JSM 2005 - Toronto

Abstract #303672

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 408
Type: Luncheons
Date/Time: Wednesday, August 10, 2005 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303672
Title: Pharmacogenomics: The Critical Path to Personalized Medical Products
Author(s): Xiaohua Zhang*+ and Amber D. Anderson
Companies: Merck Research Laboratories and GlaxoSmithKline
Address: Biometrics Research WP37T2, West Point, PA, 19486-0004, United States
Keywords: Pharmacogenomics ; Pharmacogenetics ; critical path ; NIH roadmap ; RNA interference
Abstract:

The NIH recently conducted a strategic planning exercise titled "The NIH Roadmap," which stresses the need to "redesign" the clinical research enterprise, in part to help facilitate the translation of emerging disciplines such as pharmacogenomics (PGx). As such, NIH funds multidisciplinary, multiinstitutional Pharmacogenetics Research Network (PGRN). Meanwhile, the FDA released a white paper "Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products." PGx is one of the critical paths. PGx may lead to more powerful and safer personalized drugs, to great improvement of the drug discovery and approval process, and to a big reduction of the overall cost of health care. However, PGx is still in its infancy. Before many PGx benefits can be realized, we have to face many new challenges and issues in regulatory affairs, scientific and statistical development, ethical concerns, and education of health care providers. In order to translate PGx from bench to bedside, it is vital to discuss the PGx benefits, challenges, and strategies. Here, we provide such a discussion opportunity to people from academia, regulatory agency, and industry.


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Revised March 2005