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Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention.

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Date
2008-07
Author
Moe, Jeffrey L
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Abstract
Chemoprevention agents are an emerging new scientific area that holds out the promise of delaying or avoiding a number of common cancers. These new agents face significant scientific, regulatory, and economic barriers, however, which have limited investment in their research and development (R&D). These barriers include above-average clinical trial scales, lengthy time frames between discovery and Food and Drug Administration approval, liability risks (because they are given to healthy individuals), and a growing funding gap for early-stage candidates. The longer time frames and risks associated with chemoprevention also cause exclusivity time on core patents to be limited or subject to significant uncertainties. We conclude that chemoprevention uniquely challenges the structure of incentives embodied in the economic, regulatory, and patent policies for the biopharmaceutical industry. Many of these policy issues are illustrated by the recently Food and Drug Administration-approved preventive agents Gardasil and raloxifene. Our recommendations to increase R&D investment in chemoprevention agents include (a) increased data exclusivity times on new biological and chemical drugs to compensate for longer gestation periods and increasing R&D costs; chemoprevention is at the far end of the distribution in this regard; (b) policies such as early-stage research grants and clinical development tax credits targeted specifically to chemoprevention agents (these are policies that have been very successful in increasing R&D investment for orphan drugs); and (c) a no-fault liability insurance program like that currently in place for children's vaccines.
Type
Journal article
Subject
Antineoplastic Agents
Biomedical Research
Chemoprevention
Drug Discovery
Drug Industry
Humans
Intellectual Property
Liability, Legal
Neoplasms
Orphan Drug Production
Patents as Topic
Raloxifene Hydrochloride
Permalink
https://hdl.handle.net/10161/6433
Published Version (Please cite this version)
10.1158/1940-6207.CAPR-08-0048
Publication Info
Moe, Jeffrey L (2008). Impact of economic, regulatory, and patent policies on innovation in cancer chemoprevention. Cancer Prev Res (Phila), 1(2). pp. 84-90. 10.1158/1940-6207.CAPR-08-0048. Retrieved from https://hdl.handle.net/10161/6433.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Moe

Jeffrey Moe

Adjunct Professor of Global Health
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