Fellow Nominations
Do you know someone in the Biopharmaceutical Section who deserves to become an ASA Fellow? If so, click here to determine whether the person you have in mind is already a Fellow. If not, send their name to Steve Wilson at Stephen.Wilson@fda.hhs.gov by August 31. Members of the Biopharmaceutical Section Fellows Committee will evaluate each recommendation and facilitate the creation of a nomination package for candidates judged most deserving of this honor.
The three-day FDA/Industry Statistics Workshop is one of a series of annual events that have been sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association since 1996. This year’s workshop will be held September 20–22 at the Grand Hyatt Washington in Washington, DC.
Short courses are scheduled on the first day, followed by two days of sessions on the science and statistics associated with the development of new medical products (e.g., pharmaceuticals, biologics, and devices). The workshop has been popular since its inception because it provides a unique opportunity to bring together statisticians from industry, academia, and the Food and Drug Administration for an open dialog about issues of mutual interest.
The titles of short courses and several session topics are provided below. Click here for the complete online program and registration details.
Short Courses (September 20)
- Emerging Challenges in Clinical Trial Methodologies
- Beyond Survival Analysis: Recurrent Event Responses in Clinical Trials
- Interpreting Change and Responder Analysis for Patient-Reported Outcomes
- Hot Topics: Recent Developments in Clinical Trial Methodologies
- Good Statistical Practice and Common Subtle Statistical Mistakes
- Quantitative Pharmacovigilance: Statistical Approaches to Medical Product Safety Surveillance
Session Topics (September 21–22)
- Issues and Methods for Handling Missing Data in Clinical Trials
- Risks in Your Everyday Food: Signal Detection for Global Food Safety
- Vaccine Safety, H1N1 and Other Influenza Vaccines
- Design and Analysis Issues in Active Control Veterinary Clinical Trials
- Critical Statistical Issues and Standards for Biomarker Discovery and Diagnostic Assay Development
- Issues and Suggestions Involving Subgroup Analyses
- Heterogeneity in Treatment Response: What It Is, Why It’s Important, and How to Find It
- Quantitative Assessments of Patient Reported Outcomes: Questionnaire Design and Analysis
- Population Enrichment Designs in Clinical Trials
Conference attendance is limited to 750 participants, so make sure to register early.
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