Innovative Trial Designs Conference

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