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The main purpose of this study was to investigate judgments made by employees from the pharmaceutical industry and allied health-care sectors in a set of four different drug discovery and developme ...

We used a web-based questionnaire survey to investigate how employees from the pharmaceutical and allied health industries perceive the importance of different steps within drug research and development for assessing the benefits and risks of developmental drugs to reach market registration and enter into clinical use. Key outcomes were that Pharmaceutical Processes were seen as least important while Toxicology was most important followed by Clinical Trials Phases 2 Late/3, Safety and Pharmacovigilance, and Clinical Trials Phase 2 Early. Nonparametric analysis showed that these outcomes were influenced by demographics of the selected employee target population. Since this survey was exploratory, we feel the expressed judgments of the study population are important for planning research surveys using more complex scenarios to investigate intuitive perception of risks and benefits in drug research and development.

Over the past century, the pharmaceutical industry has been a major contributor of individual and population health and societal wealth. Its products and services have contributed to longevity of large groups of patients and symptom relief from major diseases. However, during the past 2 decades, the innovative capacity of the pharmaceutical industry has lagged behind, and there have been concerns and discussions on the prevailing business model of the industry, and whether it needs to be refined and altered. Development of a new drug is a time-consuming and complex undertaking, which involves elements of discovery as well as process development. Recently, the average cost of developing a new molecular entity (NME) was estimated to be around U$800 million for small molecules and around U$1,300 million for biologics. If post approval costs for Phase IV studies, costs to gain regulatory approval in various global markets and costs for obtaining additional label claims for new indications are included and adjusted for cost increases and inflation, the cost estimates per NME increase to U$1,754 million for small molecules and U$3,911 million for biologics. Revenue streams from global market sales are only able to offset these escalating costs to a limited extent. The present dissertation focusses on the on-going change processes in the pharmaceutical industry (Big Pharma). An important change process is related to open information and open intellectual property (IP) platforms. The work also relates to entrepreneurial orientation, inherent project uncertainty and decision modelling. In the biomedical field, there are an increasing number of stakeholders that collaboratively develop, package and build transactions around technology. Such open innovation model differs from the classical closed innovation model when openness is structured in open networks and business consortia. This thesis provides examples of how open innovation models function in the context of the pharmaceutical industry and how Life Science companies could design their IP-strategies to optimize the value extraction potential from open innovation in general and open IP platforms in particular. The present work also investigates perceptions of experts within the pharmaceutical industry and allied health sectors, with respect to entrepreneurial attitudes, intent and engagements during pharmaceutical innovation and new drug development. It was shown that positive attitudes and orientation towards entrepreneurship are perceived to be of high value for the early strategic selection and validation of the drug target area, for costs assessments and pharmacoeconomics, as well as for positioning and marketing of a new drug to patients and the public. Entrepreneurial traits were however judged to be less important for some major process steps during preclinical and clinical development. Based on real scenario cases, this thesis also investigates how employees make judgments in the pharmaceutical industry and allied health care sectors. Each case study relates to go/no-go decisions taken from the various steps in drug discovery through preclinical and clinical development (IND) on to market introduction (NDA) and treatment of the target population. Results revealed that there is a major inter-individual difference between experts in their individual intuitive go/no-go/recycle decisions during the drug discovery and development process. This lack of coherence and wide variability with respect to the drug development cases selected may reflect judgment in the real world. Accordingly, increased openness, entrepreneurial awareness and orientation towards entrepreneurial engagements and skills may help the pharmaceutical business sector to improve vital parts of its value creation processes. Also, by modelling decision-making in real cases from initial drug discovery to late development and marketing, in pharmaceutical industry R&D, we demonstrated that rational decision-making can commonly be managed by a group of 10 – 15 experts when mean group judgments over a series of decision points are clear go decisions. However, when mean group judgments from one decision point to another vary from go to stop in a specific case, i.e. involves a recycle component, there will be a need to expand R&D expert input substantially. In such cases, the drug development processes more or less takes on the form of an open innovation process. Thus, our findings may be used to construct a new model on how to plan and model the size of expert input in structured decision processes similar to those practiced in the pharmaceutical industry. Based on the findings in this thesis, it may be concluded that high-tech innovation in the pharmaceutical and biotech sectors show signs of movement from a closed to a more open innovation paradigm. This change is driven by several factors such as the possibility of rapid and unlimited communication through the Internet, the increasing global availability of experts for complex decision-making, the international reach of innovators and entrepreneurs, the need of the venture capital market to support appropriate investment cases, as well as the increasing possibility and interest of external suppliers and interest groups to participate in new product and service development.

Pharmaceutical products that promise a so-called “blockbuster potential” require an increasingly coordinated medical information function at the local, continental, and global levels. A strong emphasis must be placed upon the provision and evaluation of medical information. To assist in the management of this information, a number of tools and databases are employed. These databases reveal an explosion in the published literature on a specific immunosuppressive drug that is an example of the concepts presented in this paper. This growth has paralleled the increased use of the drug and the demand for information on the product. Worldwide, database users are able to provide medical information, and produce overviews for safety, regulatory, and marketing purposes. This both facilitates the quality and reduces the time to get the final written product to the target groups.The databases and networks described embrace a number of critical success factors through the phases of drug clinical development and marke...

The increased development costs of bringing new drugs to the market is one of the main reasons for pharmaceutical companies to globalize their operations. Globalized pharmaceutical businesses require their international operations to be present in all major markets. The various subsidiaries and affiliates operate under quite different cultures and guidelines. In the absence of effective communication and teamwork, misunderstanding can easily arise and valuable synergies are lost, resulting in suboptimal customer service and product support. This paper describes a European medical and scientific managers’ network in which international meetings address activities, roles, and goals for the individual managers. By regular face-to-face contact joint decision making builds trust and team spirit. Internally, value can be assessed by the enthusiasm, willingness to participate in meetings, and commitment of all team members. Externally, effectiveness is revealed by product support, rapid growth, market penetration, and attainment of targets.

BACKGROUND The increasing use of tacrolimus as a primary immunosuppressant is paralleled by a growing number of pregnancies occurring in mothers receiving tacrolimus systemically. METHODS In this retrospective analysis during 1992-1998; data sources were case reports from clinical studies, spontaneous reports from health care professionals, routine surveys by transplant registries, and the published literature. RESULTS One hundred pregnancies in 84 mothers were recorded. Mean maternal age was 28 years. All except one mother (autoimmune disease) were solid organ transplant recipients (66% liver and 27% kid- ci ney). Mean time from transplantation to conception was 26 months. The mean daily dose of tacrolimus (range 11.7-12.8 mg/day) and the mean tacrolimus whole blood level (range 8.5-11.5 ng/ml) remained fairly constant from preconception through the third trimester. The most frequent maternal complications were graft rejection followed by preeclampsia, renal impairment, and infection. All cases of rejection were successfully treated with corticosteroids and did not result in graft loss. Of 100 pregnancies, 71 progressed to delivery (68 live births, 2 neonatal deaths, and 1 stillbirth), 24 were terminated (12 spontaneous and 12 induced), 2 pregnancies were ongoing, and 3 were lost to follow-up. Mean gestation period was 35 weeks with 59% deliveries being premature (

The present study compares the effects of Ro 31-6930, a novel potassium channel opener, with those of cromakalim and nitrendipine on blood pressure and other haemodynamic parameters. In conscious, spontaneously hypertensive rats (SHR) the oral dose of Ro 31-6930 for lowering blood pressure was 10 times lower than that of cromakalim and some 100 times lower than that of nitrendipine. In addition, the duration of antihypertensive activity of Ro 31-6930 was longer than that of cromakalim or nitrendipine. The tachycardia evoked by Ro 31-6930 and cromakalim was of shorter duration than the antihypertensive effect of either agent. In a repeat, once daily dosing experiment no tolerance was observed to the antihypertensive effect of Ro 31-6930 over a 22-day period. In conscious normotensive cats Ro 31-6930 was 10 times more potent than cromakalim and 1,000 times more potent than nitrendipine in reducing blood pressure. The duration of hypotensive activity was in excess of 5 h for each agent. In anaesthetised dogs all three agents reduced mean arterial pressure (MAP) and total peripheral resistance (TPR), while increasing cardiac output (CO) via a rise in stroke volume (SV). Both Ro 31-6930 and cromakalim significantly reduced femoral (FVR) and mesenteric vascular resistances (MVR), while only cromakalim reduced renal vascular resistance (RVR). Ro 31-6930 is a potent new antihypertensive agent that compares favourably with cromakalim and nitrendipine.