2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).

The 18 Workshop on Recent Issues in Bioanalysis (18 WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

SUMO-Specific Peptidase 5 Promotes Oesophageal Squamous Cell Carcinoma Growth through the NF-κB- Axis.

Background: This study investigates the role of small ubiquitin-like modifier (SUMO)-specific peptidase 5 (SENP5), a key regulator of SUMOylation, in esophageal squamous cell carcinoma (ESCC), a lethal disease, and its underlying molecular mechanisms.

Methods: Differentially expressed genes between ESCC mouse oesophageal cancer tissues and normal tissues were analysed via RNA-seq; among them, SENP5 expression was upregulated, and this gene was selected for further analysis. Immunohistochemistry and western blotting were then used to validate the increased protein level of SENP5 in both mouse and human ESCC samples.

An evaluation of mepolizumab as an add-on maintenance treatment for severe eosinophilic asthma.

Introduction: Clinical experience with anti-interleukin (IL)-5 biologic therapies for severe asthma has been increasing, alongside deeper and broader research focusing on the role of IL-5 and the IL-5 targeted mepolizumab. This review aims to provide an update of the evidence on the role of IL-5 and mepolizumab, with discussions of the benefits of mepolizumab and its future potential, to promote the comprehension of the pathophysiology and therapeutic approaches to asthma.

Areas Covered: For this narrative review, we conducted a database search in PubMed and Embase using the keywords 'IL-5' and 'mepolizumab,' focusing on randomized controlled trials and real-world studies up to September 2024.

Feline Papillomatosis.

Different types of feline papillomaviruses (PVs) are associated with a variety of skin lesions and neoplasia, such as papillomas and cell carcinomas, but the virus can also be found in healthy skin. In this review, the European Advisory Board on Cat Diseases (ABCD), a scientifically independent board of veterinary experts on feline infectious diseases from 11 European Countries, discusses the current knowledge of feline PV infections. Cats most likely become infected through lesions or abrasions of the skin.

Epidemiological Analysis of Fungal Infection Disease in Pediatric Population: Focus on Hospitalization from 2007 to 2022 in Veneto Region in Italy.

Fungal infections (FIs) are widespread globally, affecting both immunocompromised and immunocompetent children, with varying clinical implications based on age and comorbidities. In immunocompromised children, particularly those with hematologic oncological conditions, FI leads to substantially longer hospital stays and increased in-hospital mortality, with reported rates ranging from 15% to 20%. Our study aims to analyze the epidemiological trends of fungal infections in the pediatric population within a specific region of Italy.

Discovery of Novel Diagnostic Biomarkers for Common Pathogenic Through Pan-Genome and Comparative Genome Analysis, with Preliminary Validation.

The aim of this study was to reveal diagnostic biomarkers of considerable importance for common pathogenic , utilizing pan-genomic and comparative genome analysis to accurately characterize clinical infections. In this study, complete or assembled genome sequences of common pathogenic and closely related species were obtained from NCBI as discovery and validation sets, respectively. Genome annotation was performed using Prokka software, and pan-genomic analysis and extraction of core genes were performed using BPGA software.

Passive Monitoring of Parkinson Tremor in Daily Life: A Prototypical Network Approach.

Objective and continuous monitoring of Parkinson's disease (PD) tremor in free-living conditions could benefit both individual patient care and clinical trials, by overcoming the snapshot nature of clinical assessments. To enable robust detection of tremor in the context of limited amounts of labeled training data, we propose to use prototypical networks, which can embed domain expertise about the heterogeneous tremor and non-tremor sub-classes. We evaluated our approach using data from the Parkinson@Home Validation study, including 8 PD patients with tremor, 16 PD patients without tremor, and 24 age-matched controls.

Unmet Needs in the Management of Chronic Kidney Disease-Associated Pruritus and the Characteristics of the Ideal Treatment: A Spanish Cross-Sectional Survey from a Multidisciplinary Perspective.

Chronic kidney disease-associated pruritus (CKD-aP) is underdiagnosed and not fully understood by healthcare professionals, which leads to poor patient management and impacts patients' quality of life (QoL). The aim of this study was to analyse unmet needs in CKD-aP management and explore the attributes/characteristics that the ideal CKD-aP treatment should have from the perspective of a group of nephrologists, hospital pharmacists, nurses, patient representatives, and regional health authorities in Spain. A descriptive, cross-sectional study was conducted using an e-survey including ad hoc questions (6-point Likert scale) related to unmet needs in CKD-aP and best-worst scaling (BWS) to prioritise the attributes/characteristics of the ideal CKD-aP treatment.

Healthcare Professionals' Perspectives on Sepsis Care Pathways-Qualitative Pilot Expert Interviews.

: Despite recent decades' rapid advances in the management of patients with sepsis and septic shock, global sepsis mortality and post-acute sepsis morbidity rates remain high. Our aim was, therefore, to provide a first overview of sepsis care pathways as well as barriers and supportive conditions for optimal pre-clinical, clinical, and post-acute sepsis care in Germany. : Between May and September 2023, we conducted semi-structured, video-based, one-to-one pilot expert interviews with healthcare professionals representing pre-hospital, clinical, and post-acute care settings.

The Clinical Use of Myo-Inositol in IVF-ET: A Position Statement from the Experts Group on Inositol in Basic and Clinical Research and on PCOS (EGOI-PCOS), the Polish Society of Andrology, and the International Scientific Association for the Support and Development of Medical Technologies.

Myo-inositol plays a vital role in human health, functioning as a second messenger of FSH and facilitating the transport of glucose into the cell. Consequently, myo-inositol is regularly utilized in the treatment of polycystic ovary syndrome (PCOS), wherein it acts upon metabolic factors, improving insulin sensitivity and reducing total androgen levels. Patients with PCOS frequently suffer from infertility; thus, the use of myo-inositol has been explored in improving assistive reproductive technique (ART) procedures.

Autoimmune Type 1 Diabetes: An Early Approach Appraisal for Spain by the AGORA Diabetes Collaborative Group.

Type 1 diabetes (T1D) is an autoimmune disorder characterized by the destruction of insulin-producing pancreatic beta-cells, leading to lifelong insulin dependence. This review explores the current understanding of T1D pathogenesis, clinical progression, and emerging therapeutic approaches. We examined the complex interplay between genetic predisposition and environmental factors that could trigger the autoimmune response as well as the immunological mechanisms involved in beta-cell destruction.

Comparative Pharmacokinetic Analysis of Aflibercept and Brolucizumab in Human Aqueous Humor Using Nano-Surface and Molecular-Orientation Limited Proteolysis.

Aflibercept and brolucizumab, two anti-VEGF agents used as intravitreal injections in ophthalmology, differ significantly in molecular weight (aflibercept-115 kDa and brolucizumab-26 kDa). Using aqueous humor samples collected after drug administration, we measured and performed a comparative analysis of pharmacokinetics and half-lives of these drugs in the human eye. Since the quantification of monoclonal antibodies (mAbs) using antigen-antibody reactions, such as ELISA, is influenced by endogenous ligands or anti-drug antibodies, we employed nano-surface and molecular-orientation limited proteolysis (nSMOL), combined with liquid chromatography-tandem mass spectrometry (LC-MS/MS), for accurate measurements.

Sources and Transmission Routes of Carbapenem-Resistant : Study Design and Methodology of the SAMPAN Study.

: The global spread of carbapenem-resistant (CRPA) warrants collaborative action. Guidance should come from integrated One Health surveillance; however, a surveillance strategy is currently unavailable due to insufficient knowledge on the sources and transmission routes of CRPA. The aim of the SAMPAN study ("A Smart Surveillance Strategy for Carbapenem-resistant ") is to develop a globally applicable surveillance strategy.

Assessment of Antimicrobial Use for Companion Animals in South Korea: Developing Defined Daily Doses and Investigating Veterinarians' Perception of AMR.

There are global concerns regarding the transmission of antimicrobial-resistant pathogens from animals to humans. Especially, companion animals are increasingly recognized as a potential source due to their close interactions with people, despite a limited number of reported cases. Although, social demands regarding comprehensive surveillance for antimicrobial resistance (AMR) among companion animals are highlighted, there is a lack of a relevant system in South Korea.

Expert Judgment Supporting a Bayesian Network to Model the Survival of Pancreatic Cancer Patients.

: Pancreatic cancer is known for its poor prognosis. The most effective treatment combines surgery with peri-operative chemotherapy. Current prognostic tools are designed to predict patient outcomes and inform treatment decisions based on collected data.

A Multidisciplinary Approach to Diagnosing Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Practical Recommendations and Insights from Countries of the Gulf Cooperation Council.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive orphan hematopoietic malignancy characterized by cutaneous and systemic hematologic involvement. BPDCN is frequently misidentified, but early, accurate diagnosis is critical to extending patient survival using tagraxofusp, a first-in-class CD123-targeted therapy, and increasing their chances of receiving a potentially curative stem cell transplantation. Cases of BPDCN in countries of the Gulf Cooperation Council are lower than the extrapolated incidence from other geographic locations due to lack of awareness of key diagnostic features, lack of consensus on the minimal phenotype for diagnosis, and lack of local immunohistochemistry testing facilities, contributing to underdiagnosis in this region.

Evaluating Tumor Tissue Modified Viral (TTMV)-HPV DNA for the Early Detection of Anal Squamous Cell Carcinoma Recurrence.

Background: The incidence and mortality of anal squamous cell carcinoma (ASCC) are rising, with greater than 80% of cases linked to human papillomavirus (HPV), primarily HPV16. Post-treatment surveillance can be challenging due to the limitations of anoscopy, digital anal rectal exam (DARE), and imaging. Plasma tumor tissue modified viral (TTMV)-HPV DNA has shown strong sensitivity, specificity, and predictive value in detecting the recurrence of HPV-driven oropharyngeal cancer.

Toxicity Associated with Pembrolizumab Monotherapy in Patients with Gastrointestinal Cancers: A Systematic Review of Clinical Trials.

Pembrolizumab, an immune checkpoint inhibitor targeting programmed death 1 (PD-1), is a widely employed therapy for various gastrointestinal (GI) cancers. We conducted a systematic review of clinical trials investigating pembrolizumab monotherapy in GI cancer patients to assess the spectrum and incidence of immune-related adverse events (irAEs) associated with pembrolizumab. A comprehensive search of PubMed/MEDLINE was performed to identify clinical trials investigating pembrolizumab monotherapy in GI cancer patients.

Framing and Management of Migraines in Women: An Expert Opinion on Challenges, Current Approaches, and Future Multidisciplinary Perspectives.

Migraines are a common neurological disorder that significantly impact women, especially during their reproductive years. Hormonal, neurological, and lifestyle factors shape migraine patterns, with fluctuations during menstruation, pregnancy, perimenopause, and menopause influencing migraine prevalence and severity. This expert opinion explores current challenges, therapeutic strategies, and future directions for personalized care, addressing the limited inclusion of women in clinical research across different life stages.

Explainable AI in Diagnostic Radiology for Neurological Disorders: A Systematic Review, and What Doctors Think About It.

Artificial intelligence (AI) has recently made unprecedented contributions in every walk of life, but it has not been able to work its way into diagnostic medicine and standard clinical practice yet. Although data scientists, researchers, and medical experts have been working in the direction of designing and developing computer aided diagnosis (CAD) tools to serve as assistants to doctors, their large-scale adoption and integration into the healthcare system still seems far-fetched. Diagnostic radiology is no exception.

Prediction of pathological complete response after neoadjuvant chemotherapy for HER2-negative breast cancer patients with routine immunohistochemical markers.

Background: Pathological complete response (pCR) is an established surrogate marker for prognosis in patients with breast cancer (BC) after neoadjuvant chemotherapy. Individualized pCR prediction based on clinical information available at biopsy, particularly immunohistochemical (IHC) markers, may help identify patients who could benefit from preoperative chemotherapy.

Methods: Data from patients with HER2-negative BC who underwent neoadjuvant chemotherapy from 2002 to 2020 (n = 1166) were used to develop multivariable prediction models to estimate the probability of pCR (pCR-prob).

Feasibility pilot of a novel coaching intervention to optimize cannabis use for chronic pain management among Veterans.

Introduction: Chronic pain is common among Veterans, some of whom use cannabis for pain. We conducted a feasibility pilot study of a novel coaching intervention to help Veterans optimize use of medical cannabis products for pain management (NCT06320470).

Methods: The intervention drew from scientific literature, consultation with cannabis experts, Veteran input via a Community Advisory Board, and tenets of motivational interviewing.

Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps).

Background: Africa's involvement in clinical trials remains very low. Although the crucial role of training initiatives in building clinical trial capacity in Africa has been documented, current efforts fall short as they lack alignment with local contexts. This study aimed to design, develop, implement, and evaluate an innovative clinical trial operations training program for Africa.

[Development and validation of a clinical automatic diagnosis system based on diagnostic criteria for temporomandibular disorders].

Objective: To develop a clinical automated diagnostic system for temporomandibular disorders (TMD) based on the diagnostic criteria for TMD (DC/TMD) to assist dentists in making rapid and accurate clinical diagnosis of TMD.

Methods: Clinical and imaging data of 354 patients, who visited the Center for TMD & Orofacial Pain at Peking University Hospital of Stomatology from September 2023 to January 2024, were retrospectively collected. The study developed a clinical automated diagnostic system for TMD using the DC/TMD, built on the.