Strategic Insights for Biopharma Teams Navigating the IND Process

Contributing author: Carolina Ahrendt, MBA, PMP

As early-stage BioPharma teams prepare for IND submission, aligning regulatory strategy, CMC considerations, and clinical trial design is crucial for success. Drawing from a recent, invite-only expert-led discussion hosted by Innosphere Ventures, Halloran’s Shawn Roach, PhD, and Carolina Ahrendt, MBA, PMP dive into key milestones, best practices, and regulatory insights to guide the journey from discovery through Phase 3. See below for key takeaways.

Key Takeaways:

• Start building your regulatory strategy early and engage the FDA proactively.
• Ensure CMC development aligns with FDA expectations from Phase 1 through Phase 3.
• Use expedited programs strategically but remember they do not compromise regulatory requirements.
• Align your clinical trial design with regulatory guidelines to avoid delays and ensure a smooth IND submission.

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