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An investigation of clinical trial supply chains
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Title
An investigation of clinical trial supply chains
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ETD_1973
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http://hdl.rutgers.edu/1782.2/rucore10002600001.ETD.000051642
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eng
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theses
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Topic
Management
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Topic
Clinical pharmacology
Subject
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Topic
Drugs--Testing
Abstract
This dissertation investigates production and inventory decisions made within clinical trial supply chains in order to reduce drug supply costs. By investigating the SEC filings of public companies, we find that drug supply costs frequently account for a significant portion of pharmaceutical companies' R&D spending. To unlock value tied up in clinical trial supply chains, three unique aspects of clinical trial supply chains are explored and associated supply chain decisions are optimized. The first unique factor that differentiates the supply chains for clinical trials is the risk of failure, meaning that the investigational drug is proven unsafe or ineffective during human testing. Upon failure, any unused inventory is essentially wasted and needs to be destroyed. We explore the effect of this failure on production planning decisions and find the planner's decision to be a balancing act between waste and destruction costs versus production inefficiency. To optimally achieve this balance, we generalize the Wagner-Whitin model to incorporate the risk of failure. A second unique aspect of clinical trials is that demand can go from being quite unpredictable to fully predictable during the course of a trial. To take advantage of this demand learning, intra-trial batches can be produced, but at the expense of scale economies. Using various learning curves, we study this balance between learning and economies of scale in a finite horizon inventory model with fixed production costs and two production options: the pre-trial batch and the intra-trial batch. We characterize the optimal policy for both production batches in regards to optimally scheduling and sizing production. Lastly, we analyze the distribution networks of global clinical trial supply chains. Unique to these networks is their temporary existence; trials are ceased after patient enrollment goals are met. To manage these networks, we present a new class of multi-echelon inventory models to make stock positioning decisions, develop algorithms to identify lower and upper bounds on the optimal objective function for this new class, and leverage those algorithms to provide insights into optimal supply chain configurations.
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electronic resource
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x, 106 p. : ill.
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Ph.D.
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Includes bibliographical references (p. 99-105)
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by Adam Fleischhacker
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Fleischhacker
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Adam
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1974
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Adam Fleischhacker
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Zhao
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Yao
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chair
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Yao Zhao
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Katehakis
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Michael
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internal member
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Michael Katehakis
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Xu
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Xiaowei
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Xiaowei Xu
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Kumar
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Mahesh
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Mahesh Kumar
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Nandi
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Indranil
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Indranil Nandi
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Rutgers University
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Graduate School - Newark
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2009
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2009-10
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xx
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Rutgers University Electronic Theses and Dissertations
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ETD
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Graduate School - Newark Electronic Theses and Dissertations
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rucore10002600001
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NjNbRU
Identifier
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doi:10.7282/T33B60B7
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ETD doctoral
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Rights
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The author owns the copyright to this work.
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Copyright protected
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Open
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Fleischhacker
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Adam
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Adam Fleischhacker
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Rutgers University. Graduate School - Newark
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I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
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