Dear Mike,
Taking a drug candidate from discovery into first-in-human studies is one of the most critical, and challenging, milestones for emerging biotech and small pharma organisations. Balancing regulatory expectations, investor scrutiny and operational realities can quickly become complex.
In this live panel discussion, experts from hVIVO will share practical strategies to help demystify the path to IND readiness. Drawing on decades of hands-on development experience, the panel will explore how early, joined-up planning across non-clinical, CMC, regulatory and clinical strategy can help reduce risk and avoid costly delays.
You’ll gain insights into:
- Preparing efficiently for first-in-human studies while balancing regulatory, operational and investor expectations
- Aligning non-clinical, manufacturing and regulatory plans to minimise risk early
- Making informed decisions around vendor and CDMO selection and early clinical trial design
Meet the Speakers
Katsuhiro Mihara
Head of Clinical Development & PK/PD
Erik Gout
Head of CMC
Arthur Noach
Senior Consultant, Non-Clinical Expert
Ronald Ullers
Senior Consultant, Regulatory Affairs CMC
Register now to secure your place and gain expert insights into achieving IND readiness.
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