From Preclinical to Clinical: Essential Steps Toward First-In-Human Studies

Van derden

29/10/26

The journey from concept to First‑In‑Human (FIH) trials is filled with complex decision points—particularly for start‑ups developing therapies in challenging, multifactorial areas. Early‑stage companies often face limited resources, tight timelines, and the need to make high‑impact decisions with incomplete information. Understanding how CMC, clinical, and non‑clinical domains interconnect is essential, but theory alone rarely provides a clear path forward.

In this workshop, hosted by hVIVO’s experts across CMC, non‑clinical, and clinical development, we guide participants—especially emerging biotech and start‑up teams—step‑by‑step through the IND‑enabling early‑development pathway using a hypothetical new biological drug as the focal case study. Throughout the session, this example antibody will shape discussions and illustrate how real‑world decisions determine the success of a drug development program approaching First‑In‑Human entry.

The venue for the workshop is the Plus Ultra building in Utrecht. More information and registration can be found here.