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Connect with Veristat at Bio International Convention 2026
June 22-25, 2026 – San Diego, CA
🌎 Bringing the Global Biopharma Community Together
We’re delighted to be attending...
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.
- 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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2 min read
Connect with Veristat at DIA 2026
Jun 5, 2026 Veristat Events
June 14-18, 2026 – Philadelphia, PA
Veristat is excited to join industry leaders and innovators at the DIA 2026 Global...