Drug-Development Challenges for Small Biopharmaceutical Companies

Small biopharmaceutical companies encounter challenges in designing and implementing clinical development programs. This article discusses the approaches these companies take toward addressing such obstacles. Small biopharmaceutical companies are becoming increasingly important as drivers of innovat...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 376; no. 5; pp. 469 - 474
Main Authors Moscicki, Richard A, Tandon, P.K
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 02.02.2017
SeriesThe Changing Face of Clinical Trials
Subjects
Biomarkers - analysis
Biopharmaceuticals
Clinical trials
Clinical Trials as Topic - economics
Clinical Trials as Topic - standards
Commerce
Drug development
Drug Discovery
Drug Industry
Drugs
Genetic Markers
Historically Controlled Study
Humans
Kaplan-Meier Estimate
Pharmaceutical industry
Placebo Effect
R&D
Regulatory approval
Research & development
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Summary:Small biopharmaceutical companies encounter challenges in designing and implementing clinical development programs. This article discusses the approaches these companies take toward addressing such obstacles. Small biopharmaceutical companies are becoming increasingly important as drivers of innovation in drug development. It has recently been estimated that the majority of drugs currently in development are in the hands of small biopharmaceutical companies. 1 Such companies range in size from virtual companies with no commercial products and no revenue to those with only a few commercial programs. Small biopharmaceutical companies often encounter important challenges in designing and implementing clinical development programs. In a context in which only approximately 10% of clinical programs result in drugs that achieve regulatory approval, small-company clinical programs may have an even lower rate of . . .
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-3
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ObjectType-Review-1
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMra1510070