Getting to IND: FDA Strategy for Early-Stage Biotech
🚀 Getting to IND: FDA Strategy for Early-Stage Biotech
🔬 A must-attend session for biotech founders, R&D leaders, and anyone navigating early U.S. regulatory pathways.
Navigating the road to an Investigational New Drug (IND) application can make or break first‑in‑human timelines. From early product classification decisions to aligning clinical, nonclinical, and CMC strategies—every choice matters.
In this session, Arif S. Noorani (Partner, Sidley Austin) will share practical insights on how early-stage teams can position their programs for successful FDA engagement and avoid common pitfalls that delay development.
💡 What you’ll learn:
📌 What “getting to IND” really means—and what it doesn’t
📌 How early decisions shape your regulatory pathway and evidence expectations
📌 When and how to engage FDA effectively (including pre-IND best practices)
📌 Common misalignment patterns that slow down programs
📌 Real-world takeaways from experts during the panel discussion
🎙️ Speakers:
Arif Noorani - Partner, Sidley Austin LLP
Diana Hay, PhD - Executive Director, Business Operations, Arbele
Dr. Aung Myo - Founder & Principal Consultant, Innovicto Clinical
Dipti Thakkar, PhD - Chief Operating Officer, Hummingbird Bioscience
📘 Programme:
🕔 5:00 pm – Registration
🕠 5:20 pm – Opening Remarks
🕠 5:30 pm – Practical Insights on FDA Strategy
🕕 6:00 pm – Panel Discussion
🕖 7:00 pm – Networking Reception
Whether you're planning your first IND or refining your regulatory strategy, this session will offer a clear framework for thinking ahead, de-risking timelines, and engaging FDA with confidence.
🔗 Don’t miss this opportunity to learn from industry experts and connect with peers in the biotech community.
👉 Register Now to secure your spot!
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