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Diversity in clinicaltrials is a “scientific imperative”, but how can industry bridge the gap between “why” and “how”? Removing barriers to clinicaltrial participation for underserved groups is an essential part of addressing health inequalities. Clinicaltrial participation, she went on, was vital.
The lack of diversity in clinicaltrials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. The post IQVIA’s report card for clinicaltrial diversity: must do better appeared first on.
Pharmacompanies face many challenges when involving patients in the design of clinicaltrials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.
In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinicaltrials. Data security: The clinicaltrial data is backed-up and secure.
Clinicaltrials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.
The pharmacompany has completed enrollment of amyotrophic lateral sclerosis patients in its study investigating drugs like verdiperstat, an oral treatment.
The US big pharmacompany Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinicaltrials of the drug as data indicate a high risk of severe adverse events.
AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF). Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinicaltrial.
Dialogue requires humility on the drug company’s side—accepting that sometimes we are wrong about matters we think we understand—and trust on the patients’ side that representatives of large, for-profit entities really have come to listen. Previously, Anthony served as the Global Head of Patient Insights, Solutions and Outcomes at Sanofi.
Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, ClinicalDevelopment, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.
Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinicaltrials. physIQ has a portfolio of FDA-cleared digital biomarkers and a medical-grade platform that can transform raw sensor data into clinical insight.
As we strive to improve the medical product development process and speed the development of effective new therapies to patients, digital health solutions are becoming increasingly available, affordable, and anticipated in healthcare settings by patients, clinicians, and caregivers alike, driving expectations for trial participants.
Xtalks spoke with Maria Reyes Boceta-Muñoz, Clinical Operations Head of Development R&D at GlaxoSmithKline in Spain, Portugal & Israel, to understand the current vaccine development climate and where the sector is headed.
That was the message from ‘The New Normal: Balancing the rapid evolution of trial design with patient need’ panel at the NIHR’s Clinical Research Network Virtual Event on Delivering Complex and Innovative Design (CID) Studies. Thankfully, many pharmacompanies seem to be gradually improving on this. Thanks very much’.”.
Over the years, his career has evolved from routine case processing at large pharmacompanies to a more strategic role in smaller settings, where he feels his impact more directly. He notes that the patient voice is critical, and with more involvement, patient advocacy groups will play an important role in clinicaldevelopment.
In testing new treatments, what is promising in animal models may not transfer particularly well to humans, which helps to explain why there is a 90% failure rate during clinicaldevelopment. Once selected, Quris can in-license them, progress them through to phase 1 trials and, those that succeed, can be licensed to pharmacompanies.
In many cases, pharmacompanies select a contract development and manufacturing organisation (CDMO) to develop products versus doing the work themselves for reasons related to cost, convenience, and capacity. The differences between adult and paediatric dosage forms are typically significant.
Novartis has joined the ranks of big pharmacompaniesdeveloping TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Pharmacompanies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.
The handover comes four years after Pamplona Capital Management bought the company for around $5 billion, and just a few weeks after lab tech company Thermo Fisher Scientific agreed to acquire another CRO – PPD – in a deal valued at $17.4
“If you look at the development we signed 15,000 people in six weeks in a trial set up by the NHS. It spotlighted the UK as a place to do clinicaldevelopment. Speed is everything in clinicaldevelopment. It is really important and we have seen a lot of pharmacompanies interested in the UK.
The company has also signed a licensing agreement with Ono Pharmaceutical , a Japanese pharmacompany, transferring exclusive rights to develop and commercialise anamorelin in Japan, South Korea, and Taiwan. Cancer Cachexia Pipeline.
As summarised by The National Institutes of Health, this includes reducing the number of redundant clinicaltrials, enhancing the statistical strength of studies, reducing overall costs and risks, and improving study participant recruitment, all while triggering creativity and innovation between collaborators.
This philosophy was behind Xperiome’s recent decision to split into two different functions – Raremark, a community where patients and carers can share their experiences of living with rare diseases, and Xperiome, which leverages those insights for pharmacompanies looking to develop drugs for these conditions. About the author.
In an effort to slow the spread of the disease and prevent a second wave, pharmacompanies around the world are continuously looking to advance new methods of treatment. This week’s round up dives into developments from companies based in Australia and the US. Saama Technologies, Inc. ,
The FOCUS trial is Ultimovacs’ fourth Phase II clinicaltrial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We The trial will evaluate the addition of UV1 to a standard of care treatment with PD-1 checkpoint inhibitor pembrolizumab as compared to pembrolizumab monotherapy.
As this issue’s contributors discuss, by working together pharmacompanies and healthcare providers can significantly enhance oncology treatment for patients. Therapeutic cancer vaccine trials have an opportunity to leverage recent interest in vaccine technology to make headway in oncology, says Advanced Clinical’s Christopher Oelkrug.
These samples are often made available to support the research efforts of pharmacompaniesdeveloping new antibacterial agents. In addition to drug discovery and development, isolates can also be used in the design and testing of rapid diagnostics tools, and can inform site selection during the clinicaltrials process.
After a year in which the need for digital transformation in pharma reached white heat levels, the sector mustn’t cool off in 2021 and revert to business-as-usual. A return to normal is the longed for goal for many of us, but pharmacompanies must decide what their future normal should look like.
Key players such as Novartis , Annexin Pharmaceuticals , Gene Signal , Ocular Therapeutics , and Asclepix Therapeutics along with other pharmacompanies are investigating their candidates proactively in a quest to launch their therapies as soon as possible in the Retinal vein occlusion market.
Clinicaltrial monitoring Completing clinical studies more quickly can mean critical medicines and treatments reach patients faster. Companies that combine rapid innovation with speedy but safe trials can gain a multifaceted competitive advantage.
The US FDA is working with stakeholders, including patients, patient advocates, product developers, and researchers, to fulfill its multiple, complex responsibilities towards improving rare disease clinicaldevelopment. However, in the end, developing therapies and drugs for rare diseases is a team sport and a team effort.
WHO is tracking vaccine development worldwide which are in different phases, similarly in India around seven leading companies working independently and in collaboration are in various Phases of clinicaltrials. The first part of Phase-1 trials commenced at PGIMS, Rohtak on July 17. Zydus Cadila ( ZyCoV-D ).
It almost hadn’t made it through clinicaldevelopment, facing problems with ineffective chiral isomers and limited efficacy in animal testing, but showed such impact in human trials that it blew the competition away. Despite some setbacks, Pfizer remains one of the biggest pharmacompanies in the world today.
Although they have, by definition, small addressable markets, the treatments cost just as many resources to develop as therapies for more common diseases – sometimes more, because of the added difficulty of finding sufficiently large patient populations for trials and finding disease experts to run them. So that is the trick.
With other drugs in the pipeline too, van de Winkel said the company aims to continue to break new ground with next-generation antibody-based therapies. He notes that it already has 21 partnerships with pharmacompanies and will aim to keep more product rights than it did in the past.
Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharmacompanies, and gives tips for companies navigating this enormous market. From 2008 to 2017, he served as an executive director of the clinicaldevelopment department at Celgene (now part of Bristol-Myers Squibb).
Similarly, many clinicaltrials are going on to further strengthen the therapeutic pipeline for different Neurological Conditions. The companies in the Parkinson’s Disease Therapeutics Market include Cortexyme, Cerevel Therapeutics, Amneal Pharmaceuticals, Pharma Two B, Cerevance, AbbVie, Theranexus, and others.
In the past two years, the industry has faced considerable challenges due to a constrained financing environment, forcing many emerging and early-stage biotech companies to restructure their operations, merge with other companies or narrow their research and development (R&D) efforts by shelving certain assets.
Pharmacompanies have also made headway in rare diseases as several pipeline projects came to fruition. Calliditas said part A of the global phase 3 NeflgArd clinicaltrial has met its target, measuring the effect of Nefecon versus placebo in patients with the disease known as IgAN for short. Rare disease progress.
The current Viela pipeline includes four therapeutic candidates currently in nine development programs. Besides Uplizna, VIB4920, VIB7734 and VIB1116 are the three candidates in different stages of clinicaldevelopment. The trial failed to meet primary endpoint or other secondary endpoints. .
It builds on the company’s four partnership projects: two with the generics and biosimilars firm Hikma, one with US biotech Inhibrix and another with an unnamed biosimilars partner. Regulators may not require the large phase 3 trials needed to approve completely new drugs, as safety is proven.
Priothera will use the funds to progress the clinicaldevelopment of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. 1. -- -->. -- [if lte IE 8]-->
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