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ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)
Session Chair(s)
AnnCatherine M. Downing, PharmD
Chief Operating Officer - Lilly Research Laboratories, Eli Lilly and Company, United States
FDA’s CID Pilot Program aims to improve drug development efficiency and promote innovation. Development and regulatory evaluation of a single sponsor master protocol to study multiple novel treatments for multiple types of chronic pain are discussed.
Learning Objective : Explain the advantages for sponsors and patients of a complex innovative design (CID) to expedite development of multiple therapies for multiple indications; Describe the key considerations in the protocol design and operational planning; Discuss the regulatory agency perspective and the experience of addressing regulatory challenges of the CID.
Speaker(s)
A Drug Development Challenge Leads to a Complex, Innovative Design in Chronic Pain
AnnCatherine M. Downing, PharmD
Chief Operating Officer - Lilly Research Laboratories, Eli Lilly and Company, United States
Complex Innovative Design Pilot Program: Industry Update
Karen Lynn Price, PhD
Senior Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company, United States
Master Protocols and the CID Experience
Dionne Price, PhD
Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Single-Sponsor Master Protocol: The Site Perspective
Timothy R Smith, MD, RPh, FACP
President and Chief Executive Officer, Studymetrix Research, LLC, United States
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