Overview
March 29: Short Course
April 1: Short Course
April 6-8: Conference
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.
Featured
Short Course or Primer
-
Mar 29, 2022
Design, Analysis and Evaluation of Confounding Bias Using RWD
Learn more -
Apr 01, 2022
Practical Bayesian Approaches in Healthcare: Industry and Regulatory Perspectives
Learn more
Learning objectives
- Discuss the use of RWD and methods used to minimize bias and confounding variables
- Discuss utilizing Bayesian methods to support decision making in drug development and clinical trial design and analysis
- Describe how the ICH E9(R1) esteemed framework can be used to clarify the impact of decentralized clinical trials on the scientific question(s)
- Identify statistical issues, safety, and efficacy measures in the design of pediatric Covid-19 vaccine trials and potential statistical solutions to the uncertainty of developing vaccines
- Evaluate the uses of synthetic controls in the regulatory and nonregulatory spaces
Program Committee
-
Brenda Crowe, PhD • Associate Vice President, Statistics
Eli Lilly and Company, United States -
Fairouz Makhlouf, PhD • Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States -
Satrajit Roychoudhury, PhD • Executive Director, Statistical Research and Innovation
Pfizer, Inc., United States -
Yuan-Li Shen, DrPH • Deputy Division Director, Division of Biometrics V, OB, OTS, CDER
FDA, United States -
Ruthie Davi, PhD, MS • Vice President, Data Science and Statistician
Medidata, a Dassault Systèmes Company, United States -
Mallorie Fiero, PhD • Master Mathematical Statistician, CDER
FDA, United States -
Lisa Hampson, PhD • Senior Director, Advanced Methodology & Data Science
Novartis Pharma AG, 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 -
Judith C. Maro, PhD, MS • Assistant Professor, Department of Population Medicine
Harvard Medical School; Point 32 Health, United States -
Venkat Sethuraman, PhD, MBA, MS • Senior Vice President, Global Biometrics and Data Sciences
Bristol Myers Squibb, United States -
Li Wang, PhD • Senior Director, Head of Statistical Innovation
AbbVie , United States -
Yueqin Zhao, PhD • Lead Mathematical Statistician, OB, OTS, CDER
FDA, 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: Design, Analysis and Evaluation of Confounding Bias Using RWD
Short Course: Practical Bayesian Approaches in Healthcare: Industry and Regulatory Perspectives
Additional Information
Live Meeting Policies
Discover DIA’s Live In-Person and Live Virtual Events
