Is a pIND meeting always a prerequisite for success, or is it sometimes a bottleneck?

Many in our industry view the pre-IND meeting as a mandatory rite of passage, a non-negotiable step in every drug development journey. But I challenge that assumption. While invaluable in certain complex scenarios, blanket application can inadvertently slow down groundbreaking innovation.

My experience suggests that the true value of a pIND lies in mitigating specific risks, not acting as a "well-baby check" or a crutch for corporate anxiety. When the path forward is clear, and the data speaks for itself, sometimes direct engagement with an IND filing can be the more agile approach. It's about strategic risk assessment, not simply ticking a box.

The future of drug development demands agility and a clear-eyed view of process optimization. We must continually evaluate whether our established norms truly serve the ultimate goal: bringing life-changing therapies to patients faster.

So, is a pIND meeting always necessary? My take: it's not, except in specific circumstances where the risk of an IND hold is a realistic possibility. What's your take on this balance of diligence and dynamism?

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Key Takeaways:

• 👶 Not a "Well-Baby Check": A pIND meeting shouldn't be a routine, all-encompassing check-up for every project.

• 😟 No Anxiety Soother: Companies shouldn't use pIND meetings simply to alleviate their own anxieties about an IND filing.

• ⚖️ Strategic Risk Mitigation: The true value of a pIND lies in addressing specific, identified risks for complex cases.

• 🚀 Agility over Dogma: Sometimes, a direct IND filing is the more efficient and agile path to getting therapies to patients.

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