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!

#biotech #FDA #IND #drugdevelopment #startups #innovation