Returns on Research and Development for 1990s New Drug Introductions

Grabowski, Henry G.; Vernon, John M.; DiMasi, Joseph A.

doi:10.2165/00019053-200220003-00002

Cited by 248 publications

(222 citation statements)

References 15 publications

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“…The benefit b(0) is the present value of the expected profit from the regulatory approval of the drug if the drug's true treatment effect is zero. Both parameters vary a lot from drug to drug (Grabowski et al, 2002;DiMasi et al, 2003), but the relevant data for individual drugs are not readily available. candidates that were abandoned or were not approved.…”

Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

“…candidates that were abandoned or were not approved. Grabowski et al (2002) collected sales data for drugs analyzed by DiMasi et al (2003) that were introduced in 1990-1994.…”

Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

“…Both the distribution of sales and the distribution of clinical trial costs are very dispersed, so this is a point from a large range of deterrent test levels For example, Grabowski et al (2002) report that sales of drugs in the top decile of the distribution are almost 5.5 times higher than the mean. The deterrent test level for an average top-decile drug with average clinical trial costs would then be 2.7%.…”

Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

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An economic theory of statistical testing

Tetenov

2016

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Standard-Nutzungsbedingungen:Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Zwecken und zum Privatgebrauch gespeichert und kopiert werden.Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich machen, vertreiben oder anderweitig nutzen.Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, gelten abweichend von diesen Nutzungsbedingungen die in der dort genannten Lizenz gewährten Nutzungsrechte.

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Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

“…candidates that were abandoned or were not approved. Grabowski et al (2002) collected sales data for drugs analyzed by DiMasi et al (2003) that were introduced in 1990-1994.…”

Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

Section: Statistical Testing For Drug Approvalmentioning

confidence: 99%

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An economic theory of statistical testing

Tetenov

2016

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“…A incerteza prevalesce também sobre a receptividade do mercado. Um estudo realizado por Grabowski et al 32 mostra que apenas 30% dos medicamentos conseguem recuperar o investimento realizado.…”

Section: Patentes Farmacêuticas E Saúde Públicaunclassified

Patentes farmacêuticas e saúde pública: desafios à política brasileira de acesso ao tratamento anti-retroviral

Meiners

2008

Cad. Saúde Pública

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“…Of pharmaceuticals that do win approval, only one in three will produce revenues that match or exceed development costs. 6 The revenue stream and profits produced by one pharmaceutical will basically have to pay for the tens of thousands of antecedent compounds produced, screened, and rejected along the way.…”

Section: The Economic Riskmentioning

confidence: 99%

Strategic challenges in neurotherapeutic pharmaceutical development

Gallen¹

2004

Neurotherapeutics

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Summary:Developing new therapeutics presents formidable economic, scientific, and medical challenges that are exacerbated by special factors in neurotherapeutics development, e.g., the complexity of the CNS with its attendant need to sometimes affect multiple pathways, the lack of clarity of disease etiology, inadequacy of available animal models, and difficulties in defining disease populations and quantifying treatment response. This paper reviews the economic challenges faced by therapeutics developers in general and neurotherapeutics developers in particular. It discusses key scientific challenges, particularly those pertinent to neurotherapeutics development, as a background to proposing a different industrial strategy to drive future therapeutics development. This Biodesign strategy potentially surpasses previous paradigms by incorporating elements such as the use of disease modeling to select better targets and potential therapies, information science-based approaches to enhance small molecule chemistry, exploitation of the potential for biological technologies to rapidly generate mechanistic probes, and development of improved approaches for using animal models and studying human molecules mechanistically and biologically. Synergistic use of these elements can change the overall business model of companies engaged in neurotherapeutics development. The Biodesign paradigm has the potential to both markedly enhance the development of new therapies and to address some of the economic challenges facing healthcare systems and therapeutics developers alike.

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Returns on Research and Development for 1990s New Drug Introductions

Cited by 248 publications

References 15 publications

An economic theory of statistical testing

An economic theory of statistical testing

Patentes farmacêuticas e saúde pública: desafios à política brasileira de acesso ao tratamento anti-retroviral

Strategic challenges in neurotherapeutic pharmaceutical development

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