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.

Impact of Infertility and Medically Assisted Reproduction Treatments on Female Sexuality.

Objective: To evaluate the impact of infertility and Medically Assisted Procreation (MAP) on female sexuality. Human sexuality presents a multifaceted complexity, shaped by diverse factors and individual intricacies. Infertility and assisted reproductive treatments entail a prolonged and arduous journey, amplifying pre-existing sexual dysfunctions and serving as a rigorous trial of the affected women's sexuality and the resilience of couples.

Early Initiation of Dangle Protocol in Lower Extremity Free Flap Microsurgery.

Background:  Defects of the lower extremity often require free tissue transfer to provide adequate soft tissue reconstruction. Patients typically undergo a postoperative dangle protocol to condition the flap to withstand the increase in venous pressure. The purpose of this study was to evaluate the safety and postoperative length of stay after early initiation of dangle.

Radiosensitization impact assessment of silica-layered iron oxide nanocomposites with various shell thickness.

Silica shell is considered to be a promising design that enhances nanocomposite stability, cellular internalization, and consequentially therapeutic impacts by overcoming their aggregation under physiological conditions. This study addressed synthesizing silica-layered iron oxide-based nanoparticles (SCINPs) with different shell thicknesses (1-SCINPs, 2-SCINPs, 3-SCINPs, and 4-SCINPs). Also, the impact of shell thickness on the nanoparticle's cellular internalization and the radio-sensitizing effect of prepared nano-formulations were assessed.

Reasons for consultation in gynecological and obstetrical emergencies among adolescents in Tunisia.

Objectives: The main objective is to study gynecological and obstetrical emergencies among adolescents admitted to the emergency room in our department.

Methods: At the Farhat Hached University Hospital in Sousse's Obstetrics and Gynecology Department, we carried out a retrospective study. Sociodemographic and clinical characteristics of adolescents who consulted over a period of 12 months were described.

Comparative effectiveness and safety of eplerenone and spironolactone in patients with heart failure: a systematic review and meta-analysis.

Background: Eplerenone and spironolactone, recognized as mineralocorticoid receptor antagonists (MRAs), have been reported to improve clinical prognosis among individuals diagnosed with heart failure (HF). However, the difference in the clinical effects between eplerenone and spironolactone in individuals with HF remains uncertain. We aimed to assess the impact of eplerenone compared to spironolactone on clinical outcomes within the HF population.

Prototype Implementation of a Digitizer for Earthquake Monitoring System.

A digitizer is considered one of the fundamental components of an earthquake monitoring system. In this paper, we design and implement a high accuracy seismic digitizer. The implemented digitizer consists of several blocks, i.

Appropriateness of colonoscopies in a Tunisian endoscopy center: factors and EPAGE-I/II criteria comparison.

Background: There is a growing demand for colonoscopy, worldwide, resulting in increased rate of inappropriate referrals. This "overuse" of colonoscopies has become a major burden for health care.

Objectives: to assess the appropriateness of colonoscopies performed at the endoscopy unit of the university hospital of Sousse and to compare these results of appropriateness according to the European Panel of Appropriateness of Gastrointestinal Endoscopy (EPAGE) I and EPAGE II criteria.

Monomethyl auristatin E (MMAE), a payload for multiple antibody drug conjugates (ADCs), demonstrates differential red blood cell partitioning across human and animal species.

Monomethyl auristatin E (MMAE) has been used as a payload for several Food and Drug Administration (FDA) approved antibody-drug conjugates (ADCs). It is known that MMAE is released from the ADC following binding, internalisation and proteolytic degradation in target tissues. A striking discrepancy in systemic MMAE levels has been observed across species with 50-fold higher MMAE levels in human than that in rodents when normalised by ADC dose with unknown mechanism.

Novel 6-hydroxybenzothiazol-2-carboxamides as potent and selective monoamine oxidase B inhibitors endowed with neuroprotective activity.

In neurodegenerative diseases, using a single molecule that can exert multiple effects to modify the disease may have superior activity over the classical "one molecule-one target" approach. Herein, we describe the discovery of 6-hydroxybenzothiazol-2-carboxamides as highly potent and selective MAO-B inhibitors. Variation of the amide substituent led to several potent compounds having diverse side chains with cyclohexylamide 40 displaying the highest potency towards MAO-B (IC = 11 nM).

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 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.

Enhancing proficiency in ascites puncture through procedural simulation: an audit type study investigating medium-term skill retention.

Introduction: Medical simulation has become an essential teaching method for all health professionals. It not only allows to acquire technical and non-technical knowledge, but also helps the maintenance of acquired knowledge in the medium and long term. Ascites puncture is part of the basic technical procedures learned by medical students during their internship.

The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results.

Approved antibody-drug conjugates (ADCs) for HER2-positive breast cancer include trastuzumab emtansine and trastuzumab deruxtecan. To develop a differentiated HER2 ADC, we chose an antibody that does not compete with trastuzumab or pertuzumab for binding, conjugated to a reduced potency PBD (pyrrolobenzodiazepine) dimer payload. PBDs are potent cytotoxic agents that alkylate and cross-link DNA.

2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).

The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Motor Strength Measurements Obtained Using an Inexpensive Spring Tensiometer and a Clinical Dynamometer Correlated Well: A Prospective Cohort Study.

Objective: Manual muscle strength testing is the primary method for testing muscle strength in clinical settings but is highly subjective. An objective measure of muscle strength can be obtained using a handheld dynamometer, but its cost inhibits its widespread usage. We hypothesized that a spring tensiometer (ST) could be an objective tool that can be used as a viable alternative to a dynamometer.

Beyond Physical Well-being: Exploring Demographic Variances in Psychosocial Well-being before Breast Reconstruction.

Unlabelled: A patient's preoperative satisfaction with their breasts and baseline psychosocial, sexual, and physical well-being are important considerations when planning breast reconstruction. We sought to elucidate variances in preoperative responses among patients undergoing postmastectomy breast reconstruction.

Methods: Preoperative BREAST-Q responses and demographic data, including race, generation, median household incomeinstitutional review board and body mass index (BMI) were collected from breast cancer patients scheduled for mastectomy.

Self-Reported Questionnaire to Evaluate Functional Abilities in Middle Age: A Call for Delphi Expert Panel.

Early detection of functional decline is important for promoting optimal aging. Self-reported questionnaires can efficiently assess functional abilities. Therefore, we aimed to highlight the lack of functional ability assessment questionnaires for the middle-aged population (MA, 45-65 years) and the need to develop such a questionnaire.

Short-term Satisfaction, Psychosocial Impact, and Complication Profile of Reduction Mammaplasty During Adolescence.

Background: Reduction mammaplasty is an effective and safe treatment option for adults with symptomatic macromastia, but there are few data regarding outcomes in adolescents.

Objectives: The purpose of this study was to determine the short-term psychosocial impact, satisfaction, and safety of reduction mammaplasty when performed during adolescence.

Methods: A retrospective review was performed of a single pediatric plastic surgeon's experience with reduction mammaplasty from 2018 to 2021 in patients aged ≤18 years.

Percutaneous Renal Biopsy in Egyptian Children: A Five-year Single-Center Experience.

Ultrasound-guided percutaneous renal biopsy (PRB) stands as an important tool of diagnostic and prognostic value, besides its role in determining the best therapeutic option in some diseases. The advance in medicine over the past years made PRB safer and more feasible. This is an observational retrospective study in a tertiary referral center of pediatric nephrology and was conducted to determine both the indications and the histopathological findings of renal biopsies performed in pediatric patients.

Dose-enhancement of MCF 7 cell line radiotherapy using silica-iron oxide nanocomposite.

Cancer radiotherapy is one of the most effective regimens of cancer treatments, but cancer cell radioresistance remains a concern. Radiosensitizers can selectively improve the efficacy of radiotherapy and reduce inherent damage. The purpose of this work is to evaluate the effect of silica-coated iron oxide magnetic nanoparticles (SIONPs) as a radiosensitizer and compare their therapeutic effect with that of Iron oxide magnetic nanoparticles (IONPs).