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1 Introduction
Pages 1-2

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From page 1...
... Combining investigational cancer therapies early in their develop ment is thought to be a promising strategy for identifying cancer treatments that will be effective in the long term, especially when a combination targets multiple pathways and byways in the development or progression of cancer, or more than one step in a pathway, potentially conferring greater benefit than a therapy directed at a single target. How ever, this approach to drug development presents several unique challenges, including developing and applying appropriate preclinical tests and clinical trial designs, prioritizing which combination therapies should be tested, avoiding toxicity of multiple agents, and overcoming legal and cultural barriers that impede collaboration among pharmaceutical com panies, and between pharmaceutical companies and academic or government research institutions.
From page 2...
... draft guidance on this topic; • ultural and legal issues that affect collaboration; C • essons learned from codeveloping human immunodeficiency L virus and cancer combination therapies; and • urrent examples that can serve as possible models of collabora C tion to develop combination cancer therapies. A key goal of this workshop was to identify potential solutions to improve collaboration and accelerate the development of promising combination investigational cancer therapies.


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