Overview

Keynote Speakers

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

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
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, PhD
Professor,
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

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

Short Course or Primer

To keep you at the forefront.

Apr 25, 2016

Tutorial 1:

Signal Detection from Drug Safety Databases using Likelihood Ratio Tests

Learn more

Apr 25, 2016

Tutorial 2:

Recurrent Event Data Analysis in Clinical Trials

Learn more

Apr 25, 2016

Tutorial 1:

Signal Detection from Drug Safety Databases using Likelihood Ratio Tests

Learn more

Apr 25, 2016

Tutorial 2:

Recurrent Event Data Analysis in Clinical Trials

Learn more

Program Committee

Aloka Chakravarty, PhD Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
Jerald Schindler, DrPH Chief Executive Officer
Strategic Statistics, United States
Frank Bretz, PhD Distinguished Quantitative Research Scientist
Novartis , Switzerland
Joan Buenconsejo, PhD, MPH Head of Cardiovascular and Neuroscience Biostatistics
Bristol Myers Squibb, United States
Brenda Crowe, PhD Associate Vice President, Statistics
Eli Lilly and Company, United States
Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
Quintiles, United States
Cristiana Mayer, DrSc, PhD Head of Biostatistics
Johnson & Johnson Vision, United States
Ram Tiwari, PhD, MS Head of Statistical Methodology
Bristol Myres Squibb , United States
Steve Wilson, PhD Senior Staff Fellow, OB, OTS, CDER
FDA, United States
Peiling Yang, PhD Supervisory Mathematical Statistician
FDA, United States
Pandurang M Kulkarni, PhD Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
Eli Lilly and Company, 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