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Overview

Conference | Day One: November 3 7:30AM-6:00PM | Day Two: November 4 7:30AM-5:00PM

Celebrating its 5th year, DIA’s Innovative Trial Designs Conference (previously titled Master Protocols and Complex Innovative Design) will bring together a truly multidisciplinary group of experts in clinical trial planning, execution, and analysis.

Contribute your perspective and discuss both the common and unique challenges and opportunities for innovation to meet the patient’s needs through protocol design.



  • Event Goals and Offerings

    • Discuss industry perspectives on innovations in clinical trials
    • Address daily challenges with implementing and adopting innovative designs
    • Seek collaborative solutions with a truly multidisciplinary group of experts
    • Examine the growing body of knowledge, experience, and resources to better meet patient needs
    • Evaluate real case examples of different types of innovative trials
    • View Agenda







  • Why You Can’t Miss It

    • Advance innovative regulatory science in clinical trial operations
    • Develop strong partnerships with stakeholders to aid development of digital technologies
    • Increase trials efficiency to clinical drug development and operations
    • Provide framework for productive patient engagement
    • Increase overall efficiency for productive and successful outcomes
    • Register Now



  • Learning Objectives

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

    • Identify the advantages and disadvantages of platform and umbrella trial designs
    • Assess the feasibility of implementing platform and umbrella trial designs in future clinical trials
    • Discuss operational considerations of platform and umbrella trials
    • Define the recent FDA guidance documents on clinical trial population diversity
    • Discuss new technologies and innovative trial designs that could potentially enhance trial population diversity
    • Obtain information from case examples to avoid potential pitfalls
    • Share a roadmap for the documentation and operationalization of innovative clinical trials
    • Discuss operational challenges and provide an explanation of available tools
    • Present suggested best practices and lessons learned for the future trial development
    • Apply machine learning into the drug development processes
    • Calculate the Probability of Success using Bayesian methodology
    • Recognize opportunities to use data more effectively
    • Determine types of Real-World Evidence (RWE) and RWD which could augment-by-design decentralized or adaptive clinical trial designs during study start and execution
    • Connect sources of patient data or community data to Electronic Data Capture (EDC) or Clinical Data Repository (CDR) for on-study deployment, emphasizing the value of Real-time data acquisition and processing
    • Evaluate data security and privacy, and identify barriers to uploading RWD back to patient’s Electronic Medical Records (EMR) or patient accessible dashboards to enhance routine patient care and engage patients in the clinical trial
    • Register Now



  • Meeting Designed For

    Join all-stage professionals from every corner of the vast innovative trial designs industry and related fields:

    • eClinical/Clinical Data Management
    • Strategic Planning
    • Good Clinical Practice
    • Patient Engagement
    • Research & Development
    • Rare, Orphan Diseases
    • Statistics and Data Science
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Program Committee

  • Daniel  Millar, MBA
    Daniel Millar, MBA Senior Director, Strategic Business Transformation Quantitative Sciences
    Janssen Research & Development, United States
  • Michelle  Detry, PhD
    Michelle Detry, PhD Director, Adaptive Trial Execution & Senior Statistical Scientist
    Berry Consultants LLC, United States
  • Freda  Cooner, PhD
    Freda Cooner, PhD Executive Director, Biostatistics
    Arcutis Biotherapeutics, Inc., United States
  • Amy  Burd, PhD
    Amy Burd, PhD Vice President, Research Strategy
    Leukemia & Lymphoma Society, United States
  • Terry  Katz, MS
    Terry Katz, MS Senior Director, Biostatistics and DM Planning and Functional Excellence
    Daiichi Sankyo, United States
  • Yi  Liu, PhD
    Yi Liu, PhD Vice President, Biometrics
    Nektar Therapeutics, United States
  • May F Mo, MBA, MS
    May F Mo, MBA, MS Executive Director, Biostatistics
    Amgen Inc, United States
  • Veronica  Bubb, DBA
    Veronica Bubb, DBA Vice President of Operations
    Advance Research Associates, United States
  • Dionne  Price, PhD
    Dionne Price, PhD Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Terri A Roberson, MBA
    Terri A Roberson, MBA Senior Director, Operations, Global External Research & Development
    Eli Lilly and Company, United States
  • Pritibha  Singh, MBA, MSc
    Pritibha Singh, MBA, MSc Account Associate Director
    Novartis Data42 AG, Switzerland
  • Peter P. Stein, MD
    Peter P. Stein, MD Director, Office of New Drugs, CDER
    FDA, United States
  • Rui (Sammi)  Tang
    Rui (Sammi) Tang Vice President, Global Head of Biometrics
    Servier Pharmaceuticals, United States
  • Representative Invited
    Representative Invited DIA, United States
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