Portfolio Management in New Drug Development

Ding, Min; Dong, Songting; Eliashberg, Jehoshua; Gopalakrishnan, Arun

doi:10.1007/978-1-4614-7801-0_3

Cited by 12 publications

(9 citation statements)

References 79 publications

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“…The first is the “portfolio-centric approach”. Generic manufacturers include re-innovation design (i.e., the process of producing the next generation of generics with revised and refined features of successfully-launched products) in their portfolio ostensibly to provide personalized, cost-effective generic products that meet the demand of healthcare systems, policymakers, and patients [ 8 ]. One way is through what is called re-innovation or sometimes called the production of “super generics”.…”

Section: Introductionmentioning

confidence: 99%

“…Godman and his colleagues proposed a 4 “E” methodology (Education, Engineering, Economics and Enforcement) for developing initiatives to increase generic drug utilization in Europe [ 8 ] (Table 2 ). Initiatives focusing on “Education” are usually programs that influence generic prescribing by disseminating educational materials.…”

Section: Introductionmentioning

confidence: 99%

“…With more complicated branded products losing their patent protection, bioequivalence methodologies for complex drugs or dosage forms need to be developed. Guidance documents with updated standards or reference documents from the FDA may encourage generic manufacturers to proceed with the development of new products [ 8 , 35 ]. Regular engagement with OGD may help drug manufacturers contain costs and decrease time-to-market delays.…”

Section: Introductionmentioning

confidence: 99%

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Forces influencing generic drug development in the United States: a narrative review

Lee

Chen

Romanelli

et al. 2016

J of Pharm Policy and Pract

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BackgroundThe United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing.Main resultsGeneric drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics.ConclusionsWe present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. We also review proposed strategies that regulators may use to incentivize generic drug development.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Forces influencing generic drug development in the United States: a narrative review

Lee

Chen

Romanelli

et al. 2016

J of Pharm Policy and Pract

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“…Take-up may therefore also reflect that such research is conducted as part of the firm's high-level strategic agenda encompassing both research and development, e.g. through the use of R&D portfolio management (Ding et al, 2014). Such high-level strategic decisions imply an early commitment of budget and personnel, which may make take-up decisions prone to the sunk-cost fallacy, optimism bias and over-commitment (Peck et al, 2015;Eliëns et al, 2018).…”

Section: Conclusion and Discussionmentioning

confidence: 99%

Many are called, few are chosen: the role of science in drug development decisions

et al. 2023

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Pharmaceutical firms are extremely selective in deciding which patented drug candidates are taken up into clinical development, given the high costs and risks involved. We argue that the scientific base of drug candidates, and who was responsible for that scientific research, are key antecedents of take-up into clinical trials and whether the patent owner ('internal take-up') or another firm ('external take-up') leads the clinical development effort. We hypothesize that patented drug candidates that refer to scientific research are more likely to be taken up in development, and that in-house conducted scientific research is predominantly associated with internal take-up due to the ease of knowledge transfer within the firm. Examining 18,360 drug candidates patented by 136 pharmaceutical firms we find support for these hypotheses. In addition, drug candidates referring to in-house scientific research exhibit a higher probability of eventual drug development success. Our findings underline the importance of a 'rational drug design' approach that explicitly builds on scientific research. The benefits of internal scientific research in clinical development highlight the potential downside of pervasive organizational specialization in the life sciences in either scientific research or clinical development.

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“…It is an independent, expert and invested group, under no obligation to agree with expert reviewer assessments or with formal investment decisions made by the CEPI Board. At the time of this CfP, the SAC comprised: 8 representatives of governments, regulators and multilateral organizations; 7 representatives of nonprofit R&D organizations; 6 academics; 4 industry representatives; and 4 independent subjectmatter experts [58].…”

Section: 5step 4 Eliciting Platform Preferences (W K )mentioning

confidence: 99%

Prioritizing investments in rapid response vaccine technologies for emerging infections: A portfolio decision analysis

Gouglas

Marsh²

2021

PLoS ONE

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This study reports on the application of a Portfolio Decision Analysis (PDA) to support investment decisions of a non-profit funder of vaccine technology platform development for rapid response to emerging infections. A value framework was constructed via document reviews and stakeholder consultations. Probability of Success (PoS) data was obtained for 16 platform projects through expert assessments and stakeholder portfolio preferences via a Discrete Choice Experiment (DCE). The structure of preferences and the uncertainties in project PoS suggested a non-linear, stochastic value maximization problem. A simulation-optimization algorithm was employed, identifying optimal portfolios under different budget constraints. Stochastic dominance of the optimization solution was tested via mean-variance and mean-Gini statistics, and its robustness via rank probability analysis in a Monte Carlo simulation. Project PoS estimates were low and substantially overlapping. The DCE identified decreasing rates of return to investing in single platform types. Optimal portfolio solutions reflected this non-linearity of platform preferences along an efficiency frontier and diverged from a model simply ranking projects by PoS-to-Cost, despite significant revisions to project PoS estimates during the review process in relation to the conduct of the DCE. Large confidence intervals associated with optimization solutions suggested significant uncertainty in portfolio valuations. Mean-variance and Mean-Gini tests suggested optimal portfolios with higher expected values were also accompanied by higher risks of not achieving those values despite stochastic dominance of the optimal portfolio solution under the decision maker’s budget constraint. This portfolio was also the highest ranked portfolio in the simulation; though having only a 54% probability of being preferred to the second-ranked portfolio. The analysis illustrates how optimization modelling can help health R&D decision makers identify optimal portfolios in the face of significant decision uncertainty involving portfolio trade-offs. However, in light of such extreme uncertainty, further due diligence and ongoing updating of performance is needed on highly risky projects as well as data on decision makers’ portfolio risk attitude before PDA can conclude about optimal and robust solutions.

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Portfolio Management in New Drug Development

Cited by 12 publications

References 79 publications

Forces influencing generic drug development in the United States: a narrative review

Forces influencing generic drug development in the United States: a narrative review

Many are called, few are chosen: the role of science in drug development decisions

Prioritizing investments in rapid response vaccine technologies for emerging infections: A portfolio decision analysis

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