Comment from UCB, Inc.
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Summary: UCB, Inc. and a team of academic experts submitted a proposal to include a workshop on Digital Twins and In Silico Trials in the FDA's Rare Disease Innovation Hub Future Programming. They argue that these computational strategies are essential for addressing the evidentiary challenges of developing treatments for rare diseases with small patient populations.
UCB, Inc.; Dr. Ravi B. Parikh, MD, MPP; Dr. Ashley Eadie, PhD; Dr. Naomi Scheinerman; PhD; and Professor Holly Fernandez Lynch, JD, MBE, (hereby referred to as “the Team”) are pleased to jointly submit a proposal in response to the Food and Drug Administration’s (“FDA”) request for comments on Rare Disease Innovation Hub Future Programming. Please see our attached proposal.