White Papers & Resources

Bracing for Biosimilars
Kuyler Doyle, Tony Lanzone, and Fahti Khosrow-Shahi
 This article examines the current movement toward an abbreviated approval pathway for follow-on biologics in the US and assesses the potential impact on current biotechnology products.
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CRO Management: Why Sponsors Don’t Do a Better Job and What They Can Do About It
Gary Tyson, Senior Vice President, Clinical Development Practice
 Gary Tyson, Senior Vice President and head of our Clinical Development Practice, suggests ways to improve the relationship between CROs and sponsors
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Doing More with Less in Clinical Development: How to Enhance Efficiency Through Better Organizational Planning
Mike Menta
 This article addresses how to enhance efficiency in today's challenging, resource-constrained environment.
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Maximizing Asset Value: The Importance of Commercialization Strategies for Early Stage Assets
Fahti Khosrow-Shahi, Emily Hua, and Jemma Richards
Senior Vice President, Vice President, and Consultant, Brand Management Practice
 The glory days of big blockbuster products are waning. Quickly emerging, however, is a market that is characterized by rigorous complexities and relentless competition in which pharmaceutical executives are forced to explore new options for maximizing product potential throughout the life cycle. By focusing on creating strategic commercialization plans earlier in the drug development process, executives are hoping to better prime each product for success.
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Optimizing the Impact of the Medical Affairs Function
Gary Tyson and Kuyler Doyle
 To assess the evolving role of Medical Affairs and evaluate current organizational structures, responsibilities, and communication with Marketing, Campbell Alliance conducted primary research to learn how organizations have reacted to their changing environments. Our findings and analysis are included in this article.
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Planning for Change: Adapting to Shifts in the Global Market Access Landscape
Lujing Wang
 This article outlines the complexities associated with the rise of payer influence and global payer differences, and provides product planners with key considerations for adapting global market access strategies to the new climate.
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Realizing Benefts from Your EDC Investment
Tim Dietlin
 Tim Dietlin of our Clinical Development Practice discusses strategies for getting the most out of your EDC investment
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REMS: The New Reality
Kuyler Doyle, Jay Jauregui, and Gary Tyson
 This article highlights the challenges of new regulatory restrictions, lists potential competitive advantages to these programs, and describes how organizations need to adjust to the evolving risk mitigation landscape.
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Three Ps to Better and Faster Protocol Development
Gary Tyson
 This article highlights the “three Ps” that organizations can address to improve the speed and quality of their protocol development process.
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