scholarly journals ROLE OF EFFECTIVE PROJECT MANAGEMENT IN REDUCING DRUG DEVELOPMENT COST

2017 ◽  
Vol 10 (3) ◽  
pp. 53
Author(s):  
Faisal B A Zaidi ◽  
Salma Ahmed ◽  
Munish Makkad
Keyword(s):  
Project Management ◽  
Drug Development ◽  
Site Selection ◽  
Late Phase ◽  
Critical Role ◽  
Project Manager ◽  
Development Cost ◽  
The Cost ◽  
Patient Enrollment

ABSTRACTPharmaceuticals are passing through the difficult phase due to increasing numbers of patents expiry along with increasing cost of drug development.Protocol design, regulatory cycle time, site selection, patient enrollment and monitoring are some of the cost contributing elements for late phaseclinical trials. This paper applies the principles of project management and suggests means to reduce the cost of late phase drug development. It alsothrows light on the critical role that a project manager can play in overall drug development process.Keywords: Cost of drug development, Effective project management, Reduction in cost of drug development.

Architecture of an Integrated Collaboration Portal for Clinical Trial

2015 ◽  
pp. 127-162
Author(s):  
Partha Chakraborty
Keyword(s):  
Clinical Trial ◽  
Development Cost ◽  
Training Activities ◽  
The Cost ◽  
Key Events ◽  
Document Review ◽  
Patient Enrollment ◽  
And Training ◽  
Clinical Trial Activity

Collaboration is defined as the actions for individuals and teams to work together for a common goal. There are several bottlenecks to an efficient and effective collaborative model of clinical trial including: the lack of a centralized, consistent, globally accessible platform to manage and store essential study related documentation; inconsistent or incomplete work assignments; inefficient notification of key events requiring follow-on action; and incomplete, missing, expired, or redundant documentation and training activities and need to maintain multiple credential to access various system, Removing these barriers is an important part of establishing an environment that fosters collaboration among all constituencies involved in managing clinical trial keeping them connected, informed, and on task by providing access to everyone at any time, from anywhere.The case study below introduces need of an integrated clinical collaboration platform, addressing key functionality of such an platform and describes the architecture & design consideration to industrialize such a platform. The intended audience of this case study is the architects & designers of similar systems. The clinical trial activity for a drug in research is approximately 70% of the overall drug development cost. It is estimated that 4% of the cost of a trial is in 'rework' involving communication, regulatory issues, patient enrollment, document review and replacement of patients. The integrated clinical collaboration platform has potential to eliminate significant amount of cost of re-work, which is in order of $3.5M per trial.

‘Smart' Project Management

2016 ◽  
pp. 179-192
Author(s):  
Céline M. Silvius ◽  
Gilbert Silvius
Keyword(s):  
Project Management ◽  
Mobile Devices ◽  
Project Managers ◽  
Project Manager ◽  
Team Collaboration ◽  
Team Members ◽  
Explorative Study ◽  
Management Processes ◽  
Share Information

Mobile devices and applications are changing the way individuals gather, process and share information. A development which also applies to project management. This chapter reports an explorative study on the functionality of 50 project management apps. The apps were analyzed on the variables: type of functionality, project management processes supported, methodology/standard supported, topics covered, website support, languages supported, project roles supported, number of team members supported and number of projects supported. Our analysis showed that the functionality of project management apps today is mainly focused on two application areas: (A) Supporting the role of the project manager individually in the planning/organizing processes of the project and (B) Supporting team communication and team collaboration. Lacking in functionality seems to be the communication/collaboration with project sponsor and other stakeholders. Based on our study we recommend project managers to be selective when starting to use project management apps.

Recruiting a Project Manager

2015 ◽  
Vol 6 (1) ◽  
pp. 54-65 ◽  
Author(s):  
Neelov Kar ◽  
Subhro Mitra
Keyword(s):  
Project Management ◽  
Critical Role ◽  
Project Managers ◽  
Project Manager ◽  
Management Project ◽  
Management Principle ◽  
Project Deliverables ◽  
The Right ◽  
Client Program ◽  
Tools And Methods

Project management is a practice based profession. Just knowing the project management principles does not make a person a successful project manager. It is more important to assess how the candidate applies the project management principle in practice than merely knowing the theoretical aspects of project management. Project Managers play a critical role in the organization. They are responsible for maintaining the revenue stream by ensuring steady flow of project deliverables, be it an internal initiative or a client program. As a Hiring Manager one has to use the right tools and methods to select the right candidate for the position of Project Manager. In this article some of the basic qualities of a Project Manager and the interview techniques adopted to select a Project Manager are discussed. The paper ends with discussion on new competency areas of Project Managers and new roles played by Project Managers in those areas.

‘Smart' Project Management

2016 ◽  
pp. 579-593
Author(s):  
Céline M. Silvius ◽  
Gilbert Silvius
Keyword(s):  
Project Management ◽  
Mobile Devices ◽  
Project Managers ◽  
Project Manager ◽  
Team Collaboration ◽  
Team Members ◽  
Explorative Study ◽  
Management Processes ◽  
Share Information

Mobile devices and applications are changing the way individuals gather, process and share information. A development which also applies to project management. This chapter reports an explorative study on the functionality of 50 project management apps. The apps were analyzed on the variables: type of functionality, project management processes supported, methodology/standard supported, topics covered, website support, languages supported, project roles supported, number of team members supported and number of projects supported. Our analysis showed that the functionality of project management apps today is mainly focused on two application areas: (A) Supporting the role of the project manager individually in the planning/organizing processes of the project and (B) Supporting team communication and team collaboration. Lacking in functionality seems to be the communication/collaboration with project sponsor and other stakeholders. Based on our study we recommend project managers to be selective when starting to use project management apps.

Ontology Development and the Role of Knowledge in E-Government Project Management

2016 ◽  
pp. 475-496
Author(s):  
Bongani Ngwenya
Keyword(s):  
Developing Countries ◽  
Project Management ◽  
Critical Role ◽  
Ontology Development ◽  
Government Project ◽  
Information And Communication ◽  
Management Approaches ◽  
Services Implementation

The literature suggests that the elaboration of ontology contributes to the standardization and classification of concepts and terminologies, and it has been happening in some sectors, such as software engineering, e-Government services implementation, and project management. In the area of e-Government, knowledge plays a critical role in the development of e-Government transformation project management ontology, which aims at adopting and customizing the existing project management approaches according to the specific challenges encountered in the e-Government environment. It is in this context that this chapter presents an ontological representation of the concepts of e-Government project management in one of the developing countries in southern Africa. The chapter further intends to collaborate in the excellence and productivity of the management of the e-Government project process. This will also enable the interoperability and knowledge reuse between all factors and stakeholders related with the implementation of such types of projects as a lesson for developing countries. The data was collected by use of an interview protocol or schedule, and the researcher interviewed relevant employees of the two ministries, the Ministry of Information Technology and the Ministry of Information and Communication. The data was then analyzed qualitatively to draw a model that the Zimbabwean government is adopting.

Metabolite identification in preclinical and clinical phase of drug development

2021 ◽  
Vol 22 ◽  
Author(s):  
Yali Wu ◽  
Lulu Pan ◽  
Zhendong Chen ◽  
Yuandong Zheng ◽  
Xingxing Diao ◽  
...  
Keyword(s):  
Drug Development ◽  
Kinase Inhibitors ◽  
Critical Role ◽  
Metabolite Identification ◽  
Correct Identification ◽  
Drug Candidates ◽  
Clinical Phase ◽  
Natural Medicines ◽  
Insight Into

: Metabolite identification plays a critical role in the phases during drug development. Drug metabolites can contribute to efficacy, toxicity, and drug-drug interaction. Thus, the correct identification of metabolites is essential to understand the behavior of drugs in humans. Drug administration authorities (e.g., FDA, EMA, and NMPA) emphasize evaluating the safety of human metabolites with exposure higher than 10% of the total drug-related components. Many previous reviews have summarized the various methods, tools, and strategies for the appropriate and comprehensive identification of metabolites. In this review, we focus on summarizing the importance of identifying metabolites in the preclinical and clinical phases of drug development. Summarized scenarios include the role of metabolites in pharmacokinetics/pharmacodynamics (PK/PD) analysis, disproportional exposure of metabolites that contribute to drug toxicity, changes in metabolite exposure in renal-impaired patients, covalent tyrosine kinase inhibitors (anticancer drugs), and metabolite identification of drug candidates from natural medicines. This review is aimed to provide meaningful insight into the significant role of metabolite identification in drug development.

Sustainability Assessment for Project Managers

2013 ◽  
pp. 288-302 ◽  
Author(s):  
Gilman C. K. Tam
Keyword(s):  
Project Management ◽  
Assessment Tool ◽  
Sustainability Assessment ◽  
Project Managers ◽  
Project Manager ◽  
Evaluation Framework ◽  
Implementation Project ◽  
Design And Implementation ◽  
Project Sustainability

In the two decades since the Earth Summit in 1992, an increasing number of projects have built sustainability considerations into project design and implementation. Project managers without knowledge and guidance on sustainability assessment would find it difficult to drive projects and programs contributing towards a sustainable society. The purpose of this chapter is to devise an assessment tool for project managers incorporating the concept of pillar-based and principles-based sustainability approaches as well as the EIA-driven and objectives-led assessment methodologies. The definitions of sustainability in project management and program management are discussed as basis for the establishment of sustainability evaluation framework. The views of project management community regarding the role of project manager in handling project related sustainability activities are discussed. This chapter contributes to devising a practical assessment tool for project managers in managing project sustainability.

scholarly journals Angiographic Review of Choroidal Involution in Eyes with Retinopathy of Prematurity Treated with Bevacizumab

2020 ◽  
Author(s):  
Yasmin Islam ◽  
Lorick Andersen ◽  
Swati Agarwal-Sinha
Keyword(s):  
Retinopathy Of Prematurity ◽  
Late Phase ◽  
Critical Role ◽  
Intravitreal Bevacizumab ◽  
Retinal Function ◽  
Peripheral Retina ◽  
Phase Imaging ◽  
History Of ◽  
Choroidal Vasculature

Purpose: Retinopathy of prematurity (ROP) is considered a disease of the inner retina; however, there is increasing evidence that demonstrates choroidal vasculature loss in ROP, leading to degeneration of outer retinal function and visual deterioration. Central choroidal thinning is noted in children with history of ROP using optical coherence tomography (OCT) imaging. This study characterizes the presence and persistence of choroidal loss angiographically in eyes of infants treated with intravitreal bevacizumab (IVB) for stage 3 ROP. Methods: Retrospectively reviewed the fluorescein angiography (FA) images of 62 eyes of 31 infants treated with IVB monotherapy. The eyes with good quality early-, mid-, and late-phase imaging were included in this study. The presence of choroidal hypofluoresence involving the central and or peripheral retina were noted. In infants with multiple FAs, serial FAs were analyzed for persistence of choroidal hypofluorescence. Results: The mean age and birth weight of infants was 24.4 weeks PMA and 683 grams, respectively. All infants received IVB monotherapy. 24 of 62 angiography images of sufficient quality reviewed showed the presence of choroidal hypofluorescence involving central and peripheral lobular loss in the early phase and its persistence into mid and late phases. 12 eyes demonstrated persistent choroidal loss on sequential FA until three years chronological age. Conclusions: The study demonstrates the presence of choroidal vascular loss angiographically both central and peripheral fundus in infants with ROP. It highlights the critical role of choroidal involution in outer retinal function that could affect visual outcomes.

Ontology Development and the Role of Knowledge in E-Government Project Management

2015 ◽  
pp. 289-310
Author(s):  
Bongani Ngwenya
Keyword(s):  
Developing Countries ◽  
Project Management ◽  
Critical Role ◽  
Ontology Development ◽  
Government Project ◽  
Information And Communication ◽  
Management Approaches ◽  
Services Implementation

The literature suggests that the elaboration of ontology contributes to the standardization and classification of concepts and terminologies, and it has been happening in some sectors, such as software engineering, e-Government services implementation, and project management. In the area of e-Government, knowledge plays a critical role in the development of e-Government transformation project management ontology, which aims at adopting and customizing the existing project management approaches according to the specific challenges encountered in the e-Government environment. It is in this context that this chapter presents an ontological representation of the concepts of e-Government project management in one of the developing countries in southern Africa. The chapter further intends to collaborate in the excellence and productivity of the management of the e-Government project process. This will also enable the interoperability and knowledge reuse between all factors and stakeholders related with the implementation of such types of projects as a lesson for developing countries. The data was collected by use of an interview protocol or schedule, and the researcher interviewed relevant employees of the two ministries, the Ministry of Information Technology and the Ministry of Information and Communication. The data was then analyzed qualitatively to draw a model that the Zimbabwean government is adopting.

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