Commercialization of Biopharmaceuticals

Biotekniikkaa pidetään yhtenä lupaavimmista nykyään tunnetuista teknologioista. Biotekniikan alalta erityisesti uusien lääkeaineiden kehittely on saavuttanut huomiota julkisuudessa. Biotekniikkaa lääkeaineiden kehittämiseen soveltavien yritysten määrä on kasvanut nopeasti viimeisen vuosikymmenen aikana, mutta tämänhetkiset tulokset osoittavat, että yritykset voisivat hyötyä riskien hallintaan ja kaupallistamiseen liittyvien prosessien kehittämisestä. Tutkielma keskittyy biolääkkeiden kaupallistamiseen, erityisesti suomalaisten uusien biolääkeyritysten kannalta. Tutkielma jakaantuu kahteen osaan: ensimmäinen osa tutkii kaupallistamista käsitteenä ja biolääkeliiketoiminnan erityispiirteitä. Toinen osa keskittyy kaupallistamisen empiiriseen tutkimukseen, joka kattaa viisi suomalaista uutta biolääkeyritystä. Empiirisen osan tavoitteena oli tunnistaa ne keinot, jotka auttavat menestyksekkään kaupallistamisprosessin luomisessa tuotekehitysvaiheen läpäisseelle lääkeaineelle. Saavutetut tulokset voidaan tiivistää neljän kriittisen menestystekijän ympärille, jotka ovat 1) tuote, 2) viestintä, 3) uskottavuus ja 4) yhteistyökumppanin valinta. Ensimmäinen menestystekijä on ainutlaatuinen biolääke, joka parantaa kansantaloudellisesti merkittäviä tauteja. Toisen menestystekijän avulla yritys viestittää uudesta ainutlaatuisesta tuotteestaan mahdollisille yhteistyökumppaneilleen. Kolmas menestystekijä kohdistuu yrityksen uskottavuuteen uutena korkean teknologian biolääkeaineiden kehittäjänä. Uskottavuustekijä on erityisen tärkeä suhteiden luomisessa kansainvälisiin lääkeyrityksiin. Neljäs tekijä keskittyy yhteistyökumppanin valintaan, joka alan erityisluonteesta johtuen on tärkeä uudelle biolääkeyritykselle. Viimeiseksi havaittiin, että uusi biolääkeyritys virtuaalisen rakenteensa vuoksi tarvitsee hyvät johdon suhdemarkkinointikyvyt.

Thrombin-receptor antagonist vorapaxar in acute coronary syndromes

Background: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. Methods: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P = 0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P = 0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups. Conclusions: In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER ClinicalTrials.gov number, NCT00527943.)

Elektroniikkatehtaan toiminnanohjausjärjestelmän hankinta

Työn tavoitteena oli löytää sopivin tapa toiminnanohjaamiseen ja laadunseurantaan elektroniikan koulutustehtaalla. Ohjausjärjestelmiä tullaan käyttämään niin oman palvelutoiminnan ohjaamisessa kuin elektroniikan opiskelijoiden koulutuksessakin. Hankinnan lähtökohtana pidettiin valmisohjelmistoja. Työn alkuvaiheissa tutustuttiin kirjallisuuden avulla erilaisiin toiminnanohjausmenetelmiin sekä hyvän tietojärjestelmän ominaisuuksiin. Työn loppuosassa tutkittiin tarjolla olevia ohjelmistoratkaisuja sekä etsittiin potentiaalisimmat toimittajat Internetin ja kohdeorganisaation kontaktien avulla. Toimittajia vertailtiin toisiinsa heidän kotisivujensa, esitteidensä, esittelyidensä sekä heidän järjestelmiensä käyttäjien antaman palautteen perusteella. Ensimmäisenä vertailusta tiputettiin ne toimittajat, joiden fokustoimialoissa ei ollut elektroniikkateollisuutta, joiden tuote olisi vaatinut räätälöintiä tai jotka olivat keskittyneet konsernitasoisiin ratkaisuihin. Seuraavassa vaiheessa putosivat ne toimittajat, joiden tuote ei sopinut koulutuskäyttöön. Lopulta mahdollisia toiminnanohjausjärjestelmän toimittajia jäi jäljelle kolme ja tilastollisen prosessin valvonnan toteuttajia vain yksi.

Kokonaistoimittajan operatiivisen toiminnanohjauksen tietojärjestelmät imuohjatun tuotannon verkostossa

Tutkimuksen tavoitteena oli kehittää kansainvälisesti toimivan suuren yrityksen johtaman verkoston kokonaistoimittajatason yritysten käyttöön yksinkertainen viitekehys, jota yritykset voivat käyttää operatiivista toimintaa ohjaavien tietojärjestelmien hallinnassa. Kirjallisuuskatsauksen lisäksi suoritettiin empiiristä tutkimusta tarkastelemalla verkostoyritysten toimintaa operatiivisten toiminnanohjausjärjestelmien kehitysprojektien kannalta. Samalla tarkasteltiin kahden pohjoiskarjalaisen yritysverkoston kokonaistoimittajien nykytilannetta toiminnanohjauksen tietojärjestelmien osalta ja verkostotoiminnan vaikutusta niihin. Tutkimuksessa havaittiin, että kokonaistoimittajien on kasvatettava osaamistaan nykyaikaisten tietojärjestelmien osalta kyetäkseen vastaamaan kansainvälisen päähankkijan asettamiin vaatimuksiin kiristyvässä kilpailutilanteessa. Imuohjatun verkoston toiminnanohjauksen kannalta on ensiarvoisen tärkeää että verkoston toiseksi ylimmällä portaalla toimivien kokonaistoimittajien tietojärjestelmät tukevat moderneja toimintatapoja niin sanomavälityksen kuin tuotannon- ja materiaalin ohjauksen osalta. Tulosten perusteella voidaan todeta, että tyypillisen kokonaistoimittajayrityksen tietämys tietojärjestelmäasioista on varsin matalalla tasolla. Tutkimuksen tuloksena syntyi myös kuusiportainen viitekehys operatiivisen toiminnanohjauksen tietojärjestelmien jatkuvan kehittämisen tueksi.

eBusiness Adoption in Metalforming SMEs in the Automotive Industry

Competition in the automotive industry has led the participants trying to find new ways of reducing costs, increasing efficiency and improve responsiveness to gain competitive advantage. It is not anymore single companies competing against each others, it is the whole supply chains competing. This has already earlier led the big multinational companies to gain benefits by using electronic means of doing business (eBusiness). Lower down the chain the smaller companies have not yet taken advantage of the potential benefits of eBusiness methods. Therefore, the full benefits from eBusiness methods have yet to be discovered. The aim of the Thesis is to find ways of taking advantage of eBusiness methods with their limited resources. Because small and medium sized enterprises (SME) many times lack of eBusiness knowledge this project also aims to clarify the idea of eBusiness, present the potential possibilities and benefits from eBusiness and the requirements needed to achieve them. The Thesis presents information of eBusines especially in the automotive industry. Together with this information and the information acquired from the case study company a simple route map is developed which SMEs can use gain competitive advantage by eBusiness methods.

Die Schweizer Wirtschaftselite im Spannungsfeld zwischen Globaliesierungs-prozessen und nationalen Institutionen

The purpose of this article is to show how globalization processes contributed to the decline of national institutions in the selection and development of Swiss business elites, drawing from empirical data from two recent research projects. The first database contains profile characteristics of CEOs and chairmen from 110 biggest Swiss companies over a 30 years period. The second database contains information collected in 2009 on profiles and careers of more than 900 top managers working for more than 100 multinational corporations in four countries (France, Germany, United Kingdom and Switzerland). The analysis of our data allows us to illustrate and describe the globalization of profiles and the decline of national and traditional elements. The Swiss case can be brought in perspective and compared with other countries, in particular with France.

El fútbol y el negocio del entretenimiento global. Los clubes como multinacionales del ocio

El artículo tiene como objetivo analizar el proceso de expansión internacional de los clubes más ricos del fútbol español durante la primera década del siglo XXI, Real Madrid y FC Barcelona. Después de que los clubes de la Premier League inglesa fueran los primeros en crear una estrategia de branding internacional, otras ligas y organizaciones deportivas han adoptado sus mismos sistemas de gestión empresarial. En España, el Real Madrid y el FC Barcelona son el ejemplo más evidente, por su número de fans en todo el mundo, por sus acuerdos internacionales en la comercialización de sus productos con otras organizaciones y por la presencia que tienen sus marcas en todo el mundo gracias a las inversiones de sus fundaciones en escuelas de fútbol en concepto de Responsabilidad Social Corporativa. Por eso, ambos clubes, Real Madrid y FC Barcelona, pueden calificarse de nuevas multinacionales del ocio.

Suomen väliyhteisölainsäädäntö ja sen asettamat vaa-timukset suomalaisille yrityksille: ulkomaiset väliyh-teisöt osana kansainvälisen konsernin verosuunnittelua

Tämän tutkielman tavoitteena on esitellä Suomen väliyhteisölainsäädäntö sekä tutkia, miten kansainväliset konsernit ja niihin kuuluvat suomalaiset yhteisöt voivat hyödyntää ulkomaisia väliyhteisöjä toimintansa verosuunnittelussa. Väliyhteisöjen käytön mahdollisuuksia pohditaan ottaen huomioon väliyhteisölain sille asettamat reunaehdot. Tutkielmassa käytetään sekä oikeusdogmaattista että analyyttista tutkimusotetta. Suomen väliyhteisölainsäädäntö jättää kansainvälisesti toimiville yrityksille muu-tamia mahdollisuuksia hyödyntää alhaisen verotuksen maahan perustettuja väliyhteisöjä. Huomioon on kuitenkin otettava väliyhteisölain ohella monia muitakin tekijöitä, kuten konserniyhtiöiden asuinvaltioiden sisäinen lainsäädäntö, verosopimusverkosto sekä EU:n välitöntä verotusta koskevat direktiivit. Yleissääntönä voidaankin sanoa, että väliyhteisöjärjestelyn kautta mahdollisesti saavutettavia etuja on aina arvioitava tapauskohtaisesti.

Diffusion of Administrative Innovation: TQM Implementation and Effectiveness in a Global

The main objective of this dissertation is to create new knowledge on an administrative innovation, its adoption, diffusion and finally its effectiveness. In this dissertation the administrative innovation is approached through a widely utilized management philosophy, namely the total quality management (TQM) strategy. TQM operationalizes a self-assessment procedure, which is based on continual improvement principles and measuring the improvements. This dissertation also captures the theme of change management as it analyzes the adoption and diffusion of the administrative innovation. It identifies innovation characteristics as well as organisational and individual factors explaining the adoption and implementation. As a special feature, this study also explores the effectiveness of the innovation based on objective data. For studying the administrative innovation (TQM model), a multinational Case Company provides a versatile ground for a deep, longitudinal analysis. The Case Company started the adoption systematically in the mid 1980s in some of its units. As part of their strategic planning today, the procedure is in use throughout the entire global company. The empirical story begins from the innovation adoption decision that was made in the Case Company over 22 years ago. In order to be able to capture the right atmosphere and backgrounds leading to the adoption decision, key informants from that time were interviewed, since the main target was to clarify the dynamics of how an administrative innovation develops. In addition, archival material was collected and studied, available memos and data relating to the innovation, innovation adoption and later to the implementation contained altogether 20500 pages of documents. A survey was furthermore conducted at the end of 2006 focusing on questions related to the innovation, organization and leadership characteristics and the response rate totalled up to 54%. For measuring the effectiveness of the innovation implementation, the needed longitudinal objective performance data was collected. This data included the profit unit level experience of TQM, the development of the self assessment scores per profit unit and performance data per profit unit measured with profitability, productivity and customer satisfaction. The data covered the years 1995-2006. As a result, the prerequisites for the successful adoption of an administrative innovation were defined, such as the top management involvement, support of the change agents and effective tools for implementation and measurement. The factors with the greatest effect on the depth of the implementation were the timing of the adoption and formalization. The results also indicated that the TQM model does have an effect on the company performance measured with profitability, productivity and customer satisfaction. Consequently this thesis contributes to the present literature (i) by taking into its scope an administrative innovation and focusing on the whole innovation implementation process, from the adoption, through diffusion until its consequences, (ii) because the studied factors with an effect on the innovation adoption and diffusion are multifaceted and grouped into individual, organizational and environmental factors, and a strong emphasis is put on the role of the individual change agents and (iii) by measuring the depth and consistency of the administrative innovation. This deep analysis was possible due to the availability of longitudinal data with triangulation possibilities.

Impact of early valve surgery on outcome of Staphylococcus aureus prosthetic valve infective endocarditis: analysis in the International Collaboration of Endocarditis-Prospective Cohort Study.

BACKGROUND: The impact of early valve surgery (EVS) on the outcome of Staphylococcus aureus (SA) prosthetic valve infective endocarditis (PVIE) is unresolved. The objective of this study was to evaluate the association between EVS, performed within the first 60 days of hospitalization, and outcome of SA PVIE within the International Collaboration on Endocarditis-Prospective Cohort Study. METHODS: Participants were enrolled between June 2000 and December 2006. Cox proportional hazards modeling that included surgery as a time-dependent covariate and propensity adjustment for likelihood to receive cardiac surgery was used to evaluate the impact of EVS and 1-year all-cause mortality on patients with definite left-sided S. aureus PVIE and no history of injection drug use. RESULTS: EVS was performed in 74 of the 168 (44.3%) patients. One-year mortality was significantly higher among patients with S. aureus PVIE than in patients with non-S. aureus PVIE (48.2% vs 32.9%; P = .003). Staphylococcus aureus PVIE patients who underwent EVS had a significantly lower 1-year mortality rate (33.8% vs 59.1%; P = .001). In multivariate, propensity-adjusted models, EVS was not associated with 1-year mortality (risk ratio, 0.67 [95% confidence interval, .39-1.15]; P = .15). CONCLUSIONS: In this prospective, multinational cohort of patients with S. aureus PVIE, EVS was not associated with reduced 1-year mortality. The decision to pursue EVS should be individualized for each patient, based upon infection-specific characteristics rather than solely upon the microbiology of the infection causing PVIE.

Knowledge creation and transfer in an iterative project environment

This Master’s Thesis examines knowledge creation and transfer processes in an iterative project environment. The aim is to understand how knowledge is created and transferred during an actual iterative implementation project which takes place in International Business Machines (IBM). The second aim is to create and develop new working methods that support more effective knowledge creation and transfer for future iterative implementation projects. The research methodology in this thesis is qualitative. Using focus group interviews as a research method provides qualitative information and introduces the experiences of the individuals participating in the project. This study found that the following factors affect knowledge creation and transfer in an iterative, multinational, and multi-organizational implementation project: shared vision and common goal, trust, open communication, social capital, and network density. All of these received both theoretical and empirical support. As for future projects, strengthening these factors was found to be the key for more effective knowledge creation and transfer.

Passport to a profession in the degree of pharmacy: how to integrate university students into the real world of work: "Passport to a profession in Pharmacy"

The incorporation of the Spanish university system into the European Higher Education Areahas brought about a series of adaptations. Among the recommendations is the inclusion ofan external training period in a company, which has resulted in significant changes in thedegree syllabus in order to balance the theoretical and practical education required by thestudents. This new framework has been legally confirmed by the Spanish Government and, inthe case of the University of Barcelona, by the publication of internal guidelines. Takingadvantage of this new opportunity to adapt the Pharmacy degree to real-world problems inindustry, the Dean’s team of the Faculty of Pharmacy, with the support of the Facultyadministrative staff and the Students Advisory Service, have assumed the challenge ofincluding a new subject in the syllabus entitled Training in Companies.In parallel, a new activity has been set up to ensure that the students choose the mostsuitable company department/job for them and to help them pass the company interview.Under the name of Passport to a Profession, a series of ten explanatory talks has beenscheduled every academic year. These talks deal with a broad range of topics aimed atproviding the students with the basic tools they will need to make the most of a companytraining period and to make headway in the professional world when they finish theirdegree. In addition, three Faculty of Pharmacy-Pharmaceutical company workshops and tworound-table conferences have been held in the last two years in order to bring the universityand industry together. Notably, the project to provide students with company training isexpanding on an international level, with two to three undergraduate students contractedevery year by a United Kingdom-based multinational pharmaceutical company.The statistical data of the whole process has been analysed for a more in-depthunderstanding of the activity and to improve the programme.

Evolution of Ba and Role of Absorptive Capacity in Collaboration between MNCs and Chinese Universities in China

During the recent years, collaboration with Chinese universities has aroused growing interest among multinational companies (MNCs). Cross-cultural university-industry (U-I) collaboration creates various challenges in collaborative knowledge creation and innovation due to the differences e.g. between university and company motivation, objectives and activities. Also different values, norms, and means of actions result often in collisions and misunderstandings. This thesis examines the establishment of the relationships and the evolution of the collaboration between MNCs and Chinese universities. Empirical findings underscore that the partners in collaboration are required to possess research interest as well as capability to acquire, assimilate and exploit new external knowledge. Time and communication have a critical role in the evolution of the collaboration. In China the personal relationships, guanxi, play an important role. Collaborative knowledge creation requires a platform, Ba, which enables the creation of common understanding, commitment, trust and mutual respect. Empirical data has been collected through interviewing company experts and academe of Chinese universities from ICT and forest industries as well as attending panel discussions and meetings with the experts from the field of study.

Regulation of Port Charges in Spain: Global versus Local Competition

This article examines the determinants of traffic volumes and the revenues per tonne generated by Spain’s port authorities. The interest of the study lies on the strong differences between port authorities in a context of strict regulation but that provides some scope for price competition. We find that port charges influence the amount of traffic that a port is able to generate. Furthermore, we find clear evidence of local price competition and report mixed results for global competition. Revenues per tonne are higher in ports operating more international regular lines and with multinational terminal operators, while they are lower in ports with nearby competing facilities and where the market share of the dominant shipping firm is high.

The Changing Face of Psychiatric Nursing –Care or Control?

This report has been written as part of the project “Toward improved quality – developing nurse’s continuing vocational training in hospitals and inpatient units”. Its overall goal is to ensure high quality, ethically appropriate and therapeutically effective interventions to enable nurses to manage distressed and disturbed patients in European psychiatric hospitals and inpatient units. In this large-scale, multinational projects there are all together six European countries involved: Finland, Ireland, England, Portugal, Italy and Lithuania. The project work plan were during autumn 2006 and spring 2007. The content of this publication was produced in the first stage of the project aiming to collect the preliminary source material for the project. The literature review was carried out in the project stage, providing the groundwork for the next steps for the project. This project aims to develop an interactive multinational portal with training material. Therefore, it is important to share an understanding of basic information, psychiatric nurse’s continuing vocational education, laws and ethical codes and patient restriction used in mental health care. In this publication, the purpose of the material produced here is to understand nurses’ educational need related to vocational continuing education and to be used in further project stages as an empirical data collection. The data were collected as a preliminary source material for latter phases where nurse’s perceptions of the current practice, nurse’s attitudes to mental illness, prevalence of use of seclusion room and existing and desired vocational training provision will be collected in six different European countries. The following organisations are involved in this project: University of Turku, Dublin City University, St. Vincent Hospital, National Council for the Professional Development of Nursing and Midwifery, University of Padova, Klaipeda College - Health Faculty, Klaipeda Psychiatric Hospital, Escola Superior de Enfermagem de Lisboa, Centro Hospitalar Psiquiátrico de Lisboa, Omnia Vocational Institution the Espoo Region, Kellokoski psychiatric hospital, Hyvinkää hospital area, Pirkanmaa Hospital District, Kingston University & St. George’s Medical School and South West London & St. George’s Mental Health NHS Trust. A wide variety of different countries, organisations and individuals in this project give us a strong confidence that theoretical, practical, ethical and political issues around the topic of interest will be taken account during this project lifetime. We are aware the content of this book will be partially outdated almost as soon as it has been published. We still hope that this publication will encourage nurses and different professions working in mental health care field to have a basic understanding of similarities and differences between different European countries related in mental health care. We also hope that this publication will inspirate and motivate nurses in maintaining and developing the quality of psychiatric care in Europe.