Indication assessment ensures a clear understanding of unmet medical needs, patient segmentation, and what the therapeutic profile—efficacy, safety, dosing, etc.—needs to look like to meet those needs.
Running efficient and effective clinical trials for medical device and diagnostic companies has become increasingly complex. The sheer volume of available genetic and epigenetic data on patients, outcomes data on different procedures and treatments, and the variety of data from personal health trackers can be overwhelming.
The happenings at Halloran’s Clinical Operations Retreat for Executives (better known as CORE) have long been kept under wraps. This year marked the 11th retreat, and we wanted to give everyone a peek inside.
When the FDA bestows an “orphan” designation, it validates a product’s potential benefit. However, sponsors can pursue and receive an orphan designation for a pediatric population which waives Pediatric Research Equity Act (PREA) requirements and exempts the product from clinical studies in a pediatric population.
The biggest impact of the consolidation among academic research and healthcare organizations for the biopharmaceutical industry could occur if a for-profit mentality diminishes an academic institution’s emphasis on basic science and translational research, Laurie Halloran, president and CEO of Halloran Consulting Group, told Scrip.