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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)

Session Chair(s)

AnnCatherine M. Downing, PharmD

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)

AnnCatherine M. Downing, PharmD

A Drug Development Challenge Leads to a Complex, Innovative Design in Chronic Pain

AnnCatherine M. Downing, PharmD

Eli Lilly and Company, United States

Chief Operating Officer - Lilly Research Laboratories

Karen Lynn Price, PhD

Complex Innovative Design Pilot Program: Industry Update

Karen Lynn Price, PhD

Eli Lilly and Company, United States

Senior Research Fellow, Statistical Innovation Center/Design Hub

Dionne  Price, PhD

Master Protocols and the CID Experience

Dionne Price, PhD

FDA, United States

Deputy Director, Office of Biostatistics, OTS, CDER

Timothy R Smith, MD, RPh, FACP

Single-Sponsor Master Protocol: The Site Perspective

Timothy R Smith, MD, RPh, FACP

Studymetrix Research, LLC, United States

President and Chief Executive Officer

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