Overview
Co-sponsored with FDA!
The 17th Annual 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, and other medical products. As an open forum to discuss timely topics of mutual theoretical and practical interest to statisticians and clinical trial professionals, 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
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Mar 16, 2023
Short Course: Estimand Framework Implementation
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Program Committee
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Fairouz Makhlouf, PhD • Deputy Director, Office of Biostatistics, Office of Translational Science, CDER
FDA, United States -
Satrajit Roychoudhury, PhD • Senior Director, Statistical Research and Innovation
Pfizer, Inc., United States -
Anup Amatya • Mathematical Statistician
FDA, United States -
Hye Soo Cho • Statistical Analyst
FDA, United States -
Mallorie Fiero, PhD • Lead Mathematical Statistician, CDER
FDA, United States -
Shanti V Gomatam, PhD • Mathematical Statistician
FDA, United States -
Lisa Hampson, PhD • Director, Advanced Methodology & Data Science
Novartis Pharma AG, Switzerland -
Karen Higgins, PhD • Mathematical Statistician
FDA, United States -
Dalong Patrick Huang, PhD • Mathematical Statistician, CDER
FDA, United States -
Lisa Renee Bailey Iacona, PhD, MPH • Vice President, Oncology Biometrics
AstraZeneca Pharmaceuticals LP, United States -
Xiang Ling • Statistician
FDA, United States -
Jerald Schindler, DrPH • Vice President, Enterprise Biostatistics
Medtronic, United States -
Venkat Sethuraman, PhD, MBA • Senior Vice President, Global Biometrics and Data Sciences
Bristol Myers Squibb, United States -
Guoxing Soon, PhD • Lead Mathematical Statistician
FDA, United States -
Li Wang, PhD • Senior Director, Head of Statistical Innovation
AbbVie , United States -
Yun Wang • Deputy Division Director
FDA, United States -
Lisa Wruck, PhD • Duke University
Associate Professor of Biostatistics & Bioinformatics, United States -
Brenda Crowe, PhD • Associate Vice President, Statistics
Eli Lilly and Company, United States -
Stella C. Grosser, PhD, MS • Division Director, Office of Biostatistics, OTS, CDER
FDA, United States
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Additional Information
Discover DIA’s Live In-Person and Live Virtual Events
DIA/FDA Biostatistics Industry and Regulator Forum Resource Kit
PRE-CONFERENCE SHORT COURSES
Short Course: Estimand Framework Implementation
