Master Protocol Workshop

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Overview

The modernization of clinical trials is driven by the need to address important clinical questions more efficiently while decreasing costs. Master Protocol (MAPs), including basket, umbrella, and platform trials, provide a method to answer multiple questions in one overall trial structure. Although MAPs require more intentional planning, coordination, and upfront investment in creating an infrastructure for execution, they provide an opportunity to more efficiently address a broader set of objectives than would be possible in an independent trial. MAPs such as I-SPY 2, EPAD, DIAN-TU, GBM AGILE, and others are part of this emerging family of clinical trials having the purpose of speeding development of innovative medicines for patients.

This year’s Master Protocol Workshop focuses on Adaptive Platform Trials (APTs), powerful trials that study multiple therapies with multiple patient populations at once. Join industry, patient, regulatory agency, and other government experts to explore funding and start-up considerations, regulatory engagement, and key operational concerns through the lens of four different APT implementation models. A panel of global regulators will share their perspectives on the implementation of these trials in their regions, application to a wide range of therapeutic areas beyond oncology, and progress toward global regulatory alignment.

Need approval in order to attend?

Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

Check out our 2019 Program!

Who should attend?

Professionals involved in:

Biostatistics, including Adaptive Design and Bayesian Statistics
Clinical Research
Research and Development
Trial Design
Clinical Operations
Therapeutic Area Development, Management, and Operationist
Rare disease, oncology, immunology, Alzheimer’s disease
Medical Affairs
Medical Science Liaisons
Medical Writing
Regulatory Affairs

Learning objectives

At the end of this workshop participants should be able to:

Describe value drivers behind adaptive platform trials for key stakeholders (patient organizations, research sponsors, public institutions, regulatory agencies, and others) including how they may benefit and contribute to trial start up
Discuss how stakeholder groups have successfully organized and started platform trials within common models of collaboration (patient organization driven, single company sponsor, multiple company sponsor, and government/public institution driven), addressing key elements such as funding, governance, and regulatory engagement paths
Summarize regional regulatory perspectives on adaptive platform trials and current progress toward global alignment
Discuss emerging best practices for key operational components that are critical success factors for platform trials, such as data sharing and network building

Program Committee

Daniel Millar, MBA • Senior Director, Strategic Business Transformation Quantitative Sciences
Janssen Research & Development, United States
Zoran Antonijevic, MSc • Vice President, Statistical Consulting
Abond CRO Inc., United States
Scott M Berry, PhD • President and Senior Statistical Scientist
Berry Consultants LLC, United States
Abby Bronson, MBA • Vice President, Patient Advocacy and External Innovation
Edgewise Therapeutics, United States
Lisa LaVange, PhD • Professor and Associate Chair, Department of Biostatistics
University of North Carolina at Chapel Hill , United States
Victoria Manax Rutson, MD • Chief Medical Officer
Pancreatic Cancer Action Network, United States
MaryAnn Morgan-Cox, PhD • Senior Director, Immunology Design Hub
Eli Lilly and Company, United States
Rui (Sammi) Tang • Vice President, Biometric of Oncology
Servier Pharmaceuticals, United States

Contact us

Registration Questions?

Send Email
1.888.257.6457

On Demand Content Preview Webinar

Operationalizing Master Protocols Encore Presentation