Overview

The evolution of clinical trial designs has accelerated since the onset of the pandemic to meet patient and logistical need. While elements of randomized controlled trials remain a gold standard, clinical trials continue to transform, building on innovations in study design and statistical approaches, as well as regulatory flexibilities, with the promise of bringing new medicines to patients more quickly than ever.

Supported by advancement in clinical trail operations, development of digital technologies along with strong partnerships and collaborations amongst key stakeholders, clinical trials are poised to reach more people and add efficiency to clinical drug development. Master protocol and complex innovative designs continue to provide frameworks that hold enormous promise for engaging patients more productively, increasing overall efficiency and improving successful outcomes.

DIA’s Master Protocols and Complex Innovative Design Meeting will bring together a truly multidisciplinary group of experts in clinical trial planning, execution, and analysis to share and discuss both the common and unique challenges and opportunities in the adoption of master protocols and complex innovative design. 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 implementation of innovation in clinical trial designs.

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Who should attend?

Professionals and students from industry, academia, and government involved in all phases of the healthcare product lifecycle who are interested in applying new skills and tools to improve program and project execution including:

Learning objectives

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

Articulate the challenges and opportunities for the use of complex innovative design and master protocols
Explain how master protocols and CIDs contribute to increased efficiency and other enhancements of medical product research to ultimately accelerate patient access to innovative therapies
Describe the purpose, anticipated outcomes, and progress to date of the FDA CID Pilot Program
Discuss the views of global regulatory authorities (e.g., FDA, EMA, etc.) on CIDs and their suitability/applicability for clinical research in their respective regions; explore aspects and further opportunities for alignment among global regulatory agencies in regard to CID adoption
Examine several examples of master protocol designs, complex adaptive designs, and designs using Bayesian techniques, and discuss their regulatory suitability, potential challenges, and benefits for patients and medical product developers
Summarize learnings from the use of master protocols to develop vaccines and therapeutics for COVID-19 and how they apply to developing interventions for other indications

Program Committee

Daniel Millar, MBA Senior Director, Strategic Business Transformation
Johnson & Johnson, United States
Robert A. Beckman, MD Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics
Georgetown University Medical Center, United States
Fanni Natanegara, PhD Sr. Director, Global Statistical Sciences - Japan
Eli Lilly and Company, Japan
Zoran Antonijevic, MSc Vice President, Statistical Consulting
Abond CRO Inc., United States
Michelle Detry, PhD Director, Adaptive Trial Execution & Senior Statistical Scientist
Berry Consultants LLC, United States
Kristin Dolinski Director, US Regulatory Policy and Intelligence
BeiGene, United States
AnnCatherine M. Downing, PharmD Chief Operating Officer - Lilly Research Laboratories
Eli Lilly and Company, United States
Anne-Marie Duliege Chief Medical Officer
Pancreatic Cancer Action Network, United States
Yi Liu, PhD Vice President, Biometrics
Nektar Therapeutics, United States
Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States
Pritibha Singh, MBA, MSc Senior Manager, Corporate Affairs Analytics & Insights
Novartis AG, Switzerland
Rui (Sammi) Tang Vice President, Global Head of Biometrics
Servier Pharmaceuticals, United States