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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FDA Fast Track designations reach 20th year

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially...
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Three questions on indication assessment

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.
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How to get the most out of a CRO’s bid defense

Bid defenses can, when executed properly, be extremely valuable. We have some insights to share that we have learned from sitting through years of CRO bid defenses and seeing both the relationships and the conduct of the clinical study play out afterward.
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