clinical development Articles
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The power of autoantibodies to enhance clinical development success in Systemic Sclerosis (SSc)
An unmet need for disease-modifying therapy persists for patients with Systemic Sclerosis SSc is an autoimmune disease characterised by widespread vascular injury, progressive fibrosis of the skin and internal organs, and a specific pattern of autoantibodies. The clinical manifestations of SSc are highly heterogenous with significant internal organ manifestations causing a greater mortality ...
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How Moderna is Building a Digital Biotech
At Moderna, building a digital biotech is a foundational component of who we are and is a key enabler of our mission to create a new class of mRNA medicines for patients. Incorporating digital into everything we do is mission-critical to us. Read about our digitization strategy new white paper, which includes the ability of our digital infrastructure, built from ground up, to enable ...
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Harnessing the utility of autoantibodies to overcome challenges associated with clinical development in Systemic Lupus Erythematosus (SLE)
Overcoming issues of heterogeneity in disease classification and enabling new approaches to successful drug development. SLE is an autoimmune disease with a wide range of clinical manifestations. It affects approximately 5 million people worldwide and its prevalence varies in different geographies. SLE accounts for around 70% of all cases of lupus, other forms being cutaneous lupus, ...
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Dynamic process modelling of patients` no-show rates and overbooking strategies in healthcare clinics
Abstract: Clinic appointment cancellation and 'no-shows' by patients can disturb day-to-day scheduling and lead to inefficient resource allocation and lost revenue. This paper presents an approach for dynamic process modelling and analysis of patients' no-show rates in conjunction with the overbooking strategy. To this end, a dynamic discrete event simulation model of a clinic operation is ...
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hVIVO used Nuvonis’ GMP Vero cells to produce Novel SARS-CoV-2 virus for a human challenge model
One of the main benefits of using Nuvonis’ fully tested GMP Vero cells is the unparalleled speed towards clinical trials. A case example from one of our customers, hVIVO: First contact with Nuvonis in July 2020, due diligence, contracting, provision of GMP Vero cells and protocols, as well as full documentation Production of GMP material in November 2020 ...
By Nuvonis
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Dynamic process modelling of patients' no–show rates and overbooking strategies in healthcare clinics
Clinic appointment cancellation and 'no–shows' by patients can disturb day–to–day scheduling and lead to inefficient resource allocation and lost revenue. This paper presents an approach for dynamic process modelling and analysis of patients' no–show rates in conjunction with the overbooking strategy. To this end, a dynamic discrete event simulation model of a clinic ...
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Navigating Cancer Announces New Appointment to Board of Directors
Navigating Cancer announced today that Alexandra Snyder, MD, Chief Medical Officer at Generate Biomedicines, has agreed to join its board of directors. Dr. Snyder is succeeding David M. Rubin, Ph.D. who served on Navigating Cancer’s Board from 2015 to the present. “We are pleased to welcome Dr. Snyder to Navigating Cancer’s Board and especially value her point of view as a ...
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Dr Annalisa Jenkins in conversation with Adam M Hill. `Extra Time` podcast
Annalisa Jenkins' inspirational career spans over 25 years in the global biopharma industry – she started her career at St Barts, in London, where she trained as a cardiologist, before joining the British Royal Navy as a medical officer during the Gulf Conflict, achieving the rank of surgeon lieutenant commander during her time there. Annalisa spent almost two decades producing a pipeline ...
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Building effective institutional frameworks to support pharmacogenetic research: an international empirical analysis
As science unravels the genetic basis of disease, the opportunities offered by pharmacogenetics and pharmacogenomics (PGx) for future healthcare become more and more apparent. The objective of this paper is to analyse the current state of PGx research and explore future strategies for more efficient research projects and supportive infrastructures. Based on internet searches and an online survey ...
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Development of new levodopa treatment strategies in Parkinson`s disease-from bedside to bench to bedside
Abstract This review will illustrate the process of moving from an idea through preclinical research and Galenic developments into clinical investigations and finally to approval by regulatory agencies within the European Union. The two new treatment strategies described, levodopa/carbidopa intestinal gel and levodopa/carbidopa microtablets, for advanced Parkinson's disease, have been ...
By Sensidose AB
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Oxygen testing in pharmaceutical research & development - Case Study
As part of their pharmaceutical development, Almac use the Gaspace Advance Micro from Systech Illinois to test oxygen levels in pharmaceutical packaging. The Almac Group was founded by Sir Allen McClay in 2002 with its global headquarters located in Northern Ireland and extensive facilities in the UK, US and Asia Pacific. Almac offer the most comprehensive range of services extending from ...
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Symberix Featured in PNAS
Durham, NC (April 28, 2020) - A review article published in PNAS highlights Symberix's efforts to understand the role of the human microbiota in drug efficacy and toxicity. Symberix co-founder Matt Redinbo is featured in the article alongside other leaders from the emerging field of “pharmacomicrobiomics” -- the study of mechanisms behind the microbial impact on drug metabolism. ...
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Breakthrough Device Designation Received From the FDA for EndoArt
NESS ZIONA, Israel, Feb. 5, 2020 /PRNewswire/ -- EyeYon Medical (https://eye-yon.com/) is a start-up company developing a variety of ophthalmic products for vision-threatening conditions. EyeYon's new product, now on an accelerated path as a Breakthrough Device, is an Artificial Endothelial Layer - EndoArt® - a polymer film implant, attached to the posterior corneal surface, to treat chronic ...
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Ultromics at the American Society of Echocardiography’s 2023 Scientific Sessions
Ultromics will be sharing its groundbreaking AI research and innovation at the American Society of Echocardiography’s annual Scientific Sessions. ASE’s Foundations and the Future of Cardiovascular Ultrasound sessions bring together echo professionals and enthusiasts from across forty-five countries with a selection of networking events, seminars, and workshops from the top minds in ...
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Useful Approaches for Labeling Peptides with Fluorescent Dyes
Due to the high sensitivity, flexibility, selectivity, and environmental stability, fluorescent techniques are broadly applied in biological research. Peptides provide unique possibilities for the development of efficient and selective fluorescent sensors because of their modular nature, synthetic accessibility, and biomolecular recognition potential. Accordingly, labeling peptides with ...
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Symberix Featured in Nature
Durham, NC (February 3, 2020) - An article in Nature highlights Symberix's efforts to understand the complex relationship between drugs and the microbiome. The paper discusses recent contributions to the emerging field of “pharmacomicrobiomics” -- the study of how microbes impact drug disposition, efficacy, and toxicity. Symberix is developing bacteria-targeted small molecules that ...
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OneThree`s Workflow for Predicting Drug Toxicity - Case study
Background OneThree Biotech was born out of the largest precision medicine institute in America with the purpose of decreasing the failure rate of bringing therapeutics to market using biology driven artificial intelligence. Our technology was builtin a lab setting; allowing us to engineer our methodologies around real-world results. While working with major biotech and pharma partners; ...
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Seascape Clinical Graduates From PharmStars Accelerator
Seascape Clinical was one of 12 companies – selected from nearly 100 global applicants – that participated in the first cohort of the 10-week PharmStars Accelerator Program. This (female founded!) pharma-focused accelerator program was designed to bridge the gaps between pharmaceutical companies seeking innovative solutions, and digital health startup ...
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Are clinicians delivering the best care for patients with bladder and bowel dysfunction? A recent study suggests otherwise
People with neurogenic bladder and/or bowel dysfunction often suffer from highly individualized symptoms. It can be difficult to quantify change in an individual’s symptoms using standardized measurement tools, and points to the value of Patient—Centered Outcome Measures. As a relatively new concept, Patient—Centered Outcome Measures (PCOM) aims to place patients, their ...
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Clinical CRISPR Success Demonstrates Need for Quality Control
The Clinical CRISPR Successes Are Stacking Up. But Where’s the Emphasis on Quality Control? In mid-September, Intellia released some promising data on two of their CRISPR-based therapeutics. These results are a significant milestone for genome editing and validation of its effectiveness in the clinic. However, the safety of CRISPR-based therapeutics has been a major concern and part of a ...
By CRISPR QC
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