Fast-Tracking First-In-Human: A Startup-Focused Guide to IND Readiness and Early Clinical Success

Practical guidance for startups navigating IND readiness and early clinical planning.

Taking a drug candidate from discovery to first-in-human trials is a defining moment for any biotech or pharmaceutical company. For startups and small organizations, this journey toward IND-readiness can feel overwhelming — balancing investor expectations, regulatory hurdles, and operational complexities.

Join hVIVO’s team of experts for an interactive panel discussion designed to demystify the process. Our experts will share practical strategies and best practices to help you navigate critical aspects of early drug development planning such as investor due diligence, manufacturing issues, non-clinical program planning, regulatory strategy, vendor selection, and clinical trial design. For those preparing for IND-enabling activities, this session will equip you with actionable insights to help accelerate your path to the clinic and reduce risk.

Key Takeaways

• How startups and small pharma can efficiently prepare for first-in-human studies while balancing regulatory, operational, and investor expectations
• Best practices for aligning non-clinical, manufacturing, and regulatory strategies to reduce risk and avoid costly delays
• Practical guidance on vendor and CDMO selection, along with early clinical trial design decisions that can accelerate the path to IND and first-in-human trials

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