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Optimal Enrollment in Late-Stage New drug development with Learning of drug's Efficacy for Group-Sequential Clinical Trials

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M&SOM-MANUFACTUrING & SErVICE OPErATIONS management 2022年第1期25卷 88-107页

作者： Tian, Zhili Hazen, Gordon B. Li, Hong Univ Houston Marilyn Davies Coll Business Dept Gen Business Mkt & Supply Chain Management Houston TX 77002 USA Northwestern Univ Dept Ind Engn & Management Sci Evanston IL 60208 USA Univ Calif Davis Sch Med Dept Publ Hlth Sci Davis CA 95616 USA

Problem definition: The cost for developing a new drug ranged from $1 billion to more than $2 billion between 2010 and 2019. In addition to high development costs, the efficacy of the candidate drug, patient enrollment, the market exclusivity period (MEP), and the planning horizon are uncertain. Moreover, slow enrollment leads to increased costs, canceled clinical trials, and lost potential revenue. Many firms, hoping to detect efficacy versus futility of the candidate drug early to save development costs, plan interim analyses of patient response data in their clinical trials. Academic/practical relevance: The problem for optimizing patient-enrollment rates has an uncertain planning horizon. We developed a continuous-time dynamic programming (dP) model with learning of a drug's efficacy and MEP to assist firms in developing optimal enrollment policies in their clinical trials. We also established the optimality equation for this dP model. Through a clinical trial for testing a cancer drug developed by a leading pharmaceutical firm, we demonstrate that our dP model can help firms effectively manage their trials with a sizable profit gain (as large as $270 million per drug). Firms can also use our model in simulation to select their trial design parameters (e.g., the sample sizes of interim analyses). Methodology: We update a drug's efficacy by Bayes' rules. Using the stochastic order and the likelihood-ratio order of distribution functions, we prove the monotonic properties of the value function and an optimal policy. results: We established that the value of the drug-development project increases as the average response from patients using the candidate drug increases. For drugs having low annual revenue or a strong market brand or treating rare diseases, we also established that the optimal enrollment policy is monotonic in the average patient response. Moreover, the optimal enrollment rate increases as the variance of the MEP decreases. Managerial implications: F

关键词： clinical trial management learning of drug efficacy new drug development management optimal enrollment rate r&d project management market exclusivity period

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Checkpoints in New Product development

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ENGINEErING management JOUrNAL 2020年第4期32卷 283-297页

作者： Li, Jinsheng Zhang, di Liu, Liping Nanjing Normal Univ Sch Business 1st Wenyuan Rd Nanjing Peoples R China

Outsourcing the development of new products requires firms to establish strategies to monitor and control progress. We explore the value of establishing checkpoints within the product development lifecycle and provide a basis for determining the most appropriate point at which to review the progress of a development project. We find that establishing checkpoints reduces risk and allows firms to adjust their revenue-sharing ratio according to the progress of the project. We determine that the success of outsourcing is affected by the feasibility of the project and the level of effort and capabilities of the agent.

关键词： New Product development Checkpoint Outsourcing r&d project management Innovation and New Product development Program and project management

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Clinical Trials for New drug development: Optimal Investment and Application

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M&SOM-MANUFACTUrING & SErVICE OPErATIONS management 2017年第3期19卷 437-452页

作者： Kouvelis, Panos Milner, Joseph Tian, Zhili Washington Univ Olin Business Sch St Louis MO 63130 USA Univ Toronto Rotman Sch Management Toronto ON M5S 3E6 Canada Florida Int Univ Coll Business Miami FL 33199 USA

Phase III clinical trials are expensive and require enrolling and treating hundreds or thousands of patients at many sites. The time and cost required to do so are uncertain, as is the economic value of the drug upon completion. We consider the problem of determining when and how many test sites should be opened and the rate at which patients should be recruited. We model the problem as a discrete time, discounted dynamic program with the objective of maximizing the expected net present value of a drug based on the costs of conducting the trial and on the drug's quality-moderated likelihood of approval and its subsequent expected revenue stream if approved. We show the optimal policy is characterized by a series of thresholds on the number of patients enrolled over time that indicate when additional test centers should be opened and how many patients should be targeted. We demonstrate using data from completed clinical trials that for low-to moderate-valued drugs, these thresholds are relevant to the firm's decisions. We extend the problem to the case with multiple interim analyses and demonstrate that optimizing the clinical trial capacity and its utilization provides significant value in addition to the option value of stopping the trial early.

关键词： pharmaceutical drug development clinical trial r&d project management optimal investment

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A multilingual ontology framework for r&d project management systems

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EXPErT SYSTEMS WITH APPLICATIONS 2010年第6期37卷 4626-4631页

作者： Liu, Ou Ma, Jian Hong Kong Polytech Univ Sch Accounting & Finance Hong Kong Hong Kong Peoples R China City Univ Hong Kong Dept Informat Syst Hong Kong Hong Kong Peoples R China

r&d project management systems are developed to facilitate the efficient management of r&d projects in government-funding agencies and universities. They should support r&d information sharing among researchers and research administrators from different nationalities using different languages. This paper presents an ontology-based methodology to the development of r&d project management systems with multilingual supports. In particular, a multilingual ontology is proposed, which consists of domain model, application model, user model and linguistic model. The methodology is used in the development of an r&d project management system for the Innovation and Technology Commission of the Hong Kong SAr Government. The system supports three languages and facilitates r&d information sharing among users with different culture backgrounds and usage preferences. (C) 2009 Elsevier Ltd. All rights reserved.

关键词： r&d project management Multilingual ontology User preference

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Managing the Performance Trade-Offs from Partner Integration: Implications of Contract Choice in r&d projects

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PrOdUCTION ANd OPErATIONS management 2015年第10期24卷 1552-1569页

作者： MacCormack, Alan Mishra, Anant Harvard Univ Sch Business Soldiers Field Boston MA 02163 USA George Mason Univ Sch Business Fairfax VA 22030 USA

Formal contracts represent an important governance instrument with which firms exercise control of and compensate partners in r&d projects. The specific type of contract used, however, can vary significantly across projects. In some, firms' govern partnering relationships through fixed-price contracts, whereas in others, firms' use more flexible time and materials or performance-based contracts. How do these choices affect the costs and benefits that arise from greater levels of partner integration? Furthermore, how are these relationships affected when the choice of contract is misaligned with the scope and objectives of the partnering relationship? Our study addresses these questions using data from 172 r&d projects that involve partners. We find that, (i) greater partner integration is associated with higher project costs for all contract types;(ii) greater partner integration is associated with higher product quality only in projects that adopt more flexible time and materials or performance-based contracts;and (iii) in projects where the choice of contract is misaligned with the scope and objectives of the partnering relationship, greater partner integration is associated with higher project costs, but not with higher product quality. Our results shed light on the subtle interplay between formal and relational contracting. They have important implications for practice, with respect to designing optimal governance structures in partnered r&d projects.

关键词： partner integration contract choice r&d project management relational contracting partnering performance

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research and development project management best practices and absorptive capacity: Empirical evidence from Spanish firms

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INTErNATIONAL JOUrNAL OF project management 2015年第8期33卷 1704-1716页

作者： Vicente-Oliva, Silvia Martinez-Sanchez, Angel Berges-Muro, Luis Ctr Univ Def Acad Gen Mil Zaragoza 50090 Spain Univ Zaragoza Dept Direcc & Org Empresas Escuela Ingn & Arquitectura Zaragoza 50018 Spain Univ Zaragoza Dept Ingn Proc Fabricac Escuela Ingn & Arquitectura Zaragoza 50018 Spain

Evidence from a study carried out in a sample of Spanish firms indicates that research and development (r&d) project management practices are positively related to absorptive capacity of knowledge (AC), although the influence of these practices differs for each AC dimension. Managers realize that learning from past experiences in r&d projects develops the capacity to gain access to relevant external knowledge. However, the positive relationship between management practices and absorptive capacity is only significant for transforming and exploiting external knowledge in r&d projects. The article discusses the managerial implications of improving absorptive capacity within the management of r&d projects and the firm, for every AC dimension. (C) 2015 Elsevier Ltd. APM and IPMA. All rights reserved.

关键词： Absorptive capacity Knowledge management Managerial practices r&d project management

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Cultural differences and Process Adaptation in International r&d project management

Cultural Differences and Process Adaptation in International...

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16th International Conference on management Science and Engineering

作者： Li Ji-zhen Li Xing Tsinghua Univ Res Ctr Technol Innovat Beijing 100084 Peoples R China Aalborg Univ Dept Hist Int & Social Studies DK-9220 Aalborg Denmark

ISBN: (纸本)9781424439706

In the era of globalization, Western companies have started to explore China as a source of technology. Yet, Western r&d project management processes in China are frequently facing many problems. Some of the problems can be conceptualized by analyzing a number of known cultural contrasts between Chinese and Western ways of business interactions, such as collectivism versus individualism, personal relationship and group harmony versus impersonal contractual attitude, strong versus weak uncertainty avoidance, etc. A case study on Alcatel-Lucent China research Technology Center shows how r&d project process can be effectively tuned to.. align with local cultural environment through a new generation stage-gate process model. The overseas company's branch has recognized the need to make its process both faster and more effective for telecommunication software development, and has gained remarkable project success. At the same time, lessons and recommendations on the adaptability to Chinese style business and management interactions will be drawn from the case study for international companies that locate r&d projects in China.

关键词： r&d project management stage-gate process culture differences process adaptation localization

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When the future of biodiversity depends on researchers' and stakeholders' thought-styles

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FUTUrES 2013年 53卷 13-21页

作者： Couix, Nathalie Hazard, Laurent INRA UMR AGIR 1248 CS 52627 F-31326 Castanet Tolosan France

The future of biodiversity depends on actions taken today by a variety of actors working together to overcome the complexity that creates its conservation. designing and implementing these actions put to the test the ability of such a group of actors from different scientific disciplines and professions to share and build the knowledge that is needed to do so. The success of conservation projects depends to a large extent on the integration of different kinds of knowledge and their underlying epistemologies. This integration characterizes transdisciplinarity. An increasing amount of studies focuses on the difficulties to develop transdisciplinary approaches due to the sub-division and specialization of research disciplines. Little work deals with the difficulties faced by the researchers that are engaged in a mode of knowledge production associating different scientific disciplines and professions. Among these difficulties, the link between the content of science and the values and believes underlying researchers' and stakeholders' perspectives remains unexplored although it is a critical point in the success of collaboration. A transdisciplinary project on local seed use in an ecological restoration in the Pyrenees is taken as an example to show how not taking into account such link could lead to the failure of a project. Analyzing this failure revealed that the success of a problem-based project is highly dependent on the compatibility of each partner's thought-style, i.e., epistemological background, values and conception of the world. Since the success of a transdisciplinary project depends on the ability of the partners to collaborate, not only technical and methodological issues should be debated as it is always the case, but also the paradigms underlying the collective action. Overcoming thought-style divergences require the partners to enter into a collective learning process. This learning process deserves a specific task dedicated to a reflexive analysis i

关键词： Collective learning Ecological restoration Partnership r&d project management Thought-style Transdisciplinarity

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Antecedents to ambidexterity competency in high technology organizations

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JOUrNAL OF OPErATIONS management 2012年第1-2期30卷 134-151页

作者： Chandrasekaran, Aravind Linderman, Kevin Schroeder, roger Univ Minnesota Carlson Sch Management S Minneapolis MN USA Ohio State Univ Fisher Coll Business Columbus OH 43210 USA

High tech organizations confront dual demands of exploring new products/processes and exploiting existing products/processes. research shows that ambidextrous organizations can better manage these dual demands, but our understanding of the antecedents that lead to ambidexterity is still emerging. In addition, previous research has taken a piecemeal approach to understand ambidexterity and does not fully consider its multilevel nature. This research takes a multilevel perspective and argues that a competency in ambidexterity involves three capabilities at different organizational levels: decision risk (strategic level), structural differentiation (project level), and contextual alignment (meso level). After correcting for endogeneity we empirically examine the relationship between these antecedents and ambidexterity competency by collecting multi-level data from 34 high tech business units and 110 exploration and exploitation r&d projects. The results indicate that decision risk and contextual alignment affect ambidexterity competency for high tech organizations. Structural differentiation does not affect ambidexterity competency but has mixed effects on r&d project performance. (C) 2011 Elsevier B.V. All rights reserved.

关键词： Exploration Exploitation High tech organizations r&d project management

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Task design, Team Context, and Psychological Safety: An Empirical Analysis of r&d projects in High Technology Organizations

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PrOdUCTION ANd OPErATIONS management 2012年第6期21卷 977-996页

作者： Chandrasekaran, Aravind Mishra, Anant Ohio State Univ Fisher Coll Business Columbus OH 43210 USA George Mason Univ Sch Management Fairfax VA 22030 USA

High technology organizations need to develop new products or processes that address the dual goals of exploration and exploitation. The competing viewpoints and the asymmetric nature of market returns associated with these goals in r&d projects can heighten stress levels among project team members and reduce their psychological safety. While current research calls for greater focus on task design for improving psychological safety, we know little about how team contextual factors affect this relationship. This study develops and tests a conceptual framework that examines the moderating role of r&d team contextual factors, namely, relative exploration and project-organization metric alignment on the relationship between a key task design variable, namely, team autonomy, and psychological safety. relative exploration captures the extent to which exploration goals are emphasized over exploitation goals in an r&d project, while project-organization metric alignment measures the extent to which project metrics are aligned with broader organizational metrics. Furthermore, we examine the performance consequences of psychological safety in r&d projects. The empirical analysis is conducted using primary data collected from multiple informants across 110 r&d projects in 34 high technology business units. Our results indicate that relative exploration and project-organization metric alignment have contrasting moderating effects. Furthermore, the effect of psychological safety on project performance is found to be indirect and mediated through team turnover. Implications of the study findings, limitations, and directions for future research are discussed.

关键词： r&d project management psychological safety exploration exploitation team turnover

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