Statisticians, clinicians and other industry, academia, CRO and agency personnel come together to share information, ideas and experiences using current and emerging statistical methodologies and quantitative approaches used to develop evidence of the safety and efficacy of new drug and biologic therapeutic products.
Horsham, PA (Vocus) March 17, 2009
Speakers from the FDA Center for Drug Evaluation and Research (CDER), industry, and academia will convene at the Drug Information Association's (DIA's) 3rd Annual Statistics Forum (April 26-29; Arlington, VA) to discuss statistical methodologies and quantitative approaches in the development and review of therapeutic drugs and biologics.
Featured topics will include:
- New directions and guidance for safety planning and reporting
- Follow-up on FDA Guidances: Adaptive design; Non-inferiority; Missing data; Multiplicity
"The annual FDA/DIA Statistics Forum provides an open forum to discuss the statistical and regulatory implications of FDA initiatives and Guidances," explains Program Co-chair Barry Schwab, PhD, Vice President, Clinical Biostatistics, Johnson & Johnson Pharmaceutical Research and Development, LLC. "Statisticians, clinicians and other industry, academia, CRO and agency personnel come together to share information, ideas and experiences using current and emerging statistical methodologies and quantitative approaches used to develop evidence of the safety and efficacy of new drug and biologic therapeutic products."
A joint keynote address will be delivered by ShaAvhree Buckman, MD, PhD, Acting Director, Office of Translational Sciences, CDER, FDA, and Peter (Tony) Lachenbruch, PhD, MS, Professor, College of Health and Human Services, Oregon State University.
About the Drug Information Association (DIA)
DIA 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, Mumbai, India, and Beijing, China, 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.
Contact: Joe Krasowski