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Biostatistics and FDA Regulation: The Convergence of Science and Law

May 20 2014 8:00AM - May 20 2014 5:00PM | Wasserstein Hall at Harvard Law School 1585 Massachusetts Avenue Cambridge, MA 02138

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Overview 

For full event information, agenda and to register, please visit the FDLI website:


Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences. Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval. Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point up the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA. This one-day symposium will provide attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation.


A Symposium Presented by DIA, FDLI and Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Who Should Attend 

  • Regulatory attorneys
  • Consultants
  • Law students
  • Academics
  • Government attorneys
  • Industry members who use clinical trials

Learning Objectives 

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

  • Describe the increasing importance of biostatistics in food and drug law context
  • Explain basic biostatistical principles and related disputes in legal settings
  • Identify statistics issues in FDA regulation
  • Discuss emerging issues such as precision medicine, next-generation statistical analysis and comparative effectiveness measures

 


 

CANCELLATION POLICY
Because registration will be done through the FDLI website, the DIA cancellation policy listed below does not apply. Please refer to the FDLI website for the applicable cancellation policy.

Contact Information 

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

Agenda  

Day 1 Tuesday, May 20, 2014

  • 8:00AM - 8:45AM

    Registration and Continental Breakfast
  • 8:45AM - 9:00AM

    Welcome and Announcements

    Speaker(s):

    • Michael Levin-Epstein, JD
      Senior Vice President for Product Development and Editor-in-Chief
      The Food and Drug Law Institute, United States
    • Holly Fernandez Lynch
      Executive Director
      The Petrie-Flom Center at Harvard Law School, United States
  • 9:00AM - 10:30AM

    Introduction to Statistics and Regulatory Law

    Speaker(s):

    • Qi Jiang, PhD
      Executive Director, Global Biostatistical Science
      Amgen Inc., United States
    • Robert T. O'Neill, PhD
      Senior Statistical Advisor, Office of Translational Sciences, CDER
      FDA, United States
    • Moderated by
      Coleen Klasmeier, JD
      Global Coordinator, Food, Drug and Medical Device Regulatory Practice
      Sidley Austin LLP, United States
  • 10:30AM - 11:00AM

    Networking Break
  • 11:00AM - 12:15PM

    Safety Issues

    Speaker(s):

    • Lee-Jen Wei, PhD
      Professor, Department of Biostatistics
      Harvard School of Public Health, United States
    • Geoffrey Levitt, JD
      Senior Vice President and Associate General Counsel, Regulatory and Policy
      Pfizer Inc., United States
    • Janet Turk Wittes, PhD
      President
      Statistics Collaborative Inc., United States
    • Moderated by
      Qi Jiang, PhD
      Executive Director, Global Biostatistical Science
      Amgen Inc., United States
  • 12:15PM - 1:30PM

    Luncheon Speaker
  • 1:30PM - 2:30PM

    Statistics Disputes in Life Sciences Litigation

    Speaker(s):

    • Anand Agneshwar
      Partner
      Arnold & Porter LLP, United States
    • Nathan A. Schachtman
      Counsel
      Ulmer & Berne LLP, United States
    • Lee-Jen Wei, PhD
      Professor, Department of Biostatistics
      Harvard School of Public Health, United States
    • Moderated by
      Aaron Katz
      Partner
      Ropes & Gray LLC, United States
  • 2:30PM - 3:30PM

    Question Time with FDA Officials: Emerging Issues

    Speaker(s):

    • Robert T. O'Neill, PhD
      Senior Statistical Advisor, Office of Translational Sciences, CDER
      FDA, United States
  • 3:30PM - 3:45PM

    Networking Break
  • 3:45PM - 4:50PM

    Can We Handle the Truth: Rountable Discussion

    Speaker(s):

    • Anand Agneshwar
      Partner
      Arnold & Porter LLP, United States
    • Moderated by
      Janet Turk Wittes, PhD
      President
      Statistics Collaborative Inc., United States
  • 4:50PM - 5:00PM

    Closing Remarks and Adjournment

    Speaker(s):

    • Coleen Klasmeier, JD
      Global Coordinator, Food, Drug and Medical Device Regulatory Practice
      Sidley Austin LLP, United States

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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