scholarly journals A case study of a patient‐centered reverse translational systems‐based approach to understand adverse event profiles in drug development

2022 ◽  
Author(s):  
Sarah Kim ◽  
Gezim Lahu ◽  
Majid Vakilynejad ◽  
Theodoros G. Soldatos ◽  
David B. Jackson ◽  
...  
Keyword(s):  
Adverse Event ◽  
Drug Development ◽  
Patient Centered

scholarly journals Exploring How and Why to Develop Patient-Centered Packaging: A Multiple-Case Study with Pharmaceutical Companies

2021 ◽  
Author(s):  
Giana Carli Lorenzini ◽  
Annika Olsson
Keyword(s):  
Drug Development ◽  
Case Study Research ◽  
Multiple Case Study ◽  
Business Case ◽  
Lessons Learned ◽  
Pharmaceutical Companies ◽  
Research Approach ◽  
Patient Centered ◽  
Multiple Case

Abstract Background Patient centricity has gained attention ranging from regulatory authorities to patient advocacy groups, calling for pharmaceutical companies to revise their traditional business approach to drug development by including the development of solutions that are meaningful in patients’ lives. Medication packaging is one area where empirical evidence is lacking about the incorporation of patient centricity. This study aimed to explore patient centricity applied to pharmaceutical companies’ packaging, and to identify the specific challenges faced and lessons learned when developing patient-centered packaging. Methods The study followed a multiple-case study research approach based on five cases of patient-centered packaging development in mid- and large-sized pharmaceutical companies. Results Patient-centered packaging is often associated with the intuitive and self-explanatory use of the medication by patients. Patient-centered packaging comes with challenges, but also offers opportunities for the creation of better solutions for patients and learning for the teams involved. To overcome these challenges, it is essential to build a business case that justifies such development, one where patient needs are present from the start and aligned with other imperative deadlines of drug development, with stakeholders onboard. Conclusion Patient-centered packaging is the exception rather than the norm in packaging development due to a conventional approach where packaging plays an ancillary role to drug protection. The cases presented here challenge this approach and can inspire other companies to carry out patient-centered packaging development. The cases are also relevant to other actors who are interested in continuously promoting the dialogue about patient centricity in healthcare.

Safety Signal Detection in the Drug Development Process

2015 ◽  
pp. 64-89
Author(s):  
Ramin B. Arani ◽  
Antoni F.Z. Wisniewski
Keyword(s):  
Adverse Event ◽  
Drug Development ◽  
Signal Detection ◽  
Safety Information ◽  
Safety Signal ◽  
Drug Development Process ◽  
Safety And Efficacy ◽  
Strength Of Association ◽  
Efficacy Profile ◽  
Complicated Task

Drug development is a complex set of inter-linked processes in which the cumulative understanding of a drug's safety and efficacy profile is shaped during different learning phases. Often, drugs are approved based on limited safety information, for example in highly at risk or rare disease populations. Therefore, post approval, regulatory organizations have mandated proactive surveillance strategies that include the collection of reported adverse events experienced by exposed populations, some of whom may have been on treatment for extended periods of time. Analyzing these accumulating adverse event reports to understand their clinical significance, given the limitations imposed by the methods of data collection, is a complicated task. The aim of this chapter is to provide the readers with a general understanding of safety signal detection and assessment, followed by a description of statistical methods (both classical and Bayesian) typically utilized for quantifying the strength of association between a drug and an adverse event.

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.

Diabetic ketoacidosis in acromegaly: a case study—somatostatin analogs adverse event or disease complication?

2019 ◽  
Vol 57 (4) ◽  
pp. 491-493 ◽  
Author(s):  
Nunzia Prencipe ◽  
Fabio Bioletto ◽  
Chiara Bona ◽  
Filippo Gatti ◽  
Silvia Grottoli
Keyword(s):  
Adverse Event ◽  
Diabetic Ketoacidosis ◽  
Somatostatin Analogs
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