Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.

Project Orbis was initiated in May 2019 by the Oncology Center of Excellence to facilitate faster patient access to innovative cancer therapies by providing a framework for concurrent submissions and review of oncology products among international partners. Since its inception, Australia's Therapeutic Goods Administration (TGA), Canada's Health Canada (HC), Singapore's Health Sciences Authority (HSA), Switzerland's Swissmedic (SMC), Brazil's National Health Surveillance Agency (ANVISA), United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA), and most recently Israel's Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, have joined Project Orbis. While each country has its own expedited review pathways to bring promising therapies to patients, there are some similarities and differences in pathways and timelines.

Osteoarthritic pain model influences functional outcomes and spinal neuropeptidomics: A pilot study in female rats.

Osteoarthritis, the leading cause of chronic joint pain, is studied through different animal models, but none of them is ideal in terms of reliability and translational value. In this pilot study of female rats, 3 surgical models of osteoarthritic pain, destabilization of the medial meniscus (DMM), cranial cruciate ligament transection (CCLT), and the combination of both surgical models (COMBO) and 1 chemical model [intra-articular injection of monosodium iodoacetate (MIA)] were compared for their impact on functional pain outcomes [static weight-bearing (SWB) and punctate tactile paw withdrawal threshold (PWT)] and spinal neuropeptides [substance P (SP), calcitonin gene-related peptide (CGRP), bradykinin (BK), and somatostatin (SST)]. Six rats were assigned to each model group and a sham group.

Impact of biotic and abiotic factors on the expression of fungal effector-encoding genes in axenic growth conditions.

In phytopathogenic fungi, the expression of hundreds of small secreted protein (SSP)-encoding genes is induced upon primary infection of plants while no or a low level of expression is observed during vegetative growth. In some species such as Leptosphaeria maculans, this coordinated in-planta upregulation of SSP-encoding genes expression relies on an epigenetic control but the signals triggering gene expression in-planta are unknown. In the present study, biotic and abiotic factors that may relieve suppression of SSP-encoding gene expression during axenic growth of L.

Evaluation of an overlapping pubic and ischiatic osteotomy for the improvement of acetabular ventroversion in dogs: an ex vivo study.

Objectives: To assess the potential of a new single-session surgical procedure, the overlapping pubic and ischiatic osteotomy (OPIO) for modification of bilateral hip conformation. We hypothesized that OPIO would be simple to perform with currently available surgical equipment, through a single surgical approach, with minimal potential morbidity, and that it would allow adequate simultaneous bilateral improvement of coxofemoral joint conformation in patients at risk of canine hip dysplasia.

Methods: The OPIO procedure was performed in the pelves of five large breed canine cadavers.

Different waves of effector genes with contrasted genomic location are expressed by Leptosphaeria maculans during cotyledon and stem colonization of oilseed rape.

Leptosphaeria maculans, the causal agent of stem canker disease, colonizes oilseed rape (Brassica napus) in two stages: a short and early colonization stage corresponding to cotyledon or leaf colonization, and a late colonization stage during which the fungus colonizes systemically and symptomlessly the plant during several months before stem canker appears. To date, the determinants of the late colonization stage are poorly understood; L. maculans may either successfully escape plant defences, leading to stem canker development, or the plant may develop an 'adult-stage' resistance reducing canker incidence.

Concurrent validity of different functional and neuroproteomic pain assessment methods in the rat osteoarthritis monosodium iodoacetate (MIA) model.

Background: Lack of validity in osteoarthritis pain models and assessment methods is suspected. Our goal was to 1) assess the repeatability and reproducibility of measurement and the influence of environment, and acclimatization, to different pain assessment outcomes in normal rats, and 2) test the concurrent validity of the most reliable methods in relation to the expression of different spinal neuropeptides in a chemical model of osteoarthritic pain.

Methods: Repeatability and inter-rater reliability of reflexive nociceptive mechanical thresholds, spontaneous static weight-bearing, treadmill, rotarod, and operant place escape/avoidance paradigm (PEAP) were assessed by the intraclass correlation coefficient (ICC).

Interorganizational collaboration in occupational rehabilitation: perceptions of an interdisciplinary rehabilitation team.

Introduction: Various obstacles to and facilitators of collaboration between an interdisciplinary work rehabilitation team and the stakeholders (workers, insurers, physicians, and employers) exist, but are not well characterized.

Methods: An observational study was conducted, using videotapes of interdisciplinary team discussions of ongoing cases involving 22 workers absent from work due to musculoskeletal disorders. The actions taken and strategies adopted by the team in an effort to overcome the obstacles to collaboration were studied.

The values underlying team decision-making in work rehabilitation for musculoskeletal disorders.

Purpose: This paper presents the results of a qualitative study on the values underlying the decision-making process of an interdisciplinary team working in a work rehabilitation facility of a Québec teaching hospital.

Methods: In order to document the values underlying the decision-making process, a single case observational study was conducted. Interdisciplinary team weekly discussions on ongoing cases of 22 workers absent from work due to musculoskeletal disorders were videotaped.