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First-in-Human Studies: How Much Complexity Is Too Much?
Session Chair(s)
Royce A. Morrison, MD, MS, FACP
Senior Consultant
Pacific Pharma Group, LLC, United States
On the first-in-human (FIH) fast track, what defines “just right” design? Join us to hear experience of sponsor development teams, CROs, investigators and regulatory agencies, and best practice guidance on appropriate limits for FIH study complexity.
This session has been developed by the Clinical Pharmacology Community.
Learning Objective : Discuss trends that disrupt standard early-phase sequences and drive study complexity; Identify major safety and development program risks caused by too much complexity; Describe best practices to mitigate risks.
Speaker(s)
The IRB: Regulatory Protection
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
The CRO: Avoiding "Too Much" in First-in-Human
Mary L. Westrick, PHD
University of Wisconsin, United States
Adjunct Professor
First-in-Human at the Clinical Front Line
William B. Smith, MD
Alliance for Multispecialty Research, LLC , United States
CEO
The Polarized Perspectives of the Sponsor for Phase 1
Stacie J. Bell, PHD
Samumed LLC, United States
Director, Clinical Pharmacology and Development