Leading scientists from academia, the FDA, and industry will present and lead discussion on the current status of the rapidly emerging field of drug transporters, the clinical relevance of drug uptake and efflux transporters, and the application of in vitro and in vivo tools to drug discovery and development
Horsham, PA (Vocus) July 25, 2008
The Drug Information Association (DIA) and the Food and Drug Administration (FDA) will host the Critical Path Initiative (CPI) on the Move: Complexities and Challenges (September 15 -16; Bethesda, MD) and the Critical Path Transporter Workshop (October 2-3; North Bethesda, MD).
"The FDA Critical Path Initiative is a key FDA science-based effort to modernize the science and tools used in the development, evaluation, manufacture, and use of all FDA-regulated products, explains Program Co-chair Rachel E. Behrman, MD, MPH, Director, Office of Critical Path Programs, OC, FDA. "This workshop will explore what has been accomplished, current projects and their status, and future opportunities."
The Critical Path Initiative (CPI) on the Move: Complexities and Challenges will feature speakers/panelists such as Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA; Mark B. McClellan, MD, PhD, Chair, Reagan-Udall Foundation and Director, Engelberg Center for Health Care Reform Brookings; and Raymond Woosley, MD, PhD, President and CEO, Critical Path Institute.
The Critical Path Transporter Workshop will be held in collaboration with PhRMA, the American Association of Pharmaceutical Scientists, and International Society for the Study of Xenobiotics.
"Leading scientists from academia, the FDA, and industry will present and lead discussion on the current status of the rapidly emerging field of drug transporters, the clinical relevance of drug uptake and efflux transporters, and the application of in vitro and in vivo tools to drug discovery and development," notes Program Committee Member Shiew-Mei Huang, PhD, FCP, Deputy Director, Office of Clinical Pharmacology, CDER, FDA.
Featured sessions will include:
- Focus on key transporters
- Current and future technical challenges
- Drug development and FDA examples
In March 2004, FDA first announced the Critical Path Initiative, which was designed to identify additional mechanisms through applied scientific studies to develop better methods and new technologies that may improve the product development process. Since that time, a number of efforts have launched to leverage collaborations to modernize development of new genomic, imaging, statistical, methodological, analytical, and informatics tools, with the ultimate goal of reducing the uncertainty about product performance throughout the medical product life cycle.
About the Drug Information Association (DIA)
The Drug Information Association serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit http://www.diahome.org or call 215-442-6100.