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Operations and Supply Chain Management Commons™
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Full-Text Articles in Operations and Supply Chain Management
Turning The Tables In Research And Development Licensing Contracts, Niyazi Taneri, Pascale Crama
Turning The Tables In Research And Development Licensing Contracts, Niyazi Taneri, Pascale Crama
Research Collection Lee Kong Chian School Of Business
Research and development (R&D) collaborations between an innovator and her partner are often undertaken when neither party can bring the product to market individually, which precludes value creation without a joint effort. Yet, the uncertain nature of R&D complicates the monitoring of effort, and the resulting moral hazard reduces a collaboration’s value. Either party can avoid this outcome by acquiring the capability that is missing and then taking sole ownership of the project. That approach involves two types of risks: one related to whether the other party’s capability will be acquired and one related to how well it will be …
Inducing Compliance With Postmarket Studies For Drugs Under Fda's Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Inducing Compliance With Postmarket Studies For Drugs Under Fda's Accelerated Approval Pathway, Liang Xu, Hui Zhao, Nicholas C. Petruzzi
Research Collection Lee Kong Chian School Of Business
Problem definition: In 1992, the Food and Drug Administration (FDA) instituted the accelerated approval pathway (AP) to allow promising drugs to enter the market based on limited evidence of efficacy, thereby permitting manufacturers to verify true clinical benefits through postmarket studies. However, most postmarket studies have not been completed as promised. We address this noncompliance problem. Academic/practical relevance: The prevalence of this noncompliance problem poses considerable public health risk, thus compromising the original purpose of a well-intentioned AP initiative. We provide an internally consistent and implementable solution to the problem through a comprehensive analysis of the myriad complicating factors and …