DIA/FDA Statistics 2016 Forum

The following round table discussions are planned for this year’s forum. Joining a discussion is optional and prior to the conference all registered attendees will be asked, via an email from DIA, to pre-select a table if they are interested in participating.

1. A Discussion of Populations and Analyses in the Context of Safety Evaluation
Discussion Leader: Shanti Gomatam, Mathematical Statistician, CDER, FDA

2. Current Statistical Issues for Assessment of Analytical Biosimilarity-From both Regulatory and Industry Perspectives
Discussion Leader: Cassie Dong, Math Stat, CDER,FDA

3. Similarity of Dissolution Profiles
Discussion Leader: Thomas Hoffelder, Statistician, Boehringer Ingelheim

4. Organizing a Therapeutic Area SWG for Alzheimer's
Discussion Leader: Stephen Wilson, Director, CDER, FDA

5. Interpretation of drug effects on the components of a composite endpoint in cardiovascular trials
Discussion Leader: Junshan Qiu, Statistician, CDER, FDA

6. Missing data in Psychiatry Trials and Estimands
Discussion Leader: Eiji Ishida, Mathematical Statistician, CDER, FDA

7. Challenges in Evaluating Patient-Reported Outcomes (PROs) and Patient Preference Information (PPI) for Rare Diseases: the Case of Hemophilia
Discussion Leader: Million Tegenge, Visiting Scientist (Clinical Pharmacology), CBER, FDA

8. Bayesian Analysis on Borrowing Historical Information for the Analysis of Rare Disease
Discussion Leader: Judy Li, Mathematical Statistician, CBER, FDA

9. Challenges and Opportunities in Choosing Endpoints for Oncology Clinical Trials
Discussion Leader: Anwar Hossain, Research Scientist, Eli Lilly & Company

10. Statistical Challenges in Clinical Trials for Ultra-Rare Disease
Discussion Leader: MyungShin Oh, Principal Statistician, BioMarin

11. The Statistician's Enhanced Team Role in an Adaptively Designed Trial
Discussion Leader: Eva Miller, Senior Director, Biostatistics, inVentiv Health Clinical

12. GCP Knowledge for Statisticians: ASA-DIA White Paper Draft