The FDA/DIA 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 used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.

We use this opportunity to come together annually in the Washington, DC area to describe important issues, discuss solutions and review progress and problems. We feel that it is important for all stakeholders to examine their roles in this enterprise and ask the hard questions that need to be answered – to develop appropriate, scientific/regulatory consensus regarding our purpose and process.

In recent years, thought leaders from government agencies, industry, and academia have discussed:

·         Biomarker development and assessments

·         Considerations for specific Guidances, including those for Adaptive

·         Design, Non-inferiority, Multiplicity and Missing Data;

·         Statistical challenges in analyzing safety data such as meta-analytic methods, analysis of rare adverse events, and multiplicity;

·         Current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new therapeutic products;

·         FDA’s “Critical Path” initiative and the 2007 Food and Drug

·         Administration Amendments Act – emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and the need for new statistical thinking;

·         Best practices for developing appropriate, scientific and regulatory consensus;

·         The impact of regulations and Guidances on statistical practice;

·         Ideas for improving the communication between Industry Statisticians and Reviewers; and,

·         The previous year’s statistical and regulatory “highlights.”

WHO SHOULD ATTEND

·         Statisticians

·         Clinicians

·         Epidemiologists

·         Drug safety professionals

·         Regulatory and medical communication scientists

TRAVEL AND HOTEL The most convenient airport is Ronald Reagan National Airport and attendees should make airline reservations as early as possible to ensure availability. The Marriott Bethesda North Hotel & Conference Center is holding a block of rooms at the reduced rate below until March 26, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single $179                             Double $179

Please contact the Marriott Bethesda North Hotel & Conference Center by telephone at +1.301.822.9200 and mention the DIA event. The hotel is located at 5701 Marinelli Road, Bethesda, MD 20852, USA.