Decision-making in product portfolios of pharmaceutical research and development &amp;ndash; managing streams of innovation in highly regulated markets

Jekunen, Antti

doi:10.2147/dddt.s68579

Cited by 37 publications

(35 citation statements)

References 29 publications

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“…The number of patents a company files, or alternatively the research and development (R&D) costs per patent filed, are often used as an output measure for the efficiency of drug development and the future of a firm. [ 76 ] Since most patented molecules do not make it to the market as an actual medicine, both datasets are incomplete representations of productivity[ 77 ].…”

Section: Life Cycles and Market Dynamicsmentioning

confidence: 99%

Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

2017

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ContextRecent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines.MethodA systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines.FindingsChanges in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered.ConclusionA fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

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Section: Life Cycles and Market Dynamicsmentioning

confidence: 99%

Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

2017

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“…In the early stages of a research project, biomedical scientists often perform "candidate selection," wherein they select potential targets for future study [1]. For instance, when exploring a certain cancer, scientists may identify a few dozen genes on which to experiment.…”

Section: Introductionmentioning

confidence: 99%

Large-Scale Validation of Hypothesis Generation Systems via Candidate Ranking

Sybrandt

Shtutman

Safro

2018

2018 IEEE International Conference on Big Data (Big Data)

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The first step of many research projects is to define and rank a short list of candidates for study. In the modern rapidity of scientific progress, some turn to automated hypothesis generation (HG) systems to aid this process. These systems can identify implicit or overlooked connections within a large scientific corpus, and while their importance grows alongside the pace of science, they lack thorough validation. Without any standard numerical evaluation method, many validate generalpurpose HG systems by rediscovering a handful of historical findings, and some wishing to be more thorough may run laboratory experiments based on automatic suggestions. These methods are expensive, time consuming, and cannot scale. Thus, we present a numerical evaluation framework for the purpose of validating HG systems that leverages thousands of validation hypotheses. This method evaluates a HG system by its ability to rank hypotheses by plausibility; a process reminiscent of human candidate selection. Because HG systems do not produce a ranking criteria, specifically those that produce topic models, we additionally present novel metrics to quantify the plausibility of hypotheses given topic model system output. Finally, we demonstrate that our proposed validation method aligns with real-world research goals by deploying our method within MOLIERE, our recent topic-driven HG system, in order to automatically generate a set of candidate genes related to HIVassociated neurodegenerative disease (HAND). By performing laboratory experiments based on this candidate set, we discover a new connection between HAND and Dead Box RNA Helicase 3 (DDX3). Reproducibility: code, validation data, and results can be found at sybrandt.com/2018/validation.

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“…The importance of the rational decision-making dimension has large support in the literature and is emphasized in theoretical approaches like behavioral analysis (Dean and Sharfman, 1993a), mathematical game theory ( Jekunen, 2014) and real options reasoning (Child and Hsieh, 2014;Johal et al, 2007). Yet, a growing number of recent research publications stresses the notion that rational decision-making may often be intermingled with, or combined with intuitive and political decision-making, especially in innovation decision-making processes (Calabretta et al, 2017;Elbanna, 2006;Kester et al, 2009;Stanczyk et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Contingent use of rational, intuitive and political decision-making in R&D

Kolbe

Bossink

Man

2019

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Purpose The purpose of this paper is to gain insight into the contingent use of rational, intuitive and political decision-making in R&D. Design/methodology/approach This research is based on a study in an R&D department of a multinational high-tech firm in the Netherlands. The study consists of a case study design, focusing on four embedded cases, longitudinally studying each case. Findings The literature distinguishes three dimensions of innovation decision-making processes: rational, intuitive and political. By studying these interwoven dimensions over time, this study finds that the dominant use of each of these dimensions differs across the innovation process. There is an emphasis on intuitive decision-making in an early phase, followed by more emphasis on political decision-making, and moving to more emphasis on rational decision-making in a later phase of the R&D process. Furthermore, the predominant choice in a specific innovation phase for one of the three decision-making dimensions is influenced by the decision-making dimension that is dominantly employed in the preceding phase. Research limitations/implications This study contributes to the innovation decision-making literature by developing and applying a model that distinguishes rational, intuitive and political decision-making dimensions, the interactions among these dimensions in innovation decision-making in R&D, and the contingency of these dimensions upon the innovation phase. It calls for further research into the contingent nature of innovation decision-making processes. Practical implications For practitioners this study has two relevant insights. First it highlights the importance and usefulness of intuitive and political decision-making in addition to the prevailing emphasis on rational decision-making. Second, practitioners may be more alert to consciously changing their dominant decision-making approach across the phases of the innovation process. Third, companies may adjust their human resource policies to this study’s findings. Originality/value The literature on rational, intuitive and political decision-making is quite extensive. However, research has hardly studied how these decision-making dimensions develop in conjunction, and over time. This paper reports on a first study to do so and finds that the dominant use of these dimensions is contingent upon the phase of the R&D process and on the decision-making dimensions used in earlier phases. The study suggests that using a contingency approach can help to further integrate the debate in research and practice.

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Decision-making in product portfolios of pharmaceutical research and development – managing streams of innovation in highly regulated markets

Cited by 37 publications

References 29 publications

Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

Large-Scale Validation of Hypothesis Generation Systems via Candidate Ranking

Contingent use of rational, intuitive and political decision-making in R&D

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