Plan de negocio para la creación e internacionalización de un laboratorio biomolecular: Proyecta BM

El equipo emprendedor, que consta de profesionales conocedores del sector de servicios de salud, específicamente de laboratorios clínicos y negocios internacionales, identificó que los laboratorios biomoleculares para atender el diagnóstico y tratamiento de enfermedades no transmisibles como el cáncer, son de gran necesidad no solo en el Perú, sino también para cualquier otro país latinoamericano. Sin embargo, la actual oferta es pobre y poco especializada y es totalmente dependiente de otros laboratorios localizados en países desarrollados. La presente tesis evalúa la factibilidad de brindar este servicio a escala industrial, y evidencia que el entorno externo es favorable, porque los aspectos políticos, económicos, sociales, demográficos, tecnológicos y globales son auspiciosos para el desarrollo de esta idea de negocio. Los actuales laboratorios que están en la capacidad de ofrecer este tipo de servicio, prefieren la tercerización y la concentración de sus esfuerzos en los ingresos por servicios de laboratorio clínico. Por otro lado, luego de un análisis cualitativo de los países latinoamericanos, se determinó que Ecuador es un mercado propicio para la internacionalización, por cuanto la principal institución que atiende las enfermedades de cáncer (Solca), busca soluciones que le permita bajar sus costes de laboratorio, y no tiene ninguna restricción de contratación con empresas a su voluntad. La actual demanda potencial es de aproximadamente más 5.000 pacientes al año. Esta demanda, sin ser el total de su potencial, hace que el negocio sea sumamente atractivo y aún más al identificar que el know how del negocio es posible que sea adquirido, por contratos de transferencia tecnológica, cuyo coste es totalmente amortizable con los ingresos. Dada la importante ventaja comparativa que se adquieren al realizar las operaciones desde el Perú (por distancia y bajos costos de mano de obra), permite que la propuesta de valor no solo sea un bajo coste, sino agregar servicio especializado, de puerta a puerta, que le permitirá al cliente reducir sus costos y mejorar su atención a pacientes. La presente tesis ha demostrado la viabilidad económico-financiera, luego de la evaluación en un horizonte de cinco años, obteniendo que para una inversión de USD 550.000, el flujo de caja del accionista arroja un VAN de USD 547 mil, con una TIR de 64%

Screening policies, preventive measures and in-hospital infection of COVID-19 in global surgical practices

none14siThis research was funded in part by the European Society of Degenerative Disease. The study was registered with an analysis plan on ClinicalTrials.gov (NCT04344197).Background In a surgical setting, COVID-19 patients may trigger in-hospital outbreaks and have worse postoperative outcomes. Despite these risks, there have been no consistent statements on surgical guidelines regarding the perioperative screening or management of COVID-19 patients, and we do not have objective global data that describe the current conditions surrounding this issue. This study aimed to clarify the current global surgical practice including COVID-19 screening, preventive measures and in-hospital infection under the COVID-19 pandemic, and to clarify the international gaps on infection control policies among countries worldwide.Methods During April 2-8, 2020, a cross-sectional online survey on surgical practice was distributed to surgeons worldwide through international surgical societies, social media and personal contacts. Main outcome and measures included preventive measures and screening policies of COVID-19 in surgical practice and centers' experiences of in-hospital COVID-19 infection. Data were analyzed by country's cumulative deaths number by April 8, 2020 (high risk, >5000; intermediate risk, 100-5000; low risk, <100).Results A total of 936 centers in 71 countries responded to the survey (high risk, 330 centers; intermediate risk, 242 centers; low risk, 364 centers). In the majority (71.9%) of the centers, local guidelines recommended preoperative testing based on symptoms or suspicious radiologic findings. Universal testing for every surgical patient was recommended in only 18.4% of the centers. In-hospital COVID-19 infection was reported from 31.5% of the centers, with higher rates in higher risk countries (high risk, 53.6%; intermediate risk, 26.4%; low risk, 14.8%; P<0.001). Of the 295 centers that experienced in-hospital COVID-19 infection, 122 (41.4%) failed to trace it and 58 (19.7%) reported the infection originating from asymptomatic patients/staff members. Higher risk countries adopted more preventive measures including universal testing, routine testing of hospital staff and use of dedicated personal protective equipment in operation theatres, but there were remarkable discrepancies across the countries.Conclusions This large international survey captured the global surgical practice under the COVID-19 pandemic and highlighted the insufficient preoperative screening of COVID-19 in the current surgical practice. More intensive screening programs will be necessary particularly in severely affected countries/institutions.openBellato, Vittoria; Konishi, Tsuyoshi; Pellino, Gianluca; An, Yongbo; Piciocchi, Alfonso; Sensi, Bruno; Siragusa, Leandro; Khanna, Krishn; Pirozzi, Brunella Maria; Franceschilli, Marzia; Campanelli, Michela; Efetov, Sergey; Sica, Giuseppe S; Feo, C;Bellato, Vittoria; Konishi, Tsuyoshi; Pellino, Gianluca; An, Yongbo; Piciocchi, Alfonso; Sensi, Bruno; Siragusa, Leandro; Khanna, Krishn; Pirozzi, Brunella Maria; Franceschilli, Marzia; Campanelli, Michela; Efetov, Sergey; Sica, Giuseppe S; Feo,

Abdominoplasty after massive weight loss. Safety preservation fascia technique and clinical outcomes in a large single series-comparative study

IntroductionWeight loss after bariatric surgery causes very important modifications to the patient's silhouette. Abdominal fat and skin excess reduction are associated with several complications. The most frequent are seroma and hematoma whereas major complications, such as pulmonary embolism, are less frequent. This study aimed to describe our technical procedure for abdominoplasty in patients with massive weight loss after bariatric surgery.MethodsIn total, 196 patients were included. All patients who underwent abdominoplasty classic (group A) and abdominoplasty with the preservation and lift of Scarpa fascia (group B) and with umbilical transposition between May 2018 and May 2021 were included. Patients with concomitant correction of ventral hernia were excluded. Demographic and operative data were analyzed according to comorbidities and postoperative complications.ResultsThere were 160 (81.6%) women. The mean age was 43.6 years; the mean weight was 86.7 kg; and the mean BMI was 28.6 kg/m2. Five patients (2.5%) presented postoperative seroma. Four patients (2%) presented partial dehiscence/skin necrosis one of them requiring a revision. Finally, 26 patients presented a postoperative complication, with an overall incidence of 12.6%. The average postoperative hospital stay was 3.6. The rates of seroma were significantly higher in men, patients with a BMI > 30 kg/m2, and aged >50 years.ConclusionPreserving Scarpa Fascia during surgical post-bariatric patient procedures reduces the seroma formation and the scar complication and reduces the tension of the inguinal-pubic region with correction of our deformation after weight loss. Improves reducing the drain and reducing seroma incidence suction and hospital stay

Long-term and real-world safety and efficacy of retroviral gene therapy for adenosine deaminase deficiency

Adenosine deaminase (ADA) deficiency leads to severe combined immunodeficiency (SCID). Previous clinical trials showed that autologous CD34+ cell gene therapy (GT) following busulfan reduced-intensity conditioning is a promising therapeutic approach for ADA-SCID, but long-term data are warranted. Here we report an analysis on long-term safety and efficacy data of 43 patients with ADA-SCID who received retroviral ex vivo bone marrow-derived hematopoietic stem cell GT. Twenty-two individuals (median follow-up 15.4 years) were treated in the context of clinical development or named patient program. Nineteen patients were treated post-marketing authorization (median follow-up 3.2 years), and two additional patients received mobilized peripheral blood CD34+ cell GT. At data cutoff, all 43 patients were alive, with a median follow-up of 5.0 years (interquartile range 2.4-15.4) and 2 years intervention-free survival (no need for long-term enzyme replacement therapy or allogeneic hematopoietic stem cell transplantation) of 88% (95% confidence interval 78.7-98.4%). Most adverse events/reactions were related to disease background, busulfan conditioning or immune reconstitution; the safety profile of the real world experience was in line with premarketing cohort. One patient from the named patient program developed a T cell leukemia related to treatment 4.7 years after GT and is currently in remission. Long-term persistence of multilineage gene-corrected cells, metabolic detoxification, immune reconstitution and decreased infection rates were observed. Estimated mixed-effects models showed that higher dose of CD34+ cells infused and younger age at GT affected positively the plateau of CD3+ transduced cells, lymphocytes and CD4+ CD45RA+ naive T cells, whereas the cell dose positively influenced the final plateau of CD15+ transduced cells. These long-term data suggest that the risk-benefit of GT in ADA remains favorable and warrant for continuing long-term safety monitoring. Clinical trial registration: NCT00598481 , NCT034786

Analisi dei modelli organizzativi di risposta al COVID-19 in Italia: evidenze da 2 anni di ISTANT REPORT Altems

Sistematizzazione e pubblicazione settimanalmente un report per analizzare in modo sistemico e comparativo i modelli di risposta adottati dalle Regioni in risposta all'emergenza da COVID- 1

Hemophagocytic inflammatory syndrome in ADA-SCID: report of two cases and literature review

Hemophagocytic inflammatory syndrome (HIS) is a rare form of secondary hemophagocytic lymphohistiocytosis caused by an impaired equilibrium between natural killer and cytotoxic T-cell activity, evolving in hypercytokinemia and multiorgan failure. In the context of inborn errors of immunity, HIS occurrence has been reported in severe combined immunodeficiency (SCID) patients, including two cases of adenosine deaminase deficient-SCID (ADA-SCID). Here we describe two additional pediatric cases of ADA-SCID patients who developed HIS. In the first case, HIS was triggered by infectious complications while the patient was on enzyme replacement therapy; the patient was treated with high-dose corticosteroids and intravenous immunoglobulins with HIS remission. However, the patient required HLA-identical sibling donor hematopoietic stem cell transplantation (HSCT) for a definitive cure of ADA-SCID, without HIS relapse up to 13 years after HSCT. The second patient presented HIS 2 years after hematopoietic stem cell gene therapy (GT), secondarily to Varicella-Zoster vaccination and despite CD4+ and CD8+ lymphocytes’ reconstitution in line with other ADA SCID patients treated with GT. The child responded to trilinear immunosuppressive therapy (corticosteroids, Cyclosporine A, Anakinra). We observed the persistence of gene-corrected cells up to 5 years post-GT, without HIS relapse. These new cases of children with HIS, together with those reported in the literature, support the hypothesis that a major dysregulation in the immune system can occur in ADA-SCID patients. Our cases show that early identification of the disease is imperative and that a variable degree of immunosuppression could be an effective treatment while allogeneic HSCT is required only in cases of refractoriness. A deeper knowledge of immunologic patterns contributing to HIS pathogenesis in ADA-SCID patients is desirable, to identify new targeted treatments and ensure patients’ long-term recovery

COVID-19 Severity in Multiple Sclerosis: Putting Data Into Context

Background and objectives: It is unclear how multiple sclerosis (MS) affects the severity of COVID-19. The aim of this study is to compare COVID-19-related outcomes collected in an Italian cohort of patients with MS with the outcomes expected in the age- and sex-matched Italian population. Methods: Hospitalization, intensive care unit (ICU) admission, and death after COVID-19 diagnosis of 1,362 patients with MS were compared with the age- and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher risk: Expanded Disability Status Scale [EDSS] score > 3 or at least 1 comorbidity, lower risk: EDSS score ≤ 3 and no comorbidities) by the χ2 test, and the risk excess was quantified by risk ratios (RRs). Results: The risk of severe events was about twice the risk in the age- and sex-matched Italian population: RR = 2.12 for hospitalization (p < 0.001), RR = 2.19 for ICU admission (p < 0.001), and RR = 2.43 for death (p < 0.001). The excess of risk was confined to the higher-risk group (n = 553). In lower-risk patients (n = 809), the rate of events was close to that of the Italian age- and sex-matched population (RR = 1.12 for hospitalization, RR = 1.52 for ICU admission, and RR = 1.19 for death). In the lower-risk group, an increased hospitalization risk was detected in patients on anti-CD20 (RR = 3.03, p = 0.005), whereas a decrease was detected in patients on interferon (0 observed vs 4 expected events, p = 0.04). Discussion: Overall, the MS cohort had a risk of severe events that is twice the risk than the age- and sex-matched Italian population. This excess of risk is mainly explained by the EDSS score and comorbidities, whereas a residual increase of hospitalization risk was observed in patients on anti-CD20 therapies and a decrease in people on interferon

Clinical Features, Cardiovascular Risk Profile, and Therapeutic Trajectories of Patients with Type 2 Diabetes Candidate for Oral Semaglutide Therapy in the Italian Specialist Care

Introduction: This study aimed to address therapeutic inertia in the management of type 2 diabetes (T2D) by investigating the potential of early treatment with oral semaglutide. Methods: A cross-sectional survey was conducted between October 2021 and April 2022 among specialists treating individuals with T2D. A scientific committee designed a data collection form covering demographics, cardiovascular risk, glucose control metrics, ongoing therapies, and physician judgments on treatment appropriateness. Participants completed anonymous patient questionnaires reflecting routine clinical encounters. The preferred therapeutic regimen for each patient was also identified. Results: The analysis was conducted on 4449 patients initiating oral semaglutide. The population had a relatively short disease duration (42%  60% of patients, and more often than sitagliptin or empagliflozin. Conclusion: The study supports the potential of early implementation of oral semaglutide as a strategy to overcome therapeutic inertia and enhance T2D management