Knowledge creation in pharmaceutical R&D

Knowledge Creation Processes in Research & Development –A Case Study in the Pharmaceutical Industry

 
Objective: The objective was to explore and to gain an in-depth understanding of the knowledge creation processes in pharmaceutical R&D. The objective was explored through a specific pharmaceutical development project, called X.
 
Main research question:

  • What characterises the knowledge-creation processes in pharmaceutical R&D?

Research questions:

  • To what extent has qualitative studies been conducted to explore knolwedge creation in pharmaceutical R&D?
  • What are the characteristics of the knowledge-sharing enablers and barriers in pharmaceutical development project X?
  • What are the characteristics of the knowledge-sharing processes in pharmaceutical development project X?
  • What characterises the organisational context surrounding knowledge creation in pharmaceutical development project X?

Study design: This PhD thesis is a qualitative, exploratory, single case study carried out in a drug development project in Novo Nordisk, Denmark
Methods: The data collection methods include systematic literature review, semi-structured interviews, and document account analysis.
The project is finalized in January 2010. Results will be published in four peer reviewed articles.
(PhD student Anne-Mette Lilleøre. Main supervisor: Ebba Holme Hansen. Other supervisors: Pia Thorbek, Novo Nordisk A/S)

Clinical and intervention studies

Electronic monitoring of patient adherence in hypertension: survey and clinical assessments of a reminder and monitoring device

Aim: This PhD project aims at evaluating the electronic reminder device, ‘Helping Hand’, produced by Bang & Olufsen Medicom a/s. The research questions are:
To what extent has electronic monitoring of compliance been used in the treatment of hypertension?

  • What are patients’ and health professionals’ attitudes towards ‘Helping Hand’?
  • To what extent does the use of “The Helping Hand” improve adherence to long term treatment?
  • To what extent does the use of “The Helping Hand” improve blood pressure?

Methods: The data collection methods include systematic literature review, surveys and randomized clinical trials.

  • Electronic monitoring has been used rather scarcely and overall study quality is relatively low.
  • 3/4 of patients and health professionals assessed  Helping Hand positively
  • 2/3 wish to continue to use Helping Hand
  • Helping Hand improves compliance with 6%
  • Counselling based on Helping Hand seems to improve compliance with 15%

The project is finalized during summer 2009. Results are/will be published in six peer reviewed articles.
(PhD student Arne Christensen. Main supervisor: Ebba Holme Hansen. Other supervisors: Lona L Christrup and Paul Erik Fabricius, B&O Medicom a/s)
 

Rational individualised pharmacotherapy

Aim: The purpose of this project is to find the approach which could provide the most cost-effective individualised pharmacotherapy for depressive patients. The project is focused on two areas of interest: pharmacogenomics as a pre-treatment tool for choice of a particular pharmaceutical and interventions, which together with an antidepressant could provide a better outcome for a patient than antidepressants alone.
Methods: On basis of literature findings, focus areas will be specified, experts will be identified, and questionnaires for on-line Delphi survey will be formulated. Based on information collected from the Delphi survey and the literature, cost and effectiveness of these two approaches will be evaluated in an economic model with the aim to identify the most cost-effective direction.
Results: Genotyping for polymorphism within serotonin transporter promoter is the most studied predictor for antidepressant response. However, remission rates with genotyping as a pre-treatment tool, as they were assessed by experts, do not appear to be superior to existing practice, i.e., without genotyping.
(PhD student Svetlana Østergaard. Main supervisor: Claus Møldrup. Other supervisor: Christian Kronborg, Syddansk Universitet)

Patients’ and consumers’ preferences and attitudes

The population's medicine use

Medicine use may be a behaviour reflecting a general coping strategy to overcome daily stressors over and above formal therapeutic indications.
Aim: The main aim of this PhD thesis is to examine the association between perceived stress, sense of coherence (SOC) and use of over-the-counter analgesics (OTCA) among 25-44 year old adults.
Method: Two national cross-sectional surveys. The dependent variable is use of over-the-counter analgesics (OTCA). The independent variables are perceived stress and SOC. Demographic variables and pain and discomfort symptoms are included as co-variables.
Results: The results indicate that OTCA are used inappropriately to treat feelings of stress, with increasing levels of stress there are increasing odds for OTCA use and the association can not be explained by prevalence of symptoms. There is also an association between SOC and use of OTCA, and SOC modifies the association between stress and OTCA use.
(PhD student Vibeke Koushede. Main supervisor: Ebba Holme Hansen. Other supervisors: Anette Andersen, University of Southern Denmark, and Bjørn E. Holstein, Faculty of Health Sciences)

Psychosocial and sociocultural factors in the cause of disparities in medicine use among children and adolescents

Differences in morbidity and mortality between conventionally defined ethnic groups have been widely documented, but these differences continue to be poorly understood.

Aim: This PhD project aims at exploring the causes of health disparities between different ethnic groups by means of analyzing the predictive power of psychosocial and sociocultural factors in medicine use among children and adolescents. The research questions are:

1. Do differences in prescriptions among children and adolescents with different foreign backgrounds remain after adjusting by parental socioeconomic position?
2. What are the most vulnerable groups and the most frequently prescribed drug groups among the Danish children and adolescent population?
3. Is ethnicity associated with psychosocial stress and medicine use among Danish children and adolescents?
4. Is ethnicity associated with psychosocial stress and medicine use? a cross-country study

Methods: The data collection methods include Danish registers, Danish and international surveys and systematic literature review. The data sources are:

1. The Register of medicinal products statistics (Danish national prescription register)
2. Health Behavior in School-aged Children (HBSC) – Danish contribution
3. Health Behavior in School-aged Children (HBSC) – International Data set

The project has started the first of June 2009.

(PhD student Lourdes Cantarero-Arévalo. Main supervisor: Ebba Holme Hansen. Co-supervisors: Anette Andersen and Bjørn E. Holstein)

The meaning of medicines in a user perspective

Pharmacovigilance/Medicines safety

 

Aim: The objective is to provide a research foundation for improvement of medicine use with a special view to safety. 
Method: Critical reviews, analyses of licensing material, analyses of adverse drug reactions (ADRs) reported to national and international databases and analyses of ADR reporting practices in clinical settings.
Research covers ADRs in adults as well as children. Critical reviews of the existing literature and empirical research have been performed. Analyses of licensing material for medicines licensed for use in adults as well as children have been carried out. The evidence regarding medicines not licensed for children but prescribed off-label is explored. Several studies analysing ADRs reported for children in Denmark are conducted.
(Lise Aagaard, Ebba Holme Hansen)

Methodology development

Modern Medicines

 Aim

The aim of research within Modern Medicines is to contribute with high level research by applying innovative research methods the newest trends and aspects of the use of medicines in society from both an individual and societal perspective.

 Research themes

The research strategy in Modern Medicines will focus on the following themes: 1) the use of individualized medicines, 2) lifestyle medicines and medicines to enhance daily-life activities and 3) modern medical marketing.

 Use of individualized medicines              

Objective: Pharmacogenomics has often been positioned as being synonymous with individualized medicine. This research theme focus on expanding the meaning of individualized medicine to encompass individualized -diagnosis, -prescribing, -monitoring, -compliance, -information and -marketing as well as classic pharmacogenomics. The main objective of the individualized medicines theme is to contribute to individualized optimized drug use by developing technological support systems for the most important of above individualised situations in each specific disease area.[iii]

 Lifestyle medicines and medicines to enhance daily-life activities

Objective: In 1999 Møldrup, introduced the term Medically Enhanced Normality (MEN) to cover the use of pharmaceuticals for non-disease conditions other than doping or recreational drug use. MEN deals with how modern pharmaceuticals are used not only to heal, cure and prevent but also to enhance matters in people's ordinary and healthy lives.[iv],[v],[vi]  The objective of this research theme is to develop a new theory that covers all aspects of MEN and draws upon the theoretical framework of Medicalization, a strong heritage in Social Pharmacy research.

 Modern medical marketing

Objective: The aim of the research in modern medical marketing is to analyze cases of current and future medical marketing campaigns in the light of rational pharmacotherapy as theoretical framework, and evaluate to which extent these campaigns deliver input to a sustainable and responsible healthcare environment.


[i] Osler, W. The Evolution of modern medicine. A series of lectures delivered at Yale University on the Silliman Foundation in April 1913.

[iii] Møldrup, C.Beyond pharmacogenetics - individualized medicine in a holistic perspective. Personalized Medicine 2009 Accepted

[iv] Møldrup C. Den medicinerede normalitet. Copenhagen: Gyldendal; 1999.

[v] Møldrup C, Almarsdóttir A, Morgall JM. Medically Enhanced Normality. International journal of pharmacy practice 2003; 11:243-247.

[vi] Møldrup C, Nielsen RR. Public acceptance of drug use for non-disease conditions. CuRRent MediCAl ReseARCH And OpiniOn 2006; 22(4):777-780.

 

 

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Department of Pharmacology and Pharmacotherapy
Topgrafik
Page maintained by Rita Elkjær
Last update: 26.01.2011

University of Copenhagen
Faculty of Pharmaceutical Sciences
Universitetsparken 2
2100 Copenhagen
Denmark

Phone +45 35 33 60 00
Fax +45 35 33 60 01
Mail farma@farma.ku.dk
Web www.farma.ku.dk