Amanda Moore, Luke Timmerman, Jenny Gordon, Debra Schaumberg, Kanya Rajangam
(Left to right) Amanda Moore, Luke Timmerman, Jenny Gordon, Debra Schaumberg, and Kanya Rajangam
“Knowing what you want in the long run, not just from first-in-human or dose escalation, but the big picture strategy for your program, and how you can de-risk that, is one of the biggest challenges that goes along with a Phase I/II trial.”
Emerging biotechnology companies face a unique landscape of risk when transitioning from preclinical development to clinical trials, compounded by resource constraints and limited experience with regulatory processes.
We sat down with a panel of experts and asked them to share their practical insights and real-world experiences with common early-phase trial challenges that disproportionately impact emerging biotechs. They share their advice for recognizing and avoiding pitfalls that can derail Phase I/II studies, in order to avoid costly delays and improve the likelihood of clinical success.
