Fit-for-purpose pharmacogenomic biomarkers in drug development: a project team case study with ‘what-ifs’

2009 ◽  
Vol 10 (1) ◽  
pp. 137-147 ◽  
Author(s):  
Linda C Surh ◽  
Lawrence J Lesko ◽  
Stuart Hobbs ◽  
Steve Gutman ◽  
Lori M Minasian ◽  
...  
Keyword(s):  
Drug Development ◽  
Project Team ◽  
Fit For Purpose

The importance of quality critical reagents for the entire developmental lifecycle of a biopharmaceutical: a pharmacokinetic case study

Bioanalysis ◽  
2021 ◽  
Author(s):  
Andrew P Mayer ◽  
Kristy J Fraley
Keyword(s):  
Drug Development ◽  
High Quality ◽  
Assay Format ◽  
Development Lifecycle ◽  
Fit For Purpose ◽  
Development Phases ◽  
Detrimental Impact ◽  
Pharmacokinetic Assay

Background: High-quality critical reagents are essential to the successful support of biotherapeutic drug development regardless of the analytical platform used for support. The lack of such a reagent, early in the development lifecycle of a biotherapeutic can have detrimental impact on resource and translation of data across development phases. Results: Here, a pharmacokinetic assay case study is shared that illustrates what can occur when there is a lack of a reproducible and sustainable critical reagent early in the development lifecycle of a biotherapeutic. Various assay formats and critical reagents, as well as reagents generation programs, were initiated to find a reagent and assay format which was fit for purpose. Conclusions: Identification of appropriate critical reagents early in the development lifecycle of a biotherapeutic as advantageous.

scholarly journals Love in the time of Covid-19: a case-study of the complex laws governing weddings

Legal Studies ◽  
2021 ◽  
pp. 1-17
Author(s):  
Rebecca Probert ◽  
Stephanie Pywell
Keyword(s):  
First Century ◽  
Marriage Law ◽  
England And Wales ◽  
General Law ◽  
The Social ◽  
The Future ◽  
Fit For Purpose ◽  
The Law ◽  
The Impact

Abstract During 2020, weddings were profoundly affected by the Covid-19 pandemic. During periods of lockdown few weddings could take place, and even afterwards restrictions on how they could be celebrated remained. To investigate the impact of such restrictions, we carried out a survey of those whose plans to marry in England and Wales had been affected by Covid-19. The 1,449 responses we received illustrated that the ease and speed with which couples had been able to marry, and sometimes whether they had been able to marry at all, had depended not merely on the national restrictions in place but on their chosen route into marriage. This highlights the complexity and antiquity of marriage law and reinforces the need for reform. The restrictions on weddings taking place also revealed the extent to which couples valued getting married as opposed to having a wedding. Understanding both the social and the legal dimension of weddings is important in informing recommendations as to how the law should be changed in the future, not merely to deal with similar crises but also to ensure that the general law is fit for purpose in the twenty-first century.

Knowledge Sharing in Project Environments

2021 ◽  
Vol 12 (1) ◽  
pp. 1-17
Author(s):  
Zinga Novais ◽  
Jorge Vareda Gomes ◽  
Mário José Batista Romão
Keyword(s):  
Project Management ◽  
Knowledge Sharing ◽  
Project Managers ◽  
Project Team ◽  
Team Members ◽  
Business Operations ◽  
Successful Execution ◽  
Management Project ◽  
A Company

Projects have been increasingly used in the implementation of organizations' business operations. Knowledge sharing has been considered essential in project environment; therefore, the integration of knowledge management within project management becomes crucial for project success. The objective of this research is to study how knowledge sharing is integrated within the context of a project, and what is the perception of project team members about it. A case study was carried out in a company within the financial sector, focused on a project team of the entity. The results revealed that project managers, other professionals in project management, and the organization itself are very much aware of the importance of knowledge sharing. The results also emphasized that, regardless of the lack of incentives by top management, project team members consider that knowledge sharing highly contributes for a successful execution of projects.

Evolution of Digital Technologies and Use of Virtual Assistants in Drug Development

2019 ◽  
pp. 1-20
Author(s):  
Manu Venugopal
Keyword(s):  
Drug Development ◽  
Digital Health ◽  
Critical Role ◽  
Life Sciences ◽  
Digital Technologies ◽  
Development Phase ◽  
Health Technologies ◽  
Daunting Task ◽  
The World

The drug development phase is one of the most time-consuming and expensive stages in the lifecycle of a drug. Marred by patent expirations, price regulations, complexities in disease conditions, life sciences companies are facing a daunting task to bring new molecular entities into the market. Digital health technologies are playing a critical role in addressing some of the challenges faced during drug development. In this chapter, the author talks about the challenges and key trends in the world of drug development, use of new digital health technologies, and the future of drug development. As an example, the author dives into a specific case study on the use of virtual assistants in clinical trials and the benefits of its usage on patients, healthcare professionals, and life sciences companies.

Fit for Purpose

2021 ◽  
pp. 21-42
Author(s):  
Erika Prager ◽  
Barbara M. Hall ◽  
Laurie Wellner ◽  
B. Andrew Riggle
Keyword(s):  
Design Process ◽  
Continuous Improvement ◽  
Educational Needs ◽  
Illustrative Case ◽  
Doctor Of Education ◽  
Professional Goals ◽  
Fit For Purpose ◽  
Education Degree ◽  
Illustrative Case Study

Using an illustrative case study, this chapter explores the two-year design process of a practice-based Doctor of Education degree program in an online university. Emerging from the continuous improvement lens, the redesign process centered around the examination of the purpose of the degree in the context of meeting the educational needs of practitioners in the field. Principally, this program redesign led to greater differentiation between the practitioner-based EdD degree and the PhD to provide students with distinct options for meeting their personal and professional goals.

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