概要

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.

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Highlights & Features

学習目的

At the conclusion of this activity, participants should be able to:

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

Short Course or Primer

To keep you at the forefront.

2022年3月29日 (火)

Design, Analysis and Evaluation of Confounding Bias Using RWD:

2022年4月01日 (金)

Practical Bayesian Approaches in Healthcare:

Industry and Regulatory Perspectives

2022年3月29日 (火)

Design, Analysis and Evaluation of Confounding Bias Using RWD:

2022年4月01日 (金)

Practical Bayesian Approaches in Healthcare:

Industry and Regulatory Perspectives

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 Division Director, Division of Biometrics IX, 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 Maro, PhD, MS Associate Professor, Department of Population Medicine
Harvard Medical School, 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