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CMC Pitfalls: From Benchtop to IND

Regulatory Consulting

Successfully transitioning from academic or bench-top production to manufacture clinical-grade material is not an easy feat. There are many factors new sponsors must consider when determining readiness to file an Investigational New Drug (IND) from a manufacturing perspective. FDA guidance for INDs for Phase 1 points out that ‘insufficient data to make an evaluation of safety is the only basis of a clinical hold based on the CMC section.’

Listen to the full episode on Veristat’s Advancing Revolutionary Therapies (ART) Podcast to learn more about the key CMC fundamentals and pitfalls of preparing for an IND.

Learning Points 
    • Manufacturing considerations when preparing for an IND
    • Factors to consider when selecting a CMO for early clinical trial
    • CMC fundamentals for preparing for a pre-IND FDA meeting

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