DIA IN COOPERATION WITH FDA AND PHRMA

Tutorials October 7, 2009

Conference October 8-9, 2009

Hear FDA, NCI, Academia, and PhRMA perspectives on Clinical, Radiological, and Statistical Evaluation of rogression-Free Survival.

Progression Free Survival (PFS) endpoints are increasingly used for evaluation and approval of oncology drugs. This conference will discuss:

·         Definition of PFS: combining radiological data and clinical assessments;

·         Application of PFS in various cancers;

·         Strategies for use of independent review with PFS endpoints;

·         Approaches to the design and analysis of randomized trials with PFS as the primary endpoint

·         Increasing awareness among the oncology clinical trials community about the critical design and analysis issues with PFS outcome, and;

·         Strategies for the evaluation of alternative approaches to the analysis of PFS data.

KEYNOTE SPEAKER

Richard Pazdur, MD, Director, Office of Oncology Drug Products, CDER, FDA

In addition to his experience as a regulatory expert at FDA, Dr. Pazdur has distinguished himself in clinical and academic oncology. He served as a fellow in oncology at Rush Presbyterian-St. Luke's Medical Center at the University of Chicago and as a practicing oncologist, researcher, and teacher at Wayne State University, where he directed the medical oncology fellowship program. Dr. Pazdur was also a tenured Professor of Medicine and Assistant Vice President for Academic Affairs at M.D. Anderson Cancer Center at the University of Texas. He joined FDA in 1999 as the Director of the Division of Oncology Drug Products and was named Director of the Office of Oncology Drug Products in April 2005. He has authored over 160 peer-reviewed papers in the field of oncology, has written chapters for over 30 oncology textbooks, and is the editor of two standard reference oncology texts.

At the conclusion of this meeting, participants should be able to:

·         Describe the key issues with progression-free survival as an endpoint;

·         Explain the latest techniques used in progression-free survival; and

·         Evaluate and appraise alternative solutions.

This program will benefit Oncology professionals involved in:

·         Biostatistics

·         Regulatory affairs

·         Compliance

·         Data analysis

·         Quality assurance/Quality control

·         Oncology

·         Radiology

Conference

Constance Burnett, Phone +1-215-293-5800/email Constance.Burnett@diahome.org