Biostatistics Industry and Regulator Forum

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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?

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 conclusion of this activity, participants should be able to:

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

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