Overview

As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA has decided to change the format of the upcoming DIA/FDA Biostatistics Industry and Regulator from "face-to-face" (in-person) to entirely virtual.

For more information, please review the list of Frequently Asked Questions

Forum: May 27-29

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.

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.

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Who should attend?

Professionals from industry, academia, and government involved in all phases of the medical product lifecycle who are interested in the application of statistics to advance biopharmaceutical development and accessibility including:

Biostatisticians
Bioinformaticists, Medical Informaticists
Mathematical Statisticians
Regulatory Scientists
Clinical Pharmacologists
Clinical Trial Design and Clinical Trial Optimization Specialists
Clinical Research Physicians
Epidemiologists
Health Economists
Clinical Operations

Learning objectives

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

Describe the challenges and opportunities in applying Complex Innovative Designs 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

Program Committee

Karen Lynn Price, PhD Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States
Mat Soukup, PhD Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States
Mouna Akacha, PhD Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
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
Shiowjen Lee, PhD Deputy Director, Division of Biostatistics, OBPV, CBER
FDA, United States
Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States
Lei Nie, PhD Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
FDA, 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
Aloka Chakravarty, PhD Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States

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