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Overview

October 8-9: Workshop

The urgency to speed access to innovative therapies and vaccines has never been so evident as during the COVID-19 pandemic. With literally hundreds of potential medicines candidates under investigation, the ability to work efficiently and productively relies on open collaboration within frameworks that can answer multiple clinical questions in one overall trial structure. Master Protocols (MAPs) provide such frameworks and represent a paradigm shift in therapeutic research through an ongoing opportunity to more efficiently address a broader set of objectives than would be possible in a series of independent trials.

The concepts of Master Protocol trials have matured since the first oncology basket trials almost 20 years ago, and today we recognize multiple design types, such as adaptive platform and umbrella trials, for studying a wide array of indications. Examples include DIAN-TU (Alzheimer’s Disease), REMAP-CAP (Community-Acquired Pneumonia), HEALY ALS (Amyotrophic lateral sclerosis), PrecISE (Asthma), and ACCORD (COVID-19), among others. As Master Protocols evolve and become more mainstream, they are presenting continual design, implementation, and operational learnings that can be built upon as the drug development paradigm shifts to one of collaboration and sharing.

Now in its third year, DIA's Master Protocol Workshop focuses on design, planning, implementation, start-up, and evolving operational best practices through the lens of Master Protocol trial stakeholders. Join industry, patient, regulatory agency, other government, and NGO representatives to examine the growing body of knowledge, experience, and resources available to better meet patient needs through successful Master Protocol trials.


Program Now Available!

The program has been released! Preview all session descriptions, speakers, and more all in one place!

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Who should attend?

Professionals within biopharmaceutical and medical device research, regulatory agencies, and patient organizations, who are involved in:

  • Clinical Data Management, Clinical Operations, Clinical Research
  • Good Clinical Practice
  • Health Economics and Outcomes Research
  • Medical Affairs
  • Pharmacology
  • Patient Engagement
  • Regulatory Affairs
  • Research and Development
  • Rare/Orphan Diseases
  • Statistics
  • Strategic Planning
  • Trial Design

Learning objectives

At the conclusion of this forum, 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) and for indications beyond oncology which would benefit from rapid development, the ability to study multiple therapies simultaneously, or the ability to study multiple patient subgroups simultaneously
  • Discuss learnings that are emerging from completed and ongoing master protocol that can inform current master protocols experiencing challenges or facilitate the design and operationalization of new master protocol trials
  • Summarize regional regulatory perspectives on adaptive platform trials and current progress toward global alignment

Program Committee

  • Daniel  Millar, MBA
    Daniel Millar, MBA Senior Director, Strategic Business Transformation Quantitative Sciences
    Janssen Research & Development, United States
  • Abby  Bronson, MBA
    Abby Bronson, MBA Vice President, Patient Advocacy and External Innovation
    Edgewise Therapeutics, United States
  • Amy  Burd, PhD
    Amy Burd, PhD Vice President, Research Strategy
    Leukemia & Lymphoma Society, United States
  • Michelle  Detry, PhD
    Michelle Detry, PhD Director, Adaptive Trial Execution & Senior Statistical Scientist
    Berry Consultants LLC, United States
  • Sudheer  Doss, PhD
    Sudheer Doss, PhD Chief Data Officer and Head of Business Development
    Pancreatic Cancer Action Network, United States
  • AnnCatherine M. Downing, PharmD
    AnnCatherine M. Downing, PharmD Senior Research Advisor - Clinical
    Eli Lilly and Company, United States
  • Kimberly Ann Fisher, MA
    Kimberly Ann Fisher, MA Project Manager for Master Protocol Project
    Clinical Trials Transformation Initiative (CTTI), United States
  • Scott M Berry, PhD
    Scott M Berry, PhD President and Senior Statistical Scientist
    Berry Consultants LLC, United States
  • Lisa  LaVange, PhD
    Lisa LaVange, PhD Professor and Associate Chair, Department of Biostatistics
    University of North Carolina at Chapel Hill , United States
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Registration Questions?

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1.888.257.6457


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