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Market Knowledge and Stakeholder Considerations for the Biopharmaceutics Sector—Incorporating User Value and Societal Needs in Therapeutic Interventions

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health 2021年第11期13卷 1365-1395页

作者： James K. Timmis Raymond X. Van Der Waal jennifer h.rz Mark B. Van Der Waal Eric Claassen Linda h. M. Van De Burgwal Athena Institute for Research on Innovation and Communication in health and Life Sciences Vrije Universiteit Amsterdam Amsterdam The Netherlands Institute for Nursing Science Faculty of Medicine University of Freiburg Freiburg Germany Biointelect Sydney Australia

Purpose: Many health systems are considered ill-equipped to adequately meet future demand. Although academic entrepreneurs and small and medium-sized enterprises (SMEs) drive health technology innovation, they often suboptimally consider important market and stakeholder requirements. This can result in missed opportunities to improve health system performance, address demand-supply gaps, and achieve financial rewards. Market intelligence can provide crucial information in this regard, but scientifically sourced guidance on how to perform market research for biopharmaceutics is scarce. Our objective was, therefore, to create and provide an easily accessible biopharmaceutics market research toolbox that can be perused by academic entrepreneurs and SMEs to improve the alignment of their developments with stakeholder needs. Design: Guided by market orientation theory, we interviewed senior managers and commercialisation experts from the biopharmaceutics sector. We asked them which information they consider most relevant, and how they collect, analyse and respond to new information to align product features, positioning and stakeholder-relationship management with market needs. Findings: Our innovator toolbox consists of a high-level overview of market intelligence considerations mapped against a novel innovation framework, a stakeholder reasoning and value model, and detailed considerations (checklists) per stakeholder of biopharmaceutics interventions. Originality: We provide here the first market orientation-based overview of market intelligence considerations for the biopharmaceutics sector. Although primarily collated for academic entrepreneurs and SMEs, our innovator toolbox for the biopharmaceutics sector can help all stakeholders better understand their orientation towards markets.

关键词： healthcare Biopharmaceutic Market Orientation Market Research Unmet Need

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Comparison of open and closed hyperthermic intraperitoneal chemotherapy: Results from the United States hyperthermic intraperitoneal chemotherapy collaborative

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World Journal of Gastrointestinal Oncology 2020年第7期12卷 756-767页

作者： jennifer L Leiting Jordan M Cloyd Ahmed Ahmed Keith Fournier Andrew J Lee Sophie Dessureault Seth Felder Jula Veerapong Joel M Baumgartner Callisia Clarke harveshp Mogal Charles A Staley Mohammad Y Zaidi Sameer h Patel Syed A Ahmad Ryan J hendrix Laura Lambert Daniel E Abbott Courtney Pokrzywa Mustafa Raoof Christopher J LaRocca Fabian M Johnston Jonathan Greer Travis E Grotz Division of hepatobiliary and Pancreas Surgery Mayo ClinicRochesterMN 55901United States Division of Surgical Oncology Department of SurgeryThe Ohio State University Wexner Medical CenterColumbusOH 43210United States Department of Surgical Oncology University of Texas MD Anderson Cancer CenterHoustonTX 77030United States Department of Gastrointestinal Oncology Moffitt Cancer CenterDepartment of Oncologic SciencesMorsani College of MedicineTampaFL 33612United States Division of Surgical Oncology Department of SurgeryUniversity of CaliforniaSan DiegoCA 92093United States Division of Surgical Oncology Department of SurgeryMedical College of WisconsinMilwaukeeWI 53226United States Division of Surgical Oncology Winship Cancer InstituteEmory UniversityAtlantaGA 30322United States Department of Surgery University of Cincinnati College of MedicineCincinnatiOH 45267United States Division of Surgical Oncology Department of SurgeryUniversity of Massachusetts Medical SchoolWorcesterMA 01655United States Peritoneal Surface Malignancy Program Section of Surgical Oncology Huntsman Cancer InstituteUniversity of UtahSalt Lake CityUT 84112United States Division of Surgical Oncology Department of SurgeryUniversity of WisconsinMadisonWI 53792United States Christopher La Rocca Division of Surgical OncologyDepartment of SurgeryCity of Hope National Medical CenterDuarteCA 91010United States Department of Surgery Johns Hopkins UniversityBaltimoreMD 21287United States

BACKGROUND Cytoreductive surgery(CRS)with hyperthermic intraperitoneal chemotherapy(hIPEC)for peritoneal carcinomatosis can be performed in two ways:Open or closed abdominal *** To evaluate the impact of hIPEC method on post-operative and long-term survival *** Patients undergoing CRS with hIPEC from 2000-2017 were identified in the United States hIPEC collaborative ***-operative,recurrence,and overall survival outcomes were compared between those who received open vs closed *** Of the 1812 patients undergoing curative-intent CRS and hIPEC,372(21%)patients underwent open hIPEC and 1440(79%)underwent closed *** was no difference in re-operation or severe complications between the two *** hIPEC had higher rates of 90-d readmission while open hIPEC had a higher rate of 90-d *** multi-variable analysis,closed hIPEC technique was not a significant predictor for overall survival(hazards ratio:0.75,95%confidence interval:0.51-1.10,P=0.14)or recurrence-free survival(hazards ratio:1.39,95%confidence interval:1.00-1.93,P=0.05)in the entire *** findings remained consistent in the appendiceal and the colorectal *** In this multi-institutional analysis,the hIPEC method was not independently associated with relevant post-operative or long-term *** technique may be left to the discretion of the operating surgeon.

关键词： Mucinous appendiceal carcinoma Cytoreductive surgery Multi-institutional

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Nat Immunol:科学家阐明如何有效抑制自身免疫疾病的发生

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现代生物医学进展 2017年第8期17卷 I0002-I0003页

作者： Thomas h auml ggl #x000F6 f, Saikiran K Sedimbi Mikael C I Karlsson jennifer L Yates Elizabeth A Leadbetter Roham Parsa Robert A harris Briana hauff Salas Elizabeth A Leadbetter Department of Microbiology Tumor and Cell Biology Karolinska Institutet Solna Sweden. Trudeau Institute Saranac Lake New York USA. Department of Clinical Neuroscience Karolinska Institutet Centre for Molecular Medicine Karolinska University Hospital at Solna Solna Sweden. Department of Microbiology Immunology and Molecular Genetics University of Texas Health Science Center at San Antonio San Antonio Texas USA.

机体免疫系统中一种未知的安全机制能够保持机体免于自身免疫疾病，日前一项刊登于国际杂志Nature Immunology上的研究报告中，来自瑞典卡罗琳学院的研究人员通过研究发现。机体先天性免疫系统中的细胞能够阻止后天性的免疫系统对机体... 详细信息

机体免疫系统中一种未知的安全机制能够保持机体免于自身免疫疾病，日前一项刊登于国际杂志Nature Immunology上的研究报告中，来自瑞典卡罗琳学院的研究人员通过研究发现。机体先天性免疫系统中的细胞能够阻止后天性的免疫系统对机体固有的细胞产生反应，否则就会引发诸如系统性红斑狼疮等自身免疫疾病的发生。

关键词：自身免疫疾病机体免疫系统 Nat 科学家系统性红斑狼疮安全机制研究人员后天性

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Patient-Specific and Generic Immobilization Devices for Prostate Radiotherapy

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International Journal of Medical Physics, Clinical Engineering and Radiation Oncology 2013年第4期2卷 125-132页

作者： Adam D. Melancon Rajat J. Kudchadker Richard Amos jennifer L. Johnson Yongbin Zhang Zhiqian h. Yu Lifei Zhang Lei Dong Andrew K. Lee Departments of Radiation Oncology The University of Texas M. D. Anderson Cancer Center Houston USA Departments of Radiation Physics The University of Texas M. D. Anderson Cancer Center Houston USA Departments of Radiation Physics The University of Texas M. D. Anderson Cancer Center Houston USA Program in Medical Physics The University of Texas Graduate School of Biomedical Sciences at Houston Houston USA

The purpose of our study was to compare interfractional bony setup variations in pelvic anatomy with two immobilization devices, the patient-specific Vac-Lok and the generic Dual Leg Positioner system (both Civco Medical Solutions, Kalona, IA), for bilateral proton radiotherapy of the prostate. Two groups of 10 patients were studied. Computed tomography (CT) was performed three times a week, yielding 233 CT image sets for the vacuum system group and 252 for the other group. The translational shifts of the pelvic bone and prostate and rotation of the upper femurs of the femoral heads with respect to the simulation CT images were analyzed. Along the anterior-posterior and lateral axes, mean and systematic translational variations of the pelvic bone and prostate, relative to skin fiducials, were significantly lower in the Vac-Lok group (all p 0.01) than in the Dual Leg Positioner group. Abduction of the upper femur, the dominant rotation, had random rotational variations of 1.9° and 2.0° and systematic rotations of 3.1° and 2.9° for the vacuum and generic system groups, respectively. Femoral abduction was highly correlated with anterior prostate displacement for both femurs in both groups (p tion introduced during simulation CT, particularly with the generic immobilization system. high degrees of femoral rotation may introduce prostate translation and distal misalignment of lateral proton beams with the prostate.

关键词： Femoral head Interfractional Variation Pelvic Immobilization Proton Therapy Prostate Cancer

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Newborn screening for Duchenne muscular dystrophy in China: follow-up diagnosis and subsequent treatment

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World Journal of Pediatrics 2017年第3期13卷 197-201页

作者： Qing Ke Zheng-Yan Zhao Robert Griggs Veronica Wiley Anne Connolly jennifer Kwon Ming Qi Daniel Sheehan Emma Ciafaloni R Rodney howell Petra Furu Peter Sazani Arvind Narayana Michele Gatheridge Department of Neurology The First Affiliated HospitalZhejiang University School of MedicineHangzhouChina Department of Child health Care Children's HospitalZhejiang University School of MedicineHangzhouChina Department of Neurology University of Rochester School of Medicine and DentistryRochesterNew YorkUSA Department of Pediatrics University of Rochester School of Medicine and DentistryRochesterNew YorkUSA Disciplines of Genetic Medicine and Pediatric and Child health University of SydneyAustralia Departments of Neurology and Pediatrics Washington University School of MedicineSt.LouisMissouriUSA Center for Genetic&Genomic Medicine Zhejiang University School of Medicine and James Watson Institute of Genome SciencesHangzhouChina Department of Pediatrics University of BuffaloBuffaloNew YorkUSA University of Miami MiamiFloridaUSA Neonatal Screening PerkinElmerTurkuFinland Field Medical Affairs Marathon PharmaceuticalsNorthbrookIllinoisUSA Medical Affairs Sarepta TherapeuticsCambridgeMassachusettsUSA

Background:Newborn screening for Duchenne muscular dystrophy (DMD) is currently being initiated in Zhejiang Province,China and is under consideration in other countries,including the United *** China begins to implement DMD newborn screening (DMD-NBS),there is ongoing discussion regarding the steps forward for follow up care of positively identified patients as well as false positive and false negative *** sources:Relevant papers related to DMD-NBS,and NBS in China were reviewed in ***:The current state of DMD-NBS is discussed,along with the steps needed to effectively screen infants for this disease in China,recommendations for establishment of follow up care in patients with positive and negative screens,and measurement of patient ***:Zhejiang Province,China is ready to implement *** challenges that exist for this program,and other countries,include the ability to track patients,assist with access to care,and ensure adequate follow-up care according to evidence-based *** addition,China's large rural population,lack of specialty providers,and difficulty in educating patients regarding the benefits of treatment create challenges that will need to be addressed.

关键词： Duchene muscular dystrophy neurology neuromuscular disorders newborn screening

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Levels and trends of current-use pesticides(CUPs)in the arctic:An updated review,2010-2018

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Emerging Contaminants 2019年第1期5卷 70-88页

作者： jennifer E.Balmer Adam D.Morris hayley hung Liisa Jantunen Katrin Vorkamp Frank Riget Marlene Evans Magali houde Derek C.G.Muir Arctic Monitoring and Assessment Programme Fram CentrePO Box 6606Langnes9296TromsøNorway Department of Biology The Citadel171 Moultrie StreetCharlestonSCUSA Environment and Climate Change Canada National Wildlife Research CenterOttawaCanada Air Quality Processes Research Section Environment and Climate Change CanadaTorontoOntarioCanada Air Quality Processes Research Section Environment and Climate Change CanadaEgbertOntarioCanada Aarhus University Department of Environmental ScienceArctic Research CentreRoskildeDenmark Aarhus University Department of BioscienceRoskildeDenmark Aquatic Ecosystem Protection Research Division Environment Canada11 Innovation BlvdSaskatoonSKS7N 3H5Canada Environment and Climate Change Canada St.Lawrence CenterMontrealQuebecCanada Environment and Climate Change Canada Canada Centre for Inland WatersBurlingtonOntarioCanada

Global regulations and many regional and national controls restrict the use of substances that exhibit the potential for environmental persistence and long-range ***,many current-use pesticides(CUPs)continue to be newly discovered in remote regions,including the *** present review serves as an update,summarizing newly available information for CUPs in the Arctic environment and biota published from 2010 to *** 2010,at least seven new CUPs have been measured in Arctic media:2-methyl-4-chlorophenoxyacetic acid(MCPA),metribuzin,pendimethalin,phosalone,quizalofop-ethyl,tefluthrin and *** the large number of pesticides in current use,the number measured in the Arctic is very limited,however,modelling studies have identified additional CUPs as potential Arctic contaminants that have yet to be investigated in the *** to their recent detection,reports of CUPs in the Arctic are limited,but *** have been reported in a wide range of abiotic Arctic matrices,including air,snow,ice,freshwater and seawater,indicating their capacity for long-range atmospheric transport,however,concentrations are generally low in comparison to legacy pesticides and other persistent organic pollutants(POPs).Recent food-web studies indicate CUPs can enter Arctic terrestrial and marine food chains,however,in contrast to POPs,the highest concentrations of many CUPs were found in lower trophic-level organisms,and the lowest concentrations detected in animals at the highest trophic levels(i.e,ringed seals,polar bear,caribou,and wolves)indicating significant trophic *** detection of CUPs in the remote Arctic ecosystem reinforces the need for continued monitoring of both known and potential Arctic pollutants to prevent impacts on human and environmental health as the global arsenal of pesticides used in agriculture continuously changes.

关键词： POPs Contaminants Air Biota Long-range transport Persistence

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habitual sedentary time and stationary time are inversely related to aerobic fitness

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Sports Medicine and health Science 2022年第4期4卷 260-266页

作者： Myles W.O'Brien Madeline E.Shivgulam jennifer L.Petterson Yanlin Wua Ryan J.Frayne Said Mekari Derek S.Kimmerly Division of Kinesiology School of Health and Human PerformanceFaculty of HealthDalhousie UniversityHalifaxNova ScotiaCanada Department of Family Medicine Universitéde SherbrookeSherbrookeQuebecCanada

A one metabolic-equivalent-of-task increase in peak aerobic fitness(peak MET)is associated with a clinically relevant improvement in survival risk and all-cause *** co-dependent impact of free-living physical behaviours on aerobic fitness are poorly *** purpose of this study was to investigate the impact of theoretically re-allocating time spent in physical behaviours on aerobic *** hypothesized that substituting sedentary time with any physical activity(at any intensity)would be associated with a predicted improvement in aerobic *** volume rate of oxygen uptake(VO_(2)peak)was assessed via indirect calorimetry during a progressive,maximal cycle ergometer protocol in 103 adults(52 females;[38±21]years;[25.0±3.8]kg/m^(2);VO_(2)peak:[35.4±11.5]ml⋅kg^(-1)⋅min^(-1)).habitual sedentary time,standing time,light-(LPA),moderate-(MPA),and vigorous-physical activity(VPA)were assessed 24-h/day via thigh-worn inclinometry for up to one week(average:[6.3±0.9]days).Isotemporal substitution modelling examined the impact of replacing one physical behaviour with *** time(β=0.8,95%CI:[-1.3,-0.2])and standing time(β=0.9,95%CI:[-1.6,-0.2])were negatively associated with VO_(2)peak,whereas VPA was positively associated with relative VO_(2)peak(β=9.2,95%CI:[0.9,17.6]).Substituting 30-min/day of VPA with any other behaviour was associated with a 2.4–3.4 higher peak *** standing time was associated with a lower aerobic *** little as 10-min/day of VPA predicted a clinically relevant 0.8–1.1 peak MET ***,replacing any time with relatively small amounts of VPA is associated with improvements in aerobic fitness.

关键词： Physical activity intensity Cardiorespiratory fitness Objective activity monitoring Sedentary activity Isotemporal substitution modelling

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Sulforaphane Protects Astrocytes Against Oxidative Stress and Delayed Death Caused by Oxygen and Glucose Deprivation

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神经损伤与功能重建 2009年第2期4卷 114-124,135页

作者： CAMELIA A.DANILOV KRISh ChANDRASEKARAN jennifer RACZ LUCIAN SOANE CAROL ZIELKE AND GARY FISKUM Department of Anesthesiology University of Maryland School of Medicine Program in Neuroscience University of Maryland School of Medicine Department of Pediatrics University of Maryland School of Medicine rauma and Anesthesiology Research Center University of Maryland School of Medicine

氧化应激是缺血再灌注后星形胶质细胞损伤和死亡的重要分子机制之一,可能成为有效的干预靶点。下述治疗策略可减轻缺血再灌注条件下产生的多种反应性氮氧化合物损伤。这种方法可通过使用化学试剂或适当条件促进转录活化因子NRF2从细胞... 详细信息

氧化应激是缺血再灌注后星形胶质细胞损伤和死亡的重要分子机制之一,可能成为有效的干预靶点。下述治疗策略可减轻缺血再灌注条件下产生的多种反应性氮氧化合物损伤。这种方法可通过使用化学试剂或适当条件促进转录活化因子NRF2从细胞浆转入细胞核,并与抗氧化基因反应位点结合,来诱导缺血再灌注后损伤细胞的Ⅱ期基因反应。本研究将验证如下假说:NRF2基因表达通路激活剂sulforaphane能对体外无氧无糖环境处理的培养皮质星形胶质细胞起神经保护作用。将皮质星形胶质细胞暴露于无氧无糖环境(OGD)4 h,于干预前48 h或干预后给予5μMsulforaphane(NRF2基因表达通路激活剂)培养48 h,两种培育条件下细胞死亡均明显减少。免疫细胞化学结果表明干预前给予sulforaphane处理,细胞中DNA/RNA氧化标志物8-hydroxy-2-deox-yguanosine的表达在恢复给氧4 h后降低,两种培育条件下胞浆内及胞核内NRF2的免疫反应均增强且NQO1(NRF2转录活化基因产物)的表达和酶活性均增强。本研究提示sulforaphane可通过激活NRF2抗氧化基因表达通路,减少体外缺氧再灌注后星形胶质细胞的死亡。

关键词：缺氧再灌注 NRF2 NQ01 氧化应激 8-hydroxy 2 deoxyguanosine

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Collapsibility of the human Upper Airway: Influence of State,Posture and Instrumentation

Collapsibility of the Human Upper Airway: Influence of State...

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中国睡眠研究会第十届全国学术年会

作者： Kathleen J Maddison jennifer h Walsh Kelly L Shepherd Chrianna Bharat Bradley K Lawther Peter R Platt Peter R Eastwood David R hillman Centre for Sleep Science School of Human SciencesThe University of Western Australia West Australian Sleep Disorders Research Institute Department of Pulmonary Physiology & Sleep MedicineSir Charles Gairdner Hospital Centre for Applied Statistics The University of Western Australia Department of Research Sir Charles Gairdner Hospital Department of Anaesthesia Sir Charles Gairdner Hospital

＜正＞Background. Pharyngeal critical pressure（Pcrit） is a measure of upper airway（UA） collapsibility. Inspiratory flow-limitation is typically identified using oesophageal pressure（Pes） requiring a catheter, th...

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Sialendoscopy for sialodocholithiasis following submandibular gland excision:six variations on a theme

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World Journal of Otorhinolaryngology-head and Neck Surgery 2021年第4期7卷 291-295页

作者： jennifer E.Douglas W.Walsh Thomas Christopher Z.Wen Laurie A.Loevner Erica R.Thaler Ara A.Chalian Christopher h.Rassekh Department of Otorhinolaryngologyehead&Neck Surgery University of Pennsylvania Health System5th Floor Silverstein Building3400 Spruce StreetPhiladelphiaPA19104USA BaptisthealthMD Anderson CancerCenter BaptistHealth1301 Palm AvenueJacksonvilleFL32207USA Perelman School of Medicine at the University of Pennsylvania 3400 Civic Center BoulevardPhiladelphiaPA19104USA Department of Radiology Division of NeuroradiologyUniversity of Pennsylvania Health System3400 Spruce StreetGround Floor Founders PavilionPhiladelphiaPA19104USA

Sialendoscopy is a minimally invasive technique that facilitates the diagnosis and treatment of *** case series presents the novel use of sialendoscopy to treat sialodocholithiasis in six patients with a non-functional or surgically absent submandibular gland by a single surgeon at the University of Pennsylvania health System between March 2013 and December *** four female and two male patients had a median age of 56 years and mean follow-up of 16.2 months(range 1-44.5).All stones were successfully removed using sialendoscopy,and in 5 patients a combined approach was *** patients remain asymptomatic at last clinical *** conclude that sialendoscopy is a viable,minimally invasive method for managing sialodocholithiasis in patients with prior submandibular gland excision or atretic *** is also useful as an assistive tool when approaching complex transcervical or transoral procedures in previously instrumented patients.

关键词： Sialendoscopy Sialodocholithiasis Sialolithiasis Salivary gland disease Recurrent or retained sialolith

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