Innovative Trial Designs Conference

Menu Back to Innovative-Trial-Designs-Conference

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

Preview some overall learning growth opportunities to propel lifecycle success in trial designs, both individually and collaboratively:
- Assess implementation of umbrella trial designs in future clinical trials
- Define the recent FDA guidance documents on clinical trial population diversity
- Outline benefits/efficiencies of external and internal information-borrowing
- Describe new technologies and statistical adjustments to enhance trial population diversity
- 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 (ML) into the drug development processes
- Evaluate data security and privacy and identify Real-World Data (RWD) barriers to enhance patient care and data usage
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

Program Committee

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