Monday, April 1, 2013

Discuss PDUFA V Statistical Topics and Emerging New Issues - Apr 28 - May 1

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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.
Keynote Speakers:
International Year of Statistics
April 29 | 9:00-10:30AM ET
Janet Woodcock, MD
Left for Drug Evalulation
and Research
Robert N. Rodriguez, PhD
Senior Director
Statistical Research and Development
SAS Institute, Inc.
PDUFA V Overview
April 29 | 11:00AM-12:00PM
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.
     • 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.

     • 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
     • 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.

     • 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



Upcoming Webinars:
March 27 | 10:00-11:30AM ET
April 24 | 11:00AM-12:30PM ET
April 25-26 | 10:00-11:30AM ET

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