development, which is considered a core process. Due to this there is a debate whether or not the industry has a core process. Purpose: The purposes of this thesis are to understand how and why the pharmaceutical manufacturing industry is outsourcing, how the outsourced processes relate to their core processes and how outsourcing affects the companies, both monetary and non-monetary. Method: The empirical evidence was gathered with both quantitative and qualitative methods. Firstly, a survey was conducted to get a general picture of how the pharmaceutical manufacturing industry outsources which was then followed by three interviews to gain an in-depth knowledge of why companies have made specified decisions regarding outsourcing. The companies were selected according to a number of specific criteria. Conclusion: The thesis has highlighted that manufacturing is the most common process of outsourcing, but also that research and product development is outsourced to some extent. This was due to the fact that companies experienced resource and knowledge shortage in the outsourced processes. The study also found that the relation between the reason and the outcome of outsourcing was weak. However, the increased profitability ended last in both categories. It was also found that it is difficult to define a core process within the industry due to the diversification that today characterizes the industry. On the other hand, product development appear to be the most common core process within companies, where it also shows that companies tend not to outsource their core process.

Thesis (Ph.D.)--Antioch University, 2008.
"A dissertation submitted to the Ph.D. in Leadership & Change Program of Antioch University in partial fulfillment of the requirements for the degree of Doctor of Philosophy May 2008."--from the title page. Title from PDF t.p. (viewed July 30, 2008). Advisor: Alan Guskin, Ph.D.. Keywords: biotechnology, biopharmaceutical, leadership, founder, success, management, case study Includes bibliographical references (p. 207-218).

En prenant pour point de départ l'émergence de technologies nouvelles, ce travail s'interroge sur la capacité des acteurs d'une industrie à réorganiser leurs bases de connaissances. Dans ce but, nous nous intéressons aux processus d'intégration des connaissances que nous définissons comme la recherche de complémentarité technologique dans les bases de connaissances des acteurs engagées dans des processus d'innovation. Dans un environnement technologique donné, larecherches de complémentarité technologique définit la recherche des combinaisons technologiques les plus productives. Deux angles de recherche sont ainsi privilégiés : les processus d'intégration intra-organisationnelle des connaissances et les processus d'intégration inter-organisationnelle des connaissances. Appliqué à l'étude des biotechnologies et de l'industrie pharmaceutique, ce travail de nature économétrique mobilisant des bases de données innovations, brevets et alliancesnous permet d'avancer deux principaux résultats. Dans le cadre des processus d'intégration intra-organisationnelle des connaissances, nous montrons que la recherche de complémentarité technologique est déterminée par la détention de connaissances fondamentales qui favorise la capacité des firmes à combiner leurs savoirs et par conséquent leur capacité à innover. Dans le cadre des processus d'intégration inter-organisationnelle des connaissances, nous montrons que la recherche de complémentarité technologique détermine le choix pour les acteurs d'une industrie de former une alliance stratégique et que cette recherche de complémentarité technologique évolue tout au long du cycle de vie de la technologie

With the growing trend of globalization and rapid development of high technologies, emerging economies face more challenges in technology development because they are chasing a fast-moving frontier. They need to identify global technology trends and adapt to local needs and capabilities. Strategies for technology development differ among countries at different developmental stages. In this research, a technology policy choice framework is developed to link prospective high-tech areas, technology development strategies, and various innovative resources. The research approach is to develop a hierarchical decision model (HDM) and apply the analytic hierarchical process (AHP). Experts are invited from diverse sources to provide a balanced perspective representing different stakeholders. This research focuses on the fast developing Chinese biopharmaceutical industry as a case study. The results of this research have identified thirteen prospective biotech areas that China should invest more resources for development. These technology areas include: recombinant therapeutic proteins, recombinant vaccines, monoclonal antibody technology, cell and tissue engineering, gene therapy, antisense therapy, RNAi, nanobiotechnology, synthetic biology, bioinformatics, pharmacogenetics, gene sequencing, and biotechnology diagnostics. For most of these technology areas, the results have indicated an imitative innovation strategy should be taken as a better strategy under current technological conditions in China. The research has further found that high-tech small-to-medium companies and multinational corporations are major innovation contributors in the Chinese biopharmaceutical sector. The research outcomes can serve as guidelines in resource allocation and policy making for technology development. Based on the overall research findings, policy-makers can apply more specific policy instruments to support innovation activities. Appropriate policy measures may help the country to construct an innovative ecosystem that can serve as the driving force for future technology development.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 98-102).
For several decades, the ascendancy of the Pharma & Biotech sector was largely driven by favorable macro-economic conditions combined with an astonishing level of innovation and a clear focus on addressing unmet medical needs. Significant R&D investments led to innovative drugs that changed clinical practice across multiple illnesses and contributed to an overall rise in life expectancy around the world. Unfortunately, this trend has not continued. Since the mid-90s', the approval of novel drugs has plummeted despite record levels of R&D investment. It is estimated that between 2000 and 2010, the top 10 global Pharma and Biotech companies have collectively invested over $500 Billion in R&D. In the same period, only about 150 novel drugs entered the market. This is partly explained by the fact that quick-wins have been harvested, and that further progress in treating grievous illness is harder to achieve. This is compounded by increasing concerns about the longterm safety of drugs and the conservative regulatory climate that has prevailed since 2000. In this challenging regulatory and cost environment, the basic economic model of the industry is now being questioned. In this work I review the recent financial performance of ten major global pharmaceutical companies, and the challenges faced by the industry in moving from a deterministic, blockbuster era to a more stochastic era defined by multiple unknowns.
by Kailash Swarna.
M.B.A.

Mestrado em Economiae e Gestão de Ciência e Tecnologia
A evolução da indústria farmacêutica nas últimas décadas, embora integrando-se no quadro de desenvolvimento global da economia, preserva a sua própria autonomia, devido ao carácter eminentemente social, traduzível nos seus objectivos de combate à doença e à morte, bem como de busca progressiva do bem estar físico e psíquico da humanidade. E porque nesse domínio, nada é imutável, o grau crescente de exigência quanto a níveis de qualidade, de eficácia e de segurança no sector implica uma postura dinâmica e criativa do lado da oferta. Neste contexto, a I&D e a Inovação têm sido importantes motores da indústria farmacêutica, processos em que a dimensão imaterial predomina, influenciando o comportamento dos demais factores das actividades inovadoras. Assim, este estudo tem como âmbito a indústria farmacêutica, num contexto de globalização económica, com incidência nos vectores de l&D e de Inovação e como objectivo responder fundamentalmente a duas questões: i) Num sector em que a Inovação e a l&D são essenciais, como é o caso da indústria farmacêutica, saber qual a influência da procura, e designadamente a do consumidor final, no seu desenvolvimento; ii) na identificação do desempenho das empresas de pequena dimensão e das empresas de grande dimensão, quais as relações, de complementaridade ou de predominância, que se estabelecem entre elas no quadro da l&D e da Inovação farmacêuticas. Para responder a estas questões recorremos à revisão da literatura conhecida, que complementámos com a análise empírica de casos relativos a empresas farmacêuticas, nacionais e estrangeiras, implantadas em território português.
The evolution of the pharmaceutical industry in the last decades, although integrated in the general frame of economical development, preserves its own autonomy, owing to the eminent social nature of its objectives of action against desease and death and of progressivo search for human physical and psychic well-being. Because on this realm nothing is unchangeable, the growing dregree of exigency as to the leveis of quality, efficiency and security in the sector implies a dynamic and creative approach from the supply side. Therefore, Research and Development and Innovation have been important motors of the pharmaceutical industry, as processes where the immaterial dimension prevails and exerts influence upon the behaviour of the other factors related to the innovating activities. Consequently, the scope of the present work is the pharmaceutical industry, in a context of economical globalization, with emphasis on the R&D and Innovation vectors, being its main objective the answer to two fundamental questions: 1) In a sector where Innovation and R&D, are essential, as it is the case of the pharmaceutical industry, to know the influence that the demand, and particularly the final consummer, may exercise on its development; 2) when identifying the performance of small and big companies, what kind of complementary and/or predominance relations are established among them within the ambit of R&D and pharmaceutical innovation. In order to answer these questions, we proceeded to the re- examining of known literature, which we completed with the empirical analisys of cases related to pharmaceutical companies, both national and foreign, operating in Portugal.
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Esta dissertação analisa a vantagem competitiva das indústrias farmacêuticas, segmento saúde humana Brasil, que adotam a inovação aberta. É um estudo de caráter exploratório e abordagem qualitativa descritiva. Qual é a contribuição da inovação aberta para a vantagem competitiva da indústria farmacêutica foi a pergunta de pesquisa. Identificar a prática da inovação nas empresas selecionadas, verificar a adoção da inovação aberta e descrever a contribuição desta para a vantagem competitiva foram os objetivos específicos. O referencial teórico articula a literatura sobre inovação e vantagem competitiva para melhor entendimento das inter-relações entre os constructos. Dez organizações, duas associações e um representante da academia foram selecionados após análise de informações institucionais e registros documentais. Os principais executivos das empresas nacionais, multinacionais e associações de fabricantes responderam à pesquisa com perguntas semiestruturadas, roteiro padrão e perguntas abertas. O tratamento dos dados qualitativos seguiu a técnica de análise interpretativa. As metacategorias encontradas foram: inovação, pesquisa e desenvolvimento, inovação aberta e vantagem competitiva. Os resultados sinalizam que nestas empresas os produtos novos decorrem de inovações incrementais, radicais e disruptivas. Elas utilizam estratégias tecnológicas ofensivas, defensivas, imitativas e dependentes. No Brasil, a prática da inovação aberta entre as indústrias nacionais participantes acontece em diferentes estágios, conforme gestão interna e externa dos processos de inovação, propriedade intelectual, parcerias, pesquisa e desenvolvimento. Indústrias multinacionais que praticam a inovação aberta no exterior, não adotam no Brasil por razões que coincidem entre os entrevistados. Empresas que utilizam a inovação aberta relataram sua contribuição para recursos e capacidades valiosos, raros e inimitáveis. Dificuldades para adoção no país, também foram mencionadas. Espera-se que este estudo contribua para futuros trabalhos e pesquisas acadêmicas relacionadas à inovação aberta.

Mestrado Bolonha em Finanças
This report includes a detailed valuation of Pfizer Inc. The format of this Equity Research Report combines both rules of ISEG Master Final Work Project and the CFA institute recommendations. The choice of Pfizer Inc was firstly because the pharmaceutical industry is a trending topic nowadays, due to covid-19, and secondly because Pfizer developed the first covid-19 vaccine which awakened in me a special interest in learning more about the company. Pfizer Inc. (PFE) is a research-based, global biopharmaceutical company, that is committed to the discovery, development, manufacture, marketing, sales, and distribution of biopharmaceutical products worldwide – with 2020FY revenues of $41.9Bn and a market capitalization of $205 Bn. Pfizer has a BUY recommendation, with a 2022FY PT of $54.48/share, which represents an upside potential of 18.3%, equivalent to an annualized return of 13.4%, against the closing price of $46.07/share on August 31st, 2021, with medium risk. The PT was obtained using Discounted Cash Flow model (DCF), other methodologies were considered to reach Pfizer’s PT such as the Adjusted Present Value (APV), the Flow-to-Equity (FTE) method, the Dividend Discount Model (DDM), and a Relative Valuation using market multiples from peers. The report also includes a detailed explanation about the risks that can affect the price target, as well as a sensitivity analysis to assess the impact of those risks in the investment recommendation. This report considers all the public information available until 31st August 2021.
Este relatório inclui uma avaliação detalhada da Pfizer Inc. O formato desta Equity Research combina as regras do Projeto de Trabalho Final de Mestrado do ISEG e as recomendações do CFA Institute. A escolha da Pfizer Inc foi em primeiro lugar devido à indústria farmacêutica ser uma indústria que está na moda hoje em dia, devido à pandemia de covid-19, e em segundo lugar porque a Pfizer foi a empresa que desenvolveu a primeira vacina, o que despertou em mim um interesse especial em aprender mais sobre a empresa. A Pfizer Inc. (PFE) é uma empresa farmacêutica que opera a nível global dedicando-se à pesquisa, descoberta, desenvolvimento, produção, marketing, vendas e distribuição de produtos farmacêuticos em todo o mundo - com uma receita no final do ano de 2020 de 41,9 mil milhões de dólares e uma capitalização de mercado de 205 mil milhões de dólares. A Pfizer tem uma recomendação de COMPRA, com um preço alvo de $ 54,48/ação para o final do ano de 2022, o que representa uma potencial valorização de 18,3%, equivalente a um retorno anualizado de 13,4%, contra o preço de fecho de $ 46,07/ação em 31 de agosto de 2021, com risco médio. O preço alvo foi obtido usando o modelo dos Fluxos de Caixa Descontados (DCF), outras metodologias foram consideradas para calcular o preço alvo da Pfizer, como o Valor Presente Ajustado (APV), o método Flow-to-Equity (FTE), o Modelo de Dividendos Descontados (DDM) e uma Avaliação Relativa usando múltiplos de mercado de empresas comparáveis. O relatório também inclui uma explicação detalhada sobre os riscos que podem afetar o preço alvo bem como uma análise de sensibilidade para quantificar o impacto desses riscos na recomendação. Para este relatório foram consideradas todas as informações públicas disponíveis até 31 de agosto de 2021.
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El objetivo de esta tesis ha sido la de proporcionar un análisis económico sobre varios temas que rodean l industria farmacéutica. Mientras llevaba a cabo mi investigación, observe que la mayor parte de la investigación que analizaba esta industria era descriptiva y empírica, y que existía una carencia de un riguroso análisis teórico para explicar esta investigación. Por lo tanto, el objetivo de esta tesis es claro: usando modelos teóricos de la rama de economía industrial, he intentado explicar el funcionamiento de la industria farmacéutica para intentar dar una explicación formal desde un punto de vista económico. Por esta razón, me he concentrado en dos aspectos muy relevantes. En la primera parte, que incluye Capítulos 1 y 2, he llevado a cabo un análisis sobre los posibles efectos de implementar un sistema de precios de referencia, y cual puede ser la respuesta de las empresas a este sistema. El análisis se basa tanto en las decisiones a corto (precios) y largo (I&D) plazo. En la segunda parte, que incluye el Capítulo 3, se analiza la introducción de los llamados "branded generics", o genéricos de marca. La idea es intentar explicar la razón por la cual los productores de medicamentos de marca tienden a producir genéricos de su producto original una vez finalizada la patente sobre éste. Los medicamentos genéricos han crecido en importancia durante los últimos años. Por dar un ejemplo de su importancia, la cuota de estos medicamentos en EEUU alcanza ya el 50% del total del mercado.
Un sistema de precios de referencia es un sistema de reembolso que categoriza los productos en grupos con otros productos de similares efectos terapéuticos. El precio de referencia es el precio máximo que el pagador esta dispuesto a rembolsar por cualquier producto de ese grupo. Los productores tienen libertad a la hora de elegir sus precios. Si el precio elegido es superior al precio de referencia, será el consumidor quiena pague la diferencia. Este sistema pretende trasladar parte de la responsabilidad a los pacientes, incrementado su conciencia respecto a los costes, y dotándoles de incentivos. El objetivo de este sistema es doble: primero, se pretende incrementar la competencia en precios, y segundo, que debido a este incremento en la competencia, se reduzca el gasto público en medicamentos. La opinión de la industria es sin embargo contraria a este sistema, ya que creen que reducirá sus beneficios, disminuyendo los incentivos y medios para llevar a cabo la I&D. Nótese la importancia de la relación entre los precios de referencia y la existencia de los medicamentos genéricos (mas baratos normalmente). Los medicamentos genéricos son aquéllos que entran en el mercado una vez que la patente sobre el principio activo del medicamento original ha terminado. Su principal característica es que se venden sin marca de fantasía, y suelen ser más baratos. Estos genéricos están certificados por las correspondientes Autoridades Sanitarias como sustitutivos perfectos del medicamento de marca, dado que su principio activo es el mismo. Además, son bioequivalentes en el sentido de ser estadísticamente iguales al producto original en aspectos claves de su uso terapéutico. Sin embargo, pueden variar en las características de forma, color y empaquetamiento. Si tenemos en cuenta que no todos los pacientes cambian inmediatamente al medicamento genérico cuando entran en el mercado, esto nos hace suponer que ambos productos no son sustitutivos perfectos. Una condición necesaria para una eficiente implementación de un sistema de precios de referencia es un desarrollado mercado de genéricos. La razón de esta condición es que normalmente, el precio de referencia se suele fijar alrededor del precio mas barato del grupo. Si un genérico existiera, éste probablemente tendría el precio mas bajo. Hay que añadir que esta relación no es una condición suficiente para la eficiente implantación de este sistema. Si tenemos en cuenta que este sistema de precios de referencia esta intentando reducir precios, este sistema se tendría que implantar en mercados donde exista un elevado gasto publico en medicamentos debido a precios altos más que debido a un consumo elevado. Además, la diferencia de precios entre los productos pertenecientes al grupo debe ser considerable, si no, el ahorro potencial será mínimo.
Los precios de referencia se han implementado en varios países, el primero siendo Alemania en 1989. Desde entonces, muchos otros países han seguido el ejemplo, y más recientemente, España también los ha introducido. La manera de implementación no ha sido universal, por lo que analizaremos dos formas diferentes de implementarlos.
Los efectos de esta implantación será analizado en dos etapas, para así poder tener en consideración la naturaleza de esta industria y la importancia del I&D. En términos generales, el Capítulo 1 analiza las decisiones a corto plazo (precios y cantidades), mientras que el Capítulo 2 se concentra en la decisión a largo plazo de I&D. Específicamente, lo que tratamos de estudiar es el efecto que tendrá en precios la sustitución de un sistema de copagos por un sistema de precios de referencia. El mercado estará compuesto por un duopolio, con un medicamento de marca y otro genérico, y consideraremos dos posible escenarios. En cada escenario, queremos comparar entre dos estructuras de demanda; la primera estructura de demanda es la que resulta con un sistema de copagos, donde el paciente paga una proporción (o copago) del producto mientras que la segunda es la resultante de un sistema de precios de referencia. La diferencia entre los dos escenarios es que en el primero, bajo un sistema de copagos, el paciente paga el precio entero (es decir, el copago es igual a uno), y bajo precios de referencia el paciente sólo paga la diferencia entre el precio del producto y el precio de referencia. Implícitamente, este escenario esta asumiendo que el precio de referencia se sitúa siempre por debajo tanto del precio del medicamento de marca como del genérico. El segundo escenario, sin embargo, asume que con copagos, el paciente paga una fracción del precio (no paga el precio entero). La estructura de demanda en este escenario bajo precios de referencia también se obtiene asumiendo algo distinto al escenario anterior. Esta vez, el sistema a utilizar el es español, donde implica que el precio de referencia se sitúa por encima del precio del genérico pero por debajo del precio del medicamento de marca. Así pues, si el paciente desea comprar el genérico, esta vez pagará el mismo copago que antes, pero en cambio, si desea comprar el medicamento de marca, pagará el mismo copago que antes, pero esta vez asociado al precio de referencia, más la diferencia entre el precio del medicamento de marca y el precio de referencia. El estudio también analiza como los beneficios privados y el gasto público en medicamentos varía.
Como ya se ha comentado anteriormente, la forma de introducción de precios de referencia no ha sido universal. Hallar el precio de referencia óptimo esta más allá del objetivo de esta tesis. Por esta razón, hemos construido dos escenarios para tener en cuenta diferentes métodos de introducción de este sistema.
El principal resultado obtenido en el primer escenario es que los precios de los productos son más altos con precios de referencia, así como los costes totales del sistema, pero incrementa el bienestar. El precio neto pagado por el paciente se reduce. La intuición de este resultado es que se está comparando una situación inicial donde el consumidor paga el precio entero con una situación donde el Estado financia hasta el precio de referencia. Además, este sistema actúa como una especie de subsidio para los productores. Por lo tanto, lo que tenemos es que los consumidores compran más a un precio más barato.
Bajo el segundo escenario, el que llamamos "Precios de Referencia a la Española", y donde las Autoridades Sanitarias financian una proporción de ambos productos bajo el sistema de copagos, podemos demostrar que tanto precios como la factura farmacéutica se pueden reducir, pero a expensas de disminuir los beneficios de los productores. Esto es debido a los efectos contrapuestos que un sistema de precios de referencia implantado de este modo tiene sobre los productores de medicamentos de marca y genéricos respectivamente.
El Capítulo 2 complementa el Capítulo 1, ya que proporciona una idea sobre como la decisión de innovación de las empresas farmacéuticas se puede ver afectada con la introducción de un sistema de precios de referencia. En este capítulo usamos como modelo base la estructura de demanda del capítulo anterior que hemos denominado "precios de referencia a la Española" (segundo escenario). La importancia de este capítulo viene dada por el tipo de competencia observada en esta industria: empresas compiten tanto en precios como en innovación de producto, por lo que el objetivo de este capítulo es la de modelar explícitamente la decisión de I&D de las empresas (que en este caso sería la empresa que produce el medicamento de marca), y estudiar si esta decisión se ve afectada por el cambio de un sistema de copagos a un sistema de precios de referencia. El modelo incorpora dos tipos de medicamentos: "breakthrough" (o muy innovadores) y "me-too". Los primeros son los medicamentos de nueva generación y altamente innovadores y normalmente implican un gran esfuerzo económico para obtenerlos; los segundos se consideran mejoras de productos ya existentes, y el gasto necesario en I&D para sacarlo al mercado suele ser bastante menor. Los medicamentos "breakthrough" crean un nuevo mercado, debido a su elevado grado de innovación, y no tienen competidores directos, mientras que los me-too compiten directamente con los productos ya presentes en el mercado.
El punto de partida va a ser un mercado maduro, en el sentido que ya van a existir un medicamento de marca con su correspondiente genérico. Examinaremos los incentivos, si existieran, para que el productor del medicamento de marca se convierta en multi-productor; es decir, cuando serán los incentivos más altos, si bajo copagos o precios de referencia, para producir un medicamento breakthrough, un me-too o sustituir el medicamento antiguo por el nuevo.
Los resultados obtenidos demuestran que la decisión sobre que tipo de medicamento obtenido se ve afectado al cambiar un sistema de copagos por un sistema de precios de referencia. Cuando el productor de los medicamentos de marca produce un breakthrough, sus beneficios pueden verse reducidos si un sistema de precio de referencia es introducido. Esto es debido a que este sistema puede reducir los precios elegidos por este productor, pero también puede reducir su demanda, lo que implica una reducción de beneficios. La historia se repite cuando este mismo productor decide producir un medicamento me-too. Sustituir el medicamento antiguo por el nuevo puede ocurrir cuando la demanda potencial del nuevo medicamento es suficientemente alta. Si no fuera este el caso, el productor tendría incentivos a mantener los dos productos en el mercado, repartiéndose los ingresos. Finalmente, el análisis llevado a cabo no muestra un resultado concluyente sobe la relación entre los beneficios obtenidos por este productor de producir o un medicamento breakthrough o un me-too, independientemente del sistema reinante (copagos o precios de referencia). De todas formas, podemos decir que parece más probable que se produzca un breakthrough en vez de un me-too cuando menor sea el coste de I&D del primero en comparación con el me-too, y menor sea el poder de mercado del productor original.
Estos dos capítulos son importantes porque ofrecen una explicación formal a varios resultados empíricos. Pavcnik (2000) expone los efectos de la introducción de un sistema de precios de referencia en Alemania, y demuestra que las empresas en el sector responden a esta introducción. Los productores reducen los precios, y además, cuando hay fuerte competencia con medicamentos genéricos, esta reducción es mayor. Como menciona Pavcnik, "esto demuestra que la competencia relevante ocurre entre genéricos y medicamentos de marca con el mismo principio activo" (Pavcnik 2000, Pág. 20). También demuestra que los productores de genéricos y de marca responden de forma diferente, tanto cuantitativa como cualitativamente. Los resultados obtenidos en esta tesis dan las condiciones teóricas para que esta reducción en precios se dé. Y respecto al Capitulo 2, es el primer trabajo hasta el momento que analiza explícitamente la decisión de innovación dado que un sistema de copagos o precios de referencia existe. Como la propia Pavcnik decía en su articulo, se tiene que llevar a cabo investigación para dilucidar si esta reducción en precios conlleva una reducción en I&D; y este capitulo es un primer paso en esta investigación.
La segunda parte de esta tesis, que incluye el Capítulo 3, investiga e intenta proporcionar una intuición económica sobre un proceso que hemos visto en la industria farmacéutica. Los productores de marca, una vez que su patente ha caducado, han estado produciendo sus propios genéricos. Es un proceso de canibalismo de sus propios consumidores, ya que están produciendo un medicamento en competencia directa con su producto original. La idea detrás de esta observación el apropiamiento de las llamadas "first-mover advantages" que existen en el mercado de genéricos. Por lo tanto, el productor del medicamento original tiene incentivos a ser el primero en el mercado de los genéricos, y producir así los llamados "branded generics" o genéricos de marca. Este articulo da fuelle al caso Roche-Bolar, ya que encontramos que si el productor original también produce el genérico, en vez de que se produzca por otra empresa, los precios resultantes pueden ser mas altos, y hay una reducción en el excedente del consumidor. La idea detrás del caso Roche-Bolar es la no-prohibición de que los productores de genéricos lleven acabo la investigación pertinente antes de acabe la patente sobre el principio activo, y así reducir al máximo el tiempo transcurrido entre que caduca la patente y la entrada del primer genérico.
En este trabajo, el mercado estará segmentado. Por un lado, tendremos a los consumidores leales a la marca original, donde su demanda del producto original no se verá afectada por la entrada del genérico. Por la otra, estarán los consumidores "sensibles", es decir, los consumidores cuya demanda si se verá afectada por la entrada del genérico. Estos consumidores consideran que el medicamento de marca y el genérico son sustitutivos (aunque no perfectos). Encontramos que el productor original si tiene incentivos a producir su propio genérico, debido a esta segmentación de mercado. Esto induce un incremento en el precio del medicamento de marca, y a su vez, se traduce en una disminución del bienestar. Es como si este productor, conociendo esta segmentación, estuviera discriminando en precios entre los consumidores. El productor prefiere incrementar el precio para sus consumidores leales en vez de disminuir el precio de su medicamento de marca para estos consumidores "sensibles" al precio.
The aim of this thesis is to try to give some economic analysis on pharmaceutical issues. While conducting my research, I observed that most analysis of this industry were descriptive and empirical, and found that there was a lack of economic theory to explain the data. Hence, the objective of this research is clear: using industrial economics theoretical models, I wanted to explain the functioning of this industry in order to give a formal economic explanation for some results. For this purpose, I concentrated on two aspects of the pharmaceutical industry. In the first section, which includes Chapters 1 and 2, I focused on explaining the effects of implementing a reference price (RP) system, and the response of pharmaceutical firms to a change in the price regulation these firms face. The analysis will focus on both short (prices) and long term (R&D decisions) issues. In the second section, which includes Chapter 3, the focus is on the so-called "branded generics". I aim to explain why branded good producers also tend to produce a generic version of their original drug once the patent for the original good expires. Throughout the whole thesis, we will consider the existence of generic drugs. During the last years, these drugs have become increasingly important in the pharmaceutical industry, as explained later. To give an example that illustrates their importance, generics' share can be up to 50% of total market share in the US.
A reference price reimbursement system categorises products into groups with similar therapeutic effects so that the reference price is the maximum reimbursement of the third-party payer to the manufacturers for all products in that group. Manufacturers are free to set prices. If prices set are higher than the reference price, it is the consumer who pays the difference. Such system tries to give some responsibility to patients, increasing their consciousness about costs, and providing them incentives. The objective of this system is twofold: first, it is believed that implementing a RP system encourages price competition, and second, with this increased price competition, expenditure of Health Authorities in ethical drugs will be reduced. However, the view of the pharmaceutical firms is that the introduction of such system will make them worse off due to lower profits, which will reduce their incentives to carry out R&D. Note the importance of the relation between reference prices and the existence of generic (cheaper) products. Generic goods are those goods that enter the market when the patent on the active ingredient of the original, branded, ethical drug has expired. Their main characteristic is that they are sold without a brand, and as a result are usually cheaper than the already established, branded, medicine. In all but few cases, these generics are certified by the respective Health Authorities to be perfect substitutes to the branded good since their active ingredient is identical. Furthermore, they are bioequivalent in the sense of being statistically indistinguishable from the established product in key aspects of therapeutic use. However, they could vary in characteristics such as shape, colour, packaging and labelling. Taking into account the fact that not all consumers switch immediately to generics gives support to the idea of both goods not being perfect substitutes. A necessary condition for an efficient implementation of a reference price system is a well-developed generic market. The reason for this is that the reference price is usually set around the price of the cheapest goods available. Should a generic good exist, it would normally have the lowest prices. However, the existence of such market is not a sufficient condition for an efficient implementation of such system. Broadly speaking, reference prices are aiming to reduce prices, so such system should be implemented in markets where the high pharmaceutical public expenditure was due to high average prices rather than due to high consumption levels. Moreover, the price difference between the drugs grouped should be significant; otherwise, the potential cost-savings of implementing a reference price system will be minimal.
RPs have been implemented in many developed countries, the first one being Germany in 1989. From then on, many other countries followed Germany, and recently, Spain has also introduced it. Notice that the way RP have been implemented in each country has not been universal, so we will analyse two different possibilities of introducing such system. I believe that the analysis conducted in this thesis regarding the effects of reference prices is important due to the lack of theoretical research about this important topic. Chapters 1 and 2 give some formal economic analysis on these issues.
The effects of implementing a reference price system will be analysed in two steps. The reason for this is to try to take into account the nature of the pharmaceutical industry, and the importance of R&D. Hence, and broadly speaking, we can say that Chapter 1 will focus on short-run decisions (prices, quantities), while Chapter 2 will focus on long-term variables (R&D). More specifically, in Chapter 1, we concentrate on what will be the effects price-wise of implementing a reference price system, compared to the situation with copayments. We will have a duopoly setting, with a branded and a generic good. We will consider two possible scenarios. In each scenario, we compare the outcomes between two forms of demand structures. Broadly speaking, the aim is to examine the differences between a situation where consumers pay a fixed proportion of the price (copayments) with a situation where RP exist. The difference between the two scenarios is that in the first scenario, under copayments, the consumer pays the full price i.e. the copayment is equal to one. Under reference prices, consumers will have to pay the difference between the price of the good and this reference price. This model implies that the reference price set is below the price of both the branded and the generic good. The second scenario analysed will compare the case where, under copayments, consumers pay a percentage of the price (i.e. do not have to pay the full price anymore) with reference prices. In this setting, reference prices will be modelled as the way they have been introduced in Spain. This case implies that the reference price is set higher than the price of the generic good but lower than the price of the branded. Hence, if the consumer buys the branded good, the net price paid by the consumer will be equal to the difference between the price of the branded good and the reference price, plus the same copayment as before associated this time to the reference price. If the consumer decides to buy the generic good, then (s)he would have to pay the same copayment as before the implementation of reference prices. Furthermore, we analyse how firms' profits and expenditure of Health Authorities vary accordingly. As mentioned before, how the reference price has been set has not been universal. Finding the optimal reference price is beyond the scope of this thesis, although future research will be focusing in this issue. For this purpose, we have constructed two scenarios to take into account two possibilities that we observe in countries with such systems: setting the reference price below or above the price of the price of the generic drug (but never above the price of the branded good).
The main result of the first case analysed is that prices are higher under reference prices, as well as total costs of the system, although reference prices are welfare enhancing. The net price paid by consumers is reduced under such system. The intuition is that we have compared a situation where consumers initially pay the full price with a situation where Health Authorities finance up to the reference price. Moreover, the reference price set in this way acts as a subsidy for the producers. Summarising, what we obtain is that consumers buy more, but at a cheaper price.
When reference prices are implemented in the Spanish way, and we allow that under copayments, Health Authorities finance a proportion of the price of both goods, we show that prices and pharmaceutical costs are reduced under reference prices only if the reference price is set in a certain interval. Also profits for the duopolists might be reduced. These results are due to the opposing effects that reference prices have on branded and generic producers respectively.
Chapter 2 complements Chapter 1, since it provides insights on firms' long-run decision (R&D). The aim of this chapter is to analyse how pharmaceutical firms' decision to innovate are affected by such RP system. We compare a situation with copayments with the situation where reference prices are introduced in the Spanish way. The importance of this chapter arises due to the type of competition we are observing in this industry. Firms also compete through product innovation, as well as in prices. This is due to the regulatory measures that many developed countries have in order to control for the prices of ethical drugs. The idea of this chapter is to model explicitly the decision of the firms undertaking R&D (the branded good producers), and see how this decision is affected by the introduction of reference prices instead of copayments. The model will incorporate the two types of goods that can arise after investing resources in R&D: breakthrough or me-too drugs. The former refers to very innovative drugs, and usually imply spending sufficiently high level of resources. The latter, however, involves fewer resources, although they are considered to be improvements of existing drugs. What we observe is that breakthrough drugs create a new market, while me-too drugs will have to compete with existing branded drugs and generics, if they exist. We will have a mature market, where the initial situation involves both a branded and a generic good. We examine the incentives that the incumbent has to become multiproduct i.e. we want to analyse whether and when will the incumbent have higher incentives to produce a breakthrough drug, a me-too drug, or substitute the old drug by the new one under reference prices or copayments. The idea is that the higher the resources spent on R&D, the more differentiated the new product will be with respect to the existing ones.
Results show that the decision of what type of new drug to produce is affected by changing a copayment system to a reference price system. When the incumbent firm produces a breakthrough drug, profits for the incumbent might be reduced if the latter system is introduced. This is because implementing a reference price system can achieve price reductions, but also demand reduction for the branded goods; hence, profits are reduced and the branded good producer is left worse off under reference prices than under copayments. The story is similar when the incumbent firm produces a me-too drug. Substitution of the old drug by the new one can also occur whenever the potential demand for the new drug is sufficiently high. If this is not the case, the incumbent firm will prefer to have both goods in the market, sharing revenues, rather than concentrating sales on one drug (the new one). Finally, results show that there is no clear-cut relationship between profits earned by the incumbent firm when producing either the breakthrough or the me-too drug, irrespectively of the price regulation system. However, we can say that it seems that production of a breakthrough drug is more probable the lower the R&D cost of this drug with respect to the me-too and the lower the degree of market power that the incumbent firm has.
These two chapters are important because they offer a formal explanation of various empirical results. Pavcnik (2000) shows the effects of implementing reference prices in Germany, and demonstrates that pharmaceutical firms respond to them. She shows that producers significantly reduce prices after the reference price system was implemented, and moreover, branded producers that face more generic competition reduce prices more. As Pavcnik mentions, this shows that "the relevant competition in the pharmaceutical market occurs between generics and the brand name version of the same active ingredient rather than across products that are therapeutic substitutes" (Pavcnik (2000), page 20). She also shows that branded and generic producers respond differently quantitative and qualitatively. Results of Chapters 1 and 2 of this thesis give the theoretical conditions under which this decrease in prices can be achieved. As with respect to the different incentives for R&D, Chapter 2 is the first paper that analyses explicitly the R&D decision given that either copayments or reference prices are enforced. As Pavcnik mentions in her paper, future research has to identify this trade off between lower prices and R&D investment; this is a first step to analyse formally this trade off.
Section 2, which includes Chapter 3, gives an economic intuition to a process we have been observing during the last years in the pharmaceutical industry. Branded good producers, once the patent for the active ingredient has expired, also enter the generic market producing their own generic alternative. It is hence like a process of cannibalising their own consumers by producing a drug that can potentially be competing directly with the original good. The idea behind this observation is that the incumbent firm can take advantage of the so called first-mover advantages that exist in the generic market. Hence, since the original firm knows that generics will enter the market, it is in his own interest to be the first one in that market, and produce the so-called "branded-generics". This paper gives fuel to the Roche-Bolar case, since we find that if the branded good producer produces its generic alternative, rather than another firm specialised in the production of generics, prices can be higher, and consumer surplus can be reduced. The idea underlying the Roche-Bolar case is allowing generic producers to carry out research about the (branded) ethical drug before the patent expires, so that the time lag between the patent expiration and the introduction of these independent generic producers is minimised.
In this chapter, we will have the market segmented. On the one hand, we will have the so-called "loyal" customers, whose demand for the branded good is unaffected by the existence of generics. On the other, the "sensitive" consumers may buy the generic good. These consumers see both the branded and the generic good as (imperfect) substitutes. We find that the firm producing the branded good has incentives to produce its own generic alternative, owing to this market segmentation effect. This induces an increase in the price of the branded good, which in turn, results in a welfare reduction. Hence, it is as if the incumbent firm is price discriminating between consumers. The branded-good seller prefers to increase the price in the loyal segment and produce its own generic version for the price-sensitive customers rather than reducing the price of the branded good to these sensitive consumers.

Valuation models are used extensively in Finance and Accounting to investigate various empirical questions. Conventional valuation models express firm value as a function of discounted dividends, discounted abnormal earnings, discounted cash flows, or price multiples. One limitation from using these models is that they don’t capture unique industry valuation characteristics. However, modeling techniques can be used to modify a conventional model in order to reflect specific business processes. In the first chapter of this thesis I use modeling techniques to develop an industry-specific valuation model for pharmaceutical firms. This allows me to explore how investments in research and development, advertising, and production facilities create value for firms in this industry. In particular, the techniques used in this paper allow me to estimate and explore the economic rents generated by these investments. My valuation model is based on the cash inflows and outflows of a typical pharmaceutical firm. In the second chapter of this thesis I test whether the model is improved by adding a system of accounting accruals. I also compare the performance of my valuation model to a model with summary accounting measures to assess the importance of data disaggregation. The value of advertising investments is likely to have changed in the period investigated in this thesis because on August 8, 1997 the Food and Drug Administration announced that it would relax the rules on direct-to-consumer advertising of prescription drugs. The last chapter of this thesis is an event study of this regulatory change. I investigate the effect of the announcement on share price as well as the firm characteristics associated with the price reactions. Each chapter in this thesis answers a different question with respect to valuation in the pharmaceutical industry.

Mestrado em Biomedicina Farmacêutica
This training report describes the knowledge and experience gained during the curricular internship at the Medical Affairs unit of the Research Department of Bluepharma Indústria S.A.. The main activities addressed are related with the conduction of phase I clinical trials by a sponsor, namely bioequivalence clinical trials. In this context, is described the main applicable regulations, the management process of a clinical trial and a reflection about the main challenges in the field. Furthermore, are outlined the activities related with the management of Research, Development and Innovation projects, particularly the analysis of ideas of new pharmaceutical products, where I contribute with several researches. This first contact with the pharmaceutical industry allowed me to integrate the knowledge and skills gained in the Pharmaceutical Sciences degree with those gained in the master’s course of pharmaceutical medicine, fulfilling one of the main objectives that I define for myself: the growth and acquisition of skills, coupled with the access to a different professional reality.
O presente relatório de estágio propõe-se relatar o conhecimento e a experiência adquirida durante o estágio curricular no setor de Assuntos Médicos do departamento de Investigação da Bluepharma Indústria, S.A.. Nele são abordadas as principais atividades realizadas, inerentes à condução de ensaios clínicos de fase I por parte de um promotor, nomeadamente de ensaios de bioequivalência. Neste contexto é feita uma descrição da legislação aplicável, do processo de gestão de um ensaio clínico e uma reflexão acerca dos principais desafios nesta área. Para além disso, são também descritas atividades relacionadas com a gestão de projetos de Investigação, Desenvolvimento e Inovação, particularmente na análise de ideias de novos produtos farmacêuticos para as quais contribuí com diversas pesquisas. Este meu primeiro contacto com a indústria farmacêutica permitiu-me integrar os conhecimentos e competências da licenciatura em Ciências Farmacêuticas com os adquiridos no mestrado de Biomedicina Farmacêutica, cumprindo um dos principais objetivos que estabeleci para mim: o do crescimento e aquisição de competências aliado ao acesso a uma diferente realidade profissional.

The introductory part of the diploma thesis deals with the concept of health and the factors that influence it. The aim is to grasp the effect of socioeconomic status on the health and to analyze complementary and alternative medicines. The specificity of the health market, the expenditures on the health service, subjects which finance a health care, the state health policy focusing on drug policy and pharmacoeconomic are remarked. The paper also refers to the history of drugs and medicines, their consumption and development in conjunction with pharmacoeconomic. Marketing mix in terms of pharmacy describes the product (i.e. a drug) and its life cycle, the price and price control in the Czech Republic, distribution and promotion associated with advertising. The practical part of the master's thesis specifically shows marketing, innovation, science and research in pharmacy. The examples illustrate the corruption problems and difficulty of fighting against them. The information about the two large pharmaceutical or medical manufacturers are summarized at the end of this thesis.

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O objetivo desse estudo é discutir a estratégia de inovação aberta adotada pelas quarto maior companhias farmacêuticas norte-americanas nos último quarto anos. A inovação tem sido reconhecida como uma fonte essencial de vantagem competitiva de uma firma. A partir do momento em que empresas começam a expandir e interagir em escala global, sua estratégia de inovação começa a mudar, e adquire um aspecto mais integrado, intensificando seu relacionamento com atores externos e recursos. Essa mudança tem como objetivo reduzir o custo da inovação e aumentar sua eficiência, e tem impacto nos resultados da empresa. Essa pesquisa realiza uma pesquisa exploratória usando dois modelos de inovação aberta como referência, Lichtenthaler (2008) e Lazzarotti-Manzini-Pellegrini (2010). Entender como firmas aplicam estratégias de inovação aberta é o primeiro passo para avaliar seu impacto na estratégia geral da mesma na nova conjuntura internacional.

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.

L’objectif de cette thèse est d’étudier le fonctionnement de l’industrie pharmaceutique, et plus particulièrement les choix stratégiques des entreprises et leurs relations avec l’environnement économique et le degré de régulation. Ainsi, le premier chapitre s’intéresse aux choix de recherche et développement et de publicité des laboratoires en fonction du degré de concurrence. Le deuxième chapitre est une analyse des effets de l’introduction de la procédure de négociation anticipée des prix des médicaments entre les entreprises et les autorités de régulation en France sur les délais de mise sur le marché des nouvelles molécules. Enfin, le dernier chapitre est une étude sur les conséquences en termes de bien-être social et d’incitations à l’entrée sur le marché pour les concurrents basée sur un cas de collusion entre deux fabricants de génériques aux Etats-Unis
The objective of this thesis is to study the functioning of the pharmaceutical industry, and more precisely the strategic decisions of firms and their links with the economic environment and the degree of regulation. The focus of the first chapter is on the research and development and advertising decisions as a function of competition intensity. The second chapter analyses the effects of the introduction of an anticipated price bargaining procedure between firms and regulatory authorities in France on the launch dates of new molecules. Finally, the last chapter studies the consequences in terms of welfare and incentives for new entrants of collusion between two generic drugs producers in the US

This thesis is concerned primarily with the practical implementation of Bayesian methodology within the context of the pharmaceutical industry. The implementation includes the development, where appropriate, of analytic approximations to the posterior distributions of interest and graphical methods for mapping prior assumptions to posterior inference. Two critical areas within pharmaceutical research, critical in the sense of the controversy which they have aroused, have been investigated. First, Bayesian methods for the analysis of two-treatment crossover designs which fell in to disfavour in the late 1970's and early 1980's because of the US Food and Drug Administration's published view that the two-treatment two-period design was not the design of first choice if unequivocal evidence of a treatment effect was required were developed. Each type of design considered and for which methods are developed are illustrated with examples from clinical trials which have already been reported in the medical literature. Second, a Bayesian method is developed whose purpose is to classify test compounds into one of several toxicity classes on the basis of an LD50 estimate. The method is generalised to deal with a non-standard LD50 problem related to the prediction of results from a future LD50 experiment. Both of these applications arose out of a practical consultancy session within the context of a statistics group in the chemical/pharmaceutical industry. As part of the methods required for carrying out these analyses the zeros and weights associated with some non-standard orthogonal polynomial are developed as a result of which a new asymptotic expansion of the Behrens-Fisher density is developed. Further applications of the polynomials orthogonal to t-kernels are developed including problems associated with prediction in clinical trials. A FORTRAN program which has been implemented at a laboratory level within the pharmaceutical toxicology department at CIBA-GEIGY in Switzerland is provided SAS programs for a variety of the analyses developed for the two-treatment crossover designs are provided as are SAS programs for determining the zeros and weights of a number of different classes of orthogonal polynomials.

Thesis (S.M.M.O.T.)--Massachusetts Institute of Technology, Sloan School of Management, Management of Technology Program, 2003.
Includes bibliographical references (leaves 121-124).
This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections.
eBusiness is rapidly becoming the defacto business model of many firms. The pharmaceutical industry will continue to thrive regardless of recession, terrorism, war, or other external forces. Question is: what eBusiness technologies and trends are being currently pursued by pharmaceutical companies in managing critical relationships with business partners such as doctors, physicians, suppliers, retailers, distributors, and consumers? The purpose of this research is to provide a high-level overview of the pharmaceutical industry and companies that dominate in this vast arena. This is followed by an in-depth analysis of eBusiness in terms of phases, models, architectures, vendors, and products. Finally, eBusiness technologies and trends in global pharmaceutical organizations related to procurement, sales, and supply chain are analyzed in various case studies. This analysis ultimately leads to a carefully orchestrated conclusion that recaps this entire research based on eBusiness in the pharmaceutical industry.
by Imran Qayyum.
S.M.M.O.T.

The principle behind outsourcing is that an organization outsources tasks it strategically elects not to do within the organization. It is estimated that outsourcing has become a $4 trillion a year business (Corbett, 2005). In today's competitive healthcare marketplace, many sponsors outsource functions that were once considered core to the organization. U.S. Census data show that 10% of all business-to-business sales originated from outsourced sales (Rogers, 2008). The objective of engaging in outsourcing of sales is to improve sales efficiency and gain an edge in today's challenging market. Competition within the pharmaceutical industry coupled with increased regulatory uncertainties and cost concerns have necessitated outsourcing of sales to maintain competitiveness and to apply internal resources more effectively. This research will contribute to the current available works specific to the outsourcing of pharmaceutical sales.

The master’s thesis is devoted to the study of photoelectrochemical treatment of the wastewater from pharmaceutical industrials. The aim is achieved through the new redox hybrid materials with viologen and AuNPs and CdS, respectively. The technical task is focused on the preparation of viologen-based hybrid films and improving their electrochemical and photocatalytic properties. Based on the electrochemical, spectroscopic and microscopic analysis, the materials have shown good redox properties, good stability and good photoelectrochemical performance. The excellent redox properties and good photoelectrochemical performance of the hybrid films have improved their photocatalytic properties in wastewater treatment, and their easy preparation and good stabilities will also extend their application as the new wastewater treatment materials in the future.