Western drug executives long treated China as little more than a sales target. Think more than a billion potential customers, a gold mine for revenue, but nothing special in terms of fresh ideas. Lately, that thinking has changed fast. China now ranks as the world’s second-biggest pharmaceutical market. The country’s sales hit $112.8 billion in…
Quanterix VP: Why biomarkers are no longer supplemental
Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend. “Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are…
As the pharma industry grapples with a talent shortfall, AI makes inroads in drug-safety workflows
It turns out that AI really is doing the work. At least a growing chunk of it. Artificial intelligence is spreading through the global workforce like wildfire, dwarfing the adoption pace of the internet, with a new Anthropic report citing Gallup research that 40% of U.S. employees now use AI at work. While the field…
Early-phase study design considerations for long-term follow-up in vaccine clinical trials
Healthcare is one of the largest sources of “big data,” accounting for upwards of 30% of all data produced globally.1 Early on, the potential benefits of this data for healthcare outcomes were immediately evident. As that promise has begun to materialize, with the advent of AI and machine learning, real signals of improvement in therapeutic…
Digital ready, regulatory waiting: The clinical trial pathology paradox
While diagnostic pathologists can review scanned slides remotely with AI assistance and instant global collaboration, much of the clinical trial pathology world still ships physical glass slides between labs, dealing with FedEx delays and proprietary file formats. “For exploratory assays, yes, it’s exploding. Everyone’s enjoying artificial intelligence and machine learning for various aspects, but there’s…
Navigating the landscape of cell and gene therapy development: Insights from the FDA’s new FAQ
The U.S. Food and Drug Administration (FDA) recently released a draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.” This 40-page document, while not legally binding, offers insights into best practices for common questions received by the Office of Therapeutic Products (OTP). While each question is answered in brief, the…
FDA grants breakthrough status to LSD-based anxiety treatment
In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector…
CGT demands vision, partnership and patient-centricity to transform healthcare
As personalized medicine continues to progress, cell and gene therapy (CGT) development is poised to enable tremendous medical breakthroughs. Unlike traditional treatments which merely manage symptoms, CGT could treat the root biological cause of many diseases: the faulty genes. “The cell and gene therapy space is truly exciting. What this ultimately means for patients and…