Behind closed doors at CORE 2017

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.
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Three Orphan Drug Program problems and how the FDA plans to fix them

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.
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Is medical institution M&A squeezing out clinical research?

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.
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