Intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors. A multicenter phase Ib/IIa trial in colorectal cancer, non-small cell lung cancer, and soft tissue sarcoma patients

Start Date15 Dec 2022

Sponsor / Collaborator

IQVIA RDS Ireland Ltd.

100 Clinical Results associated with IQVIA RDS Ireland Ltd.

0 Patents (Medical) associated with IQVIA RDS Ireland Ltd.

Literatures (Medical) associated with IQVIA RDS Ireland Ltd.

01 Jan 2017·Therapeutic Innovation & Regulatory ScienceQ4 · MEDICINE

Can Pharmacovigilance Learn From the Oil and Gas Industry, Which Has Been Outsourcing for Over a Century?

Q4 · MEDICINE

Article

Author: Edwards, Brian ; Prendergast, Christine ; Dawson, Barbara ; van Leeuwen, Bert P

Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors propose that the sector can learn from other industries that have been outsourcing activities for a much longer time, such as the oil and gas industry. The Safety Case is put forward as a body of evidence that facilitates the continuous exchange of data, especially focused on risk management of the relationship between outsourcer and vendor. Finally, the authors will make an attempt to come to a global consensus in this area through the Allliance for Clinical Research Excellence and Safety (ACRES) network.

BiomedicinesQ3 · ENGINEERING & TECHNOLOGY

High Levels of Receptor Tyrosine Kinases in CCM3-Deficient Cells Increase Their Susceptibility to Tyrosine Kinase Inhibition

Q3 · ENGINEERING & TECHNOLOGY

ArticleOA

Author: Couraud, Pierre-Olivier ; Floridia, Ebel ; Macía, Manuel ; Sartages, Miriam ; Zalvide, Juan ; Pombo, Celia M ; Peñas, Patricia ; García-Colomer, Mar ; Weksler, Babette ; Iglesias, Cristina ; Romero, Ignacio A

Cerebral cavernous malformations (CCMs) are vascular malformations that can be the result of the deficiency of one of the CCM genes. Their only present treatment is surgical removal, which is not always possible, and an alternative pharmacological strategy to eliminate them is actively sought. We have studied the effect of the lack of one of the CCM genes, CCM3, in endothelial and non-endothelial cells. By comparing protein expression in control and CCM3-silenced cells, we found that the levels of the Epidermal Growth Factor Receptor (EGFR) are higher in CCM3-deficient cells, which adds to the known upregulation of Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) in these cells. Whereas VEGFR2 is upregulated at the mRNA level, EGFR has a prolonged half-life. Inhibition of EGFR family members in CCM3-deficient cells does not revert the known cellular effects of lack of CCM genes, but it induces significantly more apoptosis in CCM3-deficient cells than in control cells. We propose that the susceptibility to tyrosine kinase inhibitors of CCM3-deficient cells can be harnessed to kill the abnormal cells of these lesions and thus treat CCMs pharmacologically.

Patient Preference and AdherenceQ3 · MEDICINE

An observational, retrospective, UK and Ireland audit of patient adherence to subcutaneous interferon beta-1a injections using the RebiSmart® injection device

Q3 · MEDICINE

ArticleOA

Author: Larkin, Anne Marie ; Webster, Julie ; Parkes, Laura ; Willis, Helen

BACKGROUNDPoor adherence to disease-modifying drugs is associated with an increased risk of relapse in patients with multiple sclerosis. However, adherence is difficult to assess objectively. RebiSmart(®) (Merck Serono SA, Geneva, Switzerland), a device for subcutaneous (sc) injection of interferon (IFN) β-1a, features an electronic injection log that can assist in objective monitoring of adherence.OBJECTIVETo assess adherence to sc IFN β-1a injections using data from RebiSmart(®).METHODSThis was a single-group, observational, retrospective audit. Adherence data were collected from patients with relapsing multiple sclerosis in the United Kingdom and Ireland who had been prescribed sc IFN β-1a and had been using RebiSmart(®) for a minimum of 24 months.RESULTSIn total, 225 patients were included in the full analysis set; 72% were in the United Kingdom, and 28% were in Ireland. Overall, the mean age was 44.1 years, and 73% were women. Patients received sc IFN β-1a 44 µg (68%) or 22 µg (32%) three times per week. Mean adherence over the course of 24 months was 95.0% (median, 99.4%), and similar values were observed across all periods. The proportion of patients with 80% or higher adherence was 92.0% at 12 months and 91.1% at 24 months.CONCLUSIONHigh adherence to sc IFN β-1a was observed across all patient groups using RebiSmart(®), according to 2-year treatment adherence data. This may be partly attributed to the expert support patients received, supplemented by routine and regular contact from the MySupport patient-support program, as well as the self-motivation of patients who persisted with treatment for 2 or more years.

100 Deals associated with IQVIA RDS Ireland Ltd.

100 Translational Medicine associated with IQVIA RDS Ireland Ltd.

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