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Improving the efficiency of the later stages of the drug development process : survey results from the industry, academia, and the FDA

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dc.contributor.advisor Ernest R. Berndt and Joseph V. Bonventre. en_US
dc.contributor.author Gottschalk, Adrian Hedley Benjamin, 1975- en_US
dc.contributor.other Harvard University--MIT Division of Health Sciences and Technology. en_US
dc.date.accessioned 2005-05-17T14:58:42Z
dc.date.available 2005-05-17T14:58:42Z
dc.date.copyright 2004 en_US
dc.date.issued 2004 en_US
dc.identifier.uri http://hdl.handle.net/1721.1/16699
dc.description Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2004. en_US
dc.description Includes bibliographical references (p. 65). en_US
dc.description This electronic version was submitted by the student author. The certified thesis is available in the Institute Archives and Special Collections. en_US
dc.description.abstract Drug development in the United States is a lengthy and expensive endeavor. It is estimated that average development times range from eleven to fifteen years and exceed costs of one billion dollars. The development pathway includes basic scientific discovery, pre-clinical testing in animals, clinical development in humans, and an application process. The Food and Drug Administration is responsible for the oversight and approval of drugs going through this process. Numerous financial and economic studies have been conducted that show the benefits to accelerating the drug development process. In 1992, the United States Congress enacted the Prescription Drug User Fee Act I, which mandated faster response times from the FDA in return for user fee payments to the FDA by the drug developing companies. Data on approval times for new drugs indicate that this process was indeed shortened. In contrast, the average drug development process prior to the filing of an application has been increasing in cost and time. The first purpose of this research is to quantify the benefits of accelerated new drug application review time under the Prescription Drug User Fee Acts I and II. The second purpose of the research is to investigate what industry and the FDA can do together to reduce the development process time between the IND and NDA without compromising patient safety and welfare, specifically the Phase II, Phase III, and NDA components. The research indicates that PDUFA has improved approval times in a statistically significant way. Furthermore, the financial and social benefits as measured using net present value have far exceeded the PDUFA costs. Quantitative and qualitative surveys of fifty individuals in large pharmaceutical and biotech companies en_US
dc.description.abstract (cont.) resulted in the identification of several significant opportunities and useful suggestions for reducing development times in Phase II, Phase III, and the NDA. Specifically, company interviewees indicated that they were willing to pay additional monies for increased interaction and communication with the FDA from Phase II through the NDA in hopes of reducing information asymmetry and increasing information transparency. Other recommendations included a mandatory audit and review of a sample of NDAs post approval to identify best practices, implementation of metrics and performance tracking during clinical phases, and implementation of consistent project management and communication standards across therapeutic divisions. en_US
dc.description.statementofresponsibility by Adrian Hedley Benjamin Gottschalk. en_US
dc.format.extent 82 p. en_US
dc.format.extent 1198979 bytes
dc.format.extent 1198715 bytes
dc.format.mimetype application/pdf
dc.format.mimetype application/pdf
dc.language.iso eng en_US
dc.publisher Massachusetts Institute of Technology en_US
dc.rights 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. en_US
dc.rights.uri http://dspace.mit.edu/handle/1721.1/7582
dc.subject Harvard University--MIT Division of Health Sciences and Technology. en_US
dc.title Improving the efficiency of the later stages of the drug development process : survey results from the industry, academia, and the FDA en_US
dc.type Thesis en_US
dc.description.degree S.M. en_US
dc.contributor.department Harvard University--MIT Division of Health Sciences and Technology. en_US
dc.identifier.oclc 57470831 en_US


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