The drug development process : evaluation of PDUFA I/II and investigation into reducing drug development times
Name
57509111-MIT.pdf
Description
Full printable version
Size
3.44 MB
Format
Adobe PDF
Checksum (MD5)
7ceda1da2a7d15af48a3600440ca8f4e
Author(s)
Strobeck, Matthew W. (Matthew William), 1972-
Advisor(s)
Ernst R. Berndt and Joseph V. Bonventre.
Alternative Title
Evaluation of PDUFA I/II and investigation into reducing drug development times
Date Issued
2004
Publisher
Massachusetts Institute of Technology
Abstract
Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no alteration in the time required to progress from an investigational new drug application (IND) to an NDA filing (i.e. the clinical phase) over this same period. Since approval times began to decrease upon the initiation of the Prescription Drug User Fee Act (PDUFA), in this thesis I analyze the impact of PDUFA and calculate its benefits to companies. Due to the importance of getting new drugs to the market faster, I also investigate why there has been no significant change in the time required to test a drug clinically, and attempt to identify steps that could be taken to improve the clinical trial process. To investigate this, I evaluated ways in which the FDA and industry can work together to reduce clinical development times, without compromising safety. The results from this study show that PDUFA has had a significant impact on reducing approval times. More importantly, I determined that the direct costs of PDUFA are small in irmlparison to its benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug development has revealed potential steps both the FDA and industry can take to facilitate a more efficient process for assessing the safety and efficacy of drugs. Thus, this study represents an important step towards improving the development of medicines for the world.
Description
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004.
Includes bibliographical references (p. 59-61).
Subjects
Harvard University--MIT Division of Health Sciences and Technology.
Technology and Policy Program.
MIT Department
Harvard University--MIT Division of Health Sciences and Technology
Massachusetts Institute of Technology. Engineering Systems Division
Technology and Policy Program
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