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Tuesday, June 20 • 10:30am - 11:45am
#228: Master Protocols: New Approaches to Enrolling Hard-to-Find Subjects and Expediting Drug Development

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Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; RN 1.25

Master ("umbrella") protocols that have multiple treatment options are being used to optimize enrollment and expedite drug development based on biomarkers/specific disease traits. This session will discuss this approach and the benefits and challenges of these multi-company collaborations.

Learning Objectives

Describe the Umbrella concept; Discuss key considerations.


Theresa Crofts Ashton, PhD


The Use of Statistical Innovation to Increase Efficiency in Difficult-to-Enroll Clinical Trials
Kert Viele, PhD

Combined Adaptive Early Phase Trials: From First-Time-in-Human to Proof of Concept in One Protocol
Ulrike Lorch, MD, FFPM

Beat AML: Practicalities and Lessons Learned From the Construct of a 10-Study Leukemia Umbrella Trial
Amy Burd, PhD

Nicholas Kenny, PhD

avatar for Theresa Ashton

Theresa Ashton

Senior Director, Clinical Statistics, GlaxoSmithKline
Teri Ashton received her PhD in Biostatistics from Medical College of Virginia and has been working in the Pharmaceutical Industry for 15 years. She has worked primarily in Oncology and Infectious Diseases, leading innovative clinical trial design discussions across all phases of... Read More →


Amy Burd

Vice President, Research Strategy, Leukemia & Lymphoma Society
Amy Burd, Ph.D., is vice president of research strategy for The Leukemia & Lymphoma Society. Dr. Burd first began working with LLS in 2009 as senior director of LLS’s Therapy Acceleration Program. In her current role, Dr. Burd provides strategic planning and oversight for mission... Read More →
avatar for Nicholas Kenny

Nicholas Kenny

Executive Vice President, Oncology and Hematology, INC Research
Dr Nick Kenny leads the Oncology division (~900 oncology clinical research professionals) at INC Research, a full service global CRO headquartered in Raleigh NC, USA. Nick has over 25 years of basic and clinical research and development experience. His immediate past twelve years... Read More →
avatar for Ulrike Lorch

Ulrike Lorch

Medical Director, Richmond Pharmacology Ltd.
Dr Lorch is Medical Director of Richmond Pharmacology in London (UK). She is a Fellow of the Royal College of Anaesthetists and a Fellow of the Faculty of Pharmaceutical Medicine, holding its specialist accreditation. She has special expertise in early phase integrated, adaptive study... Read More →

Kert Viele

Director and Senior Statistical Scientist, Berry Consultants
Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, specializing in the design of Bayesian and adaptive clinical trials. He joined Berry Consultants in 2010 after serving as a faculty member in Statistics at the University of Kentucky. He is a former... Read More →

Tuesday June 20, 2017 10:30am - 11:45am CDT
S405a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  09: TranslSci-Preclin-Clin-ProdDev, Session