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Ernst Berndt and Thomas G. Roberts, Jr. Goren, Amir, S.M. Massachusetts Institute of Technology Harvard University--MIT Division of Health Sciences and Technology. Harvard University--MIT Division of Health Sciences and Technology 2008-09-03T14:53:37Z 2008-09-03T14:53:37Z 2007 2007 http://hdl.handle.net/1721.1/42207 230824339 Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2007. Includes bibliographical references (leaves 36-39). The goal of this study is to explore the economic conditions that favor the joint development of therapeutics and companion diagnostics. I hypothesize that predictive biomarkers can generate economic value in drug development by increasing success rates. I construct an economic model of the development of a hypothetical new therapy, and devote particular attention to parameters regarding safety, efficacy, cost, and market size, within a decision-theoretic framework. The results include a characterization of the dynamic net present value trade-offs between stratum size and biomarker success, as well as the identification of two complementary concepts of stratified medicine, namely, disease reclassification and value-based reimbursement. I also identify a strong potential incentive mechanism in the hands of public policy makers that could facilitate a resolution of the tension between patient interests and the interests of pharmaceutical sponsors. The conclusion is that a biomarker can compensate for smaller stratum by increasing success probabilities. However, the effects of longer development time due to biomarker inclusion counter the effects of improved success probabilities. Longer exclusivity periods for stratified medicine may be required in order to resolve the tension between patient interests and the interests of pharmaceutical sponsors. by Amir Goren. S.M. 39 leaves eng Massachusetts Institute of Technology M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 Harvard University--MIT Division of Health Sciences and Technology. Assessing the economic case for stratified medicine Economic case for stratified medicine Thesis application/pdf false Publication unknown unknown <Publication xmlns="https://www.openaire.eu/cerif-profile/1.1/" id="07ac375c-ad8d-4cd3-a684-cc4ca6ca7ec7"> <Type xmlns="https://www.openaire.eu/cerif-profile/vocab/COAR_Publication_Types">http://purl.org/coar/resource_type/c_1843</Type> <Language>eng</Language> <Title>Assessing the economic case for stratified medicine</Title> <Subtitle>Economic case for stratified medicine</Subtitle> <PublishedIn> <Publication> </Publication> </PublishedIn> <PublicationDate>2007</PublicationDate> <Authors> <Author> <DisplayName>Goren, Amir, S.M. Massachusetts Institute of Technology</DisplayName> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> </Authors> <Editors> </Editors> <Publishers> <Publisher> <DisplayName>Massachusetts Institute of Technology</DisplayName> <OrgUnit /> </Publisher> </Publishers> <License>http://dspace.mit.edu/handle/1721.1/7582</License> <Keyword>Harvard University--MIT Division of Health Sciences and Technology.</Keyword> <Abstract>The goal of this study is to explore the economic conditions that favor the joint development of therapeutics and companion diagnostics. I hypothesize that predictive biomarkers can generate economic value in drug development by increasing success rates. I construct an economic model of the development of a hypothetical new therapy, and devote particular attention to parameters regarding safety, efficacy, cost, and market size, within a decision-theoretic framework. The results include a characterization of the dynamic net present value trade-offs between stratum size and biomarker success, as well as the identification of two complementary concepts of stratified medicine, namely, disease reclassification and value-based reimbursement. I also identify a strong potential incentive mechanism in the hands of public policy makers that could facilitate a resolution of the tension between patient interests and the interests of pharmaceutical sponsors. The conclusion is that a biomarker can compensate for smaller stratum by increasing success probabilities. However, the effects of longer development time due to biomarker inclusion counter the effects of improved success probabilities. Longer exclusivity periods for stratified medicine may be required in order to resolve the tension between patient interests and the interests of pharmaceutical sponsors.</Abstract> <Access xmlns="http://purl.org/coar/access_right" > </Access> </Publication>