Dan Steiber

A record-setting number of approvals are coming out of the FDA, the most significant of which are relevant to oncology-based pharmacy practice. Meaningful breakthrough therapies are receiving accelerated approval based on evidence of impact on a surrogate end point rather than evidence of impact on the actual clinical benefit for which the drug is intended, often occurring 4 months or less after FDA acceptance of their new drug application or biologics license application. The good news is that…

AS WE LOOK back at 2019 and the landslide of new drug approvals, so many of them fall into the specialty space and oncology. To better comprehend how pharmacy can best engage with these oncology products, it is important to understand the process that most manufacturers undertake in determining how their product flows through the supply chain. One of the early goals of a specialty products manufacturer, and oncology product launch is selecting the optimal distribution model. As the growth of…