Statistical Considerations for the Development of Follow-on Biologics – An Industry Statistician’s Perspective
View Presentation *Patrick Darken, Teva Pharmaceuticals Keywords: Follow-on-Biologics, biosimilarity In order to reduce health care costs, the development of Follow-on Biologics (FoB) has received a lot of attention lately in the US. With the passage of the Patient Protection and Affordable Care Act in March of 2010, although the detailed scientific requirements still need to be sorted and clarified, a legal pathway exists in the US for the approval of FoB. Statistically-related issues and challenges associated with the development of FoB will be discussed. These include the establishment of biosimilarity of the critical quality attributes, pharmacokinetic biocomparability, and clinical/pharmacodynamic comparability including the selection of endpoints, designs, and the setting of margins. Particular attention will be paid to the topic of margins in clinical trials where scale as well as fixed margin versus synthesis methods will be 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