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.
Featured
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
- 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
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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
