Ginny brings a wealth of knowledge and experience to the table from her diverse background in nursing, law, and regulatory policy. The conversation delved into the intricacies of global regulatory practices and the importance of collaboration in the industry. Liza Laws (LL): Thanks for joining me, Ginny. Could you start by…
CluePoints is a cloud-based software platform specializing in Risk-Based Quality Management (RBQM) and data quality oversight in clinical trials. The platform is designed to streamline processes, improve data integrity, and ensure risk compliance, making clinical trials safer and more efficient. The investment by EQT, a firm with a strong track…
IQVIA recognized the intricate challenges associated with participant payments in clinical trials, which often involve cumbersome processes and multiple vendors, leading to delays and dissatisfaction among participants. Jim provides insights into the motivations and objectives behind launching this comprehensive solution. Can you explain the core motivations behind launching IQVIA’s participant…
In an interview with Biopharma Reporter, Mainz Biomed CEO Guido Baechler explains how his company’s stool test for colorectal cancer compares with well known, multicancer blood tests like Galleri. Early detection blood tests such as Grail’s Galleri typically involve isolating DNA from the blood and deploying machine-learning algorithms to scan…
The panel featured Ariel Berger, executive director of integrated solutions and real-world evidence at Aventura; John Van Hoy, executive director of AI and advanced analytics at PPD; and Gino Pirro, vice president of product and technology at PPD. The conversation highlighted how AI and real-world data are transforming the landscape…
This guideline, which ensures regulatory compliance with the requirements of ICH GCP E6, came into effect on 9 September 2023. It introduced a new consolidated framework of standards for computerised systems and electronic data in clinical trials. It is a unique guideline in its thoroughness and extent on the matter. OSP…
Last year, Astellas Pharma established a behavioral science consortium to perform research aimed at better understanding what matters to patients and their carers, findings that will be channeled into drug development. Health organizations are developing a keen interest in behavioral science too. The World Health Organization (WHO) recently appealed for…
This first-of-its-kind phase 2 grant will expedite the commercialization of cannabinoid ingredient production via precision fermentation. The funding aims to develop cost-effective active pharmaceutical ingredients for treating conditions such as appetite suppression, obesity, inflammation, and diabetes. Cellibre, established in 2019 by a team of biomanufacturing innovators, is dedicated to creating…
With his background in psychiatry, Michael observed the daily struggles of patients in Opioid Treatment Programs and developed Sonara to offer a more flexible and supportive approach. This groundbreaking solution allows patients to demonstrate responsible methadone use, earn take-home doses faster, and achieve their recovery goals with greater ease. Liza…
The expansion will introduce 200,000 sq. ft. of additional space, addressing the growing demand for Grade-A facilities amid a rising global appetite for research and development (R&D). The new storage and logistics areas will support over 500 customers, including industry giants such as AstraZeneca, Pfizer, BeiGene, and GE Healthcare. This…