RWE – From real world data to real world evidence

Real world data (RWD) refers to health data that can be used, for example, for demonstrating the value of a certain treatment or technology for patients, healthcare service providers or the society (RWE). Due to a comprehensive healthcare, data in digital format, a personal ID and a progressive research legislation, Finland is a true model country for Real World Evidence studies.

Medaffcon has conducted RWE studies from 2013 onwards; we thus hold a wide-ranging experience in the analytics and utilisation of real world data. We are intensively involved in supporting the development of biobanks, and our cooperation networks with biobanks and other register holders are strong.

In Medaffcon’s RWE studies, we have gathered new knowledge in different therapeutic areas, including:

  • Disease burden of different patient groups
  • Use of healthcare resources
  • Diagnostics of rare diseases
  • Treatment lines
  • Mortality
  • Characteristics of patient subgroups
  • Regional differences and treatment practices

 

Real World Evidence tailored to your needs!

Our process for conducting studies is clear and has been proven effective. Our scientific experts and bioinformaticians ensure that the right research methods and data sources are utilised to answer your question.

The entire process is conducted with solid RWE knowledge and expertise.

Comprehensive information on diverse information sources

 

 

Examples of clinical data used in RWE study

 

 

RWD linked to a social security number

 

 

Examples of Finnish hospital Biobanks

 

 

 

Examples of completed studies with Auria biobank:

2017

A biobank and health register analysis of burden of disease in severe asthma or COPD patients

GSK Finland

This study surveys the status and characteristics of patients with severe asthma or COPD, diagnosed in the hospital district of Southwest Finland during 2004-2015. Information regarding treatment, health care resource use and associated costs, as well as mortality will be explored.

Clinical characteristics of the Multiple Myeloma patient cohort diagnosed in Southwest Finland during 2004-2017

Amgen AB Finland

Multiple myeloma (MM) is the second most common hematological cancer representing 10-15% of all hematological malignancies. MM results from the clonal expansion of monoclonal plasma cells in the bone marrow, leading to increased secretion of abnormal immunoglobulin into urine and / or peripheral blood. Overproduction of the immunoglobulin fragment causes several deleterious systemic effects, leading to symptoms typically affecting bones and renal function. While MM still remains mostly incurable, the overall survival of MM patients has improved significantly due to the development of more effective therapies.

2016

Eosinophilic asthma

AstraZeneca

Asthma is a heterogeneous disease, often characterised by chronic inflammation of breathing organs. New treatment options have been created for the treatment of serious asthma, however, further information is needed on the biological markers that could be used in the diagnosis and follow-up of patients as well as in the evaluation of the prognosis of different phenotypes and endotypes. The aim of this non-interventional retrospective register study is to examine the significance of eosinophil levels in difficult asthma by assessing the characteristics of these patients and their use of healthcare resources.

The special characteristics of chronic lymphocytic leukaemia in the Hospital District of Southwest Finland in 2004–2013

Abbvie

Chronic lymphocytic leukaemia (CLL) is the most common haematological cancer in Western countries. It is typically found as a coincidental finding in connection with other examinations. While asymptomatic CLL typically is not treated, commonly used treatment options in the most difficult forms of the disease include chemoimmunotherapy and other new cancer-specific drugs. The treatment of CLL has developed immensely during the past ten years and therefore the prognosis has improved in all variants of the disease. This study determines the current situation of CLL, e.g. characteristics of the patient population, used treatment regiments and associated outcomes. With the information obtained, it will be possible to evaluate treatments needed in the future and how much resources they require from the healthcare.

2015

Examining the epidemiology, treatment, comorbidites and prognosis of rare immunological haematological diseases in the Hospital District of Southwest Finland in 2003–2014

Novartis Finland Oy

Chronic immunological thrombocytopenic purpura (ITP) and aplastic anaemia (AA) are rare autoimmune-based blood disorders. The exact causes of these diseases are not fully known. The prognosis of aplastic anaemia, in particular, was very poor 40 years ago as estimated survival of a patient with serious AA was only 1–2 years from the diagnosis. This study examines the prevalence, prognosis and complications of ITP and AA, related costs and treatments used. The study provides also valuable information of the impact of the treatments on prognosis of the patients.

Study on the epidemiological prevalence of melanoma, treatment effectiveness and the use of healthcare resources in the Hospital District of Southwest Finland

Novartis Finland Oy

Metastatic melanoma is a rapidly progressing disease with poor prognosis. Only in recent years, with the introduction of new effective therapies, improvements in the overall survival have been achieved. In particular, BRAF inhibitors and immunotherapy provide new treatment options for a subset of patients. Further information is, however, warranted to clarify the value of different biomarkers indicating the likely responders that would benefit from these different therapies. This study provides information on the use of different treatment options for patients with melanoma, effectiveness of the treatments used, observed comorbidities as well as utilization of healthcare resources.

Study on the epidemiological prevalence of polycythemia vera

Novartis Finland Oy

Polycythemia vera (PV) is a slowly progressing disease which can further develop into myelofibrosis or acute leukaemia in a subset of PV patients. This study examines how PV patients are divided into groups of low and high risks, and which risk factors influence the progression of polycythemia vera into either myelofibrosis or acute leukaemia. This study increases knowledge on the epidemiology of polycythemia vera and the potential factors impacting its prognosis.

2014

Study on the epidemiological prevalence and postoperative treatment of acromegaly in the Hospital District of Southwest Finland

Novartis Finland Oy

Acromegaly is a rare disease resulting from excess growth hormone. In most cases, the disease is caused by a pituitary tumour. This study provides information on the proportion of acromegaly patients whose growth hormone levels do not normalize after the removal of the pituitary tumour and proportion of patients that need somatostatin analogue treatment in order to obtain clinical response. In addition, the comorbidities between patients with instable growth hormone levels and those with recovered hormone levels will be compared. This study provides information for more optimized targeting of treatments for patients with acromegaly.

Study on the epidemiological prevalence of myelofibrosis, polycythemia vera and essential thrombocythemia and the overall survival of patients with myelofibrosis in the Hospital District of Southwest Finland

Novartis Finland Oy

Myelofibrosis (MF) is a slowly progressing disease with poor prognosis. While improvements in overall survival of patients with MF have been achieved, a proportion of MF patients develop subsequently acute leukaemia. This study assesses the proportion of MF patients whose disease transforms to leukaemia and the putative significance of JAK2V617F gene mutation in this process. This study increases knowledge on the epidemiology of myelofibrosis and the potential prognostic factors of the disease.

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”As a biostatistician, I know the statistical methods and how they can be utilized in data analysis. I know different data sources, their potential and limitations. My job is to process and analyze raw data, and provide statistical evidence for the customer to response the burning questions, to support decision-making, and to fill the data gaps.”
Iiro Toppila
Biostatistician, Medaffcon Oy

We are more than happy to tell you more!

Mariann Lassenius
Sr. Scientific Advisor
RWE Lead

Contact us

Our Real World Evidence Experts:

Mariann Lassenius
Sr. Scientific Advisor
RWE Lead

Mariann Lassenius

Sr. Scientific Advisor
RWE Lead
PhD

+358 50 3452 393 LinkedIn

Mariann joined Medaffcon’s Medical Team in June 2016.

Mariann holds a PhD in Science and has experience in medical research on diabetes and long-term complications at Folkhälsan Research Center and at the Nephrology Outpatient Clinic of the University of Helsinki.

Mariann has also gained experience in commercialising research innovations, after working as a part-time consultant at Biotech Start-Up Management.

Mariann completed her Master of Science degree at the Department of Biosciences of the University of Helsinki in 2007. She majored in Physiology and had Biochemistry as a minor.

In the field, Mariann is particularly interested in health-promoting changes enabled by digitalisation, both with regard to pharmaceutical companies and social services. Development of new medicinal products and  improvement of treatment provide the work with an extremely interesting dimension.

Mariann’s strengths at Medaffcon include her strong scientific expertise as well as the ability to analyse diverse health data in an appropriate manner and to work as a goal-oriented team player.

 


Jaana Ahlamaa
Medical and Market Access Director

Jaana Ahlamaa

Medical and Market Access Director
MD (Specialist in Surgery), PhD

+358 50 5767 325 LinkedIn

Jaana began her career in the pharmaceutical industry as a Medical Advisor in different therapeutic areas, after which she became a Medical Affairs Manager. Jaana’s areas of responsibility have included, inter alia, sales permission, pharmacovigilance and marketing support functions. In 2006, Jaana became a Medical Director, assuming responsibility for all medical functions in the Finnish affiliate of the company she represented. After this, Jaana has worked in different Medical Advisor/Director positions in different companies.

Jaana established Medaffcon in 2009 after working in the pharmaceutical industry for almost ten years. Jaana’s most essential input in Medaffcon’s team is her wide-ranging experience and knowledge in different fields of the pharmaceutical industry, as well as the ability to think innovatively. Jaana’s key areas of interests include creating and maintaining cooperation between different activities and actors in the pharmaceutical industry. Jaana is also a member of the Board of the Finnish Association of Pharmaceutical Physicians.


Outi Isomeri
Scientific Project Manager

Outi Isomeri

Scientific Project Manager
M. Sc. (Pharm.) & M. Sc. (Tech.)

+358 40 507 4092 LinkedIn

Outi Isomeri joined Medaffcon’s Medical Affairs team in December 2017. Outi holds plenty of experience from outpatient pharmaceutical service, particularly customer service and review of customer needs, after working as a pharmacist since 2009.

Outi holds a Master of Science degree in Technology, and she completed her Master’s thesis and advanced studies at the HEMA (Healthcare Engineering, Management and Architecture) institute at Aalto University, where she studied, inter alia, the management and arrangements in special healthcare. In addition to industrial engineering, her degree included health economics and analytics. Outi has worked as an analyst in different projects at NHG.

In the field, Outi is interested, in particular, in the future possibilities in individualised pharmaceutical treatment, the use of existing knowledge for the benefit of all and the possibilities to provide her own contribution for the benefit of a more functional pharmaceutical service in Finland. ”I strongly believe that there is a lot to improve in the operational models of our field, and I want to be part of analysing and planning those.” Furthermore, Outi holds an interest in market analyses and the assessment and monitoring of the overall costs of diseases.

Outi’s strengths include her diversity both as an employee and in terms of educational background. Outi is analytical, hard-working and customer-oriented professional in the pharmaceutical industry.


Päivikki Hemmilä
Scientific Advisor

Päivikki Hemmilä

Scientific Advisor
PhD

+35845 1200 632 LinkedIn

Päivikki joined Medaffcon’s Medical Affairs team in September 2017.  She has a PhD in cancer biology and worked for almost ten years as a researcher in the field. Since 2006, Päivikki has worked in different specialist positions with sales, quality, registration and research in Medical Device, pharmaceutical and CRO companies. Before joining Medaffcon Päivikki worked in Finnish Clinical Biobank Tampere, where she was responsible for the construction and development of the biobank’s quality system and operative processes.

Päivikki is intrigued by the constant development of the healthcare industry. In addition, she is interested in the possibilities and concrete benefits for developing a more effective and individualised treatment through cooperation between different actors, such as biobanks and research institutions.

At Medaffcon, Päivikki’s strengths include her solid scientific expertise as well as her wide-ranging experience in the project leader role in both academic and company-led research and product development projects. Päivikki works with a positive mind in a customer-oriented manner and makes for a reliable team player.


Maija Wolf - Medaffcon RWE
Maija Wolf
Sr. Scientific Advisor
Development Lead
Maija Wolf - Medaffcon RWE

Maija Wolf

Sr. Scientific Advisor
Development Lead
PhD, Dosentti

+358 40 5720615 LinkedIn

Maija joined Medaffcon’s team in January 2017. Maija holds a title of docent in molecular medicine and has vast research experience, especially on cancer genomics and translational research towards individualized treatment possibilities. In addition, Maija has excellent pedagogic skills and comprehensive project leader capabilities obtained from several collaborative efforts with academia and pharmaceutical industry. At Medaffcon, Maija oversees part of the biobank and register-based studies that utilize real-world data to improve patient health care. In addition to her role as a senior scientific advisor, Maija is acting as a development manager.

Maija’s strengths include solid scientific experience and wide connections to the different stakeholders of the research and health care community. She is particularly enthusiastic about the potential of widening RWE data sources and efforts that promote individualized health care.

Maija obtained her PhD in 2000, after which she continued her studies as a postdoctoral researcher at the National Institutes of Health (NIH, Maryland, USA) (2001-2002). Thereafter she has worked as a scientist and senior scientist at the VTT Medical Biotechnology and University of Turku (2002-2010), and as a senior researcher at the Institute for Molecular Medicine Finland, FIMM, University of Helsinki (2008-2017).


Werneri Tuompo
Jr. Scientific Project Manager

Werneri Tuompo

Jr. Scientific Project Manager

+358 44 041 7670 LinkedIn

Werneri Tuompo joined Medaffcon’s Medical team as a Trainee in November 2017. Werneri studies Biomedicine at the University of Eastern Finland in Kuopio. At Medaffcon, Werneri is involved in the project reviewing the individualised treatment of cancer, whereby his work relates to outlining Finnish biobanks. In the field, he is interested in the constantly changing circumstances, multiprofessional working environment and the possibilities brought by digitalisation in improving health.


Iiro Toppila
Biostatistician

Iiro Toppila

Biostatistician
M.Sc. (Tech.)

+358 44 314 1597 LinkedIn

Iiro joined Medaffcon in March 2017 as a Biostatistician. For the past four years he’s worked as a research assistant, analysing clinical and genetic patient data as part of a study on the factors impacting the appearance and progression of complications in type 1 diabetes (in FinnDiane research group). Iiro holds a Master of Science degree in Technology.

In the field, Iiro is particularly interested in the large data amounts revealed with the revolution of technology and in how the information received from the data can potentially be utilised to draw concrete conclusions, both in order to understand the nature of diseases and to advance the goals of the pharmaceutical industry and patient treatment. Iiro’s strengths include his strong statistical expertise and the ability to understand the challenges and possibilities involved in “Big Data”.


Tanja Karvonen
Health Economist

Tanja Karvonen

Health Economist
M.Sc. (Health Economics & Economics)

+358 50 3286 651 LinkedIn

Tanja joined Medaffcon’s team in November 2016. She completed her MSc in Health Economics at the University of York and graduated in 2013. Tanja did her dissertation placement  at the University of Otago (Wellington, New Zealand). Previously, Tanja has also completed a Master’s degree in the field of Economics and Business Administration. Already during her previous degree, she acquainted herself with the methods of health economics, as she was writing her Master’s thesis under the supervision of a health economist at the University of Rennes (Rennes1, France) in 2010.

Tanja has gained her most recent work experience as a researcher at the National Institute for Health and Welfare. In addition, Tanja has experience in working in an international research group, in instructing course exercises in health economics as well as in working in financial administration and customer service.

Tanja would particularly like to utilise her educational and professional knowledge in health economics in her future work projects. Tanja thinks that there is need for health economics and its development in Finland, now in particular, as the social and healthcare system is under reform. It is necessary to be aware of how scarce resources are allocated at the level of both the society and an organisation. Tanja has a special interest in economic evaluation and comparison of processes in healthcare.

Tanja’s strengths include her educational and occupational background as well as her pursuit for constant improvement.  As an employee, Tanja is customer- and goal-oriented as well as reliable.


Tatu Sainio
Health Economist
HE Lead

Tatu Sainio

Health Economist
HE Lead
M.Sc. (Economics)

+358 44 530 5525 LinkedIn

Tatu joined Medaffcon in the fall of 2016. Tatu holds a Master’s Degree in Economics and Business Administration and is currently finalizing his Health Economics studies in the University of Eastern Finland. In his Master’s Thesis Tatu analyzes the costs of outsourcing from University Hospitals perspectives.

Before joining Medaffcon Tatu has worked in the pharmaceutical industry at Boehringer Ingelheim as an Account Manager with diabetes, respiratory and anticoagulation treatment portfolios. Through his work experience Tatu understands the sales and marketing practices and the day-to-day of pharmaceutical industry. Tatu’s strengths in the industry include his experience and knowledge of the sales and marketing functions combined with his understanding of the Market Access processes.

Health Economics interest Tatu because of the possibilities it offers to examine health care both on micro and macro levels. The possibility to rationalize and to make health care and pharmaceutical decisions based on knowledge makes the field especially interesting.


Elisa Tyynysniemi
Scientific Project Manager

Elisa Tyynysniemi

Scientific Project Manager
M.Sc. (Pharmaceutical Science)

+358 40 8394 369 LinkedIn

Elisa started at Medaffcon in January 2015 as a Scientific Project Manager. Previously, Elisa has worked in drug safety unit at Novo Nordisk A/S in Copenhagen as well as sales permit related tasks in the Finnish Medicines Agency Fimea. Working at the Department of Pathology of the University of Turku, Elisa has also gained several years of experience in medical research and in working in a hospital environment.

Elisa has completed a Master’s degree in a programme for international drug development at the University of Copenhagen. She completed her Master’s thesis at Novo Nordisk A/S headquarters in Copenhagen. Elisa also holds a Bachelor of Science degree at the University of Turku in Biomedicine. Therefore, she has completed studies in Medicine, Natural Sciences, Pharmacy and Economics.

Due to her strong theoretical background and work experience, Elisa has wide understanding of the objectives of drug development both from the industrial and authority perspectives. Elisa is particularly interested in developing new medicinal treatment and improving therapeutic value. She is also excited about working with multifunctional teams and constructing seamless cooperation between different interest groups.