Despite their recognized significance for project success and innovation, the management of the early project phases is still an under-researched area in project management. For organizations to secure a continuous stream of innovation, the utilization of capabilities is crucial for managing the early phases of R&D projects. The purpose of this dissertation is to advance the understanding of the management of the early project phases in hypercompetitive environments. The thesis addresses the research question of how organizations manage the early project phases of R&D in hypercompetitive environments for frequent innovation by taking a dynamic capabilities perspective. The first conceptual study reviews the literature covering organizational change in hypercompetitive environments with a focus on projects as the vehicle to create the necessary flexibility. The study found that organizational aspects and capabilities have to go hand in hand as enabler and facilitator for a successful emergent change process. The second qualitative study investigates how organizations organize the early project phases of R&D in the pharmaceutical industry for an outcome of frequent innovation. The findings show that an optimization of combinative capabilities that balances dynamic, project and multi-project capabilities can be used as a powerful leverage to boost the outcome of frequent innovation. The third study investigates the philosophical stances and related methodologies used within the last 15 years of project management research at the example of IRNOP conferences. The findings show that ontological subjectivism and epistemological interpretivism are dominating. Moreover, case studies and qualitative methods were the most common methods, whereas mixed method studies were lacking despite their value for developing an increasingly complex research field. The final mixed method study explores how absorptive, innovative and adaptive capabilities within the early phases of pharmaceutical R&D affect project and portfolio performance. Based on the results of quantitative study, the set of capabilities has an overall effect on the set of performance outcomes and thus confirms the results of the qualitative study that a distinct capability mix is needed in the pharmaceutical R&D process. To conclude, the dissertation has comprehensively explored the management of the early project phases through four studies and by applying a multitude of methodologies.

Η συγκεκριμένη διπλωματική εργασία στηρίχθηκε στις αρχές του Φαρμακευτικού Μάρκετινγκ για την σκιαγράφηση του τομέα της καινοτομίας στην Φαρμακευτική Αγορά. Ακολουθείται μία σταδιακή, ορθολογική, οργανωμένη και ακριβή διαδικασία αναγνώρισης των χαρακτηριστικών που απαρτίζουν τη φαρμακευτική αγορά, σατον Ελληνικό χώρο με συνεχή αναφορά στα διεθνή δεδομένα που ούτως ή άλλως επηρεάζουν τον τομέα του φαρμάκου. Ειδικότερα αναλύεται η φαρμακευτική αγορά τόσο από την πλευρά των φαρμακευτικών επιχειρήσεων που αποτελούν την π[λευρά της προσφοράς, όσο και απο την πλευρά των ασθενών - καταναλωτών που αποτελούν την πλευρά της ζήτησης. Αναλύοντας τις τάσεις και τις προοπτικές καθώς και την αξία της καινοτομίας στην φαρμακευτική αγορά, μελετώντας συγκεκριμένα εργαλεία- στρατηγικές. / This diploma thesis wiil be based on the principles of Pharmaceutical Marketing for the delineation of innovation in the Pharmaceutical market. It follows a gradual, rational, organized and accurate indentification process of the characteristics that make up the Pharmaceutical market in the Greek area, with constant reference to international data anyway affecting the field of medicine. In particular, the Pharmaceutical market in analyzed both by the Pharmaceutical companies that form the sypply side and from the perspective of patients - who are consumers demand. In thiw contex, specific tools - stratefies are studied, aimed at addressing the immediate cause of the detetioration in the value of innovation in the pharmaceutical market through these its trends and prospects are analyzed.

Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro / Esta dissertação tem como objetivo estudar a relação entre propriedade intelectual, inovação e saúde pública, com foco na análise do consórcio farmacêutico para desenvolvimento do medicamento combinação em dose fixa artesunato-mefloquina (ASMQ) contra a malária. A concepção dessa iniciativa se insere num momento histórico, final dos anos 1990 e início dos anos 2000, em que estudos apontaram a insuficiência da pesquisa e desenvolvimento para as doenças negligenciadas. Na época, o cenário da malária era particularmente preocupante, dada a disseminação de resistência aos medicamentos disponíveis e à falta de perspectiva do lançamento de novos produtos contra a doença. Para proteger a última classe de antimaláricos eficazes, a saber,os derivados a base de artemisinina, uma estratégia encontrada foi a do recurso à terapia combinada a base de artemisinina (artemisinin based combination therapy ACT). Contudo, dos 4 ACTs recomendados pela OMS em 2001, apenas 1 se encontrava disponível no mercado. O projeto FACT foi então criado, em 2002, com o propósito de desenvolver dois novos ACTs artesunato-mefloquina e artesunato-amodiaquina. O consórcio do ASMQ, por suas especificidades, em particular a produção de inovação por um laboratório público do Sul e a circulação Sul-Sul de conhecimentos e tecnologias , o tornam de interesse para estudos nos campos da bioética e da saúde pública; tendo sido, por isso, escolhido como objeto desta dissertação. O estudo se apoiou em pesquisa bibliográfica, de fundamental relevância para a compreensão dos problemas de acesso e de disponibilidade de novos produtos para doenças negligenciadas, decorrentes de um modelo de inovação farmacêutica sustentado em patentes. De forma complementar, foram feitos: i) trabalho de observação durante a 65a Assembleia Mundial da Saúde, da Organização Mundial da Saúdem, evento de importância para os debates sobre propriedade intelectual e interesse público; e ii) entrevistas com integrantes de equipes das duas principais instituições participantes do consórcio FACT (Farmanguinhos/Fiocruz e DNDi). / This thesis aims to study the relationship between intellectual property, innovation and public health, considering the case of the consortium for the development of the fixed-dose combination artesunate-mefloquine (ASMQ) for the treatment of malaria. The genesis of this initiative is part of a historical moment (late 1990s and early 2000s), when studies highlighted the crisis on R&D for neglected diseases. At that time, the scenario of malaria was particularly worrying, given the spread of drug resistance and also the fact that there was no expectation for launching new antimalarials in the market. A strategy was then developed to protect the last class of effective antimalarials (artemisinin derivatives) by establishment of the artemisin-based combination therapies (ACTs). Nevertheless, only one of the four ACTs recommended by WHO in 2001 was available. The FACT project was then created in 2002 with the purpose of developing two new ACTs - artesunate-mefloquine and artesunateamodiaquine. The ASMQ Consortium, due to its specific features (production of an innovation by a public laboratory located in the South and South-South knowledge circulation), may interest the studies in the fields of Bioethics and Public Health, and was chosen to integrate this thesis. Besides the analysis of specialized literature, which was of fundamental importance for understanding the problems of access and availability that arises from the current model of innovation adopted by the pharmaceutical industry, an observation work was conducted during the 65th World Health Assembly, World Health Organization, held in Geneva during May 2012, which was of valuable importance for the debates regarding intellectual property and public interest. Also we conducted interviews with actors belonging to the two institutions participants of the consortium FACT (Farmanguinhos / Fiocruz and DNDi) in order to better understand the initiative.

Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro / Esta dissertação tem como objetivo estudar a relação entre propriedade intelectual, inovação e saúde pública, com foco na análise do consórcio farmacêutico para desenvolvimento do medicamento combinação em dose fixa artesunato-mefloquina (ASMQ) contra a malária. A concepção dessa iniciativa se insere num momento histórico, final dos anos 1990 e início dos anos 2000, em que estudos apontaram a insuficiência da pesquisa e desenvolvimento para as doenças negligenciadas. Na época, o cenário da malária era particularmente preocupante, dada a disseminação de resistência aos medicamentos disponíveis e à falta de perspectiva do lançamento de novos produtos contra a doença. Para proteger a última classe de antimaláricos eficazes, a saber,os derivados a base de artemisinina, uma estratégia encontrada foi a do recurso à terapia combinada a base de artemisinina (artemisinin based combination therapy ACT). Contudo, dos 4 ACTs recomendados pela OMS em 2001, apenas 1 se encontrava disponível no mercado. O projeto FACT foi então criado, em 2002, com o propósito de desenvolver dois novos ACTs artesunato-mefloquina e artesunato-amodiaquina. O consórcio do ASMQ, por suas especificidades, em particular a produção de inovação por um laboratório público do Sul e a circulação Sul-Sul de conhecimentos e tecnologias , o tornam de interesse para estudos nos campos da bioética e da saúde pública; tendo sido, por isso, escolhido como objeto desta dissertação. O estudo se apoiou em pesquisa bibliográfica, de fundamental relevância para a compreensão dos problemas de acesso e de disponibilidade de novos produtos para doenças negligenciadas, decorrentes de um modelo de inovação farmacêutica sustentado em patentes. De forma complementar, foram feitos: i) trabalho de observação durante a 65a Assembleia Mundial da Saúde, da Organização Mundial da Saúdem, evento de importância para os debates sobre propriedade intelectual e interesse público; e ii) entrevistas com integrantes de equipes das duas principais instituições participantes do consórcio FACT (Farmanguinhos/Fiocruz e DNDi). / This thesis aims to study the relationship between intellectual property, innovation and public health, considering the case of the consortium for the development of the fixed-dose combination artesunate-mefloquine (ASMQ) for the treatment of malaria. The genesis of this initiative is part of a historical moment (late 1990s and early 2000s), when studies highlighted the crisis on R&D for neglected diseases. At that time, the scenario of malaria was particularly worrying, given the spread of drug resistance and also the fact that there was no expectation for launching new antimalarials in the market. A strategy was then developed to protect the last class of effective antimalarials (artemisinin derivatives) by establishment of the artemisin-based combination therapies (ACTs). Nevertheless, only one of the four ACTs recommended by WHO in 2001 was available. The FACT project was then created in 2002 with the purpose of developing two new ACTs - artesunate-mefloquine and artesunateamodiaquine. The ASMQ Consortium, due to its specific features (production of an innovation by a public laboratory located in the South and South-South knowledge circulation), may interest the studies in the fields of Bioethics and Public Health, and was chosen to integrate this thesis. Besides the analysis of specialized literature, which was of fundamental importance for understanding the problems of access and availability that arises from the current model of innovation adopted by the pharmaceutical industry, an observation work was conducted during the 65th World Health Assembly, World Health Organization, held in Geneva during May 2012, which was of valuable importance for the debates regarding intellectual property and public interest. Also we conducted interviews with actors belonging to the two institutions participants of the consortium FACT (Farmanguinhos / Fiocruz and DNDi) in order to better understand the initiative.

Cette thèse de doctorat met l’emphase sur les défis rencontrés par les patients atteints de maladies rares. Elle est structurée en trois parties, chacune d’entre elles dédiée aux enjeux d’un acteur au cœur de l’Odyssée diagnostique et thérapeutique des patients atteints de maladies rares. La première partie de la thèse s’intéresse au patient et à son réseau social. Le chapitre 1 considère les sources de délai à l’accès au diagnostic, et explore notamment l’effet du capital social sur le délai d’obtention du diagnostic. Le chapitre 2 évoque les externalités négatives sur la santé maternelle d’un diagnostic d’une maladie chronique chez l’enfant. La seconde partie de la thèse est dédiée à l’industrie pharmaceutique et s’intéresse aux décisions d’investissements de R&D ciblant les maladies rares. Le chapitre 3 évalue l’effet causal de l’Orphan Drug Policy sur l’effort de recherche, et le chapitre 4 envisage les inégalités d’allocation des investissements de R&D entre les maladies rares. La partie 3 est dédiée aux décideurs publics et discute des enjeux d’évaluation des bénéfices de l’innovation thérapeutique et de la définition des conditions d’accès à cette innovation. Le chapitre 5 évalue l’effet causal de l’innovation thérapeutique sur la longévité des patients atteints de maladies rares. Le chapitre 6 est une discussion critique relative à l’utilisation d’outils. / This dissertation emphasizes the challenges raised by the management of rare diseases and is structured around three key actors of the diagnostic and therapeutic “odyssey” of patients with rare diseases. Part I is devoted to patients and their social networks. Chapter 1 considers demand-side sources of delay in receiving a diagnosis; Chapter 2 explores the health spillover effects from patients’ health to their direct support structure. Part II considers pharmaceutical firms and examines how firms’ decisions to allocate R&D investment to rare diseases are impacted by innovation policies in rare arenas. Chapter 3 evaluates the causal impact of the EU Orphan Drug policy on R&D efforts in orphan drugs, while Chapter 4 investigates the inequality in allocation of R&D investment within rare diseases. Part III focuses on policymakers and addresses the issues in measuring pharmaceutical innovation benefits along with costs in rare disease arenas, while considering the opportunity cost of healthcare expenditures. Chapter 5 measures the causal impact of pharmaceutical innovation in rare diseases on longevity, while Chapter 6 is a critical discussion of decision-making tools for rational allocation of healthcare resources, and the use of a cost-effectiveness threshold.