Call for Roundtable Discussion Topics
The organizing committee invites you to propose and volunteer to lead a roundtable luncheon discussion at the FDA/DIA Statistics Forum to be held Monday April 20 – 23, 2015 at the Bethesda North Marriott Hotel, Bethesda, MD (conveniently located near the White Flint Metro Station for those of you familiar with the Washington DC metropolitan area). Proposals should be submitted via a form at

The deadline for submission is February 27, 2015 and selection will be made by March 6, 2015. Roundtable luncheons will be held on April 21, 2015.

When submitting your proposal to lead a roundtable luncheon discussion we will ask for

  1. Your name
  2. Your phone number
  3. Your email address
  4. Your professional affiliation
  5. The roundtable discussion title (note this can be tentative)
  6. A general theme/topic (listed below)
  7. A short (2-3 sentences) description of the roundtable topic and 2-3 questions you plan to discuss

Potential roundtable luncheon discussion topics for the 2015 FDA/DIA Statistics Forum include (but are not limited to) the following broad topics that are related to the themes of the meeting:

  • Statistical Issues in Biosimilar Analytical Assessment
  • Adaptive Design and Bayesian Design
  • Observational Studies
  • Statistical Issues Related to Health Technology Assessment
  • Utilities of Modeling and Simulation in Drug Development and Evaluation
  • Subgroup Analysis
  • Quantitative Measures for Benefit-Risk Assessment
  • Estimands and Sensitivity Analyses

Each of these broad topics may have subtopics that you wish to expand upon in your luncheon dialogue--feel free to be creative. Furthermore, you are welcome to submit a roundtable topic that is unrelated to the meeting themes, though we will give preference to topics that are related.

Please use the following link to submit your discussion topic:
If selected, you will be responsible for all costs (e.g., registration, travel, lodging). Also note that the submission form does not allow for updates. If you need to update your submission, please completely resubmit your proposal. There is a field at the end of the form to indicate that it is a resubmission.
Please send questions and inquiries to
Ellen Diegel
Program Manager
Drug Information Association
Phone: 215-293-5810
Email:
We look forward to receiving your proposals by February 27, 2015, and your participation in this conference in April 2015.
Thank you,
The 9th Annual FDA/DIA Statistics Forum Roundtable Luncheon Organizers

Eugenio Andraca-Carrera, PhD

Mathematical Statistician, Division of Biometrics VII

Office of Biostatistics, Office of Translational Science

CDER, FDA

Judy Li, PhD

Mathematical Statistician

Division of Biostatistics

CBER, FDA

Cristiana Mayer, PhD

Scientific Director, Statistical Modeling

Model-Based Drug Development

Janssen Research and Development, LLC

Jeff Maca, PhD

Senior Director, Center for Statistics in Drug Development Innovation
Quintiles