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Tom Zhang, PhD, Chief Scientific Officer, Large Molecule Bioanalysis Revolutionizing Therapeutic Development with Cutting-Edge Bioanalysis Automation Cutting-edge advancements in bioanalysis (BioA) and drug R&D are reshaping the future of preventative and interventional care, but how do we harness these to their fullest potential?
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
Yet enrollment of ethnic minorities in NIH clinicaltrials and for trials studying approved devices and drugs remains low. Further efforts are urgently needed to increase diversity in the cardiology workforce, which will improve clinicaltrial diversity and cardiovascular health for all.
Interventional/Structural Fellow, Cleveland Clinic. ClinicalTrial, Medical Education. The goal of the CardioNerds ClinicalTrials Network is to pair equitable enrollment with trainee development. Among trial sites with affiliated programs, we invited program directors to nominate fellows to participate.
Amit Goyal of the Cleveland Clinic will present “The CardioNerds ClinicalTrials Network: Pairing Equitable Enrollment With Trainee Development.” The CardioNerds ClinicalTrials Network pairs equitable clinicaltrial enrollment with the personal and professional development of fellows in training.
XTALKS WEBINAR: Keys to Success in ClinicalTrials: A Strategic Guide for Biotechs and Startups Live and On-Demand: Thursday, May 22, 2025 , at 11am EDT (5pm CEST / EU-Central) Register for this free webinar to learn how biotechs can navigate endpoint challenges in clinicaltrials.
… Pfizer told employees it plans to pull back on early-stage research into treatments for rare diseases, including the development of new viral-based gene therapies , Barron’s reports. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,
The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiologyclinics across the U.S.,
The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
The context and stakeholder input have been key in developing and implementing nudges. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.
a Canadian biopharmaceutical firm specializing in cardiovascular therapies, recently reported positive results from a Phase III clinicaltrial of its leading candidate, etripamil nasal spray, for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone Pharmaceuticals Inc., How Does Etripamil Nasal Spray Work?
Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.
New data, including two late-breaking clinicaltrial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease. senior vice president, head of cardiovascular development and global drug development at Bristol Myers Squibb. “We
“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinicaltrial research work in heart health, noting most new drugs never make it to market.
In addition to being one of Poland’s top recruiting sites in cardiologytrials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. As a result, Sponsors and CROs can benefit from simplified access to international clinical research capabilities. and Europe.
This expanded clinical research opportunities for patients as a core pillar of the affiliation’s mission, with the goal of providing access to novel treatments for diagnoses in addition to standard of care. An important step was a review of the state of clinicaltrial awareness at the time of the affiliation agreement.
Tools for clinicians in point-of-care use UTICA, NY — More than 2 million coronary artery stents are implanted each year to help protect or restore normal blood flow to the heart, to treat patients suffering from angina or a heart attack due to coronary artery disease (CAD). While stents are highly effective and safe devices, […].
Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinicaldevelopment of their DA01 cell therapy approach for Parkinson’s disease.
Bayer is proud of the approval of vericiguat in Japan and the contribution it has shown in clinicaltrials.”. Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., The vericiguat program is being co-developed by Bayer and MSD. Kenilworth, NJ, USA). About Vericiguat Vericiguat 2.5
At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients.
The five new NHS Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinicaltrials in the UK by offering new ways to conduct late-phase, large-scale research projects.
This is the finding of a study by investigators at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), published today in the Journal of the American College of Cardiology (JACC). The most severe form of COVID-19 is severe respiratory failure, which requires intubation and is associated with a high mortality rate.
The acquisition of KO-MED is Velocity’s first foray into Oncology research, which accounts for roughly 40-50% of clinicaltrials globally. KO-MED has been the leading multi-site network in Poland since 2020, having enrolled over 9,000 patients into clinical research. and Europe.
Researchers from Belgium, the Netherlands, Russia, and Italy have developed a breakthrough method for quickly, accurately, and reliably diagnosing cardiac arrhythmias. The technology principles are published in JACC: Clinical […]. This is a unique method to diagnose pathogenic areas in the heart in a minute Credit: Front.
XTALKS WEBINAR: Environmental Sustainability and the Supply of Medicines for ClinicalTrials Live and On-Demand: Thursday, January 16, 2025, at 10am EST (4pm CET/EU-Central) Register for this free webinar to learn how major pharma companies are working towards environmental sustainability and reducing their environmental impact.
The Toronto-based company has recently announced positive results from an independent clinicaltrial which showed that their fluorescence imaging device MolecuLight i :X improved 12-week wound healing of diabetic foot ulcers by 204 percent. The challenge is that other specialities have diagnostic imaging to assist clinicians.
UK-based RHYTHM AI is to go ahead with a larger clinicaltrial of its artificial intelligence (AI)-driven system, which could be used as a treatment for atrial fibrillation without the need for medication. Clinicaldevelopment of the system got off the ground last year when the company announced the closure of a £2.15m financing round.
An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. It is also rolling out the artificial heart in France within the framework of a 52-patient clinicaltrial.
Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinicaldevelopment in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.
Felker and Dr. Udelson join current advisors to support the development ofalfapump ® DSR for the management of fluid overload in patients with heart failure. The Sequana Medical management team is working closely with its advisors on the development of alfa pump DSR (Direct Sodium Removal). GHENT, Belgium, Oct.
the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinicaltrial is to evaluate the safety, tolerability, and?preliminary?efficacy?of Senior Vice President, ClinicalDevelopment, BlueRock Therapeutics.
. – A medical-device startup that aims to improve the health of pregnant women is the top winner in an annual pitch contest presented by the Massachusetts Medical Device Development Center (M2D2). Now in its ninth year, the M2D2 $200K Challenge showcases the inventions […].
Introduction to Electronic Case Report Forms (eCRF) In the ever-evolving landscape of clinicaltrials, the transition from traditional paper-based case report forms to electronic Case Report Forms (eCRFs) has marked a significant advancement in how clinical data is collected, managed, and analyzed.
1 Patients can develop a wide range of symptoms, including liver disease and/or psychiatric or neurological symptoms, such as personality changes, tremors and difficulty walking, swallowing or talking. ALXN1840 is a potential new once-daily, oral medicine in development for the treatment of Wilson disease.
Pharma brands can develop: Whitepapers on clinicaltrials showcasing drug effectiveness. Scientific blogs discussing new advancements in oncology, cardiology, or rare diseases. Behind-the-scenes research lab videos showcasing drug development. Case studies on patient outcomes using specific treatments.
During the course of her more than 30 years in the industry, she has spanned a broad range of therapeutic areas, including oncology, immunology, infectious disease, cardiology, neuroscience, Alzheimer’s disease, medical devices, and more. Honorable Mentor—Jag Dosanjh, AbbVie.
Three ongoing influenza vaccine cardiovascular outcomes trials could hold insights into testing novel interventions against COVID-19 Seasonal influenza vaccine development and mass production, as well as three international influenza vaccine cardiovascular outcomes trials currently underway, may inform future efforts targeted at developing and evaluating (..)
The company’s commercial priorities are three-fold: (1) Initially focusing its commercial efforts on rare diseases within its prolific neurology and cardiology franchises (2) pioneer new markets where there are no available treatments (3) create new standards of care where there has been a lack of innovation to optimize patient care.
Bronchitol was developed by Pharmaxis Ltd., market and congratulate all Chiesi team members and partners who supported the clinical process.”. In three large-scale global clinicaltrials totaling 761 patients aged 18 years and older, Bronchitol use led to a sustained improvement in FEV 1 (Forced Expiratory Volume) versus control.
We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinicaltrials. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials.
We did not get a Class II certification for diabetes only, or orthopedics or cardiology; we got a disease-agnostic certification. Now, as we develop new predictive algorithms, whether that is in diabetes, cardiology, respiratory or oncology, we can bring those algorithms to our platform because it is disease-agnostic.
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– Continued advancement of pipeline, including initiation of three Phase 3 development programs and two novel IND filings in Q4 2020 – – Expects to exceed the high end of 2020 revenue guidance, given at Q3 2020 results, of $5.9-$5.95 12, 2021– Alexion Pharmaceuticals, Inc. “For
Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinicaltrials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of ClinicalTrial Management.
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