Perspectiva general
Forum: April 23-25
The DIA/FDA Biostatistics Industry and Regulator Forum is a collaboration by DIA and FDA. We have focused this event on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360 degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.
Now in its twelfth year, the forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.
Highlights
- Co-Sponsored with the FDA
- In-depth discussions on new and revised guidances
- Town Hall: An open discussion lead by an expert panel of leaders from industry and regulatory agencies
- Each session is co-chaired by an Industry-FDA team
- Two interactive half day Short Courses for even more in-depth knowledge-sharing
- Poster Presentations from researchers across the statistics field
- Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
- DIA Statistics Open Community Meeting
Preconference Short Courses
- Artificial Intelligence, Machine Learning, and Precision Medicine
This short course will provide an overview of statistical machine learning and artificial intelligence techniques with applications to precision medicine, in particular to deriving optimal individualized treatment strategies for precision medicine. - Causal Inference: Weighting Methods and Case Studies
This course will start with a general overview on causal inference methods using weighting and a case-study using IPW method, then we will introduce recently developed methodology of overlap weights, which places emphasis on clinical equipoise and has statistical advantages over IPW.
On-Demand Complimentary Webinar
Structured Exploration of Clinical Trial Data
Gain an overview of a structured approach for safely applying these more advanced methods, discuss their application in practice, and explore how they can be used to guide scientific research.
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Comité del programa
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Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States -
Dionne Price, PhD Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States -
Mouna Akacha, PhD Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland -
Aloka Chakravarty, PhD Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States -
Jonathan Haddad, MPH HIV Disease Area Head, Clinical Statistics
GlaxoSmithKline, United States -
Rima Izem, PhD Associate Director Statistical Methodology
Novartis, Switzerland -
Pandurang M Kulkarni, PhD Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
Eli Lilly and Company, United States -
Min Lin, MD, PhD Statistical Science Director
Astrazeneca, United States -
Jingyu (Julia) Luan, PhD Executive Regulatory Science Director, BioPharmaceuticals R&D
AstraZeneca, United States -
Karen Lynn Price, PhD Senior Research Fellow, Statistical Innovation Center/Design Hub
Eli Lilly and Company, United States -
Frank W. Rockhold, PhD, MSc Professor of Biostatistics
Duke Clinical Research Institute, Duke University Medical Center, United States -
William Wang, PhD President
Merck & Co, Inc, United States -
Amy Xia, PhD Vice President, Center for Design and Analysis
Amgen Inc., United States -
Lisa LaVange, PhD Professor Emerita
University of North Carolina at Chapel Hill, United States -
Nevine Zariffa Vice President and Head Biometrics & Information Sciences
Astrazeneca Pharmaceuticals, United States
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