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.
Featured
Short Course or Primer
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Mar 16, 2023
Short Course: Estimand Framework Implementation
Learn more -
Mar 23, 2023
Short Course: Group Sequential and Adaptive Designs in Drug Development: Methodology, Practical Aspects, and Examples
Learn more -
Mar 21, 2023
Short Course: Methods to Support Patient-Focused Medical Product Development: Key Concepts from FDA’s Patient-Focused Drug Development Guidance Series
Learn more
Who should attend?
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Meeting Designed For
- Access & Value
- Clinical Development & Operations
- Clinical Safety & Pharmacovigilance
- Data & Data Standards
- Preclinical & Early Phase Research
- Regulatory
- Quality Assurance / Control & CMC
- Statistics
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Learning Objectives
At the conclusion of this activity, participants should be able to:- Discuss approaches to collecting novel types of data for evidence generation and analytic methods needed to power new approaches to data
- Identify and discuss issues relevant to applying the ICH E9(R1) framework to complex innovative trials
- Identify key updates for each user fee program, including launching the Rare Disease Endpoint Advancement (RDEA) Pilot program under PDUFA VII
- Recognize the purpose of the Comparative Clinical Endpoint Studies in Biosimilar Development Program and apply Bayesian designs for biosimilar product development
- Summarize and apply principles of ICH E11A draft guidance to pediatric drug development
- Discuss updates in FDA’s Project Optimus and ongoing development of dose optimization guidance and recognize approaches to develop a composite endpoint to select an optimal dose
- Describe the current use of ML in analysis of safety data by the pharmaceutical industry and regulatory agencies and identify areas of potential future applications and methods development
- Explain strengths of the estimand framework for jointly assessing efficacy and safety of a treatment and identify challenges in joint assessment of efficacy and safety
- Describe the general ideas of various methods to borrow information from external data and discuss potential applications in regulatory clinical trials
- Recognize statistical methods leveraged in the analysis of RWD and describe innovative approaches of combining RWD and clinical trial data in decision making
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 • 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 • Vice President, Enterprise Biostatistics
Medtronic, 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
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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
Contact us
Registration Questions?
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
