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
Speaker Details
Katsuhiro Mihara
Head of Clinical Development & PK/PB
Erik Gout
Head of CMC
Arthur Noach
Senior Consultant, Non-Clinical Expert
Ronald Ullers
Senior Consultant Regulatory Affairs CMC
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