Key Current Statistical Issues in Drug Development and Review: an Industry Perspective
View Presentation *José Pinheiro, Johnson & Johnson PRD Keywords: statistical designs, novel methods, guidance documents The challenging environment facing the pharmaceutical industry, with increasing development costs and a tougher regulatory environment, has led to great interest in statistical designs and methods to increase the efficiency and success rate of drug development. This talk will present an overview of current statistical issues in drug development, including an industry perspective on recent FDA draft guidance documents. Methodological interactions between regulatory and industry statisticians have always played an important role in advancing statistical and regulatory sciences, but were recently challenged by the discontinuation of PhRMA’s technical groups (TG), an accepted communication channel between FDA and industry. A new quantitative sciences industry representative group that emerged to fill the gap left by PhRMA’s TG will be presented and its activities discussed.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC