Practical Solutions for Complex Drug Development
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.
Key Objective
This hands‑on workshop provides a clear overview of IND‑enabling activities leading to FIH studies, demonstrating how CMC, non‑clinical, and clinical functions must align to advance a new therapeutic candidate.
By following the full development storyline of a fictional new biological therapy, participants will explore how typical preclinical and CMC challenges—such as toxicology considerations, formulation questions, biomarker selection, and dose‑setting complexities—directly shape IND readiness, and influence timelines and overall FIH design.
You will leave with a deeper, more practical understanding of how to navigate early‑stage, IND‑enabling development for new therapeutic candidates—supported by expert guidance, actionable tools, and the opportunity to discuss your own challenges with senior hVIVO trainers and peers.
Agenda
1:30pm Arrival, Introductions
2pm Workshop begins (with coffee breaks in between)
Working with real-world inspired scenarios in the development of our example drug candidate, you will explore in:
- End-to-end non-clinical development and how to plan a smooth transition to FIH entry.
- Managing scientific and strategic challenges, including making the right choices at critical non-clinical decision points.
- Design of the first-in-human trial, and how this can accelerate the program.
5-5.15 Closing remarks/wrap up and workshop ends
