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Thursday, June 18 • 5:00pm - 6:00pm
#514 OD: ON DEMAND - Single-Sponsor Master Protocol: Development and Regulatory Experience with a Complex Innovative Design (CID)

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Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

AnnCatherine M. Downing, PharmD

Speaker

Industry Update
AnnCatherine M. Downing, PharmD

Industry Update
Timothy R Smith, MD, RPh, FACP

Industry Update
Karen Lynn Price, PhD

FDA Update
Dionne Price, PhD



Speakers
avatar for AnnCatherine Downing

AnnCatherine Downing

Senior Research Advisor - Clinical, Eli Lilly and Company
AnnCatherine Downing received her Doctor of Pharmacy degree from Butler University in Indianapolis, Indiana. She has over 17 years of pharmaceutical industry experience across all phases of clinical development. She is currently a Sr. Clinical Research Advisor in Eli Lilly and Company's... Read More →
avatar for Timothy Smith

Timothy Smith

President and Chief Executive Officer, Studymetrix Research, LLC
Timothy R Smith, MD is President and CEO of StudyMetrix Research in St. Louis, MO. He received a Bachelor of Science in Pharmacy degree in 1983 from the University of Mississippi School of Pharmacy, and a Doctor of Medicine degree in 1989 from the University of Mississippi Medical... Read More →
avatar for Karen Price

Karen Price

Research Fellow, Statistical Innovation Center/Design Hub, Eli Lilly and Company
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis... Read More →
avatar for Dionne Price

Dionne Price

Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price promotes collaborative efforts to advance the use of complex innovative trial... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  02: ClinTrials -ClinOps, Session