Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Designing a CMC Strategy for Accelerated Development of Biotherapeutics."
As the pipeline of biologic drugs intended to treat complex disease expands, the typical timeline for drug development seems to be shortening more frequently and with more intensity. There are many drivers to accelerate development.
The potential to satisfy an otherwise unmet medical need for serious or life-threatening conditions is a common explanation for this phenomenon, with nearly 300 biologic drugs being granted fast-track designation in recent years. In order to support this, the US Food and Drug Administration (FDA) has constructed a pathway specifically designed for this scenario. Concurrent process development and analytical development is acceptable, especially when paired with a thorough risk assessment and the use of a restricted control strategy. However, despite the flexibility provided by the FDA for this approval pathway, the safety, efficacy, and evidence showing substantial improvement in patient outcome remains central to the approval process.
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