Concept
Phases of clinical research
Related publications (87)
A First-in-Human Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Neutralization Profile of Two Investigational Long-Acting Anti-SARS-CoV-2 Monoclonal Antibodies
Didier Trono, Norman Lionel Moullan
Introduction: COVID-19 remains a significant risk for the immunocompromised given their lower responsiveness to vaccination or infection. Therefore, passive immunity through long-acting monoclonal antibodies (mAbs) offers a needed approach for pre-exposure ...
2024Clinically compliant cryopreservation of differentiated retinal pigment epithelial cells
Gioele La Manno, Alex Russell Lederer, Cheng Zhao
Background aims: Age-related macular degeneration (AMD) is the most common cause of blindness in elderly patients within developed countries, affecting more than 190 million worldwide. In AMD, the retinal pigment epithelial (RPE) cell layer progressively d ...
Elsevier Sci Ltd2024Modeling tumor size dynamics based on real-world electronic health records and image data in advanced melanoma patients receiving immunotherapy
Monia Guidi, Nadia Terranova, Federico Amato, Daniel Abler, Olivier Michielin, Alexandre Wicky
The development of immune checkpoint inhibitors (ICIs) has revolutionized cancer therapy but only a fraction of patients benefits from this therapy. Model-informed drug development can be used to assess prognostic and predictive clinical factors or biomark ...
2023Elucidating and modulating regulatory pathways so as to reprogram the immunosuppressive tumor microenvironment for therapeutic benefit
Glioblastoma (GBM) is the most frequent and highly malignant form of brain cancer. New therapeutic regimens are urgently needed as GBM patients present with a minimal response to currently-approved therapies. The goal of this project is to identify new the ...
EPFL2023HTATIP2 regulates arteriogenic activity in monocytes from patients with limb ischemia
Michele De Palma, Mario Leonardo Squadrito
Use of autologous cells isolated from elderly patients with multiple comorbidities may account for the modest efficacy of cell therapy in patients with chronic limb threatening ischemia (CLTI). We aimed to determine whether proarteriogenic monocyte/macroph ...
Ann Arbor2023Determination of a clinically effective evobrutinib dose: Exposure-response analyses of a phase II relapsing multiple sclerosis study
The pharmacometric analysis of the double-blind, randomized, phase II study (NCT02975349) investigating the safety and efficacy of evobrutinib, explored exposure-response relationships and suitable dosing regimens of evobrutinib for relapsing multiple scle ...
WILEY2022Enantio- and diastereoselective construction of vicinal C(sp(3)) centres via nickel-catalysed hydroalkylation of alkenes
Xile Hu, Chao Fan, Srikrishna Bera
In drug discovery, the proportion of aliphatic carbons (C(sp(3))) and the presence of chiral carbons in organic molecules are positively correlated to their chance of clinical success. Although methods exist for the synthesis of chiral C(sp(3))-rich molecu ...
NATURE PORTFOLIO2022Assessing normalization methods in mass spectrometry-based proteome profiling of clinical samples
Background: Large-scale proteomic studies have to deal with unwanted variability, especially when samples originate from different centers and multiple analytical batches are needed. Such variability is typically added throughout all the steps of a clinica ...
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