Risk management in the development of new products in highly regulated industries

Blau, Gary; Mehta, B.R.; Bose, Sucharita; Pekny, Joe; Sinclair, Gavin; Keunker, Kay; Bunch, Paul R.

doi:10.1016/s0098-1354(00)00388-4

Cited by 71 publications

(45 citation statements)

References 2 publications

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“…Project prioritization and new product-portfolio selection has long been the domain of the new product arm of the corporation (Blau et al, 2000). Pharmaceutical product development, as any other management task, requires important decisions about the tradeoffs between the available resources, as managers decide which drugs to bring to market (Ogawa & Piller, 2006).…”

Section: Risk Management Evaluation Methodsmentioning

confidence: 99%

“…These NPV based methods include Net Present Value of Income analysis, Capacity Constrained NPV approach, and Stochastic Dominance. All of the above methods account for the financial impact of the chosen alternatives (Grabowski & Vernon, 1998;Blau et al, 2000;Smit & Trigeorgis, 2006). The Consumer Theory based approaches do not take into account the financial aspects of the new product development and analyze consumers' preferences for different product alternatives instead.…”

Section: Risk Management Evaluation Methodsmentioning

confidence: 99%

“…These approaches include Net Present Value of Income (NPV) analysis, Capacity Constrained NPV approach, and Stochastic Dominance analysis. All of these methods account for the financial impact of chosen alternatives, but differ by their complexity level, precision, and reliability of product selection (Grabowski & Vernon, 2000;Blau et al, 2000;Smit & Trigeorgis, 2006).…”

Section: Net Present Value (Npv) Based Risk Assessment Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Risk Management in the Development of New Products in the Pharmaceutical Industry

Kleczyk¹

2011

Risk Management Trends

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Section: Risk Management Evaluation Methodsmentioning

confidence: 99%

Section: Risk Management Evaluation Methodsmentioning

confidence: 99%

Section: Net Present Value (Npv) Based Risk Assessment Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Risk Management in the Development of New Products in the Pharmaceutical Industry

Kleczyk¹

2011

Risk Management Trends

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“…The failure of a single required test may prevent a potential product from reaching the marketplace. An informal overview of the importance of including the possibility of technical failure into planning is given in Blau et al (2000), who focus especially on the pharmaceutical industry. DiMasi (2001) also refers to economic, efficacy, safety and "other" reasons for cutting projects.…”

Section: Related Workmentioning

confidence: 99%

R&D project scheduling when activities may fail

Reyck

Leus

2008

IIE Transactions

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An R&D project typically consists of several stages. Due to technological risks, the project may have to be terminated before completion, each stage having a specific likelihood of success. In the project planning and scheduling literature, this technological uncertainty has typically been ignored and project plans are developed only for scenarios in which the project succeeds. In this paper we examine how to schedule projects in order to maximize their expected net present value when the project activities have a probability of failure and when an activity's failure leads to overall project termination. We formulate the problem, show that it is NP-hard, develop a branch-and-bound algorithm that allows us to obtain optimal solutions and provide extensive computational results. In the process, we establish a complexity result for an open problem in single-machine scheduling, namely for the discounted weighted-completion-time objective with general precedence constraints.

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“…Although most of the products of this sector are global ones, which means costs of R&D are "global joint costs" [2]. On the other hand, since it is essential for health to ensure a high degree of public health and keep public expenditure under control, the pharmaceutical sector is highly regulated [3][4][5].…”

Section: Introductionmentioning

confidence: 99%

A Framework for Evaluation of Pharmaceutical Industry Development in Developing Countries: Evidence From Iran

Shabaninejad¹,

Madani²,

Amineh³

et al. 2016

Asian J Pharm Clin Res

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Objectives:The pharmaceutical market is a complex market due to its complicated supply chain and the extent of government regulations in all aspects of the trade lifecycle of drug development. Considering the importance of pharmaceuticals for society and the relevant trend of globalization, managing pharmaceutical industry effectively and efficiently is vital, particularly in developing countries. The present study determines the factors affecting the development of the Iranian pharmaceutical industry based on pharmaceutical mangers' point of view. Methods:In this study, we assessed managers' perspective about the internal and external key factors affecting the development of pharmaceutical industry. Finally, their perspective about the solutions for the development of pharmaceutical industry was assessed. Accordingly, a self-designed questionnaire was sent to 65 managers at Tamin Pharmaceutical Investment Company, of which, 51 questionnaires were answered by the managers.Result: Most managers believed generic scheme reflect negatively on the development of the pharmaceutical industry and that external factors have a great impact on its improvement. They believe that branded generic transition along with supporting regulations, investment in Research and Development, and joint venture with foreign companies will improve the pharmaceutical industry. Conclusion:To sum up, for improving the pharmaceutical industry in the shortest time possible, improvement of technological capabilities and investment in R&D should be considered.

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Risk management in the development of new products in highly regulated industries

Cited by 71 publications

References 2 publications

Risk Management in the Development of New Products in the Pharmaceutical Industry

Risk Management in the Development of New Products in the Pharmaceutical Industry

R&D project scheduling when activities may fail

A Framework for Evaluation of Pharmaceutical Industry Development in Developing Countries: Evidence From Iran

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