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Glioma drug development benefits from emerging phase 0 and window-of-opportunity trial paradigm.

Clinical drug development is fundamentally difficult for rare and difficult-to-treat solid tumors, for example, glioma. Glioblastoma (GBM), an invariably fatal primary brain tumor, poses a significant challenge in the realm of effective treatments, necessitating an accelerated approach to innovative drug discovery. Investigators keep requiring a process toward obtaining more reliable early-stage signals related to drug activity and a process toward translating those signals into clinical benefits efficiently in late-stage drug development. Besides, these processes could increase the likelihood

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… Furthermore, certification of molecular analyses and quality control, along with a centralized review of imaging and standard treatment procedures, is indispensable. Functional imaging measurements heavily rely on imaging standardization levels. …

The Evolving Landscape in Multiple Myeloma: From Risk Stratification to T Cell-Directed Advanced Therapies.

Multiple myeloma is biologically and clinically a complex and heterogeneous disease which develops late in life, with the median age at the time of initial diagnosis being 66 years. In 1975, Durie and Salmon developed the first broadly adopted staging system in multiple myeloma, and in the ensuing decades, the risk stratification tools have improved and now incorporate different parameters to better predict the prognosis and to guide the treatment decisions. The International Staging System (ISS) was initially developed in 2005, revised in 2015 (R-ISS), and again in 2022 (R2-ISS). Tremendous p

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… The manufacturing and administration of CAR T cell therapy is a complex process, requiring specialized centers with extensive certification, training, resources, and infrastructure, along with close coordination among healthcare providers across institutions to ensure the process is carried out as smoothly …

Shilajit mitigates chemotherapeutic drug-induced testicular toxicity: Study on testicular germ cell dynamics, steroidogenesis modulation, and Nrf-2/Keap-1 signaling.

BACKGROUND: Medications, including chemotherapeutic drugs, contribute to male infertility as external factors by inducing oxidative stress in testicular cells. Shilajit is a naturally occurring bioactive antioxidant used in Ayurvedic medicine to treat a variety of ailments. OBJECTIVE: This study examines the potential of Shilajit to counteract the negative effects of the chemotherapeutic drug cyclophosphamide (CPA) on testicular germ cell dynamics. MATERIAL AND METHODS: Male Parkes mice received single intraperitoneal CPA injection (200 mg/kg BW) on day one, followed by daily supplementation

Abstracts From JADPRO Live at APSHO 2015.

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… The Quality Oncology Practice Initiative (QOPI) sets standards for certification of oncology practices based upon key outcome measures. One area of focus is improving continuity of care and adherence for patients prescribed oral agents. …

Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.

The paradigm of pediatric drug development has been evolving in a "carrot-and-stick"-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evaluation of treatments. Therefore, the United States and the European Pediatric Formulation Initiative have recommended applying nanotechnology-based delivery systems to tackle some of these challenges, particularly applying inorganic, polymeric, and lipid-based nanoparticles. Connected with these, adv

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… Some important EU GMP guidelines could also be of interest for ATMPs manufacturing, such as Annex 2 of the “Manufacture of biological active substances and medicinal products for human use”, Annex 13 of the “Manufacture of investigational medicinal products”, and Annex 16 of the “Certification by a qualified … Micro-, small- and medium-sized companies can also submit requests for certification to the CAT under the Article 18 of Regulation (EC) No 1394/2007, corresponding to the ATMPs regulation. …

Changes in physical fitness in acute leukemia patients during chemotherapy.

This study aimed to investigate the changes in physical fitness and patient-reported outcomes as well as the correlation between these two factors in adult patients with newly diagnosed acute leukemia during chemotherapy. This was a longitudinal observational study. Patients were recruited from a tertiary hospital in China with a follow-up period of less than 90 days. Physical fitness was assessed using body mass index (BMI), mean skinfold thickness, waist-to-hip ratio, spirometry, mean grip strength, and flexibility at T1 (before chemotherapy), T2 (7-14 days after initial chemotherapy), and T

Teams, Tools, Processes and Resources to Manage Oncologic Clinical Decision Support: Lessons Learned from City of Hope's Multistate, Academic, and Community Oncology Enterprise.

Background/Objectives: Clinical decision support systems (CDSSs) consisting of Computerized Physician Order Entry (CPOE) and oncology pathways serve as the foundation of high-quality cancer care. However, the resources needed to develop and maintain these systems have not been characterized for oncology enterprises. Methods: Executive leadership appointed a medical director and clinical pharmacist to develop and lead a Pathways and Protocols Program for the City of Hope (COH) enterprise. This involved developing a program charter and governance committee and a business case for resources to su

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… Oncology pharmacists are the most experienced in the many nuances and details needed to build a complete oncology order protocol, but few have Epic Beacon builder certification. …

Regorafenib Attenuates Osteoclasts Differentiation by Inhibiting the NF-κB, NFAT, ERK, and p38 Signaling Pathways.

Osteolytic diseases such as osteoporosis and neoplastic bone metastases are caused by the excessive activation of osteoclasts. Inhibiting the excessive activation of osteoclasts is a crucial strategy for treating osteolytic diseases. This study investigated the roles and mechanisms of regorafenib, a tyrosine kinase inhibitor, on osteoclasts and osteolytic diseases. We first identified the potential targets and mechanisms of regorafenib on osteoclast-related osteolytic diseases using network pharmacological analysis and molecular docking techniques. Then, we verified its role and mechanism on o

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… All animals were procured from Zhuhai Baishitong Biotechnology Company, with the certification number SCXK2020-0051. …

One Giant Step for Giant Cell Arteritis: Updates in Diagnosis and Treatment.

Purpose of reviewGiant cell arteritis (GCA), a medium and large vessel vasculitis occurring in the aged, remains a formidable disease, capable of taking both vision and life, through a multitude of vascular complications. Our understanding of the spectrum of its manifestations has grown over the years, to include limb claudication, aortitis, and cardiac disease, in addition to the more classic visual complications resulting from of ischemia to branches of the external and internal carotid arteries. While a clinical presentation of headache, jaw claudication, scalp tenderness, fever and other s

Barriers to Treg therapy in Europe: From production to regulation.

There has been an increased interest in cell based therapies for a range of medical conditions in the last decade. This explosion in novel therapeutics research has led to the development of legislation specifically focused on cell and gene based therapies. In Europe, the European medicines agency (EMA) designates any medicines for human use which are based on genes, tissues, or cells as advanced therapy medicinal products or advanced therapy medicinal products (ATMPs). In this article we discuss the hurdles to widespread adoption of ATMPs in Europe, with a focus on regulatory T cells (Tregs).

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… The benefits of these magnetic sorting systems is that they are closed systems, and the reagents and protocols are all CE validated which facilitates their GMP certification. …

Beyond SINS: A Critical Review of Biomechanical, Microstructural, and Radiomic Biomarkers for Predicting Fracture Risk in Spinal Metastases

Background/Objectives: Although the Spinal Instability Neoplastic Score (SINS) is widely used to estimate spinal metastases fracture risk and guide decisions on stabilisation procedures, prior studies have demonstrated mixed results. Patients with the same score exhibit clinically heterogeneous outcomes, with some SINS criteria correlating less well with the estimated fracture risk than others. There are also barriers to implementation such as the time burden required for manual calculation and interobserver variability associated with qualitative morphological criteria. SINS also lacks sensit

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… A measurable deliverable in this domain involves the development and regulatory certification of fully automated segmentation pipelines. …

Blood transfusion in haematology: A qualitative exploration of patients' and healthcare professionals' perceptions.

ObjectivesRepeated blood transfusions are indicated for the management of patients with cancer or blood disorders. Patients' perceptions about transfusions may be associated with decision-making and coping, which has been under-explored in the haematology context. This study therefore aimed to explore haematology transfusion patients' and HCPs' perceptions of blood transfusion, drawing on theory and previously identified themes of transfusion perceptions.DesignSemi-structured interview study with 14 adult blood transfusion patients and 14 HCPs (consultants, registrars, nurses) at two UK haemat

UEG Week 2017 Oral Presentations

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Global Panoramic analysis of clinical research in cell therapy: clinical trial landscape, marketed products, and regulatory trends.

IntroductionCell therapy is a vital field in modern medicine. This review assesses its global clinical development landscape, approved products, and regional regulatory characteristics.MethodsA comprehensive search and analysis of global clinical trial databases (e.g., https://clinicaltrials.gov/ClinicalTrials.gov), regulatory agency announcements, and relevant literature up to October 2025 was conducted. Key data points regarding trial numbers, phases, therapy types, and approved products were extracted and analyzed descriptively by region.ResultsA cumulative total of 10,373 cell therapy clin

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… Regarding approval mechanisms, support measures such as the Priority Medicines (PRIME) scheme and certification procedures are available to accelerate medicine assessment and reduce the development burden. …

:: 8th Европейский конгресс фармацевтики: выдержки из выступлений

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A Standardized Method for Vertical Sleeve Gastrectomy Bariatric Surgery Investigations in Cancer.

Obesity is a global epidemic that has affected the lives of over 14% of adults worldwide and over a third of Americans. Obesity is associated with the increased risk of thirteen obesity-associated cancers and poor cancer outcomes. Bariatric surgery is the most effective method of sustained weight loss and has been steadily increasing in clinical use over the past 4 decades. Importantly, bariatric surgery is established to decrease cancer risk. Vertical sleeve gastrectomy (VSG) is currently the most common bariatric surgery procedure. To evaluate underlying mechanisms of bariatric associated ca

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… Regarding acute surgery-associated issues, we ensure that all surgeons are well trained with extra time spent learning specific techniques from the veterinary staff, including certification in aseptic technique and a workshop on sutures. …

Cancer in the Oldest-Old Population in the MENA Region: Epidemiology and Temporal Trends Based on GBD 2021.

IntroductionCancer among the oldest-old (aged ≥85) is an escalating public health concern, particularly in the Middle East and North Africa (MENA), where demographic aging is advancing rapidly.MethodsWe analyzed cancer incidence and mortality trends among the oldest-old in MENA from 1990 to 2021 using Global Burden of Disease (GBD) 2021 data, and compared these trends to global patterns.ResultsCancer incidence and mortality among the oldest-old in MENA increased substantially, surpassing global trends. Between 1990 and 2021, incidence rose by 54.2% in MENA vs 25.3% globally, while mortality in

Abstracts

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The Art of Bioimmunogenomics (BIGs) 5.0 in CAR-T Cell Therapy for Lymphoma Management.

PurposeLymphoma, the most predominant neoplastic disorder, is divided into Hodgkin and Non-Hodgkin Lymphoma classifications. Immunotherapeutic modalities have emerged as essential methodologies in combating lymphoid malignancies. Chimeric Antigen Receptor (CAR) T cells exhibit promising responses in chemotherapy-resistant B-cell non-Hodgkin lymphoma cases.MethodsThis comprehensive review delineates the advancement of CAR-T cell therapy as an immunotherapeutic instrument, the selection of lymphoma antigens for CAR-T cell targeting, and the conceptualization, synthesis, and deployment of CAR-T c

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… It is essential to ensure the accessibility of information related to reagent origin, provenance, content, and certification. …

Involvement of Resveratrol against Brain Cancer: A Combination Strategy with a Pharmaceutical Approach.

A brain tumor (BT) is a condition in which there is growth or uncontrolled development of the brain cells, which usually goes unrecognized or is diagnosed at the later stages. Since the mechanism behind BT is not clear, and the various physiological conditions are difficult to diagnose, the success rate of BT is not very high. This is the central issue faced during drug development and clinical trials with almost all types of neurodegenerative disorders. In the first part of this review, we focus on the concept of brain tumors, their barriers, and the types of delivery possible to target the b

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… Several alternative devices for local distribution have already been developed after Gliadel’s certification. Phase II studies with paclitaxel employing gel technology (ReGel; Protherics, London, UK) in adults with chronic gliomas are now underway. …