Overview
Short Course: March 16, 2023 | Virtual
Short Course: March 21, 2023 | Virtual
Short Course: March 23, 2023 | Virtual
Forum: March 29-31, 2023 | Virtual
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.
Keynote Address!
March 29 | 10:15-11:00AM
Amy Abernethy, MD, PhD, President of Clinical Studies Platforms Alphabet’s Verily
Featured
Want to learn more about DIA/FDA Biostatistics Industry and Regulator Forum? You've come to the right site!
Program Committee
-
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 -
Anup Amatya, PhD Lead Mathematical Statistician
FDA, United States -
Hye Soo Cho, MS Statistician
FDA, United States -
Mallorie Fiero, PhD Master Mathematical Statistician, CDER
FDA, United States -
Shanti V Gomatam, PhD, MS, MSc Mathematical Statistician
FDA, United States -
Lisa Hampson, PhD Senior Director, Advanced Methodology & Data Science
Novartis Pharma AG, Switzerland -
Karen Higgins, PhD Supervisory Mathematical Statistician
FDA, United States -
Dalong Patrick Huang, PhD Lead Mathematical Statistician, CDER
FDA, United States -
Lisa Renee Bailey Iacona, PhD, MPH Vice President, Oncology Biometrics
AstraZeneca Pharmaceuticals LP, United States -
Xiang Ling, PhD Statistician
FDA, United States -
Jerald Schindler, DrPH Chief Executive Officer
Strategic Statistics, United States -
Venkat Sethuraman, PhD, MBA, MS 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, PhD Deputy Division Director
FDA, United States -
Lisa Wruck, PhD Associate Professor of Biostatistics and Bioinformatics
Duke School of Medicine, United States -
Representative Invited DIA, 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
Have an account?