The field of pathology is gradually going digital, marking a pronounced shift from the traditional use of glass slides, a practice that dates back to the Victorian era. Digital pathology uptake reached an “exponential” pace in the wake of the pandemic, noted Dr. Monika Lamba Saini, pathologist-scientist, director of digital innovation at Q2 Solutions, an…
Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials
Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.…
Biotech bounces back at JPM 2024 on optimism, breakthroughs and calculated bets, but uncertainties persist
At the dawn of 2024, there’s a sense of renewed optimism in the biotech sector despite recent sector-specific challenges. This week, the JP Morgan Health Care Conference witnessed strong deal-making activity. For instance, Merck agreed to acquire cancer drug developer Harpoon Therapeutics for roughly $680 million, highlighting continued interest in oncology cancer therapies. Meanwhile, Novartis…
Medable: AI-powered platform can halve trial build times
Decentralized clinical trial pioneer Medable unveiled an intelligent automation technology at the JP Morgan Health Care Conference, claiming it can slash standard trial build timelines by at least 50%. This development hinges around electronic clinical outcomes assessment (eCOA) — a common bottleneck in trial startups. “We’ve used AI to essentially take a protocol and translate…
Zai Lab’s unified approach to tackling cancer, autoimmune, and neurological diseases
Zai Lab is a global biopharmaceutical company founded in 2014 and based in China and the U.S.. Led by Chairperson and CEO Dr. Samantha Du, the company now has more than 2,000 employees internationally. Focusing on developing novel therapies for oncology, autoimmune disorders, infectious diseases, and neurological disorders, it has built a broad pipeline of…
Integrated bioanalysis strategies in nonclinical early in-vivo PK studies of siRNAs
In molecular biology, small interfering RNAs (siRNAs) have emerged as pivotal tools for regulating gene expression through RNA interference (RNAi). These double-stranded RNA molecules, consisting of 19-23 base pairs, play a crucial role in research and drug development by inducing the degradation of target mRNA and inhibiting gene expression. This article explores the complex world…
How a J&J exec found her calling in autoantibody drug development
Dr. Katie Abouzahr’s career, which began in the wards of the UK’s National Health Service (NHS) before extending into management consulting, paved the way for her leadership of autoantibody and maternal fetal medicine programs at Johnson & Johnson. “It’s not a typical pharma executive’s straight line path,” she acknowledged. “Careers can often be jungle gyms…
LSD shows promise as standalone anxiety treatment in trial
Phase 2b data from MindMed’s LSD-based therapy adds to the mounting evidence that psychedelic-assisted therapies could treat mental health conditions like anxiety, depression and PTSD. In particular, the study found statistically significant dose-dependent improvements in the Hamilton Anxiety rating scale (HAM-A) at the 100 and 200 μg dose levels in the four-week study. Similarly, recent…
Delix’s psychedelic-inspired DLX-001 appears to pose no safety or hallucinogenic risks in early testing
Biotech startup Delix Therapeutics has unveiled promising interim phase 1 safety data for its lead neuroplasticity drug candidate DLX-001 at a leading neuroscience conference, marking the first clinical validation of its “psychoplastogen” pipeline. In essence, the company is developing psychedelic-inspired therapies that can prompt neuroplasticity without the hallucinogenic, psychotomimetic, or dissociative effects typical with traditional…
Zepbound helps people lose 25% of body weight on average 88 weeks, but weight regain is a concern
Lilly’s hot weight loss drug Zepbound (tirzepatide) may be one of the most effective drug therapies for weight loss. In an open-label 36-week study, participants lost an average of 20.9% of their body weight in 36 weeks. With an average weight of 107.3 kg (236.5 lbs), that equates to about 22.4 kg (49.4 lbs) on average.…
Pfizer hemophilia drug marstacimab accepted for FDA, EU review
U.S. and European regulators have accepted applications for Pfizer’s marstacimab, an investigational treatment for hemophilia A and B. The FDA set a decision date in late 2024 while the EMA set the stage for a possible approval in early 2025. The applications are based on positive data from the phase 3 BASIS trial, presented over…
EDC fading in prominence as AI and cloud gain ground
In a year or two, the clinical trial industry may move beyond electronic data capture (EDC), a technology that has been the cornerstone of clinical data management for decades, projects Raj Indupuri, CEO of eClinical Solutions. Given the potential of electronic medical records (EMR) to feed directly into data infrastructure, the need for EDC may…
At AWS re:Invent, Pfizer exec frames digital as a core business strategy
In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics
In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake…
Can AI ‘move fast and cure things’ in healthcare?
The entry of AI into healthcare is starkly different from the accepted adage of “move fast and break things” in consumerism. In episode 1 of AI Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks, and Brian Buntz, pharma and biotech editor, discuss the opportunities, limitations, and direct impact of Ai in healthcare fields including…
Evidence on GLP-1 drugs and muscle loss remains murky
[Updated on March 18, 2024] Do GLP-1 drugs lead to loss of muscle mass? The German expression “jein,” spanning both yes and no, captures researchers’ present understanding of the complexity of this issue. Yes, recent research on glucagon-like peptide-1 (GLP-1) drugs for weight loss indicates these medications may lead to significant reductions in lean body…
Tirzepatide beats semaglutide 3-to-1 for weight loss goals in real-world data
A new real-world study (pre-print) is the first to directly compare weight loss outcomes between the popular diabetes medications Lilly’s Mounjaro (tirzepatide) and Novo Nordisk’s Ozempic (semaglutide). The results show Mounjaro users are significantly more likely to achieve meaningful weight loss. Analyzing data from more than 40,000 patients from a large U.S. health database, the…
Organon reinforces commitment to women’s health beyond reproductive health
The fact that women’s health has long been underprioritized is common knowledge. Organon, with roots going back to 1923 and having sharpened its focus on women’s health post its 2021 spinoff from Merck & Co., aims to address significant gaps in treatment and care. “Our commitment to women’s health is not just a part of…
Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study
Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology…
Vaccine mega-trials: Rare behemoths in the vaccine trial landscape
Abstract The vast majority of vaccines are prophylactic in nature. As a result, the demonstration of their efficacy paradoxically requires the infectious disease to occur among non-diseased study participants randomized between investigational vaccine and appropriate control groups. The statistics of vaccine efficacy (VE) calculation are nearly entirely and solely based on the number of observed…
Cybin sees near future for psychedelic therapy after promising interim phase 2 data
With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale. As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But…
Anticipating IND submission: Ensuring your drug is ready for preclinical toxicology studies
Drug development is often a vast and intricate journey. Each phase signifies an advancement in the process, always with an eye toward patient safety and efficacy. But before any therapeutic finds itself on the bedside tables of hopeful patients, it faces a formidable challenge: preclinical toxicology testing. As the gateway to clinical trials, this early…
Unlocking the secrets of cellular immunogenicity: A deep dive in ELISpot assays
Next generation therapies and vaccine research have recently dominated headlines and scientific discovery. This research and its ability to treat previously untreatable conditions has rightfully excited the scientific and medical communities worldwide. But the complexities involved require a nuanced approach to ensure the treatment is safe and effective. Integrating cell culture into cellular immunity testing…
Is the new $15,900 postpartum depression pill worth it?
Sage Therapeutics has pegged the wholesale acquisition price of the oral postpartum depression (PPD) drug Zurzuvae (zuranolone) at $15,900 for a 14-day course of the therapy. The drug, co-developed by Biogen, won the FDA green light in August. The companies plan on launching the drug in December. The DEA has classified zuranolone as Schedule IV,…
How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials
In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats. The lakehouse architecture aims to provide a comprehensive overview of data,…