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Keynote Speakers

Robert Califf Robert M. Califf, MD, MACC
Commissioner of Food and Drugs

Commissioner Califf discusses a new agenda for the FDA, and the role that will be played by new data sources and advances in the use of existing data.

Ronald Wasserstein

Ronald Wasserstein
Executive Director
American Statistical Association

Mr. Wasserstein will address ASA's recently released statement on p-values, statistical significance, and the sciences. Did the ASA go too far or not far enough?

New Closing Session with

Martin Posch

Martin Posch, PhD
Medical University of Vienna

Dr. Martin Posch will be presenting a talk entitled, An Extrapolation Framework to Specify Requirements for Drug Development in Children.

 Tutorials (AM): April 25, 2016*
Tutorial 1: Signal Detection from Drug Safety Databases using Likelihood Ratio Tests
Tutorial 2: Recurrent Event Data Analysis in Clinical Trials
*Tutorials require registration and an additional fee

Forum: April 25, 1:00 PM – April 27, 2016

Now in its tenth year, the DIA/FDA Statistics 2016 Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. This unique forum continues the dialogue between industry, academia, and regulatory agencies to collaboratively explore real world application of innovative approaches and solutions for statistical challenges surrounding the design and analysis of clinical trials.  Sessions will focus on the latest guidance developments, regulatory science initiatives, and the statistical methodologies and quantitative approaches used to provide evidence for the approval of new therapies.


This program is cosponsored with FDA

Forum Features

  • Half day Tutorials
  • Poster Presentations
  • Luncheon Round Table Discussions with Key Thought Leaders
  • Town Hall with Leaders from Industry and Regulatory Agencies
  • Access to Multiple Scientific Working Groups and Numerous Networking Opportunities

Featured topics

  • New ICH guidance developments
  • Qualification of biomarkers
  • Endpoints and PROs
  • Real world examples, observations, and pragmatic approaches to incorporating data from EMR, historical trial data, patient provided data, and meta-analysis into the clinical trial studies
  • Latest trends and updates from Regulatory Agencies
  • Analytical similarity
  • Single-arm trials
  • Rare diseases
  • Data analysis of reoccurring events

Who should attend?

Professionals from industry, academia, and government involved in all phases of medical product development who are interested in learning the latest state of the art techniques for pharmaceutical development:

  • Biostatisticians
  • Physicians
  • Clinical Pharmacologists
  • Health Economists
  • Epidemiologists
  • Regulatory Scientists

Learning objectives

At the conclusion of this forum, participants should be able to:

  • Discuss the latest trends and updates from Regulatory Agencies, including the US FDA and EMA
  • Introduce innovative and state of the art statistical solutions to assess safety and efficacy of new medical products in development
  • Assess the impact of new and upcoming regulations and guidances on statistical practice
  • Propose recommendations for improving the communication between industry statisticians and reviewers
  • Discuss the latest information about new ICH guidance developments related to statistics and clinical trials
  • Describe the qualification of biomarkers to include the standards for biomarkers, validation, framework and statistical requirements

Program Committee

  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Senior Statistical Advisor, Office of the Commissioner
    FDA, United States
  • Jerald S. Schindler, DrPH
    Jerald S. Schindler, DrPH Vice President
    Alkermes, Inc., United States
  • Frank  Bretz, PhD
    Frank Bretz, PhD Distinguished Quantitative Research Scientist
    Novartis Pharma AG, Switzerland
  • Joan  Buenconsejo, PhD, MPH
    Joan Buenconsejo, PhD, MPH Senior Director, Biostatistics
    AstraZeneca, United States
  • Brenda  Crowe, PhD
    Brenda Crowe, PhD Senior Research Advisor, Global Statistical Sciences
    Eli Lilly and Company, United States
  • Jeff  Maca, PhD
    Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
    Quintiles, United States
  • Cristiana  Mayer, DrSc, PhD
    Cristiana Mayer, DrSc, PhD Head of Biostatistics
    Johnson & Johnson Vision, United States
  • Ram  Tiwari, PhD, MS
    Ram Tiwari, PhD, MS Head of Statistical Methodology
    Bristol Myres Squibb , United States
  • Steve  Wilson, PhD
    Steve Wilson, PhD Senior Staff Fellow, OB, OTS, CDER
    FDA, United States
  • Peiling  Yang, PhD
    Peiling Yang, PhD Statistics Team Lead, Division Biometrics I, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
    Eli Lilly and Company, United States
  • Lisa  LaVange, PhD
    Lisa LaVange, PhD Professor and Chair, Department of Biostatistics
    University of North Carolina At Chapel Hill, United States
  • Nevine  Zariffa
    Nevine Zariffa Vice President and Head Biometrics & Information Sciences
    Astrazeneca Pharmaceuticals, United States
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