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Q&A With Harpreet Gill, Head of Decentralized Clinical Trials at Icon

Mike Hollan Gill discusses her continuing work to transform clinical trials and improve the patient experience through DCTs. Harpreet Gill Head of decentralized clinical trials Icon Harpreet Gill, head of decentralized clinical trials (DCTs) at Icon, is working to make DCTs more easily implemented and more commonly used throughout the industry. She recently spoke with Pharmaceutical Executive about her work. Pharmaceutical Executive: Can you explain the importance of decentralized trials? Harpreet Gill: As the time has gone on over the last few years (and we know the pandemic accelerated this) there’s been a greater need to think about the different ways to engage patients in clinical trials. There’s an element of efficiency there in terms of how data is collected. One of the things that we are seeing is that there are more clinical trials, but there aren’t as many patients there are interested in being involved because it can ...
- Source: drugdu
- 204
- October 19, 2023
How Mass General Brigham Is Integrating Behavioral Care Into Its Primary Care Model

Mass General Brigham launched a program this month in collaboration with behavioral health medical group Concert Health. Under the program, more than 400 Mass General primary care providers can refer their patients to Concert. The health system’s goal is to increase patients’ access to diagnoses and treatment for mild to moderate behavioral health issues — particularly for Medicaid patients, who are the most underserved. By KATIE ADAMS Health systems are increasingly realizing the importance of integrating behavioral care into primary care. Physical and mental health are interconnected, and addressing one without the other can lead to incomplete or less effective treatment. Integrating behavioral care into primary care also aids the early detection of mental health concerns, which can prevent more severe issues from developing, as well as reduces the stigma associated with seeking mental health services by making them a routine part of overall healthcare. Mass General Brigham understands the ...
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- October 19, 2023
New contrastive learning method could improve voice pathology detection

Voice pathology refers to a problem arising from abnormal conditions, such as dysphonia, paralysis, cysts, and even cancer, that cause abnormal vibrations in the vocal cords (or vocal folds). In this context, voice pathology detection (VPD) has received much attention as a non-invasive way to automatically detect voice problems. It consists of two processing modules: a feature extraction module to characterize normal voices and a voice detection module to detect abnormal ones. Machine learning methods like support vector machines (SVM) and convolutional neural networks (CNN) have been successfully utilized as pathological voice detection modules to achieve good VPD performance. Also, a self-supervised, pretrained model can learn generic and rich speech feature representation, instead of explicit speech features, which further improves its VPD abilities. However, fine-tuning these models for VPD leads to an overfitting problem, due to a domain shift from conversation speech to the VPD task. As a result, the ...
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- 214
- October 18, 2023
Quality of ultrasound scans of the liver and kidneys found to be lower in obese patients

Ultrasound of the abdominal organs is a central diagnostic tool and is recommended as the first-line approach for many medical conditions. Compared with other imaging modalities such as computed tomography (CT) and magnetic resonance imaging (MRI), ultrasound is readily available, avoids unnecessary radiation exposure and can be used in almost every case. However, the accuracy of this method is usually limited in obese individuals because the imaging quality of anatomical structures is impaired. To date, the degree of obesity at which ultrasound diagnostics are no longer sufficiently precise has not been sufficiently researched. In a recent clinical study at the University of Leipzig Medical Center, researchers found that the quality of ultrasound scans of the liver and kidneys was significantly lower in obese patients. Professor Thomas Karlas, head of the study and corresponding author of the current publication, said, “The results showed that as the body mass index of the ...
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- 164
- October 18, 2023
FDA establishes new advisory committee to provide expertise on digital health

The US Food and Drug Administration (FDA) has set up a new advisory committee to provide expertise on digital health technologies (DHTs), such as artificial intelligence, digital therapeutics and remote patient monitoring. The Digital Health Advisory Committee, which should be fully operational next year, will advise the regulator on the benefits, risks and clinical outcomes associated with the use of DHTs, as well as identify risks, barriers or consequences that could result from proposed or established FDA policy or regulation for topics related to DHTs. The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds, the FDA said, to “help ensure digital health medical devices are designed and targeted to meet the needs of diverse populations”. The agency said it is currently seeking nominations of “appropriately qualified” candidates, setting an application deadline of 11 December. Jeff Shuren, director of the FDA’s Center for Devices ...
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- 207
- October 18, 2023
Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as an adjuvant treatment for adults and adolescents aged 12 years and older with completely resected stage 2B or 2C melanoma. The decision makes Opdivo, which is already approved in the US for use in certain melanoma patients, the only PD-1 inhibitor indicated as an adjuvant treatment for eligible patients with stages 2B, 2C and 3, as well as stage 4 completely resected melanoma. The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with more than 97,000 new cases expected to be diagnosed in the US overall this year. Melanomas can be mostly treatable when caught in the very early stages, but survival rates can decrease as the disease progresses. “Within five years ...
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- October 18, 2023
Merck’s Keytruda receives approval greenlight from EU CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirmed a positive recommendation for Merck’s Keytruda (pembrolizumab) as part of a first-line treatment for advanced gastric and gastroesophageal junction cancer (GEJ). Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, would be used in conjunction with fluoropyrimidine- and platinum-containing chemotherapy in adults whose tumours express PD-L1 with a combined positive score (CPS) ≥1. The intravenously administered drug is designed to improve the immune system’s anti-tumour response by inhibiting the binding of PD-1 to its ligands PD-L1 and PD-L2, thereby activating tumor-fighting T-cells. Keytruda is also being studied as a treatment for hepatobiliary, oesophageal, pancreatic, and colorectal cancers. The EU CHMP’s positive recommendation was based on results from the Phase III KEYNOTE-859 (NCT03675737) study, a randomised, double-blind clinical trial evaluating the efficacy of Keytruda plus chemotherapy as a first-line treatment for human epidermal growth factor receptor-2 (HER2) negative, unresectable or ...
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- 175
- October 18, 2023
With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. Pfizer has stepped up to the plate with an update, and its effects are staggering as the company has slashed its 2023 revenue projection by $9 billion. Pfizer now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion. In delivering its update late Friday afternoon, a time often reserved by companies to reveal bad news, Pfizer chalked up most of the decline to a $7 billion decrease in its projection for sales of oral antiviral Paxlovid. The company has also cut its forecast for sales of COVID vaccine Comirnaty by $2 billion. Pfizer also sees earnings per share plummeting to between $1.45 and $1.65, down from ...
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- October 18, 2023
FDA clears next-gen image-guided therapy tech from GE HealthCare

BY SEAN WHOOLEY The Allia IGS Pulse system. [Image courtesy of GE HealthCare] GE HealthCare (Nasdaq:GEHC)+ announced today that the FDA granted 510(k) clearance to its Allia IGS Pulse system. The latest addition to GE HealthCare’s image-guided system (IGS) offerings features a new imaging chain. GE HealthCare says it engineered this feature to provide exceptional imaging at the right dose. This enables visible impact in complex cardiology interventions regardless of patient size. Allia IGS Pulse provides a personalized workspace to meet the operator’s specific needs and preferences. As part of the new image chain, the system features a monopolar X-ray tube used to capture images for interventional procedures. GE HealthCare says the tube — the first of its kind — provides powerful, yet quiet imaging capabilities. Its small footprint also helps clinicians reach steep angulation for better understanding of the coronary artery anatomy. More about the GE HealthCare Allia IGS ...
- Source: drugdu
- 174
- October 18, 2023
Novo Nordisk Strikes Deal for Late-Stage Hypertension & Kidney Disease Drug

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes. By FRANK VINLUAN Novo Nordisk has again turned to dealmaking to expand its pipeline, but rather than adding yet another weight loss drug prospect the company is acquiring a molecule that’s a potential treatment for uncontrolled hypertension and chronic kidney disease. The Danish pharmaceutical giant has agreed to buy ocedurenone, a drug that KBP Biosciences has advanced to Phase 3 testing. Specific financial details, such as an upfront payment and milestones, were not disclosed Monday, but Novo Nordisk said it could end up paying out up to $1.3 billion. The target of KBP’s drug is the mineralocorticoid receptor, whose overactivation is associated with hypertension and chronic kidney ...
- Source: drugdu
- 232
- October 18, 2023

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