Category: In the News

The growth in cell and gene therapy development will force industry and health technology providers to “get smart” about combining prospective clinical trial data with real-world data sources and addressing the “data quality mismatches” that will inevitably result, said Amy Abernethy, Verily clinical studies platforms president. Abernethy, the former US Food and Drug Administration principal deputy commissioner…

Beaconcure Technologies, a leader in AI-enabled clinical data validation and automation, announces enhancements to its leadership team, emphasizing its dedication to innovation in drug delivery and clinical data science. The company empowers healthcare professionals with groundbreaking tools, reducing the time and cost of delivering therapies to patients. Beaconcure is pleased to introduce the following professionals…

Fulfills agency promise after bill failed to pass last year Move faces opposition from lab groups, academic centers The FDA would have clear authority to regulate medical tests that come from a single laboratory under a proposal released by the agency Friday. The proposed rule (RIN: 0910-AI85) marks a pivotal step in the Food and…

Brittany Avin McKelvey noticed something was wrong when she had trouble yelling plays to her teammates during middle school basketball games. Eventually, she could not raise her voice so friends could hear her in the school cafeteria. Her doctor told her to rest her voice. When her voice didn’t return after months of rest, an…

The biomarker-driven Lung Cancer Master Protocol (Lung-MAP) may have enrolled a higher percentage of patients who are older, are from rural or socioeconomically deprived areas, and have Medicaid or no insurance compared with conventional, standalone clinical trials in advanced non–small cell lung cancer (NSCLC), according to a study published by Vaidya et al in JCO Precision Oncology.…

During this week’s Friends of Cancer Research (FOCR) meeting on the use of real-world data to support oncology drug development, FDA Commissioner Robert Califf shared his take on the barriers preventing the collection and utilization of high-quality real-world data (RWD) and pondered what lessons the U.S. healthcare system could stand to learn from others. The…

The “biggest area” where FDA Commissioner Rob Califf believes real-world evidence will “make a difference” is in the post-market phase, “where there are all kinds of issues that often involve other parts of the ecosystem.” He pointed to drug developers’ new focus on Alzheimer’s disease and obesity: “we’ve got these enormous markets” and significant patient…

As compared to conventional, stand-alone clinical trials in advanced non-small cell lung cancer (NSCLC), the biomarker-driven Lung Cancer Master Protocol (Lung-MAP) has enrolled higher percentages of patients who are older, patients who are from rural or socioeconomically deprived areas, and patients who have Medicaid or no insurance. These are some of the results of an…

Area of concern for oncology researchers must be addressed so trials can reflect a more accurate real-world population. At Pharma 2023 this past spring, Dirk Reitsma, MD, senior vice president, therapeutic area head of oncology, medical, and scientific strategy for PPD, part of Thermo Fisher Scientific, presented “Inclusivity in Oncology Clinical Trials.” With the many…

GODFREY— It’s been 10 years since the late Theresa Newby Harpole founded Theresa’s Research Foundation. Though she lost her fight with metastatic breast cancer at age 46, foundation members say there is plenty to celebrate and she would be proud. Theresa’s Research Foundation’s authoritative research has been published in a white paper titled “Continuing to…