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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.
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The US big pharmacompany Pfizer has voluntarily withdrawn the oral sickle cell disease treatment Oxbryta from the market and halted clinicaltrials of the drug as data indicate a high risk of severe adverse events.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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Lilly is paying $20 million upfront for exclusive rights to AK1780, a P2X7 receptor antagonist in early-stage clinicaldevelopment for neuroinflammatory pain conditions, outside Japan and China.
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.
Not only did Ploos van Amstel begin talks before big pharma rivals got wind of the development, his team was able to put forward a potentially broad development plan that could include PsA, AS and HS as well as psoriasis. It’s extremely possible a pharmacompany may want to partner and it can have many forms.
For example, at the SSIEM Annual Symposium earlier this month, the company shared data on a new candidate for the treatment of Fabry disease, a rare genetic blood disorder. Chiesi’s approach to these trials presents a clear demonstration of Chiesi’s patient-centricity approach in action. Caring for a global community.
million in 2019 and is anticipated to increase at a CAGR for the study period 2017-2030 owing to dynamic pipeline therapies in the mid-/ late-stage clinicaldevelopment and rising gastroparesis prevalence. However, double-blind trials have reported results on the contrary with practically no alleviation of symptoms.
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).
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.
A few days back, AzurRx demonstrated the caliber of its recombinant lipase enzyme, MS1819 in the treatment of severe exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) in the first five patients in a Phase 2 combination therapy trial. Million in 2017. .
As Bob and I were talking about our experiences, almost every strategic kickoff meeting I would go to, the client at the pharmacompany or whatever would say, you know there’s X amount of people who suffer with this condition but it’s underappreciated, under acknowledged, under diagnosed and under treated. Bob (83Bar): Yes, we do.
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.
Due to which, several big pharmacompanies and other industry stakeholders are actively contributing towards development of protein degradation therapies and technologies, contributing towards growth of targeted protein degradation market.
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