Overview
Short Courses: April 12-13
Forum: April 14-16
The DIA/FDA Biostatistics Industry and Regulator Forum is a unique forum addressing the statistical issues associated with the development and review of therapeutic drugs, biologics, devices, combination, and other medical products. As an open forum to discuss timely topics of mutual theoretical and practical interest to statisticians and clinical trialists, this meeting focuses on the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and measuring the progress with the implementation of innovative solutions.
An important purpose of the forum is to advance the dialogue between industry, regulatory agencies, and academia around policy, regulation, development, and review of medical products in the context of today’s scientific and regulatory environments. The program is developed collaboratively by FDA, industry, and academic experts who team up to ensure that each session brings all stakeholder perspectives to the discussion.
Attend the DIA/FDA 2021 Biostatistics Industry and Regulator Forum and join leading edge discussions: statistical analyses in COVID-19 interrupted trials and therapeutic/vaccine trials, RWE and its use in regulatory decision making pre-marketing, approaches to the incorporation of external controls – applicability and methods, the FDA RCT DUPLICATE project, enhancing diversity in clinical trial populations, and so much more!
Who should attend?
- 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 external control data to clinical development
- Explain the use of RWE to support regulatory submissions
- Apply the FDA guidance to enhance diversity and inclusion in clinical trials
- Apply lessons learned from the COVID-19 pandemic to enhance statistical leadership, collaboration, and study design in drug development
- Identify the operational challenges and considerations in executing Master Protocol
- Describe the most common designs using Master Protocols and their utility in solving clinical development challenges during the COVID-19 pandemic
- 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
Program Committee
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Brenda Crowe, PhD • Associate Vice President, Statistics
Eli Lilly and Company, United States -
Yuan-Li Shen, DrPH • Deputy Division Director, Division of Biometrics V, OB, OTS, CDER
FDA, United States -
Mouna Akacha, PhD • Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland -
Ruthie Davi, PhD, MS • Vice President, Data Science and Statistician
Medidata, a Dassault Systèmes company, United States -
Mallorie Fiero, PhD • Lead Mathematical Statistician, CDER
FDA, United States -
Lisa Renee Bailey Iacona, PhD, MPH • Vice President, Oncology Biometrics
AstraZeneca Pharmaceuticals LP, United States -
Rima Izem, PhD • Associate Director Statistical Methodology
Novartis, Switzerland -
Shiowjen Lee, PhD • Deputy Director, Division of Biostatistics, OBPV, CBER
FDA, United States -
Lisa Lupinacci, PhD, MS • Senior Vice President, Biostatistics and Research Decision Sciences
Merck and Co., Inc., United States -
Fairouz Makhlouf, PhD • Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States -
Erik Pulkstenis, PhD • Vice President, Data and Statistical Sciences
Abbvie, United States -
Venkat Sethuraman, PhD, MBA • Senior Vice President, Global Biometrics and Data Sciences
Bristol Myers Squibb, United States -
Judith Maro, PhD, MS • Assistant Professor, Department of Population Medicine
Harvard Medical School and the Harvard Pilgrim Health Care Institute, United States -
Meiyu Shen, PhD • Expert Mathematical Statistician, Office of Translational Sciences, CDER
FDA, United States -
Ram Tiwari, PhD, MS • Head of Statistical Methodology
Bristol Myres Squibb , United States -
Stella C. Grosser, PhD, MS • Division Director, Office of Biostatistics, OTS, CDER
FDA, United States
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Designing, Integrating, and Analyzing RCT/RWE in Safety Decision Making
Short Course 2: Statistical Analyses Targeting Estimands