Результаты поиска

European Recommendations for Transitioning the Care of Patients With Multiple Myeloma Treated With B-Cell Maturation Antigen Bispecific Antibodies From Academic Hospitals to Community-Based Centers and for Outpatient Step-Up Dosing.

INTRODUCTION: Safe outpatient delivery of B-cell maturation antigen-targeting bispecific antibodies (BCMA-BsAbs) in multiple myeloma (MM) is challenging, particularly during step-up dosing (SUD). Standardized guidance for European community practice is limited. METHODS: A modified Delphi methodology panel sought expert consensus on safe, effective outpatient SUD and transition of care from academic to community centers for patients receiving BCMA-BsAbs. A steering committee of 10 European specialists in MM and BCMA-BsAb delivery generated statements based on literature review and clinical exp

Совпадение в полном тексте источника
… In June 2025, a targeted review of published and publicly available data on transitions of care from academia to community settings for patients with MM treated with BCMA‐BsAbs and on outpatient SUD of BsAb therapy was conducted using PubMed and Google. …

The value-for-money assessment and funding arrangements for high-priced drugs in an era of uncertainty: a comparative analysis of national health technology assessment agencies in South Korea, England, Australia, and Canada.

BackgroundInnovative health technologies have increasingly emerged as a promising solution for patients with untreatable or challenging conditions. However, these technologies often come with expensive costs and limited evidence at the time of launch. This study assessed how these high-priced drugs with limited evidence were appraised and introduced in South Korea, England, Australia, and Canada, where cost-effectiveness analysis (CEA) generally plays a central role in pricing and reimbursement decisions.MethodsThe study analysed 22 high-priced drugs (24 indications) introduced in South Korea,

Совпадение в полном тексте источника
… Seoul: Seoul National University Industry-Academia Cooperation Foundation & National Health Insurance Service; 2022. 29. Efthymiadou O. Health technology assessment criteria as drivers of coverage with managed entry agreements: a case study of cancer medicines in four countries. …

Improving access to chimeric antigen receptor T-cells for refractory or relapsing diffuse large B cell lymphoma therapy in Asia.

Chimeric antigen receptor T-cell (CAR-T)-mediated therapies have shown promising clinical benefit in patients with refractory or relapsing (R/R) diffuse large B-cell lymphoma (DLBCL). However, CAR-T treatment presents challenges such as lack of drug accessibility, financial barriers, variable physician preference or experience, and risk assessment based on patient-specific characteristics. This article thus aims to provide an overview of the CAR-T landscape for R/R DLBCL in Asia, with a focus on identifying barriers to access, from the perspective of Asian and international lymphoma experts. P

Совпадение в полном тексте источника
… This legislation has facilitated access to innovative therapies in Europe [ 67 ], thereby highlighting the opportunities made possible by partnership between academia and the industry, which Asia could seek to adapt. …

Business Risk Mitigation in the Development Process of New Monoclonal Antibody Drug Conjugates for Cancer Treatment.

Recent developments aim to extend the cytotoxic effect and therapeutic window of mAbs by constructing antibody-drug conjugates (ADCs), in which the targeting moiety is the mAb that is linked to a highly toxic drug. According to a report from mid of last year, the global ADCs market accounted for USD 1387 million in 2016 and was worth USD 7.82 billion in 2022. It is estimated to increase in value to USD 13.15 billion by 2030. One of the critical points is the linkage of any substituent to the functional group of the mAb. Increasing the efficacy against cancer cells' highly cytotoxic molecules (

Совпадение в полном тексте источника
… Specialized multidisciplinary expertise is required, with a group of mixed academia and regulatory experts pooling their knowledge of quality, safety, and kinetics to support evaluation and formulate guidelines [ 83 ]. …

Translational Bioinformatics Applied to the Study of Complex Diseases.

Translational Bioinformatics (TBI) is defined as the union of translational medicine and bioinformatics. It emerges as a major advance in science and technology by covering everything, from the most basic database discoveries, to the development of algorithms for molecular and cellular analysis, as well as their clinical applications. This technology makes it possible to access the knowledge of scientific evidence and apply it to clinical practice. This manuscript aims to highlight the role of TBI in the study of complex diseases, as well as its application to the understanding and treatment o

Совпадение в полном тексте источника
… Given the information presented, it appears that a joint effort is needed to increase the dissemination of knowledge about TBI from academia to society, highlighting the great benefit and impact of this area on the study, understanding, and elucidation of mechanisms for the treatment of complex diseases …

Balancing Quality, Cost, and Access During Delivery of Newer Cellular and Immunotherapy Treatments.

Purpose of reviewThe chimeric antigen receptor (CAR) T-cell therapy is currently changing the landscape of hematologic malignancies with multiple FDA-approved cell therapy products in the USA. The current administration process of the CAR T-cell therapy is complicated, labor-intensive, and expensive.Recent findingsThe chimeric antigen receptor (CAR) T-cell therapy is currently changing the landscape of hematologic malignancies with multiple FDA-approved cell therapy products in the USA. The current administration process of the CAR T-cell therapy is complicated, labor-intensive, and expensive.

Совпадение в полном тексте источника
… To achieve the commercialization of CAR T cell therapy utilizing the decentralization process, we will need significant regulatory changes and active collaboration between academia and pharmaceutical companies. …

Advancing gene editing therapeutics: Clinical trials and innovative delivery systems across diverse diseases.

Gene editing is a groundbreaking therapeutic approach that can potentially treat a broad spectrum of genetic and acquired diseases. This review highlights recent clinical trials employing advanced gene editing technologies such as CRISPR-Cas9, zinc-finger nucleases (ZFNs), and base editors across multiple disease areas including metabolic disorders, autoimmune diseases, muscular dystrophies, and inherited eye disorders. Central to the success of these therapies is the development of efficient and safe delivery systems, including lipid nanoparticles (LNPs), viral vectors (adenoviral and lentivi

Совпадение в полном тексте источника
… Achieving these advancements will require sustained investment in fundamental research; refinement of gene editing tools; collaborative efforts between academia, industry, and regulatory agencies; and a commitment to long-term clinical validation. … Collaborative efforts between academia, industry, regulatory bodies, and patient communities will be essential to overcome existing barriers. …

Abstracts 12th PCNE working conference 'Partnering for better patient outcomes: challenges and opportunities 3-6 February 2021, University of Basel, Switzerland (was held online).

Аннотация не предоставлена источником. Откройте карточку для перехода к публикации.

Совпадение в полном тексте источника
… Academia and organizations involved in continuous education (CE) and professional development of community pharmacists are therefore looking for more effective strategies. Mystery visits, followed by personalized feedback to pharmacy staff, might be a potential strategy. …

Mining the FAERS database reveals new safety signals for 120 mg denosumab in oncology practice.

OBJECTIVE: To detect and quantify adverse drug event (ADE) signals linked to 120 mg denosumab in the real world. METHODS: We queried the US Food and Drug Administration Adverse Event Reporting System (FAERS) for reports on 120 mg denosumab, standardized, and categorized these events with Preferred Terms (PT) and System Organ Classes (SOC) from MedDRA version 27.1. Disproportionality analysis was performed using the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN). RESULTS: We identified 10,963 ADE reports for 120 mg of denosumab. Among 10 963 reports, 41.

Совпадение в полном тексте источника
… By standardizing medical concepts across regulators, industry, and academia, the MedDRA ensures consistent signal detection, safety profiling, and communication of medicine-related risks worldwide. Fig 1 Flowchart depicting the selection of the study population. 2.3. …

Политика и перспективы в отношении амбулаторных программ для аутологической трансплантации клеток и лечения иммуноэффективных клеток.

Высокодозированная химиотерапия с автоматической трансплантацией гематопоиетических клеток (AutoHCT) давно является комплексной формой лечения множественной миеломы и неходгкинской лимфомы. В прошлом 25 Многие учреждения сместили эту практику с госпитализации на one , которые могут быть выполнены в амбулаторном порядке, что приведет к экономии средств и повышению качества жизни пациентов. Недавно появившиеся методы лечения иммуноэффективных клеток (ИЭК) и расширение их масштабов приводят к изменению ландшафта лечения гематологовых и негематологических магнатов. Однако нынешние финансовые модел

Совпадение в полном тексте источника
… Policy options and implications Guidelines and policies from academia Autologous HCT for multiple myeloma and non-hodgkin lymphoma Numerous institutions have published on the feasibility and success of outpatient autologous HCT for MM and NHL. …

Patients' perspectives on the derivation and use of organoids.

Organoid research is enhancing understanding of human development and diseases as well as aiding in medication development and selection, raising hopes for even more future therapeutic options. Nevertheless, this work raises important ethical issues and there is a paucity of data regarding patients' perspectives on them. We report on 60 interviews with adult patients or parents of pediatric patients from diverse disease populations who receive medical care at a major academic research institution in the United States. Interviewees expressed broad support for organoid development and use. Howev

Совпадение в полном тексте источника
… Interviewee: When it comes to the academics and someone like NIH that’s government, but they’re still tied in with a lot of academia, I would probably feel more comfortable with them, knowing usually what the purpose is or usually is: to help. …

Developing a patient portal for haematology patients requires involvement of all stakeholders and a customised design, tailored to the individual needs.

BackgroundElectronic patient portals are increasingly being implemented, also in (haemato) oncology. However, portal usage is low and depends on user and provider engagement. We explored wishes, expectations and thoughts of patients with a haematologic malignancy and their physicians with regard to the electronic patient portal.MethodsBased on insights from literature and a focus group discussion we built a 44-item questionnaire. This questionnaire was spread amongst patients with a haematologic malignancy at the outpatient clinic that was not yet exposed to patient portal facilities. Haematol

Совпадение в полном тексте источника
… Recommendations for academia Future research should confirm whether the above mentioned recommendations increase patient related outcome measures like patient satisfaction, quality of life, portal usage and empowerment, or health care associated outcomes like therapy adherence. …

Sorcin: a novel potential target in therapies of cancers.

Soluble resistance-related calcium-binding protein (sorcin) is a member of the penta-EF-hand protein family. Sorcin is widely distributed in normal human tissues, such as the brain, heart, lymphocytes, kidneys, breast and skin. Findings suggest that sorcin is associated with the regulation of calcium homeostasis, cell cycle and vesicle trafficking. It has been reported that many types of non-neoplastic diseases such as diabetes, viral infection, infertility, and nervous system diseases were affected by the expression of sorcin. One of the main issues is the role of sorcin in neoplastic disease

Совпадение в полном тексте источника
… Acta Academiae Medicinae Sinicae . 2002;(02):134–139. 82. Xing CL, Li GY, Wang J, et al. Effect of cyclosporin A on sorcin gene expression and clinical effect in multiple myeloma patients. Shandong Med J . 2007;(11):10–11. 83. Sun Y, Liu W, Wang C, et al. …

The complex price setting and reimbursement of non-industrial advanced therapy medicinal products.

BACKGROUND: Advanced Therapy Medicinal Products (ATMPs) developed under the Hospital Exemption (HE) offer innovative treatments for patients with unmet medical needs, but their pricing and reimbursement (P&R) remain fragmented and poorly understood. This paper examines the P&R landscape for HE-ATMPs developed by academic developers in Spain, based on the Spanish costing guideline and extends the analysis to HE-ATMPs developed by academic and non-profit developers across Europe. METHODS: We conducted a mixed-method, exploratory study combining literature review with interviews and email enquiri

Совпадение в полном тексте источника
… However, academia dominates early-stage development of ATMPs [ 5 ], and about 25% of currently approved industrial ATMPs originate from research performed in specialized academic facilities [ 6 ]. …

Development of Web-Based Education Modules to Improve Carer Engagement in Cancer Care: Design and User Experience Evaluation of the e-Triadic Oncology (eTRIO) Modules for Clinicians, Patients, and Carers.

BackgroundCarers often assume key roles in cancer care. However, many carers report feeling disempowered and ill-equipped to support patients. Our group published evidence-based guidelines (the Triadic Oncology [TRIO] Guidelines) to improve oncology clinician engagement with carers and the management of challenging situations involving carers.ObjectiveTo facilitate implementation of the TRIO Guidelines in clinical practice, we aimed to develop, iteratively refine, and conduct user testing of a suite of evidence-based and interactive web-based education modules for oncology clinicians (e-Triadi

Совпадение в полном тексте источника
… v20i8e257 30154074 PMC6134228 60 Teles S Ferreira A Paúl C Attitudes and preferences of digitally skilled dementia caregivers towards online psychoeducation: a cross-sectional study Behav Inf Technol 2022 01 09 42 4 345 59 10.1080/0144929x.2021.2021285 61 Chang V Review and discussion: E-learning for academia …

Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries.

BackgroundNational payers across Europe have been increasingly looking into innovative reimbursement approaches - called managed entry agreements (MEAs) - to balance the need to provide rapid access to potentially beneficial orphan medicinal products (OMPs) with the requirements to circumscribe uncertainty, obtain best value for money or to ensure affordability. This study aimed to identify, describe and classify MEAs applied to OMPs by national payers and to analyse their practice in Europe.MethodsTo identify and describe MEAs, national health technology assessments and reimbursement decision

Совпадение в полном тексте источника
… This study therefore specifically reflects the views from academia and payers. Lastly, this analysis focused on MEAs applied to orphan medicinal products: it does not compare trends in MEAs between orphan- and non-orphan medicinal products. …

Direct muscular neurotization as a method of treatment of irreparable nerve injuries.

Authors have presented of 12 patients with irreparable nerve injuries treated by direct motor nerve implantation into muscle belly (direct muscular neurotization). Results were evaluated in Sunderland scale. Motor function of the neurotized muscles following 12 months from operation was in range of between M3 and M4.

Short-form quality care questionnaire-palliative care has acceptable measurement properties in Brazilian cancer patients.

BackgroundOur objective was to perform the translation, cross-cultural adaptation, and validation of the Quality Care Questionnaire-Palliative Care (QCQ-PC) into Brazilian Portuguese for cancer patients in palliative care. The translation and cross-cultural adaptation comprised the following stages: translation, synthesis of translations, back-translation, analysis by a committee of experts, testing of the pre-final version, and definition of the final version. The evaluated measurement properties were: structural validity using factor analysis, test-retest reliability using the intraclass cor

Совпадение в полном тексте источника
… ANCP - Academia Nacional de Cuidados Paliativos . Manual de Cuidados Paliativos ANCP Ampliado e atualizado. 2. São Paulo: ANCP; 2012. pp. 1–592. 3. Nunes NAH. …

[Histopathological evaluation of protective effect of L-cysteine in ethanol-induced liver damage in rats].

Rats fed standard diet were intoxicated during 4 weeks with ethanol at the dose of 0.6 g/100 g of the body weight. This poisoning causes vacuolar degeneration, disappearance of glycogen granules, steatosis of hepatocytes and focal necrosis changes in the liver. The intake of food with cysteine at the dose of 0.012 and 0.024 g/100 g/24 hrs markedly prevents histopathological changes in the liver of rats intoxicated with ethanol. Larger amounts of cysteine (0.044 g/100 g/24 hrs) intensify histopathological changes caused by ethanol in the liver of rats.

[Regressive changes in the placenta in early pregnancy in women with primary arterial hypertension].

Morphological methods, in particular histochemical technique of secondary fluorescence according to Bertalanffy were used for the assessment of regressive changes of placenta. In women with primary arterial hypertension during early pregnancy fibrinoid masses in decidua, chorion, anchoring willi, villous plate, basal plate, villous trunks and terminal villi appear. These changes are followed from one side, by an atrophy of the blood vessels and connective tissue cells, and from the other, there increases the number of decidua giant cells, as well as of syncytium and cytotrophoblast. The areas