How risk influences the choice of governance mode in biopharmaceutical inter-firm relationships

This paper proposes a new theoretical framework for assessing the influence of risk in shaping the governance form in biopharmaceutical inter-firm relationships. In particular, we propose a multidimensional operationalization of relational and performance risk and, by following Transaction Cost Economics (TCE) and Real Options (RO) theory constructs, we hypothesize a relation between the aforementioned risk components and the choice of governance form. Specifically, following TCE reasoning, we hypothesize that a high level of relational risk leads towards more hierarchical governance forms, while, following RO theory, we hypothesize that a high level of performance risk leads toward market-oriented governance forms; finally, we hypothesize a moderating effect of each risk component on the other. We empirically test our framework through the analysis of 353 inter-firm relationships signed worldwide between pharmaceutical and biotech companies from 2007 to 2010. The results show substantive support for our theoretical framework. Furthermore, we find a significant moderating effect of the performance risk on the TCE relation between relational risk and governance forms

Drivers influencing the governance of inter-firm relationships in the biopharmaceutical industry: an empirical survey in the Italian context

This paper focuses on factors influencing the choice of the governance form in inter-firm relationships (IFRs) between pharmaceutical and biotechnology companies. By reviewing the relevant literature on transaction cost economics, property right theory, real option and resources-based view, we located some drivers that might influence such relationships and we formulated a set of hypotheses linking them to governance forms. Such a theoretical framework has been empirically tested through a survey conducted among the Italian companies associated to Farmindustria. Empirical results provide some interesting insights on how shaping bio-pharmaceutical deals; we found that the developmental stage of the product/technology object of the agreement, the existence of previous collaborations between firms and the number of products marketed by the biotech company are able to influence the selection of a specific governance for

Non-typhoidal Salmonella septic arthritis in an immunocompetent child with a pharyngeal streptococcal infection

Summary We report the case of an immunocompetent child who showed monoarticular arthritis and fever, preceded by pharyngitis and arthralgias. Because group A β-hemolytic Streptococcus had been detected in the pharyngeal swab, erythromycin was given on admission. However, based on ultrasound examination, therapy with ceftriaxone and joint fluid drainage were promptly performed, and a rapid and full recovery followed. Meanwhile, Salmonella enterica infection was revealed in blood and joint fluid. Our case suggests that septic arthritis caused by a non-typhoidal Salmonella infection may occur without gastrointestinal manifestations and concomitantly with a pharyngeal streptococcal infection

Passive immunization during pregnancy for congenital cytomegalovirus infection

BACKGROUND Currently, there is no effective intervention for a primary cytomegalovirus (CMV) infection during pregnancy. METHODS We studied pregnant women with a primary CMV infection. The therapy group comprised women whose amniotic fluid contained either CMV or CMV DNA and who were offered intravenous CMV hyperimmune globulin at a dose of 200 U per kilogram of maternal weight. A prevention group, consisting of women with a recent primary infection before 21 weeks\u27 gestation or who declined amniocentesis, was offered monthly hyperimmune globulin (100 U per kilogram intravenously). RESULTS In the therapy group, 31 women received hyperimmune globulin, only 1 (3 percent) of whom gave birth to an infant with CMV disease (symptomatic at birth and handicapped at two or more years of age), as compared with 7 of 14 women who did not receive hyperimmune globulin (50 percent). Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV disease (adjusted odds ratio, 0.02; 95 percent confidence interval, ¡∞ to 0.15; P\u3c0.001). In the prevention group, 37 women received hyperimmune globulin, 6 (16 percent) of whom had infants with congenital CMV infection, as compared with 19 of 47 women (40 percent) who did not receive hyperimmune globulin. Thus, hyperimmune globulin therapy was associated with a significantly lower risk of congenital CMV infection (adjusted odds ratio, 0.32; 95 percent confidence interval, 0.10 to 0.94; P=0.04). Hyperimmune globulin therapy significantly (P\u3c0.001) increased CMV-specific IgG concentrations and avidity and decreased natural killer cells and HLA-DR+ cells and had no adverse effects. CONCLUSIONS Treatment of pregnant women with CMV-specific hyperimmune globulin is safe, and the findings of this nonrandomized study suggest that it may be effective in the treatment and prevention of congenital CMV infection. A controlled trial of this agent may now be appropriate

La clausola statutaria sui pareri degli accomandanti eccedente il limite delle «operazioni determinate» in prospettiva rimediale

SOMMARIO: Considerazioni preliminari – 1. I fatti di causa – 2. La decisione sul ricorso ex art. 700 c.p.c. – 3. Il divieto di ingerenza – 4. Nullità statutaria parziale o riqualificazione del tipo? – 5. Conclusioni

INVESTIGATION ACTIVITY ABOUT A COLLAPSED STEEL STRUCTURE SUBJECTED TO A REAL FIRE, Fire scenarios and structural behaviour of a real steel structure

The paper describes the behaviour ofa real steel structure collapsed under a fire event. 3D structural analyses were performed with SAFIR program (J-M Franssen, 2005). Different modellingare implemented with some fire load models and analyses of thebehaviour of the whole structure. The main purpose of this work was to investigate the failure types of a warehouse structure under fire conditions. Different fire conditions were applied to the steel frame sections, with ISOcurve (ISO EN 834-8:2002) and zone model approach. The analyses show that with unprotected steel sections, horizontal structures are more critical than columns. Trough applying a performance basedapproach,structure has 30 minutes of fire resistance

Placental enlargement in women with primary maternal cytomegalovirus infection is associated with fetal and neonatal disease

Background. Serological testing for primary maternal cytomegalovirus (CMV) infection during pregnancy is not routine, but ultrasound studies are routine. Therefore, we evaluated placental thickening in women with primary CMV infection during pregnancy. Methods. The study included 92 women with primary CMV infection during pregnancy and 73 CMV-seropositive pregnant women without primary CMV infection. Neonatal CMV transmission was determined by CMV culture of urine samples. Thirty-two women were treated with CMV hyperimmune globulin to either prevent or treat intrauterine CMV infection. Maximal placental thickness was measured by longitudinal (nonoblique) scanning with the ultrasound beam perpendicular to the chorial dish. Programmed placental ultrasound evaluations were performed from 16 to 36 weeks of gestation. Results. At each measurement between 16 and 36 weeks of gestation, women with primary CMV infection who had a fetus or newborn with CMV disease had placentas that were significantly thicker than those of women with primary CMV infection who did not have a diseased fetus or newborn (P <.0001); the latter group, in turn, P <.0001 had placentas that were significantly thicker than those of seropositive control subjects (P <.0001). For both women P <.0001 with and women without diseased fetuses or newborns, receipt of hyperimmune globulin after primary CMV infection was associated with statistically significant reductions in placental thickness (P <.001). Placental vertical P <.001 thickness values, which are predictive of primary maternal infection, were observed at each measurement from 16 to 36 weeks of gestation, and cutoff values ranged from 22 mm to 35 mm, with the best sensitivity and specificity at 28 and 32 weeks of gestation. Conclusions. Primary maternal CMV infection and fetal or neonatal disease are associated with sonographically thickened placentas, which respond to administration of hyperimmune globulin. These observations suggest that many of the manifestations of fetal and neonatal disease are caused by placental insufficiency

Decreasing mortality with drotrecogin alfa in high risk septic patients A meta-analysis of randomized trials in adult patients with multiple organ failure and mortality >40%

Objective. Sepsis is a complex inflammatory disease, rising in response to infection. Drotrecogin alfa, approved in 2001 for severe sepsis, has been withdrawn from the market. The aim of this study was to assess if drotrecogin alfa-activated can reduce mortality in the more severe septic patients. Methods. We searched PubMed, Embase, Scopus, BioMedCentral, and in Clinicaltrials. gov databases to identify every randomized study performed on drotrecogin alfa-activated in any clinical setting in humans, without restrictions on dose or time of administration. Our primary end-point was mortality rate in high risk patients. Secondary endpoints were mortality in all patients, in patients with an Acute Physiology and Chronic Health Evaluation (APACHE) 2 score ≥ 25 and in those with an APACHE 2 score ≤25. Results. Five trials were identified and included in the analysis. They randomized 3196 patients to drotrecogin alfa and 3111 to the control group. Drotrecogin alfa was associated with a reduction in mortality (99/263 [37.6%] vs 115/244 [47.1%], risk ratios (RR) = 0.80[0.65; 0.98], p = 0.03) in patients with multiple organ failure and a mortality risk in the control group of >40%, but not in the overall population or in lower risk populations. Conclusions. In high risk populations of patients with multiple organ failure and a mortality of >40% in the control group, Drotrecogin alfa may still have a role as a lifesaving treatment. No beneficial effect in low risk patients was found. An individual patient meta-analysis including all randomized controlled trial on sepsis is warranted, along with new studies on similar drugs such as protein C zymogen

Regression of fetal cerebral abnormalities by primary cytomegalovirus infection following hyperimmunoglobulin therapy

Objective To assess the effects of maternal and intra-amniotic hyperimmunoglobulin (HIG) infusions among cytomegalovirus (CMV) infected fetuses with ultrasound abnormalities following a primary CMV infection. Patients and Methods The subjects were fetuses with CMV-associated cerebral and other ultrasound abnormalities. Three mothers were treated with HIG infusions during pregnancy and two were untreated. Fetal ventricle size, organ echodensity and placental thickness were measured by ultrasound before and after HIG infusions. The children were evaluated between 3 and 7 years of age. Results The ventriculomegaly of all three fetuses of HIG-treated mothers regressed and the ascites, hepatic echodensities, periventricular echodensities, and intestinal echodensities disappeared. Their sensorial, mental and motor development was normal at 4, 4.7, and 7 years of age. In contrast, both infants born of untreated mothers had signs and symptoms of severe CMV cerebropathy. Conclusion The outcomes of the infants born to HIG-treated mothers support the efficacy of HIG as a treatment for CMV-infected fetuses with ultrasound cerebral abnormalities. Copyright (C) 2008 John Wiley & Sons, Ltd