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Tommy Douglas Conference Center

02 mar 2020 7:00 a.m. - 03 mar 2020 5:15 p.m.

10000 New Hampshire Ave, Silver Spring, MD 20903

DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Session 2: CID - Master Protocols

Session Chair(s)

Zoran  Antonijevic, MSc

Zoran Antonijevic, MSc

Vice President, Statistical Consulting

Abond CRO Inc., United States

Min  Lin, MD, PhD

Min Lin, MD, PhD

Statistical Science Director

Astrazeneca, United States

Rui (Sammi)  Tang

Rui (Sammi) Tang

Vice President, Global Head of Biometrics

Servier Pharmaceuticals, United States

Master Protocols test multiple therapies in one indication, one therapy for multiple indications, or both. They also allow for discontinuation or addition of treatment arms and the concept known as platform trial. Master Protocols can significantly improve the efficiency of drug development when appropriately designed and implemented. In this session we will discuss how to manage Master Protocols design and implementation complexities. We will present one case study and then follow-up with novel approaches that focus on the confirmatory stage of development.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Understand essential elements of Master Protocols
  • Recognize opportunities for application of Mater Protocols
  • Understand and apply new approaches and trends in design of Master Protocols

Speaker(s)

James  Travis, PhD

Speaker

James Travis, PhD

FDA, United States

Lead Mathematical Statistician, OB, OTS, CDER

Michael  Proschan, PhD

Design and Analysis of Treatment Trials of Ebola Virus Disease

Michael Proschan, PhD

NIAID/NIH, United States

Mathematical Statistician

Lisa  LaVange, PhD

Speaker

Lisa LaVange, PhD

University of North Carolina at Chapel Hill, United States

Professor Emerita

Vladimir  Dragalin, PhD

Complex Innovative Design for a Basket Trial

Vladimir Dragalin, PhD

Janssen R&D, at Johnson & Johnson, United States

Vice President, Scientific Fellow

Nora E Carbine

Panelist

Nora E Carbine

Georgetown Lombardi Cancer Center , United States

Georgetown Breast Cancer Advocate

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