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Activity Number: 535
Type: Topic Contributed
Date/Time: Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #319009 View Presentation
Title: Global Challenges and Collaboration in Biopharmaceutical Statistics
Author(s): Jose Pinheiro* and Yuki Ando* and Frank Bretz* and Estelle Russek-Cohen* and Abdus S. Wahed*
Companies: Johnson & Johnson and Pharmaceutical and Medical Device Agency, Japan and Novartis Pharma and FDA and University of Pittsburgh
Keywords: Drug development; Globalization; Collaboration; Multi-regional
Abstract:

The globalization of drug development aims to enable better access to the best science and molecules, to stimulate innovation and accelerate delivery of new medicines for unmet patient needs. Global collaboration between academia, governments, industry, scientific organizations and patient groups is key to efficiently achieve these goals. However, global collaboration should respect global and local aspects, including transcultural, transnational and trans-regional issues in law, culture, education and social engagement.

This session will discuss global communication and education to promote interaction and integration among statisticians working in the biopharmaceutical and related sectors, with the goal of addressing worldwide problems in biopharmaceutical statistics. Special focus will be placed on opportunities for educating the next generation of biostatisticians working in the biopharmaceutical sector and/or graduate students considering a career in biopharmaceutical statistics. The session will also discuss challenges and opportunities in global drug development and the role that international collaboration in terms of statistical education may play in addresing them.


Authors who are presenting talks have a * after their name.

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