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.

In this on-demand webinar, hVIVO experts 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 helps 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