FDA/DIA Statistics Forum

The FDA/DIA statistics forum will take place April 18–21 in Bethesda, Maryland. The forum provides a venue to discuss important statistical issues associated with the development and review of therapeutic drugs and biologics. The meeting is intended to be an annual, open dialogue to discuss FDA’s issues, initiatives, and guidance— emphasizing the statistical and regulatory challenges.

The conference is an opportunity for statisticians, clinicians, and other interested professionals from industry, academia, CROs, and government agencies to learn about and assess current and emerging statistical methodologies and quantitative approaches for developing evidence of the efficacy and safety of new drug and biologic therapeutic products.

This year’s featured topics include:

• Good meta-analysis practices
• Meta-analysis to evaluate cardiovascular risks
• FDA guidance on noninferiority
• Issues associated with meta-analysis for margin justification
• Modeling and simulation for quantitative decisionmaking in drug development
• Challenges in developing tailored therapies by subgroup identification
• Using CDISC/ADaM to create analysis-ready data sets
• Collaborative environments for statistical methodology development – the wiki way
• Comparative effectiveness research

The target audience for the conference includes statisticians, clinicians, epidemiologists, drug safety professionals, and regulatory and medical communication scientists.

Visit the conference web site and search for the conference under the Conference/Meetings tab for details or contact Ellen.Diegel@diahome.org. This conference is not cosponsored by the ASA Biopharmaceutical Section.

Corporate Sponsorship Program

Again this year, the section is indebted to our corporate sponsors for their generous support of our ongoing programs and activities.

With more than 2,000 members, the Biopharmaceutical Section is one of the largest and most active sections within the ASA. Thanks to the help and support of our corporate sponsors, we have provided unique and substantial contributions to our members and the biopharmaceutical community at large. We are able to sponsor or cosponsor several professional meetings throughout the year, including JSM sessions and the FDA/industry workshop. We are also able to provide cash awards for the Student Paper Awards competition and Best Contributed Paper competition at the Joint Statistical Meetings.

Invitations to become corporate sponsors are mailed out in the first quarter of each year. Any company interested in becoming a corporate sponsor can contact the chair of the Corporate Sponsorship Committee, Russ Helms, at Russ_Helms@RhoWorld.com.