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All Times EDT

Wednesday, September 21
Wed, Sep 21, 1:15 PM - 2:30 PM
Salon H
Leading Drug Development into the Next Generation

Panel Discussion (304746)

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*Martin Frenzel, Cytel 
*Dionne Price, Office of Translational Sciences, CDER 
*Karen Price, Eli Lilly and Company 

Keywords: Leadership, Drug Development

Statistical leadership is vital to the continued improvement of pharmaceutical drug development. It is well documented that the cost and time of drug development continue to grow at rates that are unsustainable. The statistical leader plays an important role in ensuring that drugs are developed more efficiently via innovative designs and analyses, that the right candidates move forward, and that decisions are made with a quantitative framework that properly balances all available data. The statistical leadership demonstrated throughout the COVID pandemic has led to many learnings, and now is the time to capitalize on those learnings to ensure they are carried forward. There is tremendous opportunity for statisticians to lead the pharmaceutical industry into the next generation of drug development.

In this session, statistical leaders from across industry and regulatory will discuss the current state of statistical leadership in drug development and opportunities to utilize statistical leadership to drive drug development forward. These leaders will also reflect upon the lessons learned historically that showcase the value of statistical leadership and discuss keys to the successful leadership. The intent of this session is to identify specific and actionable next steps to partner together to dramatically shift the role of statistician as leader in all phases of the drug development process. This session is in partnership with Biopharmaceutical Statistics Leadership Consortium (BSLC).

The panel speakers include: Dr. Zachary Thomas, Eli Lilly and Company; Dr. Lisa Lupinacci, Merck; FDA representatives (pending confirmation)