Dissertations / Theses on the topic 'Pharmaceutical industry'

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.

Submitted by Ariadne Braz Magalhaes (ariadnebm@hotmail.com) on 2014-03-12T22:32:49Z No. of bitstreams: 1 Dissertação_Ariadne Braz Magalhaes.pdf: 1084154 bytes, checksum: b22835162f7ea9db8becf743a4352ece (MD5)
Rejected by Luana Rodrigues (luana.rodrigues@fgv.br), reason: Boa tarde Ariadne, Devido ao fato de sua dissertação ser escrita em inglês, o abstract deve vir antes do resumo. Por gentileza, faça a alteração e poste novamente. Atenciosamente, Luana on 2014-03-13T20:19:29Z (GMT)
Submitted by Ariadne Braz Magalhaes (ariadnebm@hotmail.com) on 2014-03-13T22:22:54Z No. of bitstreams: 1 Dissertação_Ariadne Braz Magalhaes.pdf: 1083421 bytes, checksum: 2a87277d16e81f95a33ac36054f16b05 (MD5)
Approved for entry into archive by Luana Rodrigues (luana.rodrigues@fgv.br) on 2014-03-14T15:01:20Z (GMT) No. of bitstreams: 1 Dissertação_Ariadne Braz Magalhaes.pdf: 1083421 bytes, checksum: 2a87277d16e81f95a33ac36054f16b05 (MD5)
Made available in DSpace on 2014-03-14T15:16:34Z (GMT). No. of bitstreams: 1 Dissertação_Ariadne Braz Magalhaes.pdf: 1083421 bytes, checksum: 2a87277d16e81f95a33ac36054f16b05 (MD5) Previous issue date: 2014-01-29
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.

Mestrado em Biomedicina Farmacêutica
This thesis aims to highlight the importance of a Product Quality & Compliance department in a Pharmaceutical Industry, on the good performance of company's activities and the achievement of their goals and mission. Despite the wide activities performed by this Department, the purpose of this work will be completed by describing only some of their reponsibilities. The tasks described are specifically the ones I have been performing throughout my professional experience at Bluepharma - Pharmaceutical Industry, SA, initiated in June 2012 in the Quality Assurance Department until today in the currently named Product Quality & Compliance department. This thesis is structured into 4 parts. The first chapter is an introduction to this thesis, and includes its context and objectives, followed by a brief overview of the state-of-the art in the pharmaceutical industry, including the market environment, the regulatory environment and quality requirements. A small presentation of the company and the department where were and still are developed my professional activity is also made in this chapter. In the following chapter are described the main tasks performed, the complementary activities and key skills acquired throughout this professional experience. A discussion and conclusion is presented at the end, including an analysis of the reported activities, main difficulties encountered its role and importance in the company performance as well as the skills acquired during this work experience.
A presente tese tem como principal objectivo realçar a importância do trabalho desenvolvido num departamento de Qualidade de Producto & Compliance numa Indústria Farmacêutica no bom desempenho das actividades da empresa e no cumprimento dos seus objetivos e missão. Apesar da actividade deste departamento ser muito vasta o objectivo deste trabalho será cumprido através da descrição de algumas das tarefas executadas no âmbito deste. As tarefas descritas são, mais concretamente, as desempenhadas ao longo da minha experiência profissional na Bluepharma - Indústria Farmacêutica, S.A., iniciada em Junho de 2012 no departamento de Garantia da Qualidade, tendo continuidade até aos dias de hoje no agora designado departamento de Qualidade do Produto e Compliance. Esta dissertação está estruturada em 4 partes. No primeiro capítulo é feita uma introdução ao presente trabalho, com a sua contextualização e objetivos, seguindo-se uma breve abordagem do estado-da-arte da indústria farmacêutica, nomeadamente do contexto de mercado, do ambiente regulamentar e dos requisitos de qualidade. Neste capítulo é ainda apresentada a empresa e o departamento onde tem vindo a ser desenvolvida a minha atividade profissional. No capítulo seguinte são descritas as tarefas e atividades principais desempenhadas, as atividades complementares e as principais competências adquiridas ao longo desta experiência profissional. No final é apresentada uma discussão e conclusão, incluindo uma análise das atividades desenvolvidas, principais dificuldades sentidas, do papel e relevância das tarefas desenvolvidas no contexto global da empresa bem como das competências adquiridas durante esta experiência profissional.

This thesis contributes to our understanding of age and ageing in organisations through an in-depth qualitative case study of an Australian pharmaceutical organisation which employs older salespeople. The study provides insights into why the organisation prefers to employ older workers, how age is managed in the organisation, how the older employees contribute to the organisation’s business objectives and how they experience working in later life. Through their embodiment of an older aesthetic, these older salespeople are seen to act as material signifiers of and create staging value for the organisation’s older pharmaceutical products and are recognised by the organisation as a strategic human resource asset. The organisation benefits not only from their intellectual and social capital in the form of prior experience and established customer relationships but also in terms of the emotion work they perform in their interactions with customers. The thesis contributes to studies of emotions in organisations by showing that the salespeople partake in a gift exchange in which reciprocity norms and investing something of themselves are key to the success of the sales relationship. The study finds that work plays a central role in the lives of these predominantly male older workers who are intrinsically motivated to continue working. It is argued that continuing to work in later life offers these older men a way to reframe and maintain masculine identities into old age, thereby contributing to contemporary studies of ageing, which tend to focus on the experiences of older women, and also to gender studies which are dominated by studies of younger and middle-aged men. The study shows how the older men engage in ‘othering’ of older retirees and younger salespeople in explaining their ongoing attachment to the workforce. Drawing on active and productive ageing discourses they construct their own ageing as successful and thereby avoid being constructed as a burden on an ageing society.

Brands are recognised as one of the most valuable assets that a company can possess and therefore brands are key role-players in the business strategies of organisations. The rivalry amongst competitors in the pharmaceutical industry is fierce and companies should design their strategies in such a way in order to achieve competitive advantage. Brand loyalty is regarded as a powerful tool in the development of pharmaceutical brands. The main aim of this study was to measure brand loyalty in the pharmaceutical industry of South Africa and to establish whether patients are brand loyal to original pharmaceutical brands and the influence of generics on pharmaceutical brand loyalty. The measurement of brand loyalty in the pharmaceutical industry is based on Moolla’s brand loyalty framework for the FMCG (fast moving consumer goods) industry. This study also aimed to determine whether Moolla’s FMCG brand loyalty framework is applicable to the pharmaceutical industry. The twelve brand loyalty influences identified by Moolla are: Customer satisfaction; Switching costs; Brand trust; Repeat purchase; Involvement; Perceived value; Commitment; Relationship proneness; Brand affect; Brand relevance; Brand performance and Culture. The empirical study was conducted among 250 over-the-counter medicine consumers with different demographic profiles. The methodology included the sampling procedure, data collection, questionnaire development and statistical techniques used. Results were analysed with regards to Factor analysis; the Kaiser- Meyer-Olkin measure of sampling adequacy; Cronbach Alpha coefficients; Bartlett’s test of sphericity, mean values and effect sizes. The Empirical results through quantitative analysis included the validity of the research instruments, the calculation of the reliability coefficients which reported on the significance of the research variables. The results were presented in a conceptual framework to measure pharmaceutical brand loyalty. The results of this study concluded that the brand loyalty influences as identified by Moolla are important for measuring pharmaceutical brand loyalty. The results of this study also concluded that patients are indeed brand loyal and do prefer branded pharmaceuticals to generic pharmaceuticals in the over-the-counter medicine industry of South Africa. The importance of this study is the contribution of a brand loyalty framework to measure pharmaceutical brand loyalty which will aid pharmaceutical companies in the strategic management thereof.
Thesis (MBA)--North-West University, Potchefstroom Campus, 2013

Organisations are continuously seeking for strategies to improve operations and gain competitive advantage. Maintenance tends to be a key management issue for many industrial companies. Maintenance management, being an integral part of manufacturing, can influence competitive companys‟ priorities, such as cost, quality and flexibility, and, hence, business strategy directly. The pharmaceutical industry also faces some unique challenges such as increasingly stringent safety and quality regulations, the effect of innovations in medical science and healthcare and a complex and costly design-to-market process (from product concept and development to market delivery). The industry is also going through turbulent times as it has to cope with challenges common to many other industries, how to deal with increasing competition, hold down costs, and expand. Regulatory compliance is one of the significant industry drivers for pharmaceutical companies. Regulations are enacted by government authorities to ensure public health and safety. The focus of regulation is on quality assurance and control in all areas such as receiving, manufacturing, storing, packaging, despatching and delivering. Apart from the required quality and safety checks, the regulations also mandate extensive record keeping of procedures, processes and systems. This treatise will investigate the maintenance management system of a pharmaceutical company and compare it to best practices. The true name of the pharmaceutical company that will be researched will not be disclosed for confidentiality reasons, instead it will be called My Pharmaceuticals. The company is based in Port Elizabeth. The research consists of a preliminary study to identify the problem areas in the maintenance management system within the company. A literature review of best practices in maintenance management systems combined with an investigation into the best pharmaceutical practices in maintenance management systems and regulatory controls are investigated and a model will be proposed to improve the current situation at the company.

This paper is focused on the greenhouse gas emissions in the pharmaceutical sector. The case study reported is that of Chiesi Farmaceutici S.p.A., a pharmaceutical company based in Parma. Sustainability has always been a primary concern in the way Chiesi operates. Fully aware of the climate emergency that the planet Earth is tackling, Chiesi has set itself a challenge and announces its commitment to becoming carbon neutral by the end 2035, reducing its greenhouse gas emissions and offsetting emissions that are no further reducible to achieve a net zero carbon footprint. There are several existing initiatives to achieve the Carbon Neutrality. The most important initiatives are the transition to a new propellant, that has a much smaller GWP than that of the actual propellant, and the installation of an abatement system to lower the emissions during the manufacturing phase of spray products. These initiatives are used to present reduction targets to the Science Based Target initiative. Science-based targets provide a clearly defined pathway for companies to reduce greenhouse gas (GHG) emissions, helping prevent the worst impacts of climate change and future-proof business growth. Targets are considered ‘science-based’ if they are in line with what the latest climate science deems necessary to meet the goals of the Paris Agreement, limiting global warming to well-below 2°C above pre-industrial levels and pursuing efforts to limit warming to 1.5°C. Chiesi is investing a lot of time and money to set its reduction targets in line with the Paris Agreement, but the present study demonstrates that the there are several important benefits. This is a clear evidence that suggests that financial and environmental performances are far from being exclusive and this is the road to follow both for the public and the private sectors.

Denna uppsats är skriven inom området finansiering och behandlar fenomenet uppköp och företagsförvärv inom läkemedelsbranschen. I uppsatsen undersöker man läkemedelsbranschen och några nyckelaffärer utförda under de senaste fem åren. Syftet är att se om hypotesen om att det inte sker någon onormal överavkastning efter ett företagsförvärv eller sammanslagning till det köpande företaget gäller inom industrin.

Modellen som används är ”the Arbitrage Pricing Model”, innehållande variablerna S&P 500, ^DRG, USA’s inflation och volymen av omsatta aktier på New York-börsen. Denna används för att beräkna en förväntad avkastning på aktien 48 månader efter affären. Ytterligare så används AMEX läkemedelsindex (^DRG) och Standard & Poor’s 500 (S&P 500) som måttstock för att jämföra utvecklingen av aktien under 48 månader efter affären.

Hypotesen håller i tre av sex fall när indexen ^DRG och S&P 500 används som måttstock och i samtliga fall när den beräknade avkastningen används som måttstock.

De beräknade estimaten visade sig vara aningen för optimistiska givet tidpunkten för affären. Marknaden hade vuxit mycket starkt under en lång tid och var på toppen just innan den föll kraftigt i början av år 2000. Inget av företagen nådde upp till de beräknade värdena. Inte heller lyckades de återhämta sig från det kraftiga fallet I marknaden till deras ursprungliga aktievärden.

This thesis is written within the field of finance and covers the Merger & Acquisition (M&A) phenomenon within the pharmaceutical industry. The purpose with this thesis is to examine the pharmaceutical industry and, with some key acquisitions done over the last five years, see if our hypothesis about no abnormal returns after an M&A to the buying firm, holds within the industry.

The model used is the Arbitrage pricing model, incorporating the variables; S&P 500, ^DRG, US inflation and stock volume traded on NYSE, to calculate expected returns for a period of 48 months after the M&A’s. Furthermore we use AMEX pharmaceutical index (^DRG) and Standard & Poor 500 (S&P 500) as our base for measuring post-M&A performance 48 months after the M&A’s.

The hypothesis holds three out of six times when using the indices ^DRG and S&P 500 as a benchmark and all of the times when using the calculated expected returns as benchmark.

The calculated estimates turned out to be a bit too optimistic given the time of the M&A’s where the market had grown substantially over a long period and was at its peak just before it plummeted in the early 2000’s. Neither of the companies reached their estimated returns, nor did they manage to recover from the downfall to their initial stock value at the time of the merger.

The pharmaceutical industry has long been regarded as one of the most innovative industries, with ingenious products that have saved millions of lives. However, after the 1980s boom, innovation has stagnated, resulting in a high level of pressure being placed on companies. The people who work with the actual innovative aspect of discovery in these companies are the researchers. The purpose of this study is to examine how these scientists individually perceive innovation as well as setbacks in their work and what is required of them to perform innovatively. In order to find the answer to this, literature studies have been compiled together with interviews with scientists at pharmaceutical companies in the Stockholm and Uppsala region. In the course of the interviews, the main objective was to receive a broad view on how their working conditions from an innovation standpoint. During the interviews, the discussions were based on the researchers’ perspective of innovation, motivation, how they view setbacks as well as their ultimate research dream. From the interviews, I have extrapolated factors which are fundamental considerations for innovative work, both generally and in setback situations. Moreover, how setback situations are perceived, and what is considered to be success. The result from the interviews regarding innovation parameters is consistent with the theory of innovation success. All interviewees reported a significant absence of several of these factors. Above all, the importance of time, the possibility of lateral thinking through spontaneous meetings with colleagues and obstacles created by huge bureaucracy and control. The research staff did not perceive setback situations as actual setbacks but instead they deemed it as an associated factor in their profession. Half of those interviewed expressed no faith in the fact that pursuit of their work would result in a commercialized product that would help people in need.

Since the early 1990's, average bioequivalence studies have served as the international standard for demonstrating that two formulations of drug product will provide the same therapeutic benefit and safety profile when used in the marketplace. Population (PBE) and Individual (IBE) bioequivalence have been the subject of intense international debate since methods for their assessment were proposed in the late 1980's. Guidance has been proposed by the Food and Drug Administration of the United States government for the implementation of these techniques in the pioneer and generic pharmaceutical industries. As of the present time, no consensus among regulators, academia, and industry has been established. The need for more stringent population and individual bioequivalence has not been demonstrated, and it is known that the criteria proposed by FDA are actually less stringent under certain conditions. The properties of method-of-moments and restricted maximum likelihood modelling in replicate designs will be explored in Chapter 2, and the application of these techniques in the assessment of average bioequivalence will be considered. Individual and population bioequivalence criteria in replicate cross-over designs will be explored in Chapters 3 and 4, respectively, and retrospective data analysis will be used to characterise the properties and behaviour of the metrics. Simulation experiments will be conducted in Chapter 5 to address questions arising from the retrospective data analyses in Chapters 2 through 4. Additionally, simulation will be used to explore of a potential phenomenon known as 'bio-creep' - that is the transitivity of individual bioequivalence in practice. Another bioequivalence problem is then considered to conclude the thesis; that of compaxing rate and extent of exposure between differing ethnic groups as described in ICH-E5 (1998). The properties of the population bioequivalence metric and an alternative metric will be characterised in small and large samples from parallel group studies. Inference will be illustrated using data from a recent submission and simulation studies.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Global Operations Program at MIT, 2012.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 71-72).
In the U.S. news, healthcare related headlines frequent the covers of newspapers and make regular primetime news appearances and the U.S. is not alone. The world is awakening to a need for more equal access to healthcare for its citizens and governments believe this equality will be achieved through tighter regulation in huge healthcare markets such as the pharmaceutical industry. To sustain shareholder value, as a result of these changing price structures, Novartis sees a need to reassess its sourcing and procurement strategies, assessing the feasibility of value based procurement, through staged implementation. While all procurement organizations tend to focus on maximizing cost savings for a company, this approach can often alienate suppliers and leave untapped value on the table. This additional value can be captured through long-term supplier development and collaborative work to utilize a supplier's knowledge, while maximizing the value proposition both for the company and the suppliers. For this early research, there was a focus on packaging equipment at pharmaceutical production facilities. The goal has been to understand the types of savings which could be achieved by purchasing extending its measure of success beyond price reduction to include value, such as through enabling increased quality or flexibility. As a company formed from many individual companies with a myriad procurement maturity, Novartis has an extended geographic and physical footprint which requires many disjointed groups to come together to produce products. This project has focused on developing a new procurement strategy to help optimize and standardize the procurement of Novartis's packaging lines at the manufacturing facilities, enabling them to work more cohesively to deliver greater benefit to the company. Additionally, following a successful pilot of the proposed sourcing practices in the packaging equipment space could be replicated in other category spaces both in the Pharmaceutical division and throughout Novartis's other six divisions. Novartis will continue to develop and produce drugs, as the predecessor companies have excelled in doing for more than a hundred years but it should also realize what expertise should be core and where others outside of the company excel.
by Mary E. Anito.
S.M.
M.B.A.

Thesis (M. Eng. in Logistics)--Massachusetts Institute of Technology, Engineering Systems Division, 2009.
Includes bibliographical references (leaves 77-78).
The pharmaceutical industry creates products which often have more than one supply chain channel, defined as a route through the supply chain network from sourcing to the end market. Each channel's specific cost characteristics are important to the pharmaceutical industry's ability to maintain positive profit margins while meeting high customer service requirements. Determining the optimal supply chain channel involves the analysis of fuel costs, logistics, taxes, wage differences, and many more. Additionally, variables such as time and risk significantly impact the total cost of a supply chain channel, but are extremely difficult to quantify. In this research, we identify the relevant channel costs and variables for the supply chain of a large pharmaceutical corporation. After identification, our study categorizes each cost based on level of measurability and causes of variability to develop a framework identifying the most relevant costs by four product types. We then analyze market forces that affect costs over a product's lifecycle. Finally, we develop an operational model for using the framework to compare costs across multiple supply chain channels and time horizons.
by Eric C. Rimling and Wontae Thomas Seoh.
M.Eng.in Logistics

Thesis (S.M.)--Massachusetts Institute of Technology, System Design and Management Program, 2009.
Includes bibliographical references (leaves 57-59).
The pharmaceutical industry needs new modes of innovation. The industry's innovation system - based on massive investments in R&D protected by intellectual property rights - has worked well for many years, providing incentives for pharmaceutical firms to invest in developing drugs across a wide variety of major medical needs. However, this traditional drug development process is subject to decreasing productivity and increasing costs. In addition, it encourages pharmaceutical firms to focus on "blockbuster" drugs, and to neglect meeting needs in small potential markets such as "orphan" diseases and diseases primarily found in third world countries. This thesis focuses on new modes of innovation, specifically the sharing of safety information prior to clinical trials. To inform this analysis, I first discuss the data that informs why the industry is in need of new modes of innovation. I then proceed to outline the potential promise of some new modes of pharmaceutical development that are emerging. I then explore a specific novel innovation mode in more detail: the sharing of non-competitive safety information prior to clinical trials, leading to significant reductions in both costs and chances of failure in drug discovery and development. I propose that this new innovation mode offers the potential of significant benefit to both drug developers and medical patients.
by Ragu Bharadwaj.
S.M.

Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2008.
Includes bibliographical references (p. 111-114).
Historically the pharmaceutical industry has been highly profitable. However, the increasing regulatory requirements, bargaining power of buyers, and drug failures together with the threat of biosimilars and decreasing R&D productivity are creating challenges for research driven pharmaceutical companies. With future revenue growth uncertain, pharmaceutical companies must focus on cost reduction to sustain the profit margins needed to support research and development of new medicines. The lean methodology first developed by Toyota is recommended as a way to achieve operational success. A deep analysis of the current state of the pharmaceutical industry and the operational inefficiencies inherent in regulated drug production is provided. The renewed importance of operations within the pharmaceutical business model is explored through a case study of the biotechnology segment's leader, Amgen. Specifically, the design and initial rollout of the Amgen Process Excellence (APEX) initiative is studied. The APEX methodology is a six step process based on lean and six-sigma principles to guide operational improvement activities at Amgen. During the author's internship at the Rhode Island site the rollout of the APEX movement included a current state analysis of the site's financial and operational performance. As a result of this analysis, a prioritized list of improvement ideas was generated and incorporated into a future state vision for the site. Implementation of these improvement ideas is estimated to result in a reduction in cycle time by 55%, lower inventory levels, and the elimination of millions of dollars in waste. The following major conclusions were developed as a result of this work.
(cont.) First, substantial improvement opportunities exist within current pharmaceutical manufacturing. Second, pharmaceutical companies must build operational efficiencies into manufacturing process design. Lastly, operational excellence cannot simply be attained through the implementation of an improvement toolkit.
by Shonna Coffey.
S.M.
M.B.A.

Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2008.
Includes bibliographical references (leaf 66).
An Intermediate Bulk Container (IBC) is used to contain raw materials and semi-products in pharmaceutical company ABC. Due to the high price of an IBC, company ABC sought to minimize the number of IBCs needed to support the production of four separate products. In this project, five IBCs drivers that affect or determine the number of IBCs required were identified. Deterministic models were established to determine the minimum number of IBCs needed for each product given the production plan in 2009. The cleaning schedule for IBCs was modified to reuse IBCs as much as possible. In this paper, we analyze the management of 600L IBCs. We simulate a two machines finite-buffer line model to estimate the optimum buffer size. We collected equipment downtime data to estimate the parameters for the simulation model. We use the simulation to determine the number of 600L IBCs needed for each campaign; the number of 600L IBCs was reduced from 12 to 8. Additional analysis examined the reduction of usage of 1800L IBCs.
by Xiaowen Chen.
M.Eng.

Thesis: Ph. D., Massachusetts Institute of Technology, Department of Economics, 2014.
Cataloged from PDF version of thesis.
Includes bibliographical references.
This dissertation comprises of three chapters, each exploring different issues in the industrial organization of the pharmaceutical industry. In the first chapter, I study the effects of television advertising of antidepressants using a novel method comparing households near the borders of television markets. I find that advertising has positive benefits on the market as a whole, including competitors. Using this information and a simple supply model, I consider the counterfactual whereby firms work together in a co-operative. In the co-operative equilibrium, firms advertise more than five times as much as is observed in competitive equilibrium and profits would increase by about twenty percent. In the second chapter, the documented phenomenon of strategic entry delay is analyzed in the sleep aid industry in order to measure the cost to consumers of that delay. With the Hatch-Waxman Act of 1984, the FDA included an unchallengeable exclusivity period for new approved drugs, independent of patents. This generates an incentive for firms to strategically delay the introduction of new versions of drugs until just before patent expiration of the originals in order to take market share away from new generics rather than its own original product in its time of FDA exclusivity. Using detailed prescribing and pricing data, I document that delay and estimate cost to consumers in the prescription sleep aid market at about $644 million over seven years. In the final chapter, we examine firm behavior following the loss of exclusivity (LOE) of six molecules between June 2009 and May 2013 that were among the 50 most prescribed molecules in May 2013. We analyze speed of generic firm entry, prices, generic and penetration separately by four payer types (cash, Medicare Part D, Medicaid, and other third party payer -TPP) and by age (under vs. over 65). We find modest price decreases following LOE but very rapid and complete penetration of generics. While on average molecule prices decrease, the branded versions continue to increase prices after LOE. Expansion of molecule sales is increasingly common. Generic penetration rates are typically highest and most rapid for TPPs, and lowest and slowest for Medicaid. Cash customers and seniors generally pay the highest prices, TPPs and those under 65 pay the lowest prices. The presence of an authorized generic is also analyzed and found to have effects that vary across molecule.
by Bradley T. Shapiro.
Ph. D.

Japan's existing pharmaceutical industry was devastated in the Second World War. But the industry recovered quickly, and in 1963, Japan had become the second largest producer of pharmaceuticals after the United States. Unlike its automobile or electronics industries, however, Japan's pharmaceutical industry did not become a global leader. Japan remains a net importer of pharmaceuticals and few Japanese drugs are found outside of Japan. The global pharmaceutical industry is led by firms from the United States, the United Kingdom and Switzerland, rather than those from Japan. This thesis traces the development of the Japanese pharmaceutical industry after 1945, and offers several explanations for why it did not become a world-leading industry. It uses two classes of medicines, antibiotics and anti-cancer drugs, as case studies for exploring the overall history of the Japanese pharmaceutical industry. These case studies were selected because of their importance to health outcomes in post-war Japan. In the immediate post-war period, the leading causes of death in Japan were infectious diseases such as tuberculosis, but in later decades, cancer morbidity and mortality rose. Japan was found to be much more successful at developing antibiotics than anticancer drugs. This thesis shows that, while the Japanese pharmaceutical industry had caught up with its Western counterparts by the mid 1970s, it did not exploit its potential to become a global leader. A few of Japan's leading pharmaceutical firms did develop blockbuster drugs and expand overseas, but most firms remained domestically oriented. The major reasons why Japan did not develop a strong pharmaceutical industry lay in the lack of R and D incentives, the government's protectionist policies, industrial structure, and Japanese medical culture. Other reasons of secondary importance included the industry's historical origins in import houses, national differences in patterns of disease, Japan-specific drug standards, and barriers to entrepreneurship among university academics.

Mestrado em Economia Internacional e Estudos Europeus
A realização deste trabalho teve como intuito explicar o processo de internacionalização das empresas do sector da indústria farmacêutica. Para isso, foi feita, primeiramente, uma revisão extensiva da literatura sobre as estratégias de internacionalização. Com base nesta pesquisa, definiram-se as questões de investigação e hipóteses, que foram, posteriormente, testadas através da realização de um questionário. A análise focou-se nos diferentes comportamentos observados e nas razões apontadas pelas empresas para tomarem as decisões relacionadas com a internacionalização. As principais conclusões foram: - As empresas seguem modos de entrada (modelos de negócio) diferentes para diferentes países ou regiões. - Entre as principais teorias de internacionalização, o paradigma de OLI parece ser o que melhor reflete o processo de internacionalização da indústria farmacêutica. - Na decisão para onde internacionalizar, as empresas tendem a optar por mercados onde já tenham redes de contactos estabelecidos. - Durante a última crise financeira internacional (2008 - 2013) as empresas tomaram decisões de internacionalizar ou aumentar o grau de internacionalização.
The purpose of this research is to develop a greater understanding of the internationalisation strategies followed by the companies operating in the pharmaceutical sector. This study reviewed and applied a range of relevant literature that was used to develop the research questions and hypotheses that were then empirically tested by the analysis of a questionnaire made to pharmaceutical companies. The analysis focused on the different behaviours and drivers of the companies in their internationalisation strategies. And the main results are: - Companies follow distinct entry mode for different countries and regions. - Among the traditional theories, the OLI paradigm is the model that better explains the internationalisation of the pharmaceutical companies. - On their decision of where to internationalise the companies tend to go to markets where they have established networks. - During the last financial crisis (2008 ? 2013) the companies took the decision to internationalise or increase the degree of internationalisation.
info:eu-repo/semantics/publishedVersion

Mestrado em Biomedicina
O presente documento relata a minha experiência de 10 meses enquanto estagiária na Eurotrials, Consultores Científicos, uma Clinical Research Organization (CRO) portuguesa em expansão e, posteriormente, na Roche Farmacêutica Química, uma das indústrias farmacêuticas líder na área da saúde. Esta experiência, que decorreu entre Setembro de 2010 e Julho 2011, teve uma vertente multidisciplinar e monodisciplinar, o que me permitiu colocar em prática uma grande porção de conteúdos apreendidos nas disciplinas que compõem o Mestrado de Biomedicina Farmacêutica da Universidade de Aveiro, possibilitando a aquisição de variadas competências tanto a nível pessoal como profissional. Durante este período acompanhei inicialmente 9 ensaios clínicos como Clinical Research Associate (CRA) trainee e, progressivamente foi-me dada a oportunidade de realizar tarefas de forma mais autónoma e, consequentemente, de acompanhar 3 ensaios clínicos como CRA. Terminei o meu estágio curricular a desempenhar autonomamente todas as funções inerentes ao trabalho de um CRA. A elaboração deste relatório pretende descrever as atividades desenvolvidas ao longo de todo o estágio, bem como, dificuldades sentidas e aprendizagem consolidada. Para além disto, pretende também dar a conhecer a minha visão pessoal sobre o papel do CRA na condução de ensaios clínicos e os possíveis desafios a superar tendo em vista a continuidade de Ensaios Clínicos em Portugal.
This document describes my 10-month experience as trainee at Eurotrials, Scientific Consultants, an expanded Portuguese Clinical Research Organization (CRO) and later at Roche Pharmaceuticals, a pharmaceutical industry leader in healthcare. This experience, which took place between September 2010 and July 2011, had a cross-disciplinary and mono-disciplinary strand, which allowed me to put into practice a great deal of content learned in the disciplines that make up the Master of Pharmaceutical Biomedicine, University of Aveiro, enabling the acquisition of several skills, both personally and professionally. During it was given me the opportunity to follow 9 clinical trials as Clinical Research Associate (CRA) trainee and gradually it was given me the opportunity to perform tasks more autonomously and hence to follow 3 clinical trials as CRA. I have finished my curricular training being able to perform autonomously all tasks of the CRA job. The preparation of this report intends to describe the developed activities throughout the training, as well as encountered difficulties and consolidated knowledge. In addition, also intends to disclose my personal view on the role of CRA in the conduction of clinical trials and the possible challenges to overcome in order to continue clinical trials in Portugal.

Mestrado em Biomedicina Farmacêutica
O presente relatório expõe as atividades desenvolvidas durante o estágio curricular, frequentado na Bluepharma - Indústria Farmacêutica S.A. e na TREAT U, Lda. uma Spin-off da Universidade de Coimbra, no âmbito do Mestrado em Biomedicina Farmacêutica da Universidade de Aveiro. Esta foi uma experiência de 6 meses que teve duas componentes, uma multidisciplinar e outra monodisciplinar, as quais me permitiram desenvolver os conhecimentos e aptidões adquiridas ao longo do curso de mestrado e de as aplicar ao mundo real. Para além do desenvolvimento de competências profissionais, esta experiência possibilitou também a aquisição e desenvolvimento de várias aptidões, quer a nível pessoal como social. Nos primeiros dois meses desta minha experiência adquiri um conhecimento essencialmente teórico em várias áreas da indústria farmacêutica (financeira, desenvolvimento de negócio, assuntos regulamentares, investigação e desenvolvimento de medicamentos, garantia da qualidade, etc.) através da minha passagem pela Bluepharma. De seguida, na minha experiência de quatro meses na TREAT U, foi-me dada a oportunidade de realizar de forma mais independente, as funções inerentes ao cargo de assistente da gerência, com especial enfoque para atividades de gestão de projeto (incluindo assuntos regulamentares), tais como, apoio na preparação do plano de desenvolvimento não clínico e na preparação do pedido de aconselhamento científico. Este relatório começa assim por descrever os objectivos do estágio e uma breve descrição das instituições que me acolheram para a sua realização. De seguida, os conhecimentos adquiridos na vertente multidisciplinar do estágio e depois as atividades desenvolvidas no âmbito monodisciplinar. Por fim, apresenta uma análise das dificuldades e desafios encontrados bem como os esforços realizados para os ultrapassar.
This report outlines the activities undertaken during the curricular training, performed at Bluepharma, Pharmaceutical Industry S.A. and at TREAT U, Lda. a spin-off from the University of Coimbra, within the scope of the Pharmaceutical Biomedicine Master´s course of the University of Aveiro. This was a 6-month experience that had two components, one multidisciplinary and other monodisciplinary, which allowed me to develop the knowledge and skills acquired throughout the master´s course by applying them on a day-to-day basis in the real world. Beyond of professional skills development, this experience also enabled the acquisition and development of several skills at both personal and social level. In the first two months of this experience I acquired essentially a theoretical knowledge in several areas of a pharmaceutical industry (financial, business development, regulatory affairs, research and drug development, quality assurance, etc.) through my passage at Bluepharma. Following, in my four months experience at TREAT U, I was given the opportunity to perform more independently, the functions inherent to the position of assistant manager, with special focus on project management activities (including regulatory affairs), such as support in preparation of nonclinical development plan and in the preparation of the scientific advice request. This report begins with a description of the training objectives and a brief introduction to the host institutions. Then, explains the knowledge acquired in the multidisciplinary experience and furthermore the activities undertaken at a monodisciplinary level. Finally, it presents an analysis of the difficulties and challenges encountered and the efforts made to overcome them.