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Session Chair(s)
Royce A. Morrison, MD, MS, FACP
Senior Consultant
Pacific Pharma Group, LLC, United States
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
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