| Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with 'what-ifs'. | |
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MedLine Citation:
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PMID: 19102723 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Over the past four years, the annual US FDA-DIA pharmacogenomic workshops have brought together attendees with wide-ranging expertise spanning industry, regulatory authorities and academia. This special report summarizes a breakout session using a novel, interactive case format as a way to engage participants, raise awareness and share diverse learnings via 'real life' decisions that project teams might face in developing a new medicine. This case was situated just prior to approval by a Regulatory Authority as a project team is finalizing a new medicine label. To effectively integrate new biomarkers such as pharmacogenomics into developing new medicines, this session highlighted the importance in considering medical practice implications as relevant (or not) to information or actions by a prescriber; progressing validation beyond assay to clinical; and fitting pharmacogenomics into context with other evidence often built over decades during a drug's development. All converge onto a label that must communicate evidence-based use of a new medicine that is effective and safe. |
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Authors:
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Linda C Surh; Lawrence J Lesko; Stuart Hobbs; Steve Gutman; Lori M Minasian; Oscar E Della Pasqua; M J Finley Austin; Kan Lu |
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Publication Detail:
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Type: Congresses |
Journal Detail:
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Title: Pharmacogenomics Volume: 10 ISSN: 1744-8042 ISO Abbreviation: Pharmacogenomics Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2008-12-23 Completed Date: 2009-03-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100897350 Medline TA: Pharmacogenomics Country: England |
Other Details:
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Languages: eng Pagination: 137-47 Citation Subset: IM |
Affiliation:
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CEDD, Global Regulatory Affairs, Neurology & Pharmacogenetics, GlaxoSmithKline, Greenford Road, Greenford, Middlesex, UB6 OHE, UK. lcs29779@gsk.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biomarkers, Pharmacological*
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analysis Decision Making* Drug Design* Drug Industry / standards Humans Pharmacogenetics* / standards United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Biomarkers, Pharmacological |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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