SESSION KEYNOTE

Title : Harnessing the Power of Statistics: Big Challenges, Big Opportunities 
Speaker:
Dionne Price, FDA
Moderator: 
Naitee Ting

Abstract:

Ebola, antibiotic drug resistance, rare diseases, and COVID-19 are only a few of the many areas that have demanded global attention in recent years. While these areas have created immense challenges, they have also resulted in vast opportunities. From a global pandemic to ongoing oncology demands, the need to harness the power of statistics has become ever more apparent. Statisticians are taking the lead in designing and analyzing clinical trials for potential therapeutic agents that will further advance our public health. Statisticians are employing innovative approaches that will allow clinical trials to efficiently and reliably answer questions of interest.

The Food and Drug Administration (FDA) has been at the forefront of meeting the challenges arising from the evolving needs of patients. FDA statisticians play a vital role in diverse topics such as real-world evidence, patient-focused drug development, model informed drug development, and complex innovative trial designs. This talk will provide an overview of how the power of statistics is being harnessed at the FDA and beyond, with a specific focus on complex innovative trial designs.

Instructor’s Bio:

Dionne Price is the Director of Division of Biometrics IV in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA). In this role, Dr. Price provides leadership to statisticians involved in the development and application of methodology used in the regulation of drug products in therapeutic areas including anti-infectives, anti-virals, ophthalmology, rare diseases, and urology, obstetrics, and gynecology. Dr. Price is a member of the Senior Leadership Team and Statistical Policy Council within the Office of Biostatistics. Throughout her career, she has been actively involved in the FDA response to various public health challenges including serving on the Antibacterial Drug Development Task Force and being a member of teams tasked with the review of therapeutics products for the treatment of Ebola and coronavirus. She currently leads cross-cutting, collaborative efforts across FDA to advance and facilitate the use of complex innovative trial designs in pharmaceutical drug development.

 

Dr. Price holds a MS in Biostatistics from the University of North Carolina at Chapel Hill and a PhD in Biostatistics from Emory University. Her research interests are focused on the design and analyses of clinical trials. Dr. Price has co-authored papers in such journals as Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research. She also has a passion for mentoring and for teaching having taught courses for the FDA, Trinity University, and Georgetown University.

 

Dr. Price is an active member of the International Biometric Society (IBS), the American Statistical Association (ASA), and the Food and Drug Administration Statistical Association. She has served as Chair of the Biopharmaceutical Section of the ASA. The Biopharmaceutical Section boasts over 2000 members who share a common interest in the application of statistics to the development and use of therapeutic drugs and devices in humans and animals. She has also served on the Regional Advisory Board and Regional Committee of the Eastern North American Region of IBS. Dr. Price was named a Fellow of the ASA in 2018 and is a Vice-President of the ASA.

 

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