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

dc.contributor.author

Moe, Jeffrey L

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United States

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2013-03-22T17:25:46Z

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2008-07

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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.

dc.identifier

http://www.ncbi.nlm.nih.gov/pubmed/19138940

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1940-6207.CAPR-08-0048

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1940-6215

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https://hdl.handle.net/10161/6433

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eng

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American Association for Cancer Research (AACR)

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Cancer Prev Res (Phila)

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10.1158/1940-6207.CAPR-08-0048

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Antineoplastic Agents

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Biomedical Research

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Chemoprevention

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Drug Discovery

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Drug Industry

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Humans

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Intellectual Property

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Liability, Legal

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Neoplasms

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Orphan Drug Production

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Patents as Topic

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Raloxifene Hydrochloride

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

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Journal article

pubs.author-url

http://www.ncbi.nlm.nih.gov/pubmed/19138940

pubs.begin-page

84

pubs.end-page

90

pubs.issue

2

pubs.organisational-group

Duke

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Duke Science & Society

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Economics

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Global Health Institute

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Initiatives

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Institutes and Provost's Academic Units

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Trinity College of Arts & Sciences

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University Institutes and Centers

pubs.publication-status

Published

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1

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