Overview

Co-sponsored with the FDA!

The DIA/FDA Biostatistics Industry and Regulator Forum is focused on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360-degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.

Now in its thirteenth year, the forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.

Preconference Short Courses

Short Course 1: New Adaptive Design Guidance | 8:30AM-12:00PM
Short Course 2: Data Monitoring | 8:30AM-12:00PM

On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data
Gain an overview of a structured approach for safely applying these more advanced methods, discuss their application in practice, and explore how they can be used to guide scientific research.

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Continuing Education

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Continuing Education

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Learning objectives

At the completion of this conference, the participant should be able to:

Describe the challenges and opportunities in applying CID and the role of simulation
Identify the opportunities and challenges arising in patient-focused drug development
Discuss the role that statisticians play in patient-focused drug development
Explain how patient preferences and clinical outcome assessments can inform and influence regulatory submissions
Discuss the unique challenges in the assessment of complex generics from statistical, clinical, and regulatory perspectives
Identify GDUFA II enhancements for complex generics
Describe the most common designs using Master Protocols and their utility in solving clinical development challenges
Identify the operational challenges and considerations in executing Master Protocols
Discuss the pros, cons, and common mistakes for Master Protocol designs through a panel discussion
Discuss the estimand challenges and opportunities arising in oncology drug development
Evaluate the differences among stakeholder views on clinically meaningful estimands
Apply the estimand framework to the learner’s own clinical investigations
Describe the collaboration of statistical science with data science in drug development
Identify what has changed in the role of the statistician
Describe opportunities for drug development based on advancements in new technologies and data analytics
Identify common clinical issues that arise when characterizing the safety (and benefit-risk) of a pharmaceutical product
Apply good statistical practice for safety related topics

Short Course or Primer

To keep you at the forefront.

Apr 08, 2019

Short Course 1:

New Adaptive Design Guidance

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Apr 08, 2019

Short Course 2:

Data Monitoring

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Apr 08, 2019

Short Course 1:

New Adaptive Design Guidance

Learn more

Apr 08, 2019

Short Course 2:

Data Monitoring

Learn more

Program Committee

Jingyu (Julia) Luan, PhD Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
AstraZeneca, United States
Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States
Brenda Crowe, PhD Associate Vice President, Statistics
Eli Lilly and Company, United States
Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States
Rima Izem, PhD Associate Director Statistical Methodology
Novartis, Switzerland
Min Lin, MD, PhD Statistical Science Director
Astrazeneca, United States
Karen Lynn Price, PhD Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
Frank W. Rockhold, PhD, MSc Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States
William Wang, PhD President
Merck & Co, Inc, United States
Amy Xia, PhD Vice President, Center for Design and Analysis
Amgen Inc., United States
Mouna Akacha, PhD Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
Aloka Chakravarty, PhD Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Dionne Price, PhD Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States