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COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.
Clive Dix, head of the UK’s Vaccine Taskforce, told pharmaphorum in an interview that he was able to persuade Novavax to base research, development and manufacturing in the country because of its efficiency at getting trials up and running. It spotlighted the UK as a place to do clinicaldevelopment.”.
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. Both groups were poorly represented however in oncology trials. for Hispanics.
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.
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.
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.
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. In addition, 43.4 percent were using or piloting omics data.
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The US big pharmacompany Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinicaltrials of the drug as data indicate a high risk of severe adverse events.
Clinicaltrials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. I’m interested to learn more about the history of rare disease trials as it relates to the patient voice. Wendy: I do think it varies significantly from place to place.
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.
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.
Clinical stage pharmacompany PharmaKure believe their combined drug targeting amyloid deposits associated with Alzheimerâs Disease can bring quality of life to patients.
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.
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.
diff) looks like it may join a growing list of candidates that have been shelved or delayed, after the shot failed to meet its primary objective in a phase 3 trial. The pharmacompany was quick to point out however that the CLOVER trial of PF-06425090 was undermined by a lower-than expected rate of C.
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.
It’s been made possible by an all-hands-on-deck approach from the NHS, academia, regulators and other players in the health system who have worked together to produce clinical data on vaccines and therapies for COVID-19. If you look at the development we signed 15,000 people in six weeks in a trial set up by the NHS.
The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. 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 Mascha Binder, M.D.,
Gyroscope Therapeutics and its gene therapy for the sight-robbing disease geographic atrophy (GA) has been acquired by a big pharmacompany – but likely not the one you would expect.
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.
Helsinn Group , a Swiss pharma player, is evaluating Anamorelin, an orally active selective ghrelin receptor agonist against Cancer cachexia, The company is conducting Phase III trial to test the efficacy and safety of anamorelin for the treatment of weight loss and anorexia in patients with advanced NSCLC with cachexia.
Merck and its partners are hoping to have initial data from trials of the bioelectronic device by the end of 2022 , which will then be used to establish a clinicaldevelopment plan with an eye on getting approvals in major markets like Europe and the US.
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.
The new drug – Quviviq (daridorexant) – has been approved by the European Commission for adults who have been suffering insomnia for at least three months and are experiencing “considerable impact” on daytime functioning, according to the Swiss pharmacompany.
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.
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
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.
AI in pharma R&D is one of the latest innovations helping teams apply existing knowledge to new problems. Artificial intelligence (AI) has many implications for pharmaceutical companies, including on research, drug discovery and development, manufacturing and trials.
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.
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.
The FDA’s approval of Duvyzat for DMD, based on our robust and successful clinicaldevelopment program, reflects Italfarmaco’s commitment to providing a safe and proven-effective therapy that can have a meaningful impact for people living with DMD,” said Paolo Bettica, MD, PhD, chief medical officer at Italfarmaco Group in a press release.
California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in part to fund clinicaldevelopment of ARX-788, its HER2-targeting antibody drug conjugate (ADC). The company plans to list on the NYSE with the AMAM ticker.
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. Likewise, tanezumab, an anti-osteoarthritic, failed in trials. No signs of slowing down.
The American Society of Clinical Oncology (ASCO) annual conference was one of the highlights of the year in cancer research and the fact it was held virtually did not distract from some stunning clinical lung cancer trial results presented by AstraZeneca. months, compared with 6.7 months in patients treated with chemotherapy.
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.
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.
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. , Source link.
GSK gets worldwide rights to the potentially first-in-class drug, with the exception of China, and will be wholly responsible in its markets for clinicaldevelopment and commercialisation. Preliminary data has shown that the drug can reduce levels of HSD17B13 protein as well as other liver enzymes that are biomarkers for NASH.
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 ).
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