A5044306037- Single-cell and spatial transcriptomics
- Cell Image Analysis Techniques
- Biosimilars and Bioanalytical Methods
- Monoclonal and Polyclonal Antibodies Research
- Ultrasound and Hyperthermia Applications
- Biosensors and Analytical Detection
- Immune cells in cancer
- Angiogenesis and VEGF in Cancer
- Alzheimer's disease research and treatments
- Neuroinflammation and Neurodegeneration Mechanisms
- CAR-T cell therapy research
- Gene expression and cancer classification
- Immune Cell Function and Interaction
- Glycosylation and Glycoproteins Research
- Cell Adhesion Molecules Research
- Computational Drug Discovery Methods
- Salivary Gland Disorders and Functions
- Chemokine receptors and signaling
- Ultrasound and Cavitation Phenomena
- Ferroptosis and cancer prognosis
- Advanced Fluorescence Microscopy Techniques
- Extracellular vesicles in disease
- Pharmaceutical Economics and Policy
- Glycogen Storage Diseases and Myoclonus
- Advanced Biosensing Techniques and Applications
University of Rome Tor Vergata
2020-2025
Novartis (Switzerland)
2015-2024
Novartis Institutes for BioMedical Research
2012-2024
University Hospital of Zurich
2000-2003
BAF312 is a next-generation sphingosine 1-phosphate (S1P) receptor modulator, selective for S1P(1) and S1P(5 ) receptors. receptors are essential lymphocyte egress from lymph nodes drug target in immune-mediated diseases. Here, we have characterized the immunomodulatory potential of S1P receptor-mediated effects on heart rate using preclinical human data.BAF312 was tested rat experimental autoimmune encephalomyelitis (EAE) model. Electrophysiological recordings G-protein-coupled inwardly...
CAD106 is designed to stimulate amyloid-β (Aβ)-specific antibody responses while avoiding T-cell autoimmune responses. The first-in-human study demonstrated a favorable safety profile and promising response. We investigated long-term safety, tolerability response after repeated injections.Two phase IIa, 52-week, multicenter, randomized, double-blind, placebo-controlled core studies (2201; 2202) two 66-week open-label extension (2201E; 2202E) were conducted in patients with mild Alzheimer's...
The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place New Orleans, LA, USA April 1–5, with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – full immersion week bioanalysis, biomarkers, immunogenicity gene therapy. As usual, it specifically designed to facilitate sharing, reviewing, discussing agreeing...
Single‐dose pharmacokinetic (PK) profiles and multiple‐dose PK modeling were compared for long‐acting octreotide (20 or 60 mg) prolonged‐release lanreotide (90 120 over 91 days; steady‐state simulated. All treatments well tolerated. Octreotide 20‐mg profile showed increased concentration on day 1, lag from days 2 to 6, then prolonged plateau phase (days 11–41); 60‐mg was dose proportional. Lanreotide 90‐mg C max 1 elimination (apparent t 1/2 25.5 days); 120‐mg underproportional. Steady‐state...
Analytical method validation provides a means to ensure that data are credible and reproducible. This unit will provide brief introduction analytical as applied cellular analysis by flow cytometry. In addition, the practical procedures for three different types of validation. The first is limited protocol applicable research settings non-regulated laboratories. second presents minimum requirements in regulated third transfer be used when methods transferred between recommendations presented...
The 2016 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) took place Orlando, Florida with participation of close to 700 professionals from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB was once again a weeklong event - A Full Immersion Week for PK, Biomarkers Immunogenicity. As usual, it is specifically designed facilitate sharing, reviewing, discussing agreeing approaches address the most current...
Low-intensity pulsed ultrasound (LIPUS) is a widely used non-invasive approach with therapeutic purposes since it provides physical stimulation minimal thermal effects. The skin epithelium the first barrier of human body that interfaces LIPUS and subjected to highest intensity. Little known about impact on surface. This work investigates biological effects one-hour exposure 1 MHz keratinocytes HaCaT tumoral SK-MEL-28 cells. Specifically, we evaluated cellular state immediately after...
Background: Intra-arterial cerebral infusion (IACI) of radiotherapeutics is a promising treatment for glioblastoma (GBM) recurrence. We investigated the in silico feasibility and safety Yttrium-90-Poly(vinyl alcohol)-Microbubble (90Y-PVA-MB) IACI patients with recurrent GBM compared results those external beam radiation therapy (EBRT). Methods: Contrast-enhanced T1-weighted magnetic resonance imaging (T1W-MRI) was used to delineate tumor volumes CT scans were automatically segment organs at...
Abstract The current consensus recommendation papers dealing with the unique requirements for analytical validation of assays performed by flow cytometry address sensitivity (both and functional) only in general terms. In this paper, a detailed approach designing validating rare event methods is described. impact panel design optimization on lower limit quantification (LLOQ) suggestions reporting data near, or below, LLOQ are addressed. This paper serves to provide best practices...
Abstract Analytical method validation provides a means to ensure that data are credible and reproducible. This article will provide brief introduction analytical as applied cellular analysis by flow cytometry, along with practical procedures for four different types of validation. The first, Basic Protocol 1 (the limited protocol), is recommended research non‐regulated laboratories. Next, 2) presents reasonable, fit‐for‐purpose approach appropriate biopharma settings. 3 addresses the type...
The 14th edition of the Workshop on Recent Issues in Bioanalysis (14th WRIB) was held virtually June 15-29, 2020 with an attendance over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology contract research organizations, and regulatory agencies worldwide. WRIB included three Main Workshops, seven Specialized Workshops that together spanned 11 days order to allow exhaustive thorough coverage all major issues bioanalysis, biomarkers, immunogenicity, gene...
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held 27 September to 1 October 2021. Even with a last-minute move from in-person virtual, an overwhelmingly high number nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), multiple regulatory agencies still eagerly convened actively discuss most current topics interest bioanalysis. WRIB included three Main Workshops seven Specialized that together spanned...
The Basophil Activation Test (BAT) enables flow cytometry characterization of basophil reactivity against specific allergenic molecules. focus now revolves around democratizing this tool, but, as blood sample stability could be challenging, after having developed a simplified approach, herein, we aimed to characterize two strategies for implementing BAT in multicentric studies: store and ship before or processing. Fresh heparin- EDTA-anticoagulated whole samples followed both workflows:...
Single-cell technologies have recently expanded the possibilities for researchers to gain, at an unprecedented resolution level, knowledge about tissue composition, cell complexity, and heterogeneity. Moreover, integration of data coming from different sources also offers, first time, possibility draw a holistic portrait how cells behave sustain physiology during human lifespan disease. Here, we interrogated integrated publicly available single-cell RNAseq advance understanding macrophages,...
Introduction: Cyt-Geist: Current and Future Challenges in Cytometry 601 Chapter 01: Trends 01 Introduction WS18: Flow Drivers WS06: the Era of Human Cell Atlas 000 WS07: CYTO Lab Hacks: Inspiring Innovation Through Open Collaboration 605 WS15: The Status Microbiome 607 Conclusion 610 02: Shared Resource Laboratory (SRL) Best Practices 02 WS01: Balancing Science Service a 611 WS02: A Successful Imaging Facility: Guidelines for Management Publication 613 WS05: Identification Areas Where...
The main mechanism underlying cancer dissemination is the epithelial to mesenchymal transition (EMT). This process orchestrated by cytokines like TGFβ, involving "non-canonical" AKT- or STAT3-driven pathways. Recently, alteration of copper homeostasis seems involved in onset and progression cancer.We expose different breast cell lines, including two triple negative (TNBC) ones, an HER2 enriched one line representative Luminal A molecular subtype, short- long-term copper-chelation...
As with many aspects of the validation and monitoring flow cytometric methods, method transfer processes acceptance criteria described for other technologies are not fully applicable. This is due to complexity highly configurable instrumentation, cellular measurands, lack qualified reference materials most assays, limited specimen stability. There multiple reasons initiating a transfer, regulatory settings, context use. All these factors influence specific requirements transfer....
Sotrastaurin is an immunosuppressant that inhibits protein kinase C. In the prevention of acute rejection in organ transplantation, sotrastaurin might be combined with tacrolimus. A drug interaction study was performed 18 healthy subjects who received single oral doses 400 mg, tacrolimus 7 and combination. Drug blood levels lymphocyte activation proliferation were measured. Tacrolimus did not alter pharmacokinetics sotrastaurin; however, increased area under concentration-time curve by...
Sotrastaurin is an immunosuppressant that inhibits protein kinase C and blocks T-lymphocyte activation. The authors determined the effect of combining sotrastaurin with calcineurin inhibitor cyclosporine on pharmacokinetics biomarker responses to both drugs.This was a randomized, 4-period, crossover study in 20 healthy subjects who received single oral doses (1) 100 mg, (2) 400 (3) mg (4) cyclosporine. Blood samples were collected measure drug levels biomarkers activation (interleukin-2...