Gestion des risques en industrie pharmaceutique (initiation à la gestion de crise)

Le haut niveau de qualité et de sécurité atteint par l'Industrie Pharmaceutique permet de protéger les patients en diminuant le risque sanitaire de manière extrêmement importante. Néanmoins, des risques subsistent. Ces risques peuvent affecter la qualité et la sécurité des produits et par conséquent la santé des patients. Et dans certains cas, la survie de l'entreprise peut être menacée. Face à de tels enjeux, le management des risques permet de traiter les dangers potentiels qui guettent l'entreprise, et ce, afin d'assurer la maitrise de processus critiques, assurer la pérennité de l'entreprise et ainsi assurer aux patients une sécurité d'utilisation des produits. Mais le risque Zéro n'existe pas. Les crises doivent se gérer, mais cette gestion doit s'anticiper. Il existe un cadre, ou du moins une organisation générale pour tenter d'organiser le traitement de ces crises. Les principaux domaines d'anticipation et de préparation sont l'organisation quant à la mise en place d'une cellule de crise et la réflexion quant aux plans stratégiques de communication. Ces deux notions doivent être appréhendées avant la crise de façon à assurer une réactivité de l'entreprise.NANTES-BU Médecine pharmacie (441092101) / SudocSudocFranceF

Higher Early Monocyte and Total Lymphocyte Counts Are Associated with Better Overall Survival after Standard Total Body Irradiation, Cyclophosphamide, and Fludarabine Reduced-Intensity Conditioning Double Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Adults

International audienceThis single-center retrospective study aimed to report the impact of early hematopoietic and immune recoveries after a standard total body irradiation, cyclophosphamide, and fludarabine (TCF) reduced-intensity conditioning (RIC) regimen for double umbilical cord blood (dUCB) allogeneic stem cell transplantation (allo-SCT) in adults. We analyzed 47 consecutive patients older than 17 years who engrafted after a dUCB TCF allo-SCT performed between January 2006 and April 2013 in our department. Median times for neutrophil and platelet recoveries were 17 (range, 6 to 59) and 37 days (range, 0 to 164), respectively. The 3-year overall (OS) and disease-free survivals, relapse incidence, and nonrelapse mortality were 65.7%, 57.2%, 27.1%, and 19%, respectively. In multivariate analysis, higher day þ30 monocyte (!615/mm 3 ; hazard ratio [HR], .04; 95% confidence interval [CI], .004 to .36; P < .01) and day þ42 lymphocyte (!395/mm 3 ; HR, .16; 95% CI, .03 to .78; P ¼ .02) counts were independently associated with better OS. These results suggest that early higher he-matopoietic and immune recovery is predictive of survival after dUCB TCF RIC allo-SCT in adults. Factors other than granulocyte colonyestimulating factor, which was used in all cases, favoring expansion of monocytes or lymphocytes, should be tested in the future as part of the UCB transplantation procedure

Larger number of invariant natural killer T cells in PBSC allografts correlates with improved GVHD-free and progression-free survival

International audienceKey Points • Higher dose of invariant NKT cells within PBSC allograft is associated with an improved GPFS. We studied the impact of a set of immune cells contained within granulocyte colony-stimulating factor–mobilized peripheral blood stem cell grafts (na¨ıvena¨ıve and memory T-cell subsets, B cells, regulatory T cells, invariant natural killer T cells [iNKTs], NK cells, and dendritic cell subsets) in patients (n 5 80) undergoing allogeneic stem cell trans-plantation (SCT), using the composite end point of graft-versus-host disease (GVHD)-free and progression-free survival (GPFS) as the primary end point. We observed that GPFS incidences in patients receiving iNKT doses above and below the median were 49% vs 22%, respectively (P 5 .007). In multivariate analysis, the iNKT dose was the only parameter with a significant impact on GPFS (hazard ratio 5 0.48; 95% confidence interval, 0.27-0.85; P 5 .01). The incidences of severe grade III to IV acute GVHD and National Institutes of Health grade 2 to 3 chronic GVHD (12% and 16%, respectively) were low and associated with the use of antithymocyte globulin in 91% of patients. No difference in GVHD incidence was reported according to the iNKT dose. In conclusion, a higher dose of iNKTs within the graft is associated with an improved GPFS. These data may pave the way for prospective and active interventions aiming to manipulate the graft content to improve all