Program - International Chinese Statistical Association

ICSA 2010 SYMPOSIUM KEYNOTE SPEECHES
KEYNOTE SPEECHES
Speech K01-A: FDA's Critical Path Initiative: Updates, Opportunities, and New
Challenges
Speaker: Dr. ShaAvhrée Buckman, Food and Drug Administration
Location and Time: Regency AB, Monday, June 21, 8:00 a.m.– 10:00 a.m.
Abstract: In March 2004, the FDA released a report entitled “Innovation or Stagnation, Challenge
and Opportunities on the Critical Path to New Medical Products ”. This report highlighted the rising cost
of drug development coupled with the decline in new drug submissions to the FDA. It emphasized the
urgent need to modernize the medical product development process to keep pace with scientific
innovation. In 2006, FDA published 76 specific scientific activities in a 2nd report, entitled “Critical Path
Opportunities Report and List ”. The Critical Path Initiative (CPI) is FDA's effort to stimulate and
facilitate a national effort to modernize the scientific process through which a potential human drug,
biological product, or medical device is transformed from discovery or "proof of concept" into a medical
product. The goal of the CPI is to bring new scientific discoveries to bear on product development, and to
improve the accuracy of the tests we use to predict the safety and efficacy of investigational medical
products. CPI research projects focus on six key areas:
• Better Evaluation Tools -- Biomarkers and Disease Models
• Streamlining Clinical Trials
• Harnessing Bioinformatics
• Moving Manufacturing into the 21st Century
• Products to Address Urgent Public Health Needs
• At-Risk Populations.
This talk is focused on approaches which promote automation of data collection, genomic data collection,
enhanced study design techniques including adaptive designs, incorporation of pharmacogenomic
information in trials and labeling, partnering of industry and academia, educational programs to teach and
train future investigators, development of disease models and biomarkers in clinical trials, and use of
patient populations in early clinical trials.
All of these areas are critical to modernize medical product development.
About the Speaker: Dr. ShaAvhrée Buckman is the Director at the Center for Drug Evaluation and
Research, Food & Drug Administration. She received her Ph.D. in Molecular Cell Biology from
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