Innovative treatments for patients with significant unmet need requires advanced clinical development strategies and novel techniques to address key scientific and medical questions. Continued advancement in our knowledge of disease mechanisms and pathways has brought greater understanding and with it more robust tools to establish proof-of-mechanism, safety, tolerability, and effectiveness in a robust and controlled manner. As clinical studies become increasingly complex to meet scientific and regulatory requirements, it is imperative for sponsors to seek partners with demonstrated excellence in the successful conduct of complex clinical trials, such as those incorporating lipopolysaccharide (LPS) challenges, full sedation studies, and biomarker-driven bone marrow assessments, to address individual study needs.