Small molecule orphan drugs: Balancing financial incentives and complex challenges

Whitepaper

For companies pursuing an orphan drug, successfully traversing the path to regulatory submission requires striking the right balance of speed-to-clinic and cost. While there is no one-size-fits-all approach, shared characteristics of successful development projects include:

Early and frequent engagement with regulatory authorities
Alignment of CMC and clinical activities
Transparent communication among internal and external stakeholders
An integrated vendor strategy

In this whitepaper, our experts help guide you through the complex challenges of getting your small molecule orphan drug to market faster.

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