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Concurrent Tutorials
February 10, 2015 | 1:30 - 5:00 PM
Tutorial 1: Bayesian Methods for Drug Safety Evaluation and Signal Detection
Tutorial 2: Use of Historical Data in Clinical Trials

As the complexity of pharmaceutical development escalates, researchers must leverage increasingly sophisticated statistical tools for design and analysis, including broader use of Bayesian methods and adaptive designs. There has been an upturn in interest and application of adaptive design and Bayesian statistics, in part due to their inclusion within the FDA's Critical Path Opportunities List.

While these methods have already contributed in many ways to reductions in risk, time, and cost of medical product development, and to overall improvements in decision making; for many drug developers, device, and diagnostic manufactures adaptive design and Bayesian statistics are still buzz-words.  Per a recent survey conducted by DIA’s Bayesian Scientific Working Group, education continues to be a significant gap in a broader appropriate uptake of Bayesian methods, including their use in adaptive designs.  In order to improve the implementation of adaptive design and Bayesian statistics, we must demystify the practice and application of these proven methodologies.

February 2015 marks the 5th anniversary of the publication of the FDA’s draft guidance on adaptive clinical trials and the final guidance of the use of Bayesian statistics in medical device clinical trials. Join us to celebrate these important milestones for clinical trials as well as to engage FDA representatives in discussions regarding the progress of both adaptive design and Bayesian statistics and to speculate the future for this science.

This conference will present the latest advancements in the application of adaptive design and Bayesian statistics to include critical aspects such as a better understanding of methodologies, identifying opportunities for when to apply them, analysis, and improved decision making. Presentations will be given from statistical, clinical, and regulatory viewpoints to provide a more complete picture of appropriate adaptive design and Bayesian statistics implementation.

Sessions will consist of joint and independent adaptive design and Bayesian statistic plenaries as well as concurrent breakout sessions for each class of methods.   Case studies will be presented throughout the conference to encourage discussions and debates regarding the use of Bayesian and adaptive design methods within modern medical product development from presenters across industry, regulatory, and academia.

This program has been developed in collaboration with the DIA Adaptive Design Scientific Working Group and the Bayesian Statistics Scientific Working Group.

This program is being marketed in collaboration with the International Society for Bayesian Analysis (ISBA).

Featured topics

  • 5th anniversary of FDA’s final guidance of the use of Bayesian statistics
  • 5th anniversary of FDA’s draft guidance on adaptive clinical trials in medical device clinical trials

Who should attend?

Professionals from industry, academia, and government involved in medical product development from learning to confirmatory phases or in new drug/device application review:

  • Clinician
  • Pharmacologists
  • R&D Design-makers
  • Comparative Effectiveness
  • Evidence Based Medicine
  • Statisticians
  • Regulatory Scientists
  • Safety and Pharmacovigilance
  • Epidemiologists
  • Post Marketing

Learning objectives

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

  • Apply concepts related to adaptive design and Bayesian methods
  • Identify opportunities for improving pharmaceutical, device, and diagnostic product development by application of adaptive design and/or Bayesian statistics
  • Assess whether the application of adaptive design and/or Bayesian methods would improve metrics such as cost, time of development, and probability of success, compared to the application of more traditional method

Program Committee

  • Zoran  Antonijevic, MSc
    Zoran Antonijevic, MSc Executive Director, Development Design
    Amgen, United States
  • Karen Lynn Price, PhD, MA
    Karen Lynn Price, PhD, MA Senior Research Advisor
    Eli Lilly and Company, United States
  • Kenneth A. Getz, MBA
    Kenneth A. Getz, MBA Director of Sponsored Research Programs and Associate Professor
    Center For the Study of Drug Development, Tufts University School of Medicine, United States
  • Roger J. Lewis, MD, PhD
    Roger J. Lewis, MD, PhD Professor of Medicine, Department of Emergency Medicine
    Harbor UCLA Medical Center, United States
  • David  Ohlssen, PhD
    David Ohlssen, PhD Senior Expert Methodologist
    Novartis Pharmaceuticals Corporation, United States
  • Yili   Pritchett, PhD
    Yili Pritchett, PhD Senior Director, Global Development
    Astellas Pharma Inc., United States
  • M. Scott  Harris, MD, MS, FACP
    M. Scott Harris, MD, MS, FACP Principal
    Lyric Pharmaceuticals, United States
  • Estelle  Russek-Cohen, PhD
    Estelle Russek-Cohen, PhD Director, Division of Biostatistics, OBE, CBER
    FDA, United States
  • John W. Seaman, PhD
    John W. Seaman, PhD Professor of Statistics
    Baylor University, United States
  • Laura  Thompson, PhD
    Laura Thompson, PhD Mathematical Statistician, CDRH
    FDA , United States
  • Ram  Tiwari, PhD
    Ram Tiwari, PhD Director, Division of Biostatistics, CDRH
    FDA, United States
  • Sue-Jane  Wang, PhD, MA, MS
    Sue-Jane Wang, PhD, MA, MS Assoc. Dir., Adaptive Design & Pharmacogenomics, OB, OTS, CDER
    FDA, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen, Inc., United States
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