Discuss PDUFA V Statistical Topics
and
Emerging New Issues
Now in its seventh year, this unique
forum continues the dialogue on issues including FDA guidance development
and regulatory science initiatives including PDUFA V initiatives, as well
as statistical opportunities and challenges associated with data
standards and innovative approaches to the design, monitoring, analysis,
and reporting of clinical trials and assessments of safety and
effectiveness in the pre- and postmarket settings. Over the three days,
in-depth discussions on key topics relevant to the evaluation of
therapeutic products will take place, and include input from key thought
leaders from regulatory agencies, industry, and academia.
With the success of last year’s forum
we will continue to offer additional avenues for interaction and
scientific discourse via a scientific poster session during the
networking reception and an interactive round-table luncheon event.
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Janet Woodcock, MD
Director
Left for Drug Evalulation
and Research
FDA
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Robert N. Rodriguez,
PhD
Senior Director
Statistical Research and Development
SAS Institute, Inc.
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This session will discuss the key
PDUFA V commitments, current plans for their implementation, areas of
interest for statisticians in particular, and perspectives on the
potential impact on stakeholders.
Speakers:
• Stephen
J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly
and Company
• Theresa
M. Mullin, PhD, Associate Director, Office of Planning
and Informatics, CDER, FDA
• Jay
P. Siegel, MD, Chief Biotechnology Officer, Head Global
Regulatory Affairs
Janssen Research &
Development, LLC
• Stephen
E. Wilson, DrPH, Director, Division of Biometrics III,
CDER, FDA
• Robert
T. O'Neill, PhD, Senior Statistical Advisor, Office of
Translational Sciences, CDER, FDA
(Premarketing)
Benefit-Risk Assessment in Clinical Development and Regulatory Review
April 30 | 1:30-3:00PM
In this session, speakers will discuss various Benefit-risk assessment
approaches that can be potentially used to meet the needs of global
regulatory agencies and prescribers, as well as challenges that may arise
in implementing them.
Speakers:
• Qi
Jiang, PhD, Executive Director, Amgen Inc.
• Jonathan
D. Norton, PhD, Mathematical Statistician, Division of
Biometrics V, OB, CDER, FDA
• Scott
Evans, PhD, Senior Research Scientist, Harvard University
School of Public Health
• Steven
M. Snapinn, PhD, Vice President, Global Biostatistical
Science, Amgen Inc.
• Frank
W. Rockhold, PhD, Senior Vice President, Global Clinical
Safety and Pharmacovigilance
GlaxoSmithKline
• Patrick
Frey, Director, Office of Planning and Analysis, CDER,
FDA
Overview and Commentary of FDA
Guidances: Multiplicity and/or Enriched Populations
May 1 | 3:00-4:30PM
Key contributors from FDA will
present highlights of the FDA guidances, and speakers from industry and
academia will provide key suggestions and comments on the draft
guidances.
Speakers:
• Walter
Offen, PhD, Global Head of Statistical Innovation & Safety
Statistics, Abbvie
• Mohamed
A. Alosh, PhD, Team Leader, FDA
• Frank
Bretz, PhD, Global Head of Statistical Methodology,
Novartis Pharma AG, Switzerland
• Gary
G. Koch, PhD, MS, Director, University of North Carolina
at Chapel Hill
• Lisa
M. LaVange, PhD, Director, Office of Biostatistics,
Office of Translational Science
CDER, FDA
• Stephen
J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly
and Company
• Robert
J. Temple, MD, Deputy Left Director for Clinical
Science, CDER, FDA
• Kathleen
S. Fritsch, PhD, Mathematical Statistician, OTS, CDER,
FDA
• Sue-Jane
Wang, PhD, MA, MS, Associate Director, Adaptive Design
& Pharmacogenomics
Office of Biostatistics, OTS, FDA
Jumpstart Your Education
at this Annual Forum by Adding a Tutorial:
• Statistical
Methods for Safety Surveillance
• Missing
Data in Clinical Trials
• Benefit-Risk
Evaluation
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March 27 |
10:00-11:30AM ET
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April 24 |
11:00AM-12:30PM ET
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April 25-26 |
10:00-11:30AM ET
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